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S 1082 RS

Calendar No. 120ESCommentsClose CommentsPermalink

110th CONGRESS 1st Session S. 1082

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To amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisionand the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products, and for other purposes.CommentsClose CommentsPermalink

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, CommentsClose CommentsPermalink

[Struck out->]SECTION 1. SHORT TITLE; REFERENCES IN ACT.[<-Struck out][Struck out->](a) Short Title- This Act may be cited as the `Prescription Drug User Fee Amendments of 2007'.[<-Struck out][Struck out->](b) References in Act- Except as otherwise specified, whenever in this Act an amendment is expressed in terms of an amendment to a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). [<-Struck out][Struck out->]SEC. 2. DRUG FEES.[<-Struck out][Struck out->]Section 735 (21 U.S.C. 379g) is amended-- [<-Struck out][Struck out->](1) by striking the section designation and all that follows through `For purposes of this subchapter:' and inserting the following:[<-Struck out][Struck out->]`SEC. 735. DRUG FEES.[<-Struck out][Struck out->]`(a) Purpose- It is the purpose of this part that the fees authorized under this part be dedicated toward expediting the drug development process, the process for the review of human drug applications, and postmarket drug safety, as set forth in the goals identified for purposes of this subchapter in the letters from the Secretary to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.[<-Struck out][Struck out->]`(b) Reports-[<-Struck out][Struck out->]`(1) PERFORMANCE REPORT- For fiscal years 2008 through 2012, not later than 120 days after the end of each fiscal year during which fees are collected under this part, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in subsection (a) during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals. The report for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all human drug applications and supplements in the cohort.[<-Struck out][Struck out->]`(2) FISCAL REPORT- For fiscal years 2008 through 2012, not later than 120 days after the end of each fiscal year during which fees are collected under this part, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made.[<-Struck out][Struck out->]`(3) PUBLIC AVAILABILITY- The Secretary shall make the reports required under paragraphs (1) and (2) available to the public on the Internet website of the Food and Drug Administration.[<-Struck out][Struck out->]`(c) Reauthorization-[<-Struck out][Struck out->]`(1) CONSULTATION- In developing recommendations to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of human drug applications for the first 5 fiscal years after fiscal year 2012, and for the reauthorization of this part for such fiscal years, the Secretary shall consult with--[<-Struck out][Struck out->]`(A) the Committee on Energy and Commerce of the House of Representatives;[<-Struck out][Struck out->]`(B) the Committee on Health, Education, Labor, and Pensions of the Senate;[<-Struck out][Struck out->]`(C) scientific and academic experts;[<-Struck out][Struck out->]`(D) health care professionals;[<-Struck out][Struck out->]`(E) representatives of patient and consumer advocacy groups; and[<-Struck out][Struck out->]`(F) the regulated industry.[<-Struck out][Struck out->]`(2) PUBLIC REVIEW OF RECOMMENDATIONS- After negotiations with the regulated industry, the Secretary shall--[<-Struck out][Struck out->]`(A) present the recommendations developed under paragraph (1) to the Congressional committees specified in such paragraph;[<-Struck out][Struck out->]`(B) publish such recommendations in the Federal Register;[<-Struck out][Struck out->]`(C) provide for a period of 30 days for the public to provide written comments on such recommendations;[<-Struck out][Struck out->]`(D) hold a meeting at which the public may present its views on such recommendations; and[<-Struck out][Struck out->]`(E) after consideration of such public views and comments, revise such recommendations as necessary.[<-Struck out][Struck out->]`(3) TRANSMITTAL OF RECOMMENDATIONS- Not later than January 15, 2012, the Secretary shall transmit to Congress the revised recommendations under paragraph (2), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.[<-Struck out][Struck out->]`(d) Definitions- For purposes of this part:';[<-Struck out][Struck out->](2) in subsection (d)--[<-Struck out][Struck out->](A) in paragraph (1)--[<-Struck out][Struck out->](i) in subparagraph (A), by striking `505(b)(1),' and inserting `505(b), or';[<-Struck out][Struck out->](ii) by striking subparagraph (B);[<-Struck out][Struck out->](iii) by redesignating subparagraph (C) as subparagraph (B); and[<-Struck out][Struck out->](iv) in the matter following subparagraph (B), as so redesignated, by striking `subparagraph (C)' and inserting `subparagraph (B)';[<-Struck out][Struck out->](B) in paragraph (3)(C), by--[<-Struck out][Struck out->](i) striking `the list' and inserting `the list (not including the discontinued section of such list)'; and[<-Struck out][Struck out->](ii) striking `a list' and inserting `a list (not including the discontinued section of such a list)';[<-Struck out][Struck out->](C) in paragraph (4), by inserting before the period at the end the following: `(such as capsules, tablets, and lyophilized products before reconstitution)';[<-Struck out][Struck out->](D) by amending paragraph (6)(F) to read as follows:[<-Struck out][Struck out->]`(F) In the case of drugs approved under human drug applications or supplements, postmarket safety activities, including--[<-Struck out][Struck out->]`(i) collecting, developing, and reviewing safety information on approved drugs (including adverse event reports);[<-Struck out][Struck out->]`(ii) developing and using improved adverse event data collection systems (including information technology systems); and[<-Struck out][Struck out->]`(iii) developing and using improved analytical tools to assess potential safety problems (including by accessing external data bases).';[<-Struck out][Struck out->](E) in paragraph (8)--[<-Struck out][Struck out->](i) by striking `April of the preceding fiscal year' and inserting `October of the preceding fiscal year'; and[<-Struck out][Struck out->](ii) by striking `April 1997' and inserting `October 1996';[<-Struck out][Struck out->](F) by redesignating paragraph (9) as paragraph (10); and[<-Struck out][Struck out->](G) by inserting after paragraph (8) the following:[<-Struck out][Struck out->]`(9) The term `person' includes an affiliate thereof.'.[<-Struck out][Struck out->]SEC. 3. AUTHORITY TO ASSESS AND USE DRUG FEES.[<-Struck out][Struck out->](a) Types of Fees- Section 736(a) (21 U.S.C. 379h(a)) is amended-- [<-Struck out][Struck out->](1) in the matter preceding paragraph (1), by striking `2003' and inserting `2008';[<-Struck out][Struck out->](2) in paragraph (1)--[<-Struck out][Struck out->](A) in subparagraph (D)--[<-Struck out][Struck out->](i) in the heading, by inserting `OR WITHDRAWN BEFORE FILING' after `REFUND OF FEE IF APPLICATION REFUSED FOR FILING'; and[<-Struck out][Struck out->](ii) by inserting before the period at the end the following: `or withdrawn without a waiver before filing';[<-Struck out][Struck out->](B) by redesignating subparagraphs (E) and (F) as subparagraphs (F) and (G), respectively; and[<-Struck out][Struck out->](C) by inserting after subparagraph (D) the following:[<-Struck out][Struck out->]`(E) FEE FOR APPLICATION PREVIOUSLY REFUSED FOR FILING OR WITHDRAWN BEFORE FILING- An application or supplement that has been refused for filing or that was withdrawn before filing, if filed under protest or resubmitted, shall be subject to the fee under subparagraph (A) (unless an exception under subparagraph (C) or (F) applies or the fee is waived or reduced under subsection (d)), without regard to previous payment of such a fee and the refund of 75 percent of that fee under subparagraph (D).'; and[<-Struck out][Struck out->](3) in paragraph (2)--[<-Struck out][Struck out->](A) in subparagraph (A), by striking `subparagraph (B)' and inserting `subparagraphs (B) and (C)'; and[<-Struck out][Struck out->](B) by adding at the end the following:[<-Struck out][Struck out->]`(C) SPECIAL RULES FOR COMPOUNDED POSITRON EMISSION TOMOGRAPHY DRUGS-[<-Struck out][Struck out->]`(i) IN GENERAL- Except as provided in clause (ii), each person who is named as the applicant in an approved human drug application for a compounded positron emission tomography drug shall be subject under subparagraph (A) to one-quarter of an annual establishment fee with respect to each such establishment identified in the application as producing compounded positron emission tomography drugs under the approved application.[<-Struck out][Struck out->]`(ii) EXCEPTION FROM ANNUAL ESTABLISHMENT FEE- Each person who is named as the applicant in an application described in clause (i) shall not be assessed an annual establishment fee for a fiscal year if the person certifies to the Secretary, at a time specified by the Secretary and using procedures specified by the Secretary, that--[<-Struck out][Struck out->]`(I) the person is a not-for-profit medical center that has only 1 establishment for the production of compounded positron emission tomography drugs; and[<-Struck out][Struck out->]`(II) at least 95 percent of the total number of doses of each compounded positron emission tomography drug produced by such establishment during such fiscal year will be used within the medical center.'.[<-Struck out][Struck out->](b) Fee Revenue Amounts- Section 736(b) (21 U.S.C. 379h(b)) is amended to read as follows: [<-Struck out][Struck out->]`(b) Fee Revenue Amounts- Except as provided in subsections (c), (d), (f), and (g), fees under subsection (a) shall be established to generate the following revenue amounts, in each fiscal year beginning with fiscal year 2008 and continuing through fiscal year 2012: $392,783,000, plus an adjustment for workload on $354,893,000 of this amount. Such adjustment shall be made in accordance with the workload adjustment provisions in effect for fiscal year 2007, except that instead of commercial investigational new drug applications submitted to the Secretary, all commercial investigational new drug applications with a submission during the previous 12-month period shall be used in the determination. One-third of the revenue amount shall be derived from application fees, one-third from establishment fees, and one-third from product fees.'.[<-Struck out][Struck out->](c) Adjustments to Fees-[<-Struck out][Struck out->](1) INFLATION ADJUSTMENT- Section 736(c)(1) (21 U.S.C. 379h(c)(1)) is amended-- [<-Struck out][Struck out->](A) in the matter preceding subparagraph (A) by striking `The revenues established in subsection (b)' and inserting `Beginning with fiscal year 2009, the revenues established in subsection (b)';[<-Struck out][Struck out->](B) in subparagraph (A) by striking `or' at the end;[<-Struck out][Struck out->](C) in subparagraph (B) by striking the period at the end and inserting `, or,';[<-Struck out][Struck out->](D) by inserting after subparagraph (B) the following:[<-Struck out][Struck out->]`(C) the average annual change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions, for the first 5 fiscal years of the previous 6 fiscal years.'; and[<-Struck out][Struck out->](E) in the matter following subparagraph (C) (as added by this paragraph), by striking `fiscal year 2003' and inserting `fiscal year 2008'.[<-Struck out][Struck out->](2) WORKLOAD ADJUSTMENT- Section 736(c)(2) (21 U.S.C. 379h(c)(2)) is amended-- [<-Struck out][Struck out->](A) in the matter preceding subparagraph (A,) by striking `2004' and inserting `2009';[<-Struck out][Struck out->](B) in the first sentence of subparagraph (A)--[<-Struck out][Struck out->](i) by striking `, commercial investigational new drug applications' and inserting `(adjusted for changes in review activities)'; and[<-Struck out][Struck out->](ii) by inserting before the period at the end `, and the change in the number of commercial investigational new drug applications with a submission during the previous 12-month period (adjusted for changes in review activities)';[<-Struck out][Struck out->](C) in subparagraph (B), by adding at the end the following new sentence: `Further, any adjustment for changes in review activities made in setting fees and fee revenue amounts for fiscal year 2009 may not result in the total workload adjustment being more than 2 percentage points higher than it would be absent the adjustment for changes in review activities.'; and[<-Struck out][Struck out->](D) by adding at the end the following:[<-Struck out][Struck out->]`(C) The Secretary shall contract with an independent accounting firm to study the adjustment for changes in review activities applied in setting fees for fiscal year 2009 and to make recommendations, if warranted, on future changes in the methodology for calculating the adjustment for changes in review activity. After review of the recommendations by the independent accounting firm, the Secretary shall make appropriate changes to the workload adjustment methodology in setting fees for fiscal years 2010 through 2012. If the study is not conducted, no adjustment for changes in review activities shall be made after fiscal year 2009.'.[<-Struck out][Struck out->](3) RENT AND RENT-RELATED COST ADJUSTMENT- Section 736(c) (21 U.S.C. 379h(c)) is amended-- [<-Struck out][Struck out->](A) by redesignating paragraphs (3), (4), and (5) as paragraphs (4), (5), and (6), respectively; and[<-Struck out][Struck out->](B) by inserting after paragraph (2) the following:[<-Struck out][Struck out->]`(3) RENT AND RENT-RELATED COST ADJUSTMENT- Beginning in fiscal year 2010, the Secretary shall, before making the adjustments under paragraphs (1) and (2), reduce the fee amounts established in subsection (b), if actual costs paid for rent and rent-related expenses are less than $11,721,000. The reductions made under this paragraph, if any, shall not exceed the amounts by which costs fell below $11,721,000, and shall not exceed $11,721,000 in any fiscal year.'.[<-Struck out][Struck out->](4) FINAL YEAR ADJUSTMENT- Section 736(c) (21 U.S.C. 379h(c)) is amended-- [<-Struck out][Struck out->](A) in paragraph (4), as redesignated by this subsection--[<-Struck out][Struck out->](i) by striking `2007' each place it appears and inserting `2012'; and[<-Struck out][Struck out->](ii) by striking `2008' and inserting `2013'; and[<-Struck out][Struck out->](B) in paragraph (5), as redesignated by this subsection, by striking `2002' and inserting `2007'.[<-Struck out][Struck out->](d) Fee Waiver or Reduction- Section 736(d) (21 U.S.C. 379h(d)) is amended-- [<-Struck out][Struck out->](1) in paragraph (1), in the matter preceding subparagraph (A), by--[<-Struck out][Struck out->](A) inserting `to a person who is named as the applicant' after `The Secretary shall grant';[<-Struck out][Struck out->](B) inserting `to that person' after `a waiver from or a reduction of one or more fees assessed'; and[<-Struck out][Struck out->](C) striking `finds' and inserting `determines';[<-Struck out][Struck out->](2) by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively;[<-Struck out][Struck out->](3) by inserting after paragraph (1) the following:[<-Struck out][Struck out->]`(2) EVALUATION- For the purpose of determining whether to grant a waiver or reduction of a fee under paragraph (1), the Secretary shall consider only the circumstances and assets of the applicant and any affiliate of the applicant.'; and[<-Struck out][Struck out->](4) in paragraph (4), as redesignated by this subsection, in subparagraph (A), by inserting before the period at the end `, and that does not have a drug product that has been approved under a human drug application and introduced or delivered for introduction into interstate commerce'.[<-Struck out][Struck out->](e) Crediting and Availability of Fees-[<-Struck out][Struck out->](1) AUTHORIZATION OF APPROPRIATIONS- Section 736(g)(3) (21 U.S.C. 379h(g)(3)) is amended to read as follows: [<-Struck out][Struck out->]`(3) AUTHORIZATION OF APPROPRIATIONS- There are authorized to be appropriated for fees under this section such sums as are authorized to be assessed and collected under this section in each of fiscal years 2008 through 2012.'.[<-Struck out][Struck out->](2) OFFSET- Section 736(g)(4) (21 U.S.C. 379h(g)(4)) is amended to read as follows: [<-Struck out][Struck out->]`(4) OFFSET- If the cumulative amount of fees collected during fiscal years 2008, 2009, and 2010, plus the amount estimated to be collected for fiscal year 2011, exceeds the amount of fees specified in aggregate in appropriation Acts for such fiscal years, the aggregate amount in excess shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for fiscal year 2012.'.[<-Struck out][Struck out->](f) Conforming Amendments-[<-Struck out][Struck out->](1) Section 736(a) (21 U.S.C. 379h(a)), as amended by this section, is amended-- [<-Struck out][Struck out->](A) in paragraph (1)(A), by striking `subsection (c)(4)' each place it appears and inserting `subsection (c)(5)';[<-Struck out][Struck out->](B) in paragraph (2), by striking `subsection (c)(4)' and inserting `subsection (c)(5)'; and[<-Struck out][Struck out->](C) in paragraph (3), by striking `subsection (c)(4)' and inserting `subsection (c)(5)'.[<-Struck out][Struck out->](2) Section 736A(h)(3), as added by section 4 of this Act, is amended by striking `735(3)' and inserting `735(d)(3)'.[<-Struck out][Struck out->]SEC. 4. AUTHORITY TO ASSESS AND USE PRESCRIPTION DRUG ADVERTISING FEES.[<-Struck out][Struck out->]Chapter VII, subchapter C, part 2 (21 U.S.C. 379g et seq.) is amended by adding after section 736 the following new section: [<-Struck out][Struck out->]`SEC. 736A. PROGRAM TO ASSESS AND USE FEES FOR THE ADVISORY REVIEW OF PRESCRIPTION DRUG ADVERTISING.[<-Struck out][Struck out->]`(a) Types of Direct-to-Consumer Television Advertisement Review Fees- Beginning in fiscal year 2008, the Secretary shall assess and collect fees in accordance with this section as follows:[<-Struck out][Struck out->]`(1) ADVISORY REVIEW FEE-[<-Struck out][Struck out->]`(A) IN GENERAL- Except as provided in subparagraph (B), each person that on or after October 1, 2007, submits a proposed direct-to-consumer television advertisement for advisory review by the Secretary prior to its initial public dissemination shall be subject to a fee established under subsection (c)(3).[<-Struck out][Struck out->]`(B) EXCEPTION FOR REQUIRED SUBMISSIONS- A direct-to-consumer television advertisement that is required to be submitted to the Secretary prior to initial public dissemination shall not be assessed a fee unless the sponsor designates it as a submission for advisory review.[<-Struck out][Struck out->]`(C) PAYMENT- The fee required by subparagraph (A) shall be due no later than October 1 of the fiscal year in which the direct-to-consumer television advertisement shall be submitted to the Secretary for advisory review.[<-Struck out][Struck out->]`(D) MODIFICATION OF ADVISORY REVIEW FEE-[<-Struck out][Struck out->]`(i) LATE PAYMENT- If, on or before November 1 of the fiscal year in which the fees are due, a person has not paid all fees that were due and payable for advisory reviews identified in response to the Federal Register notice described in subsection (c)(3)(A), the fees shall be regarded as late. Such fees shall be due and payable 20 days before any direct-to-consumer television advertisement is submitted by such person to the Secretary for advisory review. Notwithstanding any other provision of this section, such fees shall be due and payable for each of those advisory reviews in the amount of 150 percent of the advisory review fee established for that fiscal year pursuant to subsection (c)(3).[<-Struck out][Struck out->]`(ii) LATE NOTICE OF SUBMISSION- If any person submits any direct-to-consumer television advertisements for advisory review that are in excess of the number identified by that person in response to the Federal Register notice described in subsection (c)(3)(A), that person must pay a fee for each of those advisory reviews in the amount of 150 percent of the advisory review fee established for that fiscal year pursuant to subsection (c)(3). Fees under this subparagraph shall be due 20 days before the direct-to-consumer television advertisement is submitted by such person to the Secretary for advisory review.[<-Struck out][Struck out->]`(E) LIMITS-[<-Struck out][Struck out->]`(i) IN GENERAL- The payment of a fee under this paragraph for a fiscal year entitles the person that pays the fee to acceptance for advisory review by the Secretary of 1 direct-to-consumer television advertisement and acceptance of 1 resubmission for advisory review of the same advertisement. The advertisement shall be submitted for review in the fiscal year for which the fee was assessed, except that a person may carry over no more than 1 paid advisory review submission to the next fiscal year. Resubmissions may be submitted without regard to the fiscal year of the initial advisory review submission.[<-Struck out][Struck out->]`(ii) NO REFUND- Except as provided by subsection (f), fees paid under this paragraph shall not be refunded.[<-Struck out][Struck out->]`(iii) NO WAIVER, EXEMPTION, OR REDUCTION- The Secretary shall not grant a waiver, exemption, or reduction of any fees due or payable under this section.[<-Struck out][Struck out->]`(iv) NON-TRANSFERABILITY- The right to an advisory review is not transferable, except to a successor in interest.[<-Struck out][Struck out->]`(2) OPERATING RESERVE FEE-[<-Struck out][Struck out->]`(A) IN GENERAL- Each person that, on or after October 1, 2007, is assessed an advisory review fee under paragraph (1) shall be subject to an operating reserve fee established under subsection (d)(2) only in the first fiscal year in which an advisory review fee is assessed.[<-Struck out][Struck out->]`(B) PAYMENT- Except as provided in subparagraph (C), the fee required by subparagraph (A) shall be due no later than October 1 of the first fiscal year in which the person is required to pay an advisory review fee under paragraph (1).[<-Struck out][Struck out->]`(C) LATE NOTICE OF SUBMISSION- If, in the first fiscal year of a person's participation in the Program, that person submits any direct-to-consumer television advertisements for advisory review that are in excess of the number identified by that person in response to the Federal Register notice described in subsection (c)(3)(A), that person must pay an operating reserve fee for each of those advisory reviews equal to the advisory review fee for each submission established under paragraph (1)(D)(ii). Fees required by this subparagraph shall be in addition to the fees required under subparagraph (B), if any. Fees under this subparagraph shall be due 20 days before any direct-to-consumer television advertisement is submitted by such person to the Secretary for advisory review.[<-Struck out][Struck out->]`(b) Advisory Review Fee Revenue Amounts- Fees under subsection (a)(1) shall be established to generate revenue amounts of $6,250,000 for each of fiscal years 2008 through 2012, as adjusted pursuant to subsection (c).[<-Struck out][Struck out->]`(c) Adjustments-[<-Struck out][Struck out->]`(1) INFLATION ADJUSTMENT- Beginning with fiscal year 2009, the revenues established in subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year to reflect the greater of--[<-Struck out][Struck out->]`(A) the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; United States city average), for the 12-month period ending June 30 preceding the fiscal year for which fees are being established;[<-Struck out][Struck out->]`(B) the total percentage change for the previous fiscal year in basic pay under the General Schedule in accordance with section 5332 of title 5, as adjusted by any locality-based comparability payment pursuant to section 5304 of such title for Federal employees stationed in the District of Columbia; or[<-Struck out][Struck out->]`(C) the average annual change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions, for the first 5 fiscal years of the previous 6 fiscal years.[<-Struck out][Struck out->]The adjustment made each fiscal year by this subsection shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2008 under this subsection.[<-Struck out][Struck out->]`(2) WORKLOAD ADJUSTMENT-[<-Struck out][Struck out->]`(A) IN GENERAL- Beginning with fiscal year 2009, after the fee revenues established in subsection (b) of this section are adjusted for a fiscal year for inflation in accordance with paragraph (1), the fee revenues shall be adjusted further for such fiscal year to reflect changes in the workload of the Secretary with respect to the submission of proposed direct-to-consumer television advertisements for advisory review prior to initial broadcast.[<-Struck out][Struck out->]`(B) DETERMINATION OF WORKLOAD ADJUSTMENT-[<-Struck out][Struck out->]`(i) IN GENERAL- The workload adjustment under this paragraph for a fiscal year shall be determined by the Secretary--[<-Struck out][Struck out->]`(I) based upon the number of direct-to-consumer television advertisements identified pursuant to paragraph (3)(A) for that fiscal year, excluding allowable previously paid carry over submissions; and[<-Struck out][Struck out->]`(II) by multiplying the number of such advertisements projected for that fiscal year that exceeds 150 by $27,600 (adjusted each year beginning with fiscal year 2009 for inflation in accordance with paragraph (1)).[<-Struck out][Struck out->]`(ii) PUBLICATION IN FEDERAL REGISTER- The Secretary shall publish in the Federal Register the fee revenues and fees resulting from the adjustment and the supporting methodologies.[<-Struck out][Struck out->]`(C) LIMITATION- Under no circumstances shall the adjustment result in fee revenues for a fiscal year that are less than the fee revenues established for the prior fiscal year.[<-Struck out][Struck out->]`(3) ANNUAL FEE SETTING-[<-Struck out][Struck out->]`(A) NUMBER OF ADVERTISEMENTS- The Secretary shall, 120 days before the start of each fiscal year, publish a notice in the Federal Register requesting any person to notify the Secretary within 30 days of the number of direct-to-consumer television advertisements the person intends to submit for advisory review by the Secretary in the next fiscal year. Notification to the Secretary of the number of advertisements a person intends to submit for advisory review prior to initial broadcast shall be a legally binding commitment by that person to pay the annual advisory review fee for that number of submissions on or before October 1 of the fiscal year in which the advertisement is intended to be submitted. A person shall at the same time also notify the Secretary if such person intends to use a paid submission from the previous fiscal year under subsection (a)(1)(E)(i). If such person does not so notify the Secretary, all submissions for advisory review shall be subject to advisory review fees.[<-Struck out][Struck out->]`(B) ANNUAL FEE- The Secretary shall, 60 days before the start of each fiscal year, establish, for the next fiscal year, the direct-to-consumer television advertisement advisory review fee under subsection (a)(1), based on the revenue amounts established under subsection (b), the adjustments provided under this subsection and the number of direct-to-consumer television advertisements identified pursuant to subparagraph (A), excluding allowable previously paid carry over submissions. The annual advisory review fee shall be established by dividing the fee revenue for a fiscal year (as adjusted pursuant to this subsection) by the number of direct-to-consumer television advertisements identified pursuant to subparagraph (A), excluding allowable previously paid carry over submissions.[<-Struck out][Struck out->]`(C) FISCAL YEAR 2008 FEE LIMIT- Notwithstanding subsection (b), the fee established under subparagraph (B) for fiscal year 2008 may not be more than $83,000 per submission for advisory review.[<-Struck out][Struck out->]`(D) ANNUAL FEE LIMIT- Notwithstanding subsection (b), the fee established under subparagraph (B) for a fiscal year after fiscal year 2008 may not be more than 50 percent more than the fee established for the prior fiscal year.[<-Struck out][Struck out->]`(E) LIMIT- The total amount of fees obligated for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the advisory review of prescription drug advertising.[<-Struck out][Struck out->]`(d) Operating Reserves-[<-Struck out][Struck out->]`(1) IN GENERAL- The Secretary shall establish in the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation a Direct-to-Consumer Advisory Review Operating Reserve, of at least $6,250,000 in fiscal year 2008, to continue the Program in the event the fees collected in any subsequent fiscal year pursuant to subsection (c)(3) do not generate the fee revenue amount established for that fiscal year.[<-Struck out][Struck out->]`(2) FEE SETTING- The Secretary shall establish the operating reserve fee under subsection (a)(2)(A) for each person required to pay the fee by multiplying the number of direct-to-consumer television advertisements identified by that person pursuant to subsection (c)(3)(A) by the advisory review fee established pursuant to subsection (c)(3) for that fiscal year. In no case shall the operating reserve fee assessed be less than the operating reserve fee assessed if the person had first participated in the Program in fiscal year 2008.[<-Struck out][Struck out->]`(3) USE OF OPERATING RESERVE- The Secretary may use funds from the reserves under this subsection only to the extent necessary in any fiscal year to make up the difference between the fee revenue amount established for that fiscal year under subsection (b) and the amount of fees collected for that fiscal year pursuant to subsection (a), or to pay costs of ending the Program if it is terminated pursuant to subsection (f) or if it is not reauthorized after fiscal year 2012.[<-Struck out][Struck out->]`(4) REFUND OF OPERATING RESERVES- Within 120 days of the end of fiscal year 2012, or if the Program is terminated pursuant to subsection (f), the Secretary, after setting aside sufficient operating reserve amounts to terminate the Program, shall refund all amounts remaining in the operating reserve on a pro rata basis to each person that paid an operating reserve fee assessment. In no event shall the refund to any person exceed the total amount of operating reserve fees paid by such person pursuant to subsection (a)(2).[<-Struck out][Struck out->]`(e) Effect of Failure To Pay Fees- Notwithstanding any other law or regulation of the Secretary, a submission for advisory review of a direct-to-consumer television advertisement submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for review by the Secretary until all fees owed by such person under this section have been paid.[<-Struck out][Struck out->]`(f) Effect of Inadequate Funding of Program-[<-Struck out][Struck out->]`(1) FIRST FISCAL YEAR- If on November 1, 2007, or 120 days after enactment of the Prescription Drug User Fee Amendments of 2007, whichever is later, the Secretary has received less than $11,250,000 in advisory review fees and operating reserve fees combined, the Program shall be terminated and all collected fees shall be refunded.[<-Struck out][Struck out->]`(2) SUBSEQUENT FISCAL YEARS- Beginning in fiscal year 2009, if, on November 1 of a fiscal year, the combination of the operating reserves, annual fee revenues from that fiscal year, and unobligated fee revenues from prior fiscal years is less than $9,000,000, adjusted for inflation (in accordance with subsection (c)(1)), the Program shall be terminated, and the Secretary shall notify all participants, retain any money from the unused advisory review fees and the operating reserves needed to terminate the Program, and refund the remainder of the unused fees and operating reserves. To the extent required to terminate the Program, the Secretary shall first use unobligated advisory review fee revenues from prior fiscal years, then the operating reserves, and then unused advisory review fees from the relevant fiscal year.[<-Struck out][Struck out->]`(g) Crediting and Availability of Fees-[<-Struck out][Struck out->]`(1) IN GENERAL- Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the advisory review of prescription drug advertising.[<-Struck out][Struck out->]`(2) COLLECTIONS AND APPROPRIATION ACTS- The fees authorized by this section--[<-Struck out][Struck out->]`(A) shall be retained in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year; and[<-Struck out][Struck out->]`(B) shall be available for obligation only if appropriated budget authority continues to support at least the total combined number of full-time equivalent employees in the Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, and the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch supported in fiscal year 2007.[<-Struck out][Struck out->]`(3) AUTHORIZATION OF APPROPRIATIONS- There are authorized to be appropriated for fees under this section not less than $6,250,000 for each of fiscal years 2008, 2009, 2010, 2011, and 2012, as adjusted to reflect adjustments in the total fee revenues made under this section, plus amounts collected for the reserve fund under subsection (d).[<-Struck out][Struck out->]`(4) OFFSET- Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be collected under this section pursuant to appropriation Acts for a subsequent fiscal year.[<-Struck out][Struck out->]`(h) Definitions- For purposes of this section:[<-Struck out][Struck out->]`(1) The term `advisory review' means reviewing and providing advisory comments regarding compliance of a proposed advertisement with the requirements of this Act prior to its initial public dissemination.[<-Struck out][Struck out->]`(2) The term `carry over submission' means a submission for an advisory review for which a fee was paid in a fiscal year that is submitted for review in the following fiscal year.[<-Struck out][Struck out->]`(3) The term `direct-to-consumer television advertisement' means an advertisement for a prescription drug product as defined in section 735(3) intended to be displayed on any television channel for less than 2 minutes.[<-Struck out][Struck out->]`(4) The term `person' includes an individual, a partnership, a corporation, and an association, and any affiliate thereof or successor in interest.[<-Struck out][Struck out->]`(5) The term `Program' means the Program to assess, collect, and use fees for the advisory review of prescription drug advertising established by this section.[<-Struck out][Struck out->]`(6) The term `process for the advisory review of prescription drug advertising' means the activities necessary to review and provide advisory comments on proposed direct-to-consumer television advertisements prior to public dissemination and, to the extent the Secretary has additional staff resources available under the Program that are not necessary for the advisory review of direct-to-consumer television advertisements, the activities necessary to review and provide advisory comments on other proposed advertisements and promotional material prior to public dissemination.[<-Struck out][Struck out->]`(7) The term `resources allocated for the process for the advisory review of prescription drug advertising' means the expenses incurred in connection with the process for the advisory review of prescription drug advertising for--[<-Struck out][Struck out->]`(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees, and to contracts with such contractors;[<-Struck out][Struck out->]`(B) management of information, and the acquisition, maintenance, and repair of computer resources;[<-Struck out][Struck out->]`(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies;[<-Struck out][Struck out->]`(D) collection of fees under this section and accounting for resources allocated for the advisory review of prescription drug advertising; and[<-Struck out][Struck out->]`(E) terminating the Program under subsection (f)(2), if necessary.[<-Struck out][Struck out->]`(8) The term `resubmission' means a subsequent submission for advisory review of a direct-to-consumer television advertisement that has been revised in response to the Secretary's comments on an original submission. A resubmission may not introduce significant new concepts or creative themes into the television advertisement.[<-Struck out][Struck out->]`(9) The term `submission for advisory review' means an original submission of a direct-to-consumer television advertisement for which the sponsor voluntarily requests advisory comments before the advertisement is publicly disseminated.'.[<-Struck out][Struck out->]SEC. 5. SAVINGS CLAUSE.[<-Struck out][Struck out->]Notwithstanding section 509 of the Prescription Drug User Fee Amendments of 2002 (21 U.S.C. 379g note), and notwithstanding the amendments made by this Act, part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date of enactment of this Act, shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that on or after October 1, 2002, but before October 1, 2007, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2008. [<-Struck out][Struck out->]SEC. 6. TECHNICAL AMENDMENTS.[<-Struck out][Struck out->](a) Section 737 (21 U.S.C. 379i) is amended in the matter preceding paragraph (1), by striking `subchapter' and inserting `part'. [<-Struck out][Struck out->](b) Section 739 (21 U.S.C. 379j-11) is amended in the matter preceding paragraph (1), by striking `subchapter' and inserting `part'. [<-Struck out][Struck out->]SEC. 7. EFFECTIVE DATES.[<-Struck out][Struck out->](a) In General- Except as provided in subsection (b), the amendments made by this Act shall take effect October 1, 2007.[<-Struck out][Struck out->](b) Exception- The amendment made by section 4 of this Act shall take effect on the date of enactment of this Act.[<-Struck out][Struck out->]SEC. 8. SUNSET DATE.[<-Struck out][Struck out->]Sections 735, 736, and 736A of the Federal Food, Drug, and Cosmetic Act shall cease to be effective on October 1, 2012.[<-Struck out]SECTION 1. SHORT TITLE.

This Act may be cited as the `Food and Drug Administration Revitalization Act'.CommentsClose CommentsPermalink

TITLE I--PRESCRIPTION DRUG USER FEES

SEC. 101. SHORT TITLE; REFERENCES IN TITLE.

(a) Short Title- This title may be cited as the `Prescription Drug User Fee Amendments of 2007'.CommentsClose CommentsPermalink





(b) References in Title- Except as otherwise specified, whenever in this title an amendment is expressed in terms of an amendment to a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).CommentsClose CommentsPermalink

SEC. 102. DRUG FEES.

Section 735 (21 U.S.C. 379g) is amended--CommentsClose CommentsPermalink





(1) by striking the section designation and all that follows through `For purposes of this subchapter:' and inserting the following:CommentsClose CommentsPermalink

`SEC. 735. DRUG FEES.

`(a) Purpose- It is the purpose of this part that the fees authorized under this part be dedicated toward expediting the drug development process, the process for the review of human drug applications, and postmarket drug safety, as set forth in the goals identified for purposes of this part in the letters from the Secretary to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.CommentsClose CommentsPermalink





`(b) Reports-CommentsClose CommentsPermalink





`(1) PERFORMANCE REPORT- For fiscal years 2008 through 2012, not later than 120 days after the end of each fiscal year during which fees are collected under this part, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in subsection (a) during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals. The report for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all human drug applications and supplements in the cohort.CommentsClose CommentsPermalink





`(2) FISCAL REPORT- For fiscal years 2008 through 2012, not later than 120 days after the end of each fiscal year during which fees are collected under this part, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made.CommentsClose CommentsPermalink





`(3) PUBLIC AVAILABILITY- The Secretary shall make the reports required under paragraphs (1) and (2) available to the public on the Internet website of the Food and Drug Administration.CommentsClose CommentsPermalink





`(c) Reauthorization-CommentsClose CommentsPermalink





`(1) CONSULTATION- In developing recommendations to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of human drug applications for the first 5 fiscal years after fiscal year 2012, and for the reauthorization of this part for such fiscal years, the Secretary shall consult with--CommentsClose CommentsPermalink





`(A) the Committee on Energy and Commerce of the House of Representatives;CommentsClose CommentsPermalink





`(B) the Committee on Health, Education, Labor, and Pensions of the Senate;CommentsClose CommentsPermalink





`(C) scientific and academic experts;CommentsClose CommentsPermalink





`(D) health care professionals;CommentsClose CommentsPermalink





`(E) representatives of patient and consumer advocacy groups; andCommentsClose CommentsPermalink





`(F) the regulated industry.CommentsClose CommentsPermalink





`(2) PUBLIC REVIEW OF RECOMMENDATIONS- After negotiations with the regulated industry, the Secretary shall--CommentsClose CommentsPermalink





`(A) present the recommendations developed under paragraph (1) to the Congressional committees specified in such paragraph;CommentsClose CommentsPermalink





`(B) publish such recommendations in the Federal Register;CommentsClose CommentsPermalink





`(C) provide for a period of 30 days for the public to provide written comments on such recommendations;CommentsClose CommentsPermalink





`(D) hold a meeting at which the public may present its views on such recommendations; andCommentsClose CommentsPermalink





`(E) after consideration of such public views and comments, revise such recommendations as necessary.CommentsClose CommentsPermalink





`(3) TRANSMITTAL OF RECOMMENDATIONS- Not later than January 15, 2012, the Secretary shall transmit to Congress the revised recommendations under paragraph (2), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.CommentsClose CommentsPermalink





`(d) Definitions- For purposes of this part:';CommentsClose CommentsPermalink





(2) in subsection (d)--CommentsClose CommentsPermalink





(A) in paragraph (1)--CommentsClose CommentsPermalink





(i) in subparagraph (A), by striking `505(b)(1),' and inserting `505(b), or';CommentsClose CommentsPermalink





(ii) by striking subparagraph (B);CommentsClose CommentsPermalink





(iii) by redesignating subparagraph (C) as subparagraph (B); andCommentsClose CommentsPermalink





(iv) in the matter following subparagraph (B), as so redesignated, by striking `subparagraph (C)' and inserting `subparagraph (B)';CommentsClose CommentsPermalink





(B) in paragraph (3)(C), by--CommentsClose CommentsPermalink





(i) striking `the list' and inserting `the list (not including the discontinued section of such list)'; andCommentsClose CommentsPermalink





(ii) striking `a list' and inserting `a list (not including the discontinued section of such a list)';CommentsClose CommentsPermalink





(C) in paragraph (4), by inserting before the period at the end the following: `(such as capsules, tablets, and lyophilized products before reconstitution)';CommentsClose CommentsPermalink





(D) by amending paragraph (6)(F) to read as follows:CommentsClose CommentsPermalink





`(F) In the case of drugs approved under human drug applications or supplements, postmarket safety activities, including--CommentsClose CommentsPermalink





`(i) collecting, developing, and reviewing safety information on approved drugs (including adverse event reports);CommentsClose CommentsPermalink





`(ii) developing and using improved adverse event data collection systems (including information technology systems); andCommentsClose CommentsPermalink





`(iii) developing and using improved analytical tools to assess potential safety problems (including by accessing external data bases).';CommentsClose CommentsPermalink





(E) in paragraph (8)--CommentsClose CommentsPermalink





(i) by striking `April of the preceding fiscal year' and inserting `October of the preceding fiscal year'; andCommentsClose CommentsPermalink





(ii) by striking `April 1997' and inserting `October 1996';CommentsClose CommentsPermalink





(F) by redesignating paragraph (9) as paragraph (10); andCommentsClose CommentsPermalink





(G) by inserting after paragraph (8) the following:CommentsClose CommentsPermalink





`(9) The term `person' includes an affiliate of such person.'.CommentsClose CommentsPermalink

SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.

(a) Types of Fees- Section 736(a) (21 U.S.C. 379h(a)) is amended--CommentsClose CommentsPermalink





(1) in the matter preceding paragraph (1), by striking `2003' and inserting `2008';CommentsClose CommentsPermalink





(2) in paragraph (1)--CommentsClose CommentsPermalink





(A) in subparagraph (D)--CommentsClose CommentsPermalink





(i) in the heading, by inserting `OR WITHDRAWN BEFORE FILING' after `REFUND OF FEE IF APPLICATION REFUSED FOR FILING'; andCommentsClose CommentsPermalink





(ii) by inserting before the period at the end the following: `or withdrawn without a waiver before filing';CommentsClose CommentsPermalink





(B) by redesignating subparagraphs (E) and (F) as subparagraphs (F) and (F) as subparagraphs (F) and (G), respectively; andCommentsClose CommentsPermalink





(C) by inserting after subparagraph (D) the following:CommentsClose CommentsPermalink





`(E) FEE FOR APPLICATION PREVIOUSLY REFUSED FOR FILING OR WITHDRAWN BEFORE FILING- An application or supplement that has been refused for filing or that was withdrawn before filing, if filed under protest or resubmitted, shall be subject to the fee under subparagraph (A) (unless an exception under subparagraph (C) or (F) applies or the fee is waived or reduced under subsection (d)), without regard to previous payment of such a fee and the refund of 75 percent of that fee under subparagraph (D).'; andCommentsClose CommentsPermalink





(3) in paragraph (2)--CommentsClose CommentsPermalink





(A) in subparagraph (A), by striking `subparagraph (B)' and inserting `subparagraphs (B) and (C)'; andCommentsClose CommentsPermalink





(B) by adding at the end the following:CommentsClose CommentsPermalink





`(C) SPECIAL RULES FOR COMPOUNDED POSITRON EMISSION TOMOGRAPHY DRUGS-CommentsClose CommentsPermalink





`(i) IN GENERAL- Except as provided in clause (ii), each person who is named as the applicant in an approved human drug application for a compounded positron emission tomography drug shall be subject under subparagraph (A) to one-quarterfifth of an annual establishment fee with respect to each such establishment identified in the application as producing compounded positron emission tomography drugs under the approved application.CommentsClose CommentsPermalink





`(ii) EXCEPTION FROM ANNUAL ESTABLISHMENT FEE- Each person who is named as the applicant in an application described in clause (i) shall not be assessed an annual establishment fee for a fiscal year if the person certifies to the Secretary, at a time specified by the Secretary and using procedures specified by the Secretary, that--CommentsClose CommentsPermalink





`(I) the person is a not-for-profit medical center that has only 1 establishment for the production of compounded positron emission tomography drugs; andCommentsClose CommentsPermalink





`(II) at least 95 percent of the total number of doses of each compounded positron emission tomography drug produced by such establishment during such fiscal year will be used within the medical center.'.CommentsClose CommentsPermalink





(b) Fee Revenue Amounts- Section 736(b) (21 U.S.C. 379h(b)) is amended to read as follows:CommentsClose CommentsPermalink





`(b) Fee Revenue Amounts- Except as provided in subsections (c), (d), (f), and (g), fees under subsection (a) shall be established to generate the following revenue amounts, in each fiscal year beginning with fiscal year 2008 and continuing through fiscal year 2012: $392,783,000, plus an adjustment for workload on $354,893,000 of this amount. Such adjustment shall be made in accordance with the workload adjustment provisions in effect for fiscal year 2007, except that instead of commercial investigational new drug applications submitted to the Secretary, all commercial investigational new drug applications with a submission during the previous 12-month period shall be used in the determination. One-third of the revenue amount shall be derived from application fees, one-third from establishment fees, and one-third from product fees.'.CommentsClose CommentsPermalink





(c) Adjustments to Fees-CommentsClose CommentsPermalink





(1) INFLATION ADJUSTMENT- Section 736(c)(1) (21 U.S.C. 379h(c)(1)) is amended--CommentsClose CommentsPermalink





(A) in the matter preceding subparagraph (A) by striking `The revenues established in subsection (b)' and inserting `Beginning with fiscal year 2009, the revenues established in subsection (b)';CommentsClose CommentsPermalink





(B) in subparagraph (A) by striking `or' at the end;CommentsClose CommentsPermalink





(C) in subparagraph (B) by striking the period at the end and inserting `, or,';CommentsClose CommentsPermalink





(D) by inserting after subparagraph (B) the following:CommentsClose CommentsPermalink





`(C) the average annual change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions, for the first 5 fiscal years of the previous 6 fiscal years.'; andCommentsClose CommentsPermalink





(E) in the matter following subparagraph (C) (as added by this paragraph), by striking `fiscal year 2003' and inserting `fiscal year 2008'.CommentsClose CommentsPermalink





(2) WORKLOAD ADJUSTMENT- Section 736(c)(2) (21 U.S.C. 379h(c)(2)) is amended--CommentsClose CommentsPermalink





(A) in the matter preceding subparagraph (A,) by striking `2004' and inserting `2009';CommentsClose CommentsPermalink





(B) in the first sentence of subparagraph (A)--CommentsClose CommentsPermalink





(i) by striking `, commercial investigational new drug applications' and inserting `(adjusted for changes in review activities)'; andCommentsClose CommentsPermalink





(ii) by inserting before the period at the end `, and the change in the number of commercial investigational new drug applications with a submission during the previous 12-month period (adjusted for changes in review activities)';CommentsClose CommentsPermalink





(C) in subparagraph (B), by adding at the end the following new sentence: `Further, any adjustment for changes in review activities made in setting fees and fee revenue amounts for fiscal year 2009 may not result in the total workload adjustment being more than 2 percentage points higher than it would be absent the adjustment for changes in review activities.'; andCommentsClose CommentsPermalink





(D) by adding at the end the following:CommentsClose CommentsPermalink





`(C) The Secretary shall contract with an independent accounting firm to study the adjustment for changes in review activities applied in setting fees for fiscal year 2009 and to make recommendations, if warranted, on future changes in the methodology for calculating the adjustment for changes in review activity. After review of the recommendations by the independent accounting firm, the Secretary shall make appropriate changes to the workload adjustment methodology in setting fees for fiscal years 2010 through 2012. If the study is not conducted, no adjustment for changes in review activities shall be made after fiscal year 2009.'.CommentsClose CommentsPermalink





(3) RENT AND RENT-RELATED COST ADJUSTMENT- Section 736(c) (21 U.S.C. 379h(c)) is amended--CommentsClose CommentsPermalink





(A) by redesignating paragraphs (3), (4), and (5) as paragraphs (4), (5), and (6), respectively; andCommentsClose CommentsPermalink





(B) by inserting after paragraph (2) the following:CommentsClose CommentsPermalink





`(3) RENT AND RENT-RELATED COST ADJUSTMENT- Beginning with fiscal year 2010, the Secretary shall, before making the adjustments under paragraphs (1) and (2), reduce the fee amounts established in subsection (b), if actual costs paid for rent and rent-related expenses are less than $11,721,000. The reductions made under this paragraph, if any, shall not exceed the amounts by which costs fell below $11,721,000, and shall not exceed $11,721,000 in any fiscal year.'.CommentsClose CommentsPermalink





(4) FINAL YEAR ADJUSTMENT- Section 736(c) (21 U.S.C. 379h(c)) is amended--CommentsClose CommentsPermalink





(A) in paragraph (4), as redesignated by this subsection--CommentsClose CommentsPermalink





(i) by striking `2007' each place it appears and inserting `2012'; andCommentsClose CommentsPermalink





(ii) by striking `2008' and inserting `2013'; andCommentsClose CommentsPermalink





(B) in paragraph (5), as redesignated by this subsection, by striking `2002' and inserting `2007'.CommentsClose CommentsPermalink





(d) Fee Waiver or Reduction- Section 736(d) (21 U.S.C. 379h(d)) is amended--CommentsClose CommentsPermalink





(1) in paragraph (1), in the matter preceding subparagraph (A), by--CommentsClose CommentsPermalink





(A) inserting `to a person who is named as the applicant' after `The Secretary shall grant';CommentsClose CommentsPermalink





(B) inserting `to that person' after `a waiver from or a reduction of one or more fees assessed'; andCommentsClose CommentsPermalink





(C) striking `finds' and inserting `determines';CommentsClose CommentsPermalink





(2) by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively;CommentsClose CommentsPermalink





(3) by inserting after paragraph (1) the following:CommentsClose CommentsPermalink





`(2) EVALUATION- For the purpose of determining whether to grant a waiver or reduction of a fee under paragraph (1), the Secretary shall consider only the circumstances and assets of the applicant and any affiliate of the applicant.'; andCommentsClose CommentsPermalink





(4) in paragraph (4), as redesignated by this subsection, in subparagraph (A), by inserting before the period at the end `, and that does not have a drug product that has been approved under a human drug application and introduced or delivered for introduction into interstate commerce'.CommentsClose CommentsPermalink





(e) Crediting and Availability of Fees-CommentsClose CommentsPermalink





(1) AUTHORIZATION OF APPROPRIATIONS- Section 736(g)(3) (21 U.S.C. 379h(g)(3)) is amended to read as follows:CommentsClose CommentsPermalink





`(3) AUTHORIZATION OF APPROPRIATIONS- There are authorized to be appropriated for fees under this section such sums as are authorized to be assessed and collected under this section in each of fiscal years 2008 through 2012.'.CommentsClose CommentsPermalink





(2) OFFSET- Section 736(g)(4) (21 U.S.C. 379h(g)(4)) is amended to read as follows:CommentsClose CommentsPermalink





`(4) OFFSET- If the cumulative amount of fees collected during fiscal years 2008, 2009, and 2010, plus the amount estimated to be collected for fiscal year 2011, exceeds the amount of fees specified in aggregate in appropriation Acts for such fiscal years, the aggregate amount in excess shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for fiscal year 2012.'.CommentsClose CommentsPermalink





(f) Conforming Amendments-CommentsClose CommentsPermalink





(1) Section 736(a) (21 U.S.C. 379h(a)), as amended by this section, is amended--CommentsClose CommentsPermalink





(A) in paragraph (1)(A), by striking `subsection (c)(4)' each place it appears and inserting `subsection (c)(5)';CommentsClose CommentsPermalink





(B) in paragraph (2), by striking `subsection (c)(4)' and inserting `subsection (c)(5)'; andCommentsClose CommentsPermalink





(C) in paragraph (3), by striking `subsection (c)(4)' and inserting `subsection (c)(5)'.CommentsClose CommentsPermalink





(2) Section 736A(h)(3), as added by section 104 of this title, is amended by striking `735(3)' and inserting `735(d)(3)'.CommentsClose CommentsPermalink

SEC. 104. AUTHORITY TO ASSESS AND USE PRESCRIPTION DRUG ADVERTISING FEES.

Chapter VII, subchapter C, part 2 (21 U.S.C. 379g et seq.) is amended by adding after section 736 the following new section:CommentsClose CommentsPermalink

`SEC. 736A. PROGRAM TO ASSESS AND USE FEES FOR THE ADVISORY REVIEW OF PRESCRIPTION DRUG ADVERTISING.

`(a) Types of Direct-to-Consumer Television Advertisement Review Fees- Beginning with fiscal year 2008, the Secretary shall assess and collect fees in accordance with this section as follows:CommentsClose CommentsPermalink





`(1) ADVISORY REVIEW FEE-CommentsClose CommentsPermalink





`(A) IN GENERAL- Except as provided in subparagraph (B), each person that on or after October 1, 2007, submits a proposed direct-to-consumer television advertisement for advisory review by the Secretary prior to its initial public dissemination shall be subject to a fee established under subsection (c)(3).CommentsClose CommentsPermalink





`(B) EXCEPTION FOR REQUIRED SUBMISSIONS- A direct-to-consumer television advertisement that is required to be submitted to the Secretary prior to initial public dissemination shall not be assessed a fee unless the sponsor designates it as a submission for advisory review.CommentsClose CommentsPermalink





`(C) PAYMENT- The fee required by subparagraph (A) shall be due not later than October 1 of the fiscal year in which the direct-to-consumer television advertisement shall be submitted to the Secretary for advisory review.CommentsClose CommentsPermalink





`(D) MODIFICATION OF ADVISORY REVIEW FEE-CommentsClose CommentsPermalink





`(i) LATE PAYMENT- If, on or before November 1 of the fiscal year in which the fees are due, a person has not paid all fees that were due and payable for advisory reviews identified in response to the Federal Register notice described in subsection (c)(3)(A), the fees shall be regarded as late. Such fees shall be due and payable 20 days before any direct-to-consumer television advertisement is submitted by such person to the Secretary for advisory review. Notwithstanding any other provision of this section, such fees shall be due and payable for each of those advisory reviews in the amount of 150 percent of the advisory review fee established for that fiscal year pursuant to subsection (c)(3).CommentsClose CommentsPermalink





`(ii) LATE NOTICE OF SUBMISSION- If any person submits any direct-to-consumer television advertisements for advisory review that are in excess of the number identified by that person in response to the Federal Register notice described in subsection (c)(3)(A), that person must pay a fee for each of those advisory reviews in the amount of 150 percent of the advisory review fee established for that fiscal year pursuant to subsection (c)(3). Fees under this subparagraph shall be due 20 days before the direct-to-consumer television advertisement is submitted by such person to the Secretary for advisory review.CommentsClose CommentsPermalink





`(E) LIMITS-CommentsClose CommentsPermalink





`(i) IN GENERAL- The payment of a fee under this paragraph for a fiscal year entitles the person that pays the fee to acceptance for advisory review by the Secretary of 1 direct-to-consumer television advertisement and acceptance of 1 resubmission for advisory review of the same advertisement. The advertisement shall be submitted for review in the fiscal year for which the fee was assessed, except that a person may carry over no more than 1 paid advisory review submission to the next fiscal year. Resubmissions may be submitted without regard to the fiscal year of the initial advisory review submission.CommentsClose CommentsPermalink





`(ii) NO REFUND- Except as provided by subsection (f), fees paid under this paragraph shall not be refunded.CommentsClose CommentsPermalink





`(iii) NO WAIVER, EXEMPTION, OR REDUCTION- The Secretary shall not grant a waiver, exemption, or reduction of any fees due or payable under this section.CommentsClose CommentsPermalink





`(iv) NON-TRANSFERABILITY- The right to an advisory review is not transferable, except to a successor in interest.CommentsClose CommentsPermalink





`(2) OPERATING RESERVE FEE-CommentsClose CommentsPermalink





`(A) IN GENERAL- Each person that, on or after October 1, 2007, is assessed an advisory review fee under paragraph (1) shall be subject to an operating reserve fee established under subsection (d)(2) only in the first fiscal year in which an advisory review fee is assessed.CommentsClose CommentsPermalink





`(B) PAYMENT- Except as provided in subparagraph (C), the fee required by subparagraph (A) shall be due not later than October 1 of the first fiscal year in which the person is required to pay an advisory review fee under paragraph (1).CommentsClose CommentsPermalink





`(C) LATE NOTICE OF SUBMISSION- If, in the first fiscal year of a person's participation in the Program, that person submits any direct-to-consumer television advertisements for advisory review that are in excess of the number identified by that person in response to the Federal Register notice described in subsection (c)(3)(A), that person must pay an operating reserve fee for each of those advisory reviews equal to the advisory review fee for each submission established under paragraph (1)(D)(ii). Fees required by this subparagraph shall be in addition to the fees required under subparagraph (B), if any. Fees under this subparagraph shall be due 20 days before any direct-to-consumer television advertisement is submitted by such person to the Secretary for advisory review.CommentsClose CommentsPermalink





`(b) Advisory Review Fee Revenue Amounts- Fees under subsection (a)(1) shall be established to generate revenue amounts of $6,250,000 for each of fiscal years 2008 through 2012, as adjusted pursuant to subsection (c).CommentsClose CommentsPermalink





`(c) Adjustments-CommentsClose CommentsPermalink





`(1) INFLATION ADJUSTMENT- Beginning with fiscal year 2009, the revenues established in subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year to reflect the greater of--CommentsClose CommentsPermalink





`(A) the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; United States city average), for the 12-month period ending June 30 preceding the fiscal year for which fees are being established;CommentsClose CommentsPermalink





`(B) the total percentage change for the previous fiscal year in basic pay under the General Schedule in accordance with section 5332 of title 5, as adjusted by any locality-based comparability payment pursuant to section 5304 of such title for Federal employees stationed in the District of Columbia; orCommentsClose CommentsPermalink





`(C) the average annual change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions, for the first 5 fiscal years of the previous 6 fiscal years.CommentsClose CommentsPermalink





The adjustment made each fiscal year by this paragraph shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2008 under this subsection.CommentsClose CommentsPermalink





`(2) WORKLOAD ADJUSTMENT-CommentsClose CommentsPermalink





`(A) IN GENERAL- Beginning with fiscal year 2009, after the fee revenues established in subsection (b) of this section are adjusted for a fiscal year for inflation in accordance with paragraph (1), the fee revenues shall be adjusted further for such fiscal year to reflect changes in the workload of the Secretary with respect to the submission of proposed direct-to-consumer television advertisements for advisory review prior to initial broadcast.CommentsClose CommentsPermalink





`(B) DETERMINATION OF WORKLOAD ADJUSTMENT-CommentsClose CommentsPermalink





`(i) IN GENERAL- The workload adjustment under this paragraph for a fiscal year shall be determined by the Secretary--CommentsClose CommentsPermalink





`(I) based upon the number of direct-to-consumer television advertisements identified pursuant to paragraph (3)(A) for that fiscal year, excluding allowable previously paid carry over submissions; andCommentsClose CommentsPermalink





`(II) by multiplying the number of such advertisements projected for that fiscal year that exceeds 150 by $27,600 (adjusted each year beginning with fiscal year 2009 for inflation in accordance with paragraph (1)).CommentsClose CommentsPermalink





`(ii) PUBLICATION IN FEDERAL REGISTER- The Secretary shall publish in the Federal Register, as part of the notice described in paragraph (1), the fee revenues and fees resulting from the adjustment made under this paragraph and the supporting methodologies.CommentsClose CommentsPermalink





`(C) LIMITATION- Under no circumstances shall the adjustment made under this paragraph result in fee revenues for a fiscal year that are less than the fee revenues established for the prior fiscal year.CommentsClose CommentsPermalink





`(3) ANNUAL FEE SETTING-CommentsClose CommentsPermalink





`(A) NUMBER OF ADVERTISEMENTS- The Secretary shall, 120 days before the start of each fiscal year, publish a notice in the Federal Register requesting any person to notify the Secretary within 30 days of the number of direct-to-consumer television advertisements the person intends to submit for advisory review by the Secretary in the next fiscal year. Notification to the Secretary of the number of advertisements a person intends to submit for advisory review prior to initial broadcast shall be a legally binding commitment by that person to pay the annual advisory review fee for that number of submissions on or before October 1 of the fiscal year in which the advertisement is intended to be submitted. A person shall at the same time also notify the Secretary if such person intends to use a paid submission from the previous fiscal year under subsection (a)(1)(E)(i). If such person does not so notify the Secretary, all submissions for advisory review shall be subject to advisory review fees.CommentsClose CommentsPermalink





`(B) ANNUAL FEE- The Secretary shall, 60 days before the start of each fiscal year, establish, for the next fiscal year, the direct-to-consumer television advertisement advisory review fee under subsection (a)(1), based on the revenue amounts established under subsection (b), the adjustments provided under this subsection and the number of direct-to-consumer television advertisements identified pursuant to subparagraph (A), excluding allowable previously paid carry over submissions. The annual advisory review fee shall be established by dividing the fee revenue for a fiscal year (as adjusted pursuant to this subsection) by the number of direct-to-consumer television advertisements identified pursuant to subparagraph (A), excluding allowable previously paid carry over submissions.CommentsClose CommentsPermalink





`(C) FISCAL YEAR 2008 FEE LIMIT- Notwithstanding subsection (b), the fee established under subparagraph (B) for fiscal year 2008 may not be more than $83,000 per submission for advisory review.CommentsClose CommentsPermalink





`(D) ANNUAL FEE LIMIT- Notwithstanding subsection (b), the fee established under subparagraph (B) for a fiscal year after fiscal year 2008 may not be more than 50 percent more than the fee established for the prior fiscal year.CommentsClose CommentsPermalink





`(E) LIMIT- The total amount of fees obligated for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the advisory review of prescription drug advertising.CommentsClose CommentsPermalink





`(d) Operating Reserves-CommentsClose CommentsPermalink





`(1) IN GENERAL- The Secretary shall establish in the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation a Direct-to-Consumer Advisory Review Operating Reserve, of at least $6,250,000 in fiscal year 2008, to continue the Program in the event the fees collected in any subsequent fiscal year pursuant to subsection (c)(3) do not generate the fee revenue amount established for that fiscal year.CommentsClose CommentsPermalink





`(2) FEE SETTING- The Secretary shall establish the operating reserve fee under subsection (a)(2)(A) for each person required to pay the fee by multiplying the number of direct-to-consumer television advertisements identified by that person pursuant to subsection (c)(3)(A) by the advisory review fee established pursuant to subsection (c)(3) for that fiscal year. In no case shall the operating reserve fee assessed be less than the operating reserve fee assessed if the person had first participated in the Program in fiscal year 2008.CommentsClose CommentsPermalink





`(3) USE OF OPERATING RESERVE- The Secretary may use funds from the reserves under this subsection only to the extent necessary in any fiscal year to make up the difference between the fee revenue amount established for that fiscal year under subsection (b) and the amount of fees collected for that fiscal year pursuant to subsection (a), or to pay costs of ending the Program if it is terminated pursuant to subsection (f) or if it is not reauthorized after fiscal year 2012.CommentsClose CommentsPermalink





`(4) REFUND OF OPERATING RESERVES- Within 120 days of the end of fiscal year 2012, or if the Program is terminated pursuant to subsection (f), the Secretary, after setting aside sufficient operating reserve amounts to terminate the Program, shall refund all amounts remaining in the operating reserve on a pro rata basis to each person that paid an operating reserve fee assessment. In no event shall the refund to any person exceed the total amount of operating reserve fees paid by such person pursuant to subsection (a)(2).CommentsClose CommentsPermalink





`(e) Effect of Failure To Pay Fees- Notwithstanding any other law or regulation of the Secretary, a submission for advisory review of a direct-to-consumer television advertisement submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for review by the Secretary until all fees owed by such person under this section have been paid.CommentsClose CommentsPermalink





`(f) Effect of Inadequate Funding of Program-CommentsClose CommentsPermalink





`(1) FIRST FISCAL YEAR- If on November 1, 2007, or 120 days after enactment of the Prescription Drug User Fee Amendments of 2007, whichever is later, the Secretary has received less than $11,250,000 in advisory review fees and operating reserve fees combined, the Program shall be terminated and all collected fees shall be refunded.CommentsClose CommentsPermalink





`(2) SUBSEQUENT FISCAL YEARS- Beginning in fiscal year 2009, if, on November 1 of a fiscal year, the combination of the operating reserves, annual fee revenues from that fiscal year, and unobligated fee revenues from prior fiscal years is less than $9,000,000, adjusted for inflation (in accordance with subsection (c)(1)), the Program shall be terminated, and the Secretary shall notify all participants, retain any money from the unused advisory review fees and the operating reserves needed to terminate the Program, and refund the remainder of the unused fees and operating reserves. To the extent required to terminate the Program, the Secretary shall first use unobligated advisory review fee revenues from prior fiscal years, then the operating reserves, and then unused advisory review fees from the relevant fiscal year.CommentsClose CommentsPermalink





`(g) Crediting and Availability of Fees-CommentsClose CommentsPermalink





`(1) IN GENERAL- Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the advisory review of prescription drug advertising.CommentsClose CommentsPermalink





`(2) COLLECTIONS AND APPROPRIATION ACTS- The fees authorized by this section--CommentsClose CommentsPermalink





`(A) shall be retained in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation for such fiscal year; andCommentsClose CommentsPermalink





`(B) shall be available for obligation only if appropriated budget authority continues to support at least the total combined number of full-time equivalent employees in the Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, and the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch supported in fiscal year 2007.CommentsClose CommentsPermalink





`(3) AUTHORIZATION OF APPROPRIATIONS- There are authorized to be appropriated for fees under this section not less than $6,250,000 for each of fiscal years 2008, 2009, 2010, 2011, and 2012, as adjusted to reflect adjustments in the total fee revenues made under this section, plus amounts collected for the reserve fund under subsection (d).CommentsClose CommentsPermalink





`(4) OFFSET- Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be collected under this section pursuant to appropriation Acts for a subsequent fiscal year.CommentsClose CommentsPermalink





`(h) Definitions- For purposes of this section:CommentsClose CommentsPermalink





`(1) The term `advisory review' means reviewing and providing advisory comments regarding compliance of a proposed advertisement with the requirements of this Act prior to its initial public dissemination.CommentsClose CommentsPermalink





`(2) The term `carry over submission' means a submission for an advisory review for which a fee was paid in a fiscal year that is submitted for review in the following fiscal year.CommentsClose CommentsPermalink





`(3) The term `direct-to-consumer television advertisement' means an advertisement for a prescription drug product as defined in section 735(3) intended to be displayed on any television channel for less than 2 minutes.CommentsClose CommentsPermalink





`(4) The term `person' includes an individual, a partnership, a corporation, and an association, and any affiliate thereof or successor in interest.CommentsClose CommentsPermalink





`(5) The term `process for the advisory review of prescription drug advertising' means the activities necessary to review and provide advisory comments on proposed direct-to-consumer television advertisements prior to public dissemination and, to the extent the Secretary has additional staff resources available under the Program that are not necessary for the advisory review of direct-to-consumer television advertisements, the activities necessary to review and provide advisory comments on other proposed advertisements and promotional material prior to public dissemination.CommentsClose CommentsPermalink





`(6) The term `Program' means the Program to assess, collect, and use fees for the advisory review of prescription drug advertising established by this section.CommentsClose CommentsPermalink





`(7) The term `resources allocated for the process for the advisory review of prescription drug advertising' means the expenses incurred in connection with the process for the advisory review of prescription drug advertising for--CommentsClose CommentsPermalink





`(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees, and to contracts with such contractors;CommentsClose CommentsPermalink





`(B) management of information, and the acquisition, maintenance, and repair of computer resources;CommentsClose CommentsPermalink





`(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies;CommentsClose CommentsPermalink





`(D) collection of fees under this section and accounting for resources allocated for the advisory review of prescription drug advertising; andCommentsClose CommentsPermalink





`(E) terminating the Program under subsection (f)(2), if necessary.CommentsClose CommentsPermalink





`(8) The term `resubmission' means a subsequent submission for advisory review of a direct-to-consumer television advertisement that has been revised in response to the Secretary's comments on an original submission. A resubmission may not introduce significant new concepts or creative themes into the television advertisement.CommentsClose CommentsPermalink





`(9) The term `submission for advisory review' means an original submission of a direct-to-consumer television advertisement for which the sponsor voluntarily requests advisory comments before the advertisement is publicly disseminated.CommentsClose CommentsPermalink

`SEC. 736B. SUNSET.

`This part shall cease to be effective on October 1, 2012, except that subsection (b) of section 736 with respect to reports shall cease to be effective on January 31, 2013.'.CommentsClose CommentsPermalink

SEC. 105. SAVINGS CLAUSE.

Notwithstanding section 509 of the Prescription Drug User Fee Amendments of 2002 (21 U.S.C. 379g note), and notwithstanding the amendments made by this title, part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date of enactment of this title, shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that on or after October 1, 2002, but before October 1, 2007, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2008.CommentsClose CommentsPermalink

SEC. 106. TECHNICAL AMENDMENT.

Section 739 (21 U.S.C. 379j-11) is amended in the matter preceding paragraph (1), by striking `subchapter' and inserting `part'.CommentsClose CommentsPermalink

SEC. 107. EFFECTIVE DATES.

(a) In General- Except as provided in subsection (b), the amendments made by this title shall take effect October 1, 2007.CommentsClose CommentsPermalink





(b) Exception- The amendment made by section 104 of this title shall take effect on the date of enactment of this title.CommentsClose CommentsPermalink

TITLE II--DRUG SAFETY

SEC. 200. SHORT TITLE.

This title may be cited as the `Enhancing Drug Safety and Innovation Act of 2007'.CommentsClose CommentsPermalink

Subtitle A--Risk Evaluation and Mitigation Strategies

SEC. 201. RISK EVALUATIONOUTINE ACTIVE SURVEILLANCE AND ASSESSMENT.

(a) In General- Subsection (k) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the following:CommentsClose CommentsPermalink





`(3) RISK IDENTIFICATION AND ASSESSMENT-`(A) ROUTINE ACTIVE SAFETY MONITORING- The Secretary shall facilitate a public-URVEILLANCE AND ASSESSMENT-CommentsClose CommentsPermalink





`(A) DEVELOPMENT OF THE POSTMARKET RISK IDENTIFICATION AND ANALYSIS SYSTEM- The Secretary shall, not later than 2 years after the date of enactment of the Enhancing Drug Safety and Innovation Act of 2007, act in collaboration with academic institutions and private partnership to-`(i) implement a routine active monitoring system for postmarket drug safetyentities to--CommentsClose CommentsPermalink





`(i) establish minimum standards for collection and transmission of postmarketing data elements from electronic health data systems; andCommentsClose CommentsPermalink





`(ii) focus postmarket studies under subsection (o)(4)(B) and postapproval clinical trials under subsection (o)(4)(C) more effectively on cases for which reports under paragraph (1) and other safety signal detection is not sufficient to resolve whether there is an elevated risk of a serious adverse event associated with use of a drug.`(B) PUBLIC-PRIVATE PARTNERSHIP- The public-private partnership described in subparagraph (A) shall--`(i) develop a mechanism for the pooling of relevant data from Federal and private electronic health care population databases that--`(I) includesestablish, through partnerships, a validated and integrated postmarket risk identification and analysis system to integrate and analyze safety data from multiple sources, with the goals of including, in aggregate--CommentsClose CommentsPermalink





`(aaI) at least 25,000,000 patients by Januaruly 1, 2009; and`(bb10; andCommentsClose CommentsPermalink





`(II) at least 100,000,000 patients by Januaruly 1, 2012;`(II) allows access to full-text medical records, where.CommentsClose CommentsPermalink





`(B) DATA COLLECTION ACTIVITIES-CommentsClose CommentsPermalink





`(i) IN GENERAL- The Secretary shall, not later than 1 year after the establishment of the minimum standards and the identification and analysis system under subparagraph (A), establish and maintain an active surveillance infrastructure--CommentsClose CommentsPermalink





`(I) to collect and report data for pharmaceutical postmarket risk identification and analysis, in compliance with the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996; andCommentsClose CommentsPermalink





`(II) that includes, in addition to the collection and monitoring (in a standardized form) of data on all serious adverse drug experiences (as defined in subsection (o)(2)(C)) required to be submitted to the Secretary under paragraph (1), and those events voluntarily submitted from patients, providers, and drug, when appropriate, procedures to--CommentsClose CommentsPermalink

`(cc) provide for adverse event surveillance by monitoring standardized electronic health records, as available;CommentsClose CommentsPermalink

`(III) takesdd) provide for adverse event surveillance by collecting and monitoring other information as the Secretary deems necessary to create a robust system to identify adverse events and potential drug safety signals;CommentsClose CommentsPermalink

`(ii) TIMELINESS OF REPORTING- The procedures developed under clause (i) shall ensure that such data are collected, monitored, and reported in a timely, routine, and automatic manner, taking into consideration the need for data completeness, coding, cleansing, and transmission;`(IV).CommentsClose CommentsPermalink





`(iii) PRIVATE SECTOR RESOURCES- To ensure the establishment of the active surveillance infrastructure by the date described under clause (i), the Secretary may, on a temporary or permanent basis, implement systems or products developed by private entities; and`(V) complies with the requirements of the Health Insurance Portability and Accountability Act of 1996;`(ii) support the routine and systematic collection and analysis of utilization and safety data from such pooled databases and from the Food and Drug Administration with respect to prescription drugs; and`(iii) allow for prompt investigation of.CommentsClose CommentsPermalink





`(iv) COMPLEMENTARY APPROACHES- To the extent the active surveillance infrastructure established under clause (i) is not sufficient to gather data and information relevant to priority drug safety questions, including--`(I) unresolved safety questions for drugs or classes of drugs; and`(II) for a newly-approved drug--`(aa) safety signals from clinical trials used to approve the drug and from other preapproval trials;`(bb) rare, serious drug adverse events; and`(cc) the safety of use in domestic populations not included in the trials used to approve the drug (such as older people, people with comorbidities, pregnant women, or children).`(C) OTHER APPROACHES-`(i) IN GENERAL- The Secretarythe Secretary shall develop, support, and participate in other approaches, including in other public-private partnerships,complementary approaches to gather and analyze data and information relevant to priority drug safety questionssuch data and information, including--CommentsClose CommentsPermalink





`(I) approaches that are complimentary to the routine active safety monitoring described in subparagraphs (A) and (B), especiallementary with respect to assessing the safety of use of a drug in domestic populations not included in the trials used to approve the drug (such as older people, people with comorbidities, pregnant women, or children); andCommentsClose CommentsPermalink





`(II) existing approaches such as the Vaccine Adverse Event Reporting System and the Vaccine Safety Datalink or successor databases.CommentsClose CommentsPermalink





`(v) AUTHORITY FOR CONTRACTS- The Secretary may enter into contracts with public and private entities to fulfill the requirements of this subparagraph.CommentsClose CommentsPermalink





`(C) RISK IDENTIFICATION AND ANALYSIS-CommentsClose CommentsPermalink





`(i) PURPOSE- To carry out this paragraph, the Secretary shall establish collaborations with other Government, academic, and private entities, including the Centers for Education and Research on Therapeutics under section 912 of the Public Health Service Act, to provide for the risk identification and analysis of the data collected under subparagraph (B) and data that is publicly available or is provided by the Secretary, in order to--CommentsClose CommentsPermalink





`(I) improve the quality and efficiency of postmarket drug safety risk-benefit analysis;CommentsClose CommentsPermalink





`(II) provide the Secretary with routine access to expertise to study advanced drug safety data; andCommentsClose CommentsPermalink





`(III) enhance the ability of the Secretary to make timely assessments based on drug safety data.CommentsClose CommentsPermalink





`(ii) BEST PRACTICES- With respect to such other approaches, the Secretary shall develop and implement best practices in epidemiology and the use of improved analytic tools.`(D) PUBLIC PROCESS FOR PRIORITY QUESTIONS- At least biannually, the Secretary shall seek recommendations from the Drug Safety and Risk Management Advisory Committee (or successor committee) and from other advisory committees, as appropriate, to the Food and Drug Administration on--CommentsClose CommentsPermalink





`(iI) priority drug safety questions; andCommentsClose CommentsPermalink





`(iiII) mechanisms for answering such questions, including through--CommentsClose CommentsPermalink

`(I) routine active safety monitoring; and`(IIaa) routine active surveillance under subparagraph (B); andCommentsClose CommentsPermalink

`(bb) when such monitoringsurveillance is not sufficient, postmarket studies under subsection (o)(4)(B) and postapproval clinical trials under subsection (o)(4)(C).CommentsClose CommentsPermalink

`(E) ANALYSISiii) PROCEDURES FOR THE DEVELOPMENT OF DRUG SAFETY DATA- The Secretary shall engage independent private research groups, including through the Centers for Education and Research on Therapeutics provided for under section 905 of the Public Health Service Act, to conduct analyses of data relating toCOLLABORATIONS-CommentsClose CommentsPermalink





`(I) IN GENERAL- Not later than 180 days after the date of the establishment of the active surveillance infrastructure under subparagraph (B), the Secretary shall establish and implement procedures under which the Secretary may routinely collaborate with a qualified entity to--CommentsClose CommentsPermalink

`(bb) allow for prompt investigation of priority drug safety questions.`(F, including--CommentsClose CommentsPermalink

`(II) REQUEST FOR SPECIFIC METHODOLOGY- The procedures described in subclause (I) shall permit the Secretary to request that a specific methodology be used by the qualified entity. The qualified entity shall work with the Secretary to finalize the methodology to be used.CommentsClose CommentsPermalink





`(iv) USE OF ANALYSES- The Secretary shall provide the analyses described under subparagraph (E), including the this subparagraph, including the methods and results of such analyses, about a drug to the sponsor or sponsors of such drug.CommentsClose CommentsPermalink





`(G) PUBLIC AVAILABILITY OF ANALYSES- The Secretary shall make the analyses described under subparagraph (E), including the methods and results of such analyses, available to the public for review and comment.`(Hv) QUALIFIED ENTITIES-CommentsClose CommentsPermalink





`(iI) IN GENERAL- The Secretary shall enter into contracts with a sufficient number of qualified entities to develop and provide information to the Secretary in a timely manner.CommentsClose CommentsPermalink





`(ii) QUALIFICATIONSII) QUALIFICATION- The Secretary shall enter into a contract with an entity under clause (isubclause (I) only if the Secretary determines that the entity--CommentsClose CommentsPermalink

`(Iaa) has the research capability and expertise to conduct and complete the activities under this paragraph;CommentsClose CommentsPermalink

`(IIbb) has in place an information technology infrastructure to support adverse event surveillance data and operational standards to provide security for such data;CommentsClose CommentsPermalink

`(IIIcc) has experience with, and expertise ion, the development of drug safety and effectiveness research using electronic population data;CommentsClose CommentsPermalink

`(IVdd) has an understanding of drug development and risk/benefit balancing in a clinical setting; andCommentsClose CommentsPermalink

`(Vee) has a significant business presence in the United States.CommentsClose CommentsPermalink

`(Ivi) CONTRACT REQUIREMENTS- Each contract with a qualified entity shall contain the following requirements:CommentsClose CommentsPermalink





`(iI) ENSURING PRIVACY- The qualified entity shall provide assurances that the entity will not use the data provided by the Secretary in a manner that violates--CommentsClose CommentsPermalink

`(I) the Federalaa) the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (concerning the privacy of individually-identifiable beneficiary health information); or`(II; orCommentsClose CommentsPermalink

`(bb) sections 552 or 552a of title 5, United States Code, with regard to the privacy of individually-identifiable beneficiary health information.CommentsClose CommentsPermalink

`(iiII) COMPONENT OF ANOTHER ORGANIZATION- If a qualified entity is a component of another organization--CommentsClose CommentsPermalink

`(Iaa) the qualified entity shall maintain the data related to the activities carried out under this paragraph separate from the other components of the organization and establish appropriate security measures to maintain the confidentiality and privacy of such data; andCommentsClose CommentsPermalink

`(IIbb) the entity shall not make an unauthorized disclosure of such data to the other components of the organization in breach of such confidentiality and privacy requirement.CommentsClose CommentsPermalink

`(iiiIII) TERMINATION OR NONRENEWAL- If a contract under this with a qualified entity under this subparagraph is terminated or not renewed, the following requirements shall apply:CommentsClose CommentsPermalink

`(Iaa) CONFIDENTIALITY AND PRIVACY REGULAPROTECTIONS- The entity shall continue to comply with the confidentiality and privacy requirements under this paragraph with respect to all data disclosed to the entity.CommentsClose CommentsPermalink

`(IIbb) DISPOSITION OF DATA- The entity shall return to the Secretary all data disclosed to the entity or, if returning the data is not practicable, destroy the data.CommentsClose CommentsPermalink

`(Jvii) COMPETITIVE PROCEDURES- The Secretary shall use competitive procedures (as defined in section 4(5) of the Federal Procurement Policy Act) to enter into contracts under subparagraph (H).`(K) REVIEW OF CONTRACT IN THE EVENTclause (v).CommentsClose CommentsPermalink





`(viii) REVIEW OF CONTRACT IN THE EVEN OF A MERGER OR ACQUISITION- The Secretary shall review the contract with a qualified entity under this paragraph in the event of a merger or acquisition of the entity in order to ensure that the requirements under this subparagraph will continue to be met.CommentsClose CommentsPermalink





`(D) COORDINATION- In carrying out this paragraph, the Secretary shall provide for appropriate communications to the public, scientific, public health, and medical communities, and other key stakeholders, and provide for the coordination of the activities of private entities, professional associations, or other entities that may have sources of surveillance data.'.CommentsClose CommentsPermalink





(b) Authorization of Appropriations- There are authorized to be appropriated to carry out this section $30o carry out activities under the amendment made by this section for which funds are made available under section 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h), there are authorized to be appropriated to carry out the amendment made by this section, in addition to such funds, $25,000,000 for each of fiscal years 2008 through 2012.CommentsClose CommentsPermalink

SEC. 202. RISK EVALUATION AND MITIGATION STRATEGIES.

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the following:CommentsClose CommentsPermalink





`(o) Risk Evaluation and Mitigation Strategy-CommentsClose CommentsPermalink





`(1) IN GENERAL- In the case of any drug subject to subsection (b) or to section 351 of the Public Health Service Act for which a risk evaluation and mitigation strategy is approved as provided for in this subsection, the applicant shall comply with the requirements of such strategy.CommentsClose CommentsPermalink





`(2) DEFINITIONS- In this subsection:CommentsClose CommentsPermalink





`(A) ADVERSE DRUG EXPERIENCE- The term `adverse drug experience' means any adverse event associated with the use of a drug in humans, whether or not considered drug related, including--CommentsClose CommentsPermalink





`(i) an adverse event occurring in the course of the use of the drug in professional practice;CommentsClose CommentsPermalink





`(ii) an adverse event occurring from an overdose of the drug, whether accidental or intentional;CommentsClose CommentsPermalink





`(iii) an adverse event occurring from abuse of the drug;CommentsClose CommentsPermalink





`(iv) an adverse event occurring from withdrawal of the drug; andCommentsClose CommentsPermalink





`(v) any failure of expected pharmacological action of the drug.CommentsClose CommentsPermalink





`(B) NEW SAFETY INFORMATION- The term `new safety information' with respect to a drug means information about--CommentsClose CommentsPermalink





`(i) a serious risk or an unexpected serious risk with use of the drug that the Secretary has become aware of since the later of--CommentsClose CommentsPermalink





`(I) the date of initial approval of the drug under this section or initial licensure of the drug under section 351 of the Public Health Service Act; orCommentsClose CommentsPermalink





`(II) if applicable, the last assessment of the approved risk evaluation and mitigation strategy for the drug; orCommentsClose CommentsPermalink





`(ii) the effectiveness of the approved risk evaluation and mitigation strategy for the drug obtained since the later of--CommentsClose CommentsPermalink





`(I) the approval of such strategy; orCommentsClose CommentsPermalink





`(II) the last assessment of such strategy.CommentsClose CommentsPermalink





`(C) SERIOUS ADVERSE DRUG EXPERIENCE- The term `serious adverse drug experience' is an adverse drug experience that--CommentsClose CommentsPermalink





`(i) results in--CommentsClose CommentsPermalink





`(I) death;CommentsClose CommentsPermalink





`(II) the placement of the patient at immediate risk of death from the adverse drug experience as it occurred (not including an adverse drug experience that might have caused death had it occurred in a more severe form);CommentsClose CommentsPermalink





`(III) inpatient hospitalization or prolongation of existing hospitalization;CommentsClose CommentsPermalink





`(IV) a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; orCommentsClose CommentsPermalink





`(V) a congenital anomaly or birth defect; orCommentsClose CommentsPermalink





`(ii) based on appropriate medical judgment, may jeopardize the patient and may require a medical or surgical intervention to prevent an outcome described under clause (i).CommentsClose CommentsPermalink





`(D) SERIOUS RISK- The term `serious risk' means a risk of a serious adverse drug experience.CommentsClose CommentsPermalink





`(E) SIGNAL OF A SERIOUS RISK- The term `signal of a serious risk' means information related to a serious adverse drug experience derived from--CommentsClose CommentsPermalink





`(i) a clinical trial;CommentsClose CommentsPermalink





`(ii) adverse event reports under subsection (k)(1);CommentsClose CommentsPermalink





`(iii) routine active safety monitoringurveillance under subsection (k)(3);CommentsClose CommentsPermalink





`(iv) a postapproval study, including a study under paragraph (4)(B); orCommentsClose CommentsPermalink





`(v) peer-reviewed biomedical literature.CommentsClose CommentsPermalink





`(F) UNEXPECTED SERIOUS RISK- The term `unexpected serious risk' means a serious adverse drug experience that--CommentsClose CommentsPermalink





`(i) is not listed in the labeling of a drug; orCommentsClose CommentsPermalink





`(ii) is symptomatically and pathophysiologically related to an adverse drug experience listed in the labeling of the drug, but differs from such adverse drug experience because of greater severity, specificity, or prevalence.CommentsClose CommentsPermalink





`(3) REQUIRED ELEMENTS OF A RISK EVALUATION AND MITIGATION STRATEGY- If a risk evaluation and mitigation strategy for a drug is required, such strategy shall include--CommentsClose CommentsPermalink





`(A) the labeling for the drug for use by health care providers as approved under subsection (c);CommentsClose CommentsPermalink





`(B) a timetable for submission of assessments of the strategy, that--CommentsClose CommentsPermalink





`(i) for a drug no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under this section or section 351 of the Public Health Service Act--CommentsClose CommentsPermalink





`(I) shall be no less frequently than 18 months and 3 years after the drug is initially approved and at a frequency specified in the strategy for subsequent years; andCommentsClose CommentsPermalink





`(II) may be eliminated after the first 3 years if the Secretary determines that serious risks of the drug have been adequately identified and assessed and are being adequately managed;CommentsClose CommentsPermalink





`(ii) for a drug other than a drug described under clause (i), shall occur at a frequency determined by the Secretary; andCommentsClose CommentsPermalink





`(iii) may be increased or reduced in frequency as necessary as provided for in paragraph (7)(B)(v)(VI).CommentsClose CommentsPermalink





`(4) ADDITIONAL POTENTIAL EVALUATION ELEMENTS OF A RISK EVALUATION AND MITIGATION STRATEGY-CommentsClose CommentsPermalink





`(A) RISK EVALUATION- If a risk evaluation and mitigation strategy for a drug is required, such strategy may include 1 or more of the additional evaluation elements described in this paragraph, so long as the Secretary makes the determination required with respect to each additional included element.CommentsClose CommentsPermalink





`(B) POSTAPPROVAL STUDIES- If the Secretary determines that the reports under subsection (k)(1) and routine active safety monitoring as available under subsection (k)(3) (including available otherurveillance as available under subsection (k)(3) (including available complementary approaches under subsection (k)(3)(C)) are notB)(iv)) will not be sufficient to--CommentsClose CommentsPermalink





`(i) assess a signal of a serious risk with use of a drug; orCommentsClose CommentsPermalink





`(ii) identify, based on a review of a demonstrated pattern of use of the drug, unexpected serious risks in a domestic population who use the drug, including a population not included in trials used to approve the drug (such as, including older people, people with comorbidities, pregnant women, or children),CommentsClose CommentsPermalink





the risk evaluation and mitigation strategy for the drug may require that the applicant conduct an appropriate postapproval study, such as a prospective or retrospective observational study, of the drug (which shall include a timeframe specified by the Secretary for completing the study and reporting the results to the Secretary).CommentsClose CommentsPermalink





`(C) POSTAPPROVAL CLINICAL TRIALS- If the Secretary determines that the reports under subsection (k)(1), routine active safety monitoring as available under subsection (k)(3) (including available otherurveillance as available under subsection (k)(3) (including available complementary approaches under subsection (k)(3)(C)), and a study B)(iv)), and a study or studies under subparagraph (B) will likely be inadequate to assess a signal of a serious risk with use of a drug, and there is no effective approved application for the drug under subsection (j) as of the date that the requirement is first imposed, the risk evaluation and mitigation strategy for the drug may require that the applicant conduct an appropriate postapproval clinical trial of the drug (which shall include a timeframe specified by the Secretary for completing the clinical trial and reporting the results to the Secretary) to be included in the clinical trial registry data bank provided for under subsections (i) and (j) of section 402 of the Public Health Service Act.CommentsClose CommentsPermalink





`(5) ADDITIONAL POTENTIAL COMMUNICATION ELEMENTS OF A RISK EVALUATION AND MITIGATION STRATEGY-CommentsClose CommentsPermalink





`(A) RISK COMMUNICATION- If a risk evaluation and mitigation strategy for a drug is required, such strategy may include 1 or more of the additional communication elements described in this paragraph, so long as the Secretary makes the determination required with respect to each additional included element.CommentsClose CommentsPermalink





`(B) MEDGUIDE; PATIENT PACKAGE INSERT- The risk evaluation and mitigation strategy for a drug may require that the applicant develop for distribution to each patient when the drug is dispensed either or both of the following:CommentsClose CommentsPermalink





`(i) A Medication Guide, as provided for under part 208 of title 21, Code of Federal Regulations (or any successor regulations).CommentsClose CommentsPermalink





`(ii) A patient package insert, if the Secretary determines that such insert may help mitigate a serious risk listed in the labeling of the drug.CommentsClose CommentsPermalink





`(C) COMMUNICATION PLAN- If the Secretary determines that a communication plan to health care providers may support implementation of an element of the risk evaluation and mitigation strategy for a drug, such as a labeling change, the strategy may require that the applicant conduct such a plan, which may include--CommentsClose CommentsPermalink





`(i) sending letters to health care providers;CommentsClose CommentsPermalink





`(ii) disseminating information about the elements of the strategy to encourage implementation by health care providers of components that apply to such health care providers, or to explain certain safety protocols (such as medical monitoring by periodic laboratory tests); orCommentsClose CommentsPermalink





`(iii) disseminating information to health care providers through professional societies about any serious risks of the drug and any protocol to assure safe use.CommentsClose CommentsPermalink





`(D) PREREVIEW-CommentsClose CommentsPermalink





`(i) IN GENERAL- If the Secretary determines that prereview of advertisements is necessary to ensure the inclusion of a true statement in such advertisements of information in brief summary relating to a serious risk listed in the labeling of a drug, or relating to a serious risk listed in the labeling of aprotocol to ensure the safe use described in the labeling of the drug, the risk evaluation and mitigation strategy for the drug may require that the applicant submit to the Secretary advertisements of the drug for prereview not later than 45 days before dissemination of the advertisementCommentsClose CommentsPermalink





`(ii) SPECIFICATION OF ADVERTISEMENTS- The Secretary may specify the advertisements required to be submitted under clause (i).CommentsClose CommentsPermalink





`(E) SPECIFIC DISCLOSURES-CommentsClose CommentsPermalink





`(i) SERIOUS RISK; SAFETY PROTOCOL- If the Secretary determines that advertisements lacking a specific disclosure about a serious risk listed in the labeling of a drug or about a protocol to ensure safe use described in the labeling of the drug would be false or misleading, the risk evaluation and mitigation strategy for the drug may require that the applicant include in advertisements of the drug such disclosure.CommentsClose CommentsPermalink





`(ii) DATE OF APPROVAL- If the Secretary determines that advertisements lacking a specific disclosure of the date a drug was approved and that the existing information may not have identified or allowed for full assessment of all serious risks of using the drug is necessary to protect public health and safetydisclosure of a serious risk would be false or misleading, the risk evaluation and mitigation strategy for the drug may require that the applicant include in advertisements of the drug such disclosure.CommentsClose CommentsPermalink





`(iii) SPECIFICATION OF ADVERTISEMENTS- The Secretary may specify the advertisements required to include a specific disclosure under clause (i) or (ii).CommentsClose CommentsPermalink





`(F) TEMPORARY MORATORIUM- To the extent consistent with the Constitution, if the Secretary determines that disclosure under subparagraph (E)(ii) is inadequate to protect public health and safety, and that a prohibition of direct-to-consumer advertisements of the drug for a fixed period after initial approval of the drug, not to exceed 2 years, is necessary to protect public health and safety while additional information about serious risks of the drug is collected using the reports under iv) REQUIRED SAFETY SURVEILLANCE- If the approved risk evaluation and mitigation strategy for a drug requires the specific disclosure under clause (ii), the Secretary shall--CommentsClose CommentsPermalink





`(I) consider identifying and assessing all serious risks of using the drug to be a priority safety question under subsection (k)(3)(B);CommentsClose CommentsPermalink





`(II) not less frequently than every 3 months, evaluate the reports under subsection (k)(1) and the routine active safety monitoring as available under subsection (k)(3) (including available other approaches under subsection (k)(3)(C)), the risk evaluation and mitigation strategy for the drug may require that the applicant not issue or cause to be issued direct-to-consumer advertisements of the drug for such fixed period. In making such determination, the Secretary shall consider--`(i) the number of patients who may be treated with the drug;`(ii) the seriousness of the condition for which the drug will be used;`(iii) the serious risks listed in the labeling of the drug;`(iv) the extent to which patients have access to other approved drugs in the pharmacological class of the drug and with the same intended use as the drug; and`(v) the extent to which clinical trials used to approve the drug may not have identified serious urveillance as available under subsection (k)(3) with respect to such priority drug safety question to determine whether serious risks that might occur among patients expected to be treated with the drug have been adequately identified and assessed;CommentsClose CommentsPermalink





`(III) remove such specific disclosure requirement as an element of such strategy if such serious risks have been adequately identified and assessed; andCommentsClose CommentsPermalink





`(IV) consider whether a specific disclosure under clause (i) should be required.CommentsClose CommentsPermalink





`(6) RESTRICTIONS ON DISTRIBUTION OR USE FORPROVIDING SAFE ACCESS FOR PATIENTS TO DRUGS WITH KNOWN UNUSUAL, SERIOUS RISKS-`(A) IN GENERAL- When a risk evaluation and mitigation strategy for a drug is required, and considering the adequacy of the labeling of the drug and 1 or more communication elements under paragraph (5) to mitigate a specific serious risk listed in the labeling of the drug, if the Secretary determines that the drug, which has been THAT WOULD OTHERWISE BE UNAVAILABLE-CommentsClose CommentsPermalink





`(A) ALLOWING SAFE ACCESS TO DRUGS WITH KNOWN SERIOUS RISKS- The Secretary may require that the risk evaluation and mitigation strategy for a drug include such elements as are necessary to assure safe use of the drug, because of its inherent toxicity or potential harmfulness, if the Secretary determines that--CommentsClose CommentsPermalink





`(i) the drug, which has been shown to be effective, can be safely used only if distribution or use of such drug is restricted, the Secretary may require as elements of such strategy such restrictions on distribution or use as are needed to assure safe use of the drug.`(B) LIMITS ON RESTRICTIONS TO ASSUREbut is associated with a serious adverse drug experience, can be approved only if, or would be withdrawn unless, such elements are required as part of such strategy to mitigate a specific serious risk listed in the labeling of the drug; andCommentsClose CommentsPermalink





`(ii) for a drug initially approved without elements to assure safe use, other elements under paragraphs (3), (4), and (5) are not sufficient to mitigate such serious risk.CommentsClose CommentsPermalink





`(B) ASSURING ACCESS AND MINIMIZE BURDEN- Such restrictionsING BURDEN- Such elements to assure safe use under subparagraph (A) shall--CommentsClose CommentsPermalink





`(i) be commensurate with the specific, serious risk presented by the drug;`(ii) serious risk listed in the labeling of the drug;CommentsClose CommentsPermalink





`(ii) within 30 days of the date on which any element under subparagraph (A) is imposed, be posted publicly by the Secretary with an explanation of how such elements will mitigate the observed safety risk;CommentsClose CommentsPermalink





`(iii) considering such risk, not be unduly burdensome on patient access to the drug, considering in particular--CommentsClose CommentsPermalink





`(I) patients with serious or life-threatening diseases or conditions; andCommentsClose CommentsPermalink





`(II) patients who have difficulty accessing health care (such as patients in rural areas) who have difficulty accessing health care; and`(iiior medically underserved areas); andCommentsClose CommentsPermalink





`(iv) to the extent practicable, so as to minimize the burden on the health care delivery system--CommentsClose CommentsPermalink





`(I) conform with restrictions on distribution orelements to assure safe use for other drugs with similar, serious risks; andCommentsClose CommentsPermalink





`(II) be designed to be compatible with established distribution, procurement, and dispensing systems for drugs.CommentsClose CommentsPermalink





`(C) ELEMENTS TO PROTECT PATIENT SAFETY- The restrictions on distribution or use describedASSURE SAFE USE- The elements to assure safe use under subparagraph (A) shall include 1 or more goals to evaluate or mitigate a specific serious risk listed in the labeling of the drug and, to mitigate such risk, may require that--CommentsClose CommentsPermalink





`(i) health care providers thatwho prescribe the drug have particular training or experience, or are specially certified (which training or certification with respect to the drug shall be available to any willing provider from a frontier area in a widely available training or certification method (including an on-line course or via mail) as approved by the Secretary at minimal cost to the provider);CommentsClose CommentsPermalink





`(ii) pharmacies, practitioners, or health care settings that dispense the drug are specially certified (which certification shall be available to any willing provider from a frontier area);CommentsClose CommentsPermalink





`(iii) the drug be dispensed to patients only in certain health care settings, such as hospitals;CommentsClose CommentsPermalink





`(iv) the drug be dispensed to patients with evidence or other documentation of safe-use conditions, such as laboratory test results;CommentsClose CommentsPermalink





`(v) each patient using the drug be subject to certain monitoring; orCommentsClose CommentsPermalink





`(vi) each patient using the drug be enrolled in a registry.CommentsClose CommentsPermalink





`(D) IMPLEMENTATION SYSTEM- The restrictions on distribution or use described under subparagraph (A) that employ elementselements to assure safe use under subparagraph (A) that are described in clauses (ii), (iii), or (iv) of subparagraph (C) may include a system through which the applicant is able to take reasonable steps to--CommentsClose CommentsPermalink





`(i) monitor and evaluate implementation of such elements by health care providers, pharmacists, and other parties in the health care system who are responsible for implementing such elements; andCommentsClose CommentsPermalink





`(ii) work to improve implementation of such elements by such persons.CommentsClose CommentsPermalink





`(E) EVALUATION OF RESTRICTIONSELEMENTS TO ASSURE SAFE USE- The Secretary, through the Drug Safety and Risk Management Advisory Committee (or successor committee) of the Food and Drug Administration, shall--CommentsClose CommentsPermalink





`(i) seek input from patients, physicians, pharmacists, and other health care providers about how restrictions on distribution orelements to assure safe use under this paragraph for 1 or more drugs may be standardized so as not to be--CommentsClose CommentsPermalink





`(I) unduly burdensome on patient access to the drug; andCommentsClose CommentsPermalink





`(II) to the extent practicable, minimize the burden on the health care delivery system;CommentsClose CommentsPermalink





`(ii) at least annually, evaluate, for 1 or more drugs, the restrictions on distribution or use of such drug to assess whether the restrictionelements to assure safe use of such drug to assess whether the elements--CommentsClose CommentsPermalink





`(I) assure safe use of the drug;CommentsClose CommentsPermalink





`(II) are not unduly burdensome on patient access to the drug; andCommentsClose CommentsPermalink





`(III) to the extent practicable, minimize the burden on the health care delivery system; andCommentsClose CommentsPermalink





`(iii) considering such input and evaluations--CommentsClose CommentsPermalink





`(I) issue or modify agency guidance about how to implement the requirements of this paragraph; andCommentsClose CommentsPermalink





`(II) modify restrictions under this paragraph for 1 or more drugs as appropriateelements under this paragraph for 1 or more drugs as appropriate.CommentsClose CommentsPermalink





`(F) ADDITIONAL MECHANISMS TO ASSURE ACCESS- The mechanisms under section 561 to provide for expanded access for patients with serious or life-threatening diseases or conditions may be used to provide access for patients with a serious or life-threatening disease or condition, the treatment of which is not an approved use for the drug, to a drug that is subject to elements to assure safe use under this paragraph. The Secretary shall promulgate regulations for how a physician may provide the drug under the mechanisms of section 561.CommentsClose CommentsPermalink





`(G) WAIVER IN PUBLIC HEALTH EMERGENCIES- The Secretary may waive any requirement of this paragraph during the period described in section 319(a) of the Public Health Service Act with respect to a qualified countermeasure described under section 319F-1(a)(2) of such Act, to which a requirement under this paragraph has been applied, if the Secretary has--CommentsClose CommentsPermalink





`(i) declared a public health emergency under such section 319; andCommentsClose CommentsPermalink





`(ii) determined that such waiver is required to mitigate the effects of, or reduce the severity of, such public health emergency.CommentsClose CommentsPermalink





`(7) SUBMISSION AND REVIEW OF RISK EVALUATION AND MITIGATION STRATEGY-CommentsClose CommentsPermalink





`(A) PROPOSED RISK EVALUATION AND MITIGATION STRATEGY-CommentsClose CommentsPermalink





`(i) VOLUNTARY PROPOSAL- An applicant may include a proposed risk evaluation and mitigation strategy for aIf there is a signal of a serious risk with a drug, an applicant may include a proposed risk evaluation and mitigation strategy for the drug in an application, including in a supplemental application, for the drug under subsection (b) or section 351 of the Public Health Service Act for the drug.CommentsClose CommentsPermalink





`(ii) REQUIRED PROPOSAL-CommentsClose CommentsPermalink





`(I) DETERMINATION NECESSARY TO REQUIRE A PROPOSAL-CommentsClose CommentsPermalink

`(II) CIRCUMSTANCES IN WHICH A PROPOSAL MAY BE REQUIRED- The applicant shall submit a proposed risk evaluation and mitigation strategy for a drug--CommentsClose CommentsPermalink

`(Iaa) in response to a letter from the Secretary (acting through the office responsible for reviewing the drug and the office responsible for postapproval safety with respect to the drug) sent regarding an application, including a supplemental application, for the drug, if the Secretary determines that data or information in the application indicates that an element under paragraph (4), (5), or (6) should be included in a strategy for the drug;CommentsClose CommentsPermalink

`(bb) within a timeframe specified by the Secretary, not to be less than 45 days, when ordered by the Secretary (acting through the office responsible for reviewing the drug and the office responsible for postapproval safety with respect to the drug), if the Secretary determines that new safety informationsuch offices), if the Secretary determines that new safety information indicates that--CommentsClose CommentsPermalink

`(aaAA) the labeling of the drug should be changed; orCommentsClose CommentsPermalink

`(bb) an element under paragraph (4) or (5) BB) an element under paragraph (4) or (5) should be included in a strategy for the drug; orCommentsClose CommentsPermalink

`(IIcc) within 90 days when ordered by the Secretary (acting through such offices), if the Secretary determines that new safety information indicates that an element under paragraph (6) should be included in a strategy for the drug.CommentsClose CommentsPermalink

`(iii) CONTENT OF ORDER- An order under subclauses (I) or (II) of clause (iiLETTER- A letter under clause (ii)(II)(aa) shall describe--CommentsClose CommentsPermalink





`(I) the data or information in the application that warrants the proposal of a risk evaluation and mitigation strategy for the drug; andCommentsClose CommentsPermalink





`(II) what elements under paragraphs (4), (5), or (6) should be included in a strategy for the drug.CommentsClose CommentsPermalink





`(iv) CONTENT OF ORDER- An order under item (aa) or (bb) of clause (ii)(II) shall describe--CommentsClose CommentsPermalink





`(I) the new safety information with respect to the drug that warrants the proposal of a risk evaluation and mitigation strategy for the drug; andCommentsClose CommentsPermalink





`(II) whether and how the labeling of the drug should be changed and what elements under paragraphs (4), (5), or (6) should be included in a strategy for the drug.CommentsClose CommentsPermalink





`(iv) CONTENT OF PROPOSAL- A proposed risk evaluation and mitigation strategy--CommentsClose CommentsPermalink





`(I) shall include a timetable as described under paragraph (3)(B); andCommentsClose CommentsPermalink





`(II) may also include additional elements as provided for under paragraphs (4), (5), and (6).CommentsClose CommentsPermalink





`(B) ASSESSMENT AND MODIFICATION OF A RISK EVALUATION AND MITIGATION STRATEGY-CommentsClose CommentsPermalink





`(i) VOLUNTARY ASSESSMENTS- If a risk evaluation and mitigation strategy for a drug is required, the applicant may submit to the Secretary an assessment of, and propose a modification to, such approved strategy for the drug at any time.CommentsClose CommentsPermalink





`(ii) REQUIRED ASSESSMENTS- If a risk evaluation and mitigation strategy for a drug is required, the applicant shall submit an assessment of, and may propose a modification to, such approved strategy for the drug--CommentsClose CommentsPermalink





`(I) when submitting an application, including a supplemental application, for a new indication under subsection (b) or section 351 of the Public Health Service Act;CommentsClose CommentsPermalink





`(II) when required by the strategy, as provided for in the timetable under paragraph (3)(B);CommentsClose CommentsPermalink





`(III) within a timeframe specified by the Secretary, not to be less than 45 days, when ordered by the Secretary (acting through the offices described in subparagraph (A)(ii)(I)), if the Secretary determines that new safety information indicates that an element under paragraph (3) or (4) should be modified or added to the strategy;CommentsClose CommentsPermalink





`(IV) within 90 days when ordered by the Secretary (acting through such offices), if the Secretary determines that new safety information indicates that an element under paragraph (6) should be modified or added to the strategy; orCommentsClose CommentsPermalink





`(V) within 15 days when ordered by the Secretary (acting through such offices), if the Secretary determines that there may be a cause for action by the Secretary under subsection (e).CommentsClose CommentsPermalink





`(iii) CONTENT OF ORDER- An order under subclauses (III), (IV), or (V) of clause (ii) shall describe--CommentsClose CommentsPermalink





`(I) the new safety information with respect to the drug that warrants an assessment of the approved risk evaluation and mitigation strategy for the drug; andCommentsClose CommentsPermalink





`(II) whether and how such strategy should be modified because of such information.CommentsClose CommentsPermalink





`(iv) ASSESSMENT- An assessment of the approved risk evaluation and mitigation strategy for a drug shall include--CommentsClose CommentsPermalink





`(I) a description of new safety information, if any, with respect to the drug;CommentsClose CommentsPermalink





`(II) whether and how to modify such strategy because of such information;CommentsClose CommentsPermalink





`(III) with respect to any postapproval study required under paragraph (4)(B) or otherwise undertaken by the applicant to investigate a safety issue, the status of such study, including whether any difficulties completing the study have been encountered;CommentsClose CommentsPermalink





`(IV) with respect to any postapproval clinical trial required under paragraph (4)(C) or otherwise undertaken by the applicant to investigate a safety issue, the status of such clinical trial, including whether enrollment has begun, the number of participants enrolled, the expected completion date, whether any difficulties completing the clinical trial have been encountered, and registration information with respect to requirements under subsections (i) and (j) of section 402 of the Public Health Service Act; andCommentsClose CommentsPermalink





`(V) with respect to any goal under paragraph (6) and considering input and evaluations, if applicable, under paragraph (6)(E), an assessment of how well the restrictions on distribution or use are meeting the goal or whether the goal or such restrictionelements to assure safe use are meeting the goal of increasing safe access to drugs with known serious risks or whether the goal or such elements should be modified.CommentsClose CommentsPermalink





`(v) MODIFICATION- A modification (whether an enhancement or a reduction) to the approved risk evaluation and mitigation strategy for a drug may include the addition or modification of any element under subparagraph (A) or (B) of paragraph (3) or the addition, modification, or removal of any element under paragraph (4), (5), or (6), such as--CommentsClose CommentsPermalink





`(I) a labeling change, including the addition of a boxed warning;CommentsClose CommentsPermalink





`(II) adding a postapproval study or clinical trial requirement;CommentsClose CommentsPermalink





`(III) modifying a postapproval study or clinical trial requirement (such as a change in trial design due to legitimate difficulties recruiting participants);CommentsClose CommentsPermalink





`(IV) adding, modifying, or removing a restrictionn element on advertising under subparagraph (D), (E), or (F) of paragraph (5);CommentsClose CommentsPermalink





`(V) adding, modifying, or removing a restriction on distribution or use under paragraph n element to assure safe use under paragraph (6); orCommentsClose CommentsPermalink





`(VI) modifying the timetable for assessments of the strategy under paragraph (3)(B), including to eliminate assessments.CommentsClose CommentsPermalink





`(C) REVIEW- The Secretary (acting through the offices described in subparagraph (A)(ii)(I)) shall promptly review the proposed risk evaluation and mitigation strategy for a drug submitted under subparagraph (A), or an assessment of the approved risk evaluation and mitigation strategy for a drug submitted under subparagraph (B).CommentsClose CommentsPermalink





`(D) DISCUSSION- The Secretary (acting through the offices described in subparagraph (A)(ii)(I)) shall initiate discussions of the proposed risk evaluation and mitigation strategy for a drug submitted under subparagraph (A)(i), or of an assessment of the approved risk evaluation and mitigation strategy for a drug submitted under subparagraph (B), with the applicant to determine a strategy--CommentsClose CommentsPermalink





`(i) if the proposed strategy or assessment is submitted as part of an application (including a supplemental application) under subparagraph (A)(i), (A)(ii)(II)(aa), or (B)(ii)(I), by the target date for communication of feedback from the review team to the applicant regarding proposed labeling and postmarketing study commitments, as set forth in the letters described in section 735(a);CommentsClose CommentsPermalink





`(ii) if the proposed strategy is submitted under subparagraph (A)(ii)(II)(bb) or the assessment is submitted under subclause (II) or (III) of subparagraph (B)(ii), not later than 20 days after such submission;CommentsClose CommentsPermalink





`(iii) if the proposed strategy is submitted under subparagraph (A)(ii)(II)(cc) or the assessment is submitted under subparagraph (B)(i) or under subparagraph (B)(ii)(IV), not later than 30 days after such submission; orCommentsClose CommentsPermalink





`(iv) if the assessment is submitted under subparagraph (B)(ii)(V), not later than 10 days after such submission.CommentsClose CommentsPermalink





`(E) ACTION-CommentsClose CommentsPermalink





`(i) IN GENERAL- Unless the applicant requests the dispute resolution process as described under subparagraph (F) or (G), the Secretary (acting through the offices described in subparagraph (A)(ii)(I)) shall approve and include the risk evaluation and mitigation strategy for a drug, or any modification to the strategy (including a timeframe for implementing such modification), with--CommentsClose CommentsPermalink





`(I) the action letter on the application, if a proposed strategy is submitted under subparagraph (A)(i) or (A)(ii)(II)(aa) or an assessment of the strategy is submitted under subparagraph (B)(ii)(I); orCommentsClose CommentsPermalink





`(II) an order, which shall be made public, issued not later than 50 days after the date discussions of such proposed strategy or modification begin under subparagraph (D), if a proposed strategy is submitted under subparagraph (A)(iiitem (bb) or (cc) of subparagraph (A)(ii)(II) or an assessment of the strategy is submitted under subparagraph (B)(i) or under subclause (II), (III), (IV), or (V) of subparagraph (B)(ii).CommentsClose CommentsPermalink





`(ii) INACTION- An approved risk evaluation and mitigation strategy shall remain in effect until the Secretary acts, if the Secretary fails to act as provided under clause (i).CommentsClose CommentsPermalink





`(F) DISPUTE RESOLUTION AT INITIAL APPROVAL- If a proposed risk evaluation and mitigation strategy is submitted under subparagraph (A)(i) in an application or (A)(ii)(II)(aa) in an application for initial approval of a drug and there is a dispute about the strategy, the applicant shall use the major dispute resolution procedures as set forth in the letters described in section 735(a).CommentsClose CommentsPermalink





`(G) DISPUTE RESOLUTION IN ALL OTHER CASES-CommentsClose CommentsPermalink





`(i) REQUEST FOR REVIEW- In any case other than a submission under subparagraph (A)(i) in an application or (A)(ii)(II)(aa) in an application for initial approval of a drug if there is a dispute about the strategy, not earlier than 15 days, and not later than 35 days, after discussions under subparagraph (D) have begun, the applicant shall request in writing that the dispute be reviewed by the Drug Safety Oversight Board.CommentsClose CommentsPermalink





`(ii) SCHEDULING REVIEW- If the applicant requests review under clause (i), the Secretary--CommentsClose CommentsPermalink





`(I)(aa) shall schedule the dispute for review at 1 of the next 2 regular meetings of the Drug Safety Oversight Board, whichever meeting date is more practicable; orCommentsClose CommentsPermalink





`(bb) may convene a special meeting of the Drug Safety Oversight Board to review the matter more promptly, including to meet an action deadline on an application (including a supplemental application);CommentsClose CommentsPermalink





`(II) shall give advance notice to the public through the Federal Register and on the Internet website of the Food and Drug Administration--CommentsClose CommentsPermalink

`(aa) that the drug is to be discussed by the Drug Safety Oversight Board; andCommentsClose CommentsPermalink

`(bb) of the date on which the Drug Safety Oversight Board shall discuss such drug; andCommentsClose CommentsPermalink

`(III) shall apply section 301(j), section 552 of title 5, and section 1905 of title 18, United States Code, to any request for information about such review.CommentsClose CommentsPermalink





`(iii) AGREEMENT AFTER DISCUSSION OR ADMINISTRATIVE APPEALS-CommentsClose CommentsPermalink





`(I) FURTHER DISCUSSION OR ADMINISTRATIVE APPEALS- A request for review under clause (i) shall not preclude--CommentsClose CommentsPermalink

`(aa) further discussions to reach agreement on the risk evaluation and mitigation strategy; orCommentsClose CommentsPermalink

`(bb) the use of administrative appeals within the Food and Drug Administration to reach agreement on the strategy, including the major dispute resolution procedures as set forth in the letters described in section 735(a).CommentsClose CommentsPermalink

`(II) AGREEMENT TERMINATES DISPUTE RESOLUTION- At any time before a decision and order is issued under clause (vi), the Secretary (acting through the offices described in subparagraph (A)(ii)(I)) and the applicant may reach an agreement on the risk evaluation and mitigation strategy through further discussion or administrative appeals, terminating the dispute resolution process, and the Secretary shall issue an action letter or order, as appropriate, that describes the strategy.CommentsClose CommentsPermalink





`(iv) MEETING OF THE BOARD- At the meeting of the Drug Safety Oversight Board described in clause (ii), the Board shall--CommentsClose CommentsPermalink





`(I) hear from both parties; andCommentsClose CommentsPermalink





`(II) review the dispute.CommentsClose CommentsPermalink





`(v) RECOMMENDATION OF THE BOARD- Not later than 5 days after such meeting of the Drug Safety Oversight Board, the Board shall provide a written recommendation on resolving the dispute to the Secretary.CommentsClose CommentsPermalink





`(vi) ACTION BY THE SECRETARY-CommentsClose CommentsPermalink





`(I) ACTION LETTER- With respect to a proposed risk evaluation and mitigation strategy submitted under subparagraph (A)(i) or to an assessment of the strategy submitted under subparagraph (A)(ii)(II)(aa) or to an assessment of the strategy submitted under subparagraph (B)(ii)(I), the Secretary shall issue an action letter that resolves the dispute not later than the later of--CommentsClose CommentsPermalink

`(aa) the action deadline for the action letter on the application; orCommentsClose CommentsPermalink

`(bb) 7 days after receiving the recommendation of the Drug Safety Oversight Board.CommentsClose CommentsPermalink

`(II) ORDER- With respect to a proposed risk evaluation and mitigation strategy submitted under subparagraph (A)(ii) or an assessment item (bb) or (cc) of subparagraph (A)(ii)(II) or an assessment of the risk evaluation and mitigation strategy under subparagraph (B)(i) or under subclause (II), (III), (IV), or (V) of subparagraph (B)(ii), the Secretary shall issue an order, which (with the recommendation of the Drug Safety Oversight Board) shall be made public, that resolves the dispute not later than 7 days after receiving the recommendation of the Drug Safety Oversight Board.CommentsClose CommentsPermalink





`(vii) INACTION- An approved risk evaluation and mitigation strategy shall remain in effect until the Secretary acts, if the Secretary fails to act as provided for under clause (vi).CommentsClose CommentsPermalink





`(viii) EFFECT ON ACTION DEADLINE- With respect to the application or supplemental application in which a proposed risk evaluation and mitigation strategy is submitted under subparagraph (A)(i) or in which an assessment of the strategy is submitted under subparagraph (A)(ii)(II)(aa) or in which an assessment of the strategy is submitted under subparagraph (B)(ii)(I), the Secretary shall be considered to have met the action deadline for the action letter on such application if the applicant requests the dispute resolution process described in this subparagraph and if the Secretary--CommentsClose CommentsPermalink





`(I) has initiated the discussions described under subparagraph (D) by the target date referred to in subparagraph (D)(i); andCommentsClose CommentsPermalink





`(II) has complied with the timing requirements of scheduling review by the Drug Safety Oversight Board, providing a written recommendation, and issuing an action letter under clauses (ii), (v), and (vi), respectively.CommentsClose CommentsPermalink





`(ix) DISQUALIFICATION- No individual who is an employee of the Food and Drug Administration and who reviews a drug or who participated in an administrative appeal under clause (iii)(I) with respect to such drug may serve on the Drug Safety Oversight Board at a meeting under clause (iv) to review a dispute about the risk evaluation and mitigation strategy for such drug.CommentsClose CommentsPermalink





`(x) ADDITIONAL EXPERTISE- The Drug Safety Oversight Board may add members with relevant expertise from the Food and Drug Administration, including the Office of Pediatrics, the Office of Women's Health, or the Office of Rare Diseases, or from other Federal public health or health care agencies, for a meeting under clause (iv) of the Drug Safety Oversight Board.CommentsClose CommentsPermalink





`(H) USE OF ADVISORY COMMITTEES- The Secretary (acting through the offices described in subparagraph (A)(ii)(I)) may convene a meeting of 1 or more advisory committees of the Food and Drug Administration to--CommentsClose CommentsPermalink





`(i) review a concern about the safety of a drug or class of drugs, including before an assessment of the risk evaluation and mitigation strategy or strategies of such drug or drugs is required to be submitted under subclause (II), (III), (IV), or (V) of subparagraph (B)(ii);CommentsClose CommentsPermalink





`(ii) review the risk evaluation and mitigation strategy or strategies of a drug or group of drugs; orCommentsClose CommentsPermalink





`(iii) with the consent of the applicant, review a dispute under subparagraph (G).CommentsClose CommentsPermalink





`(I) PROCESS FOR ADDRESSING DRUG CLASS EFFECTS-CommentsClose CommentsPermalink





`(i) IN GENERAL- When a concern about a serious risk of a drug may be related to the pharmacological class of the drug, the Secretary (acting through the offices described in subparagraph (A)(ii)(I)) may defer assessments of the approved risk evaluation and mitigation strategies for such drugs until the Secretary has--CommentsClose CommentsPermalink





`(I) convened, after appropriate public notice, 1 or more public meetings to consider possible responses to such concern; orCommentsClose CommentsPermalink





`(II) gathered additional information or data about such concern.CommentsClose CommentsPermalink





`(ii) PUBLIC MEETINGS- Such public meetings may include--CommentsClose CommentsPermalink





`(I) 1 or more meetings of the applicants for such drugs;CommentsClose CommentsPermalink





`(II) 1 or more meetings of 1 or more advisory committees of the Food and Drug Administration, as provided for under subparagraph (H); orCommentsClose CommentsPermalink





`(III) 1 or more workshops of scientific experts and other stakeholders.CommentsClose CommentsPermalink





`(iii) ACTION- After considering the discussions from any meetings under clause (ii), the Secretary may--CommentsClose CommentsPermalink





`(I) announce in the Federal Register a planned regulatory action, including a modification to each risk evaluation and mitigation strategy, for drugs in the pharmacological class;CommentsClose CommentsPermalink





`(II) seek public comment about such action; andCommentsClose CommentsPermalink





`(III) after seeking such comment, issue an order addressing such regulatory action.CommentsClose CommentsPermalink





`(J) INTERNATIONAL COORDINATION- The Secretary (acting through the offices described in subparagraph (A)(ii)(I)) may coordinate the timetable for submission of assessments under paragraph (3)(B), a study under paragraph (4)(B), or a clinical trial under paragraph (4)(C), with efforts to identify and assess the serious risks of such drug by the marketing authorities of other countries whose drug approval and risk management processes the Secretary deems comparable to the drug approval and risk management processes of the United States.CommentsClose CommentsPermalink





`(K) EFFECT- Use of the processes described in subparagraphs (I) and (J) shall not delay action on an application or a supplement to an application for a drug.CommentsClose CommentsPermalink





`(L) NO EFFECT ON LABELING CHANGES THAT DO NOT REQUIRE PREAPPROVAL- In the case of a labeling change to which section 314.70 of title 21, Code of Federal Regulations (or any successor regulation), applies for which the submission of a supplemental application is not required or for which distribution of the drug involved may commence upon the receipt by the Secretary of a supplemental application for the change, the submission of an assessment of the approved risk evaluation and mitigation strategy for the drug under this subsection is not required.CommentsClose CommentsPermalink





`(8) DRUG SAFETY OVERSIGHT BOARD-CommentsClose CommentsPermalink





`(A) IN GENERAL- There is established a Drug Safety Oversight Board.CommentsClose CommentsPermalink





`(B) COMPOSITION; MEETINGS- The Drug Safety Oversight Board shall--CommentsClose CommentsPermalink





`(i) be composed of scientists and health care practitioners appointed by the Secretary, each of whom is an employee of the Federal Government;CommentsClose CommentsPermalink





`(ii) include representatives from offices throughout the Food and Drug Administration (including the offices responsible for postapproval safety of drugs);CommentsClose CommentsPermalink





`(iii) include at least 1 representative each from the National Institutes of Health, the Department of Health and Human Services (other than the Food and Drug Administration), and the Veterans Health Administration; andCommentsClose CommentsPermalink





`(iv) meet at least monthly to provide oversight and advice to the Secretary on the management of important drug safety issues.CommentsClose CommentsPermalink





`(9) CIVIL MONETARY PENALTY- Notwithstanding any other provision of this Act, an applicant (as such term is defined for purposes of this section) that knowingly fails to comply with a requirement of an approved risk evaluation and mitigation strategy under this subsection shall be subject to a civil money penalty of $250,000 for the first 30-day period that the applicant is in noncompliance, and such amount shall double for every 30-day period thereafter that the requirement is not complied with, not to exceed $2,000,000.'.CommentsClose CommentsPermalink

SEC. 203. ENFORCEMENT.

(a) Misbranding- Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following:CommentsClose CommentsPermalink





`(x) If it is a drug subject to an approved risk evaluation and mitigation strategy under section 505(o) and the applicant for such drug fails to--CommentsClose CommentsPermalink





`(1) make a labeling change required by such strategy after the Secretary has approved such strategy or completed review of, and acted on, an assessment of such strategy under paragraph (7) of such section; orCommentsClose CommentsPermalink





`(2) comply with a requirement of such strategy with respect to advertising as provided for under subparagraph (D), (E), or (F) of paragraph (5) of such section.'.CommentsClose CommentsPermalink





(b) Civil Penalties- Section 303(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)) is amended--CommentsClose CommentsPermalink





(1) by redesignating paragraphs (3), (4), and (5) as paragraphs (4), (5), and (6), respectively;CommentsClose CommentsPermalink





(2) by inserting after paragraph (2) the following:CommentsClose CommentsPermalink





`(3) An applicant (as such term is used in section 505(o)) who knowingly fails to comply with a requirement of an approved risk evaluation and mitigation strategy under such section 505(o) shall be subject to a civil money penalty of not less than $15,000 and not more than $250,000 per violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding.';CommentsClose CommentsPermalink





(3) in paragraph (2)(C), by striking `paragraph (3)(A)' and inserting `paragraph (4)(A)';CommentsClose CommentsPermalink





(4) in paragraph (4), as so redesignated, by striking `paragraph (1) or (2)' each place it appears and inserting `paragraph (1), (2), or (3)'; andCommentsClose CommentsPermalink





(5) in paragraph (6), as so redesignated, by striking `paragraph (4)' each place it appears and inserting `paragraph (5)'.CommentsClose CommentsPermalink

SEC. 204. REGULATION OF DRUGS THAT ARE BIOLOGICAL PRODUCTS.

Section 351 of the Public Health Service Act (42 U.S.C. 262) is amended--CommentsClose CommentsPermalink





(1) in subsection (a)(2), by adding at the end the following:CommentsClose CommentsPermalink





`(D) Risk Evaluation and Mitigation Strategy- A person that submits an application for a license for a drug under this paragraph may submit to the Secretary as part of the application a proposed risk evaluation and mitigation strategy as described under section 505(o) of the Federal Food, Drug, and Cosmetic Act.'; andCommentsClose CommentsPermalink





(2) in subsection (j), by inserting `, including the requirements under section 505(o) of such Act,' after `, and Cosmetic Act'.CommentsClose CommentsPermalink

SEC. 205. NO EFFECT ON WITHDRAWAL OR SUSPENSION OF APPROVAL.

Section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)) is amended by adding at the end the following: `The Secretary may withdraw the approval of an application submitted under this section, or suspend the approval of such an application, as provided under this subsection, without first ordering the applicant to submit an assessment of the approved risk evaluation and mitigation strategy for the drug under subsection (o)(7)(B)(ii)(V).'.CommentsClose CommentsPermalink

SEC. 206. DRUGS SUBJECT TO AN ABBREVIATED NEW DRUG APPLICATION.

Section 505(j)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)) is amended by adding at the end the following:CommentsClose CommentsPermalink





`(E) Risk Evaluation and Mitigation Strategy Requirement-CommentsClose CommentsPermalink





`(i) IN GENERAL- A drug that is the subject of an abbreviated new drug application under this subsection shall be subject to only the following elements of the approved risk evaluation and mitigation strategy if required under subsection (o) for the applicable listed drug:CommentsClose CommentsPermalink





`(I) Labeling, as required under subsection (o)(3)(A) for the applicable listed drug.CommentsClose CommentsPermalink





`(II) A Medication Guide or patient package insert, if required under subsection (o)(5)(B) for the applicable listed drug.CommentsClose CommentsPermalink





`(III) Prereview of advertising, if required under subsection (o)(5)(D) for the applicable listed drug.CommentsClose CommentsPermalink





`(IV) Specific disclosures in advertising, if required under subsection (o)(5)(E) for the applicable listed drug.CommentsClose CommentsPermalink





`(V) A temporary moratorium on direct-to-consumer advertising, if required under subsection (o)(5)(F) for the applicable listed drug.`(VI) Restrictions on distribution orElements to assure safe use, if required under subsection (o)(6) for the applicable listed drug, except that such drug may use a different, comparable aspect of such restrictions on distribution or use as are needed to assure safe use of such drug if elements as are necessary to assure safe use of such drug if--CommentsClose CommentsPermalink





`(aa) the corresponding aspect of the restrictions on distribution or use for theelements to assure safe use for the applicable listed drug is claimed by a patent that has not expired or is a method or process that as a trade secret is entitled to protection; andCommentsClose CommentsPermalink





`(bb) the applicant certifies that it has sought a license for use of such aspect of the restrictions on distribution or use for theelements to assure safe use for the applicable listed drug.CommentsClose CommentsPermalink





`(ii) ACTION BY SECRETARY- For an applicable listed drug for which a drug is approved under this subsection, the Secretary--CommentsClose CommentsPermalink





`(I) shall undertake any communication plan to health care providers required under section (o)(5)(C) for the applicable listed drug;CommentsClose CommentsPermalink





`(II) shall conduct, or contract for, any postapproval study required under subsection (o)(4)(B) for the applicable listed drug;CommentsClose CommentsPermalink





`(III) shall inform the applicant for a drug approved under this subsection if the approved risk evaluation and mitigation strategy for the applicable listed drug is modified; andCommentsClose CommentsPermalink





`(IV) in order to minimize the burden on the health care delivery system of different restrictions on distribution or use for the drug approved under this subsection and the applicable listed elements to assure safe use for the drug approved under this subsection and the applicable listed drug, may seek to negotiate a voluntary agreement with the owner of the patent, method, or process for a license under which the applicant for such drug may use an aspect of the restrictions on distribution orelements to assure safe use, if required under subsection (o)(6) for the applicable listed drug, that is claimed by a patent that has not expired or is a method or process that as a trade secret is entitled to protection.'.CommentsClose CommentsPermalink

SEC. 207. RESOURCES.

(a) User Fees- Subparagraph (F) of section 735(d)(6) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(d)(6)), as amended by section 103, is amended--CommentsClose CommentsPermalink





(1) in clause (ii), by striking `systems); and' and inserting `systems);'CommentsClose CommentsPermalink





(2) in clause (iii), by striking `bases).' and inserting `bases); and'; andCommentsClose CommentsPermalink





(3) by adding at the end the following:CommentsClose CommentsPermalink





`(iv) reviewing, implementing, and ensuring compliance with risk evaluation and mitigation strategies.'.CommentsClose CommentsPermalink





(b) Workload Adjustment- Subparagraph (A) of section 736(c)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)(2)), as amended by section 103, is amended in the first sentence by striking `and manufacturing changes submitted to the Secretary, and' and inserting `manufacturing changes, and assessments of risk evaluation and mitigation strategies submitted to the Secretary, uses of dispute resolution under the process for reviewing and assessing risk evaluation and mitigation strategies, and'.(c) Additional Fee Revenues for Drug Safety- Section 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h), as amended by section 103, is amended by--CommentsClose CommentsPermalink





(1) striking the subsection designation and all that follows through `- Except' and inserting the following:CommentsClose CommentsPermalink





`(b) Fee Revenue Amounts-CommentsClose CommentsPermalink





`(1) IN GENERAL- Except'; andCommentsClose CommentsPermalink





(2) adding at the end the following:CommentsClose CommentsPermalink





`(2) ADDITIONAL FEE REVENUES FOR DRUG SAFETY-CommentsClose CommentsPermalink





`(A) IN GENERAL- Subject to subparagraph (C), in each of fiscal years 2008 through 2012, paragraph (1) shall be applied by substituting the amount determined under subparagraph (B) for `$392,783,000'.CommentsClose CommentsPermalink





`(B) AMOUNT DETERMINED- For any fiscal year 2008 through 2012, the amount determined under this subparagraph is the sum of--CommentsClose CommentsPermalink





`(i) $392,783,000; plusCommentsClose CommentsPermalink





`(ii) the amount equal to--CommentsClose CommentsPermalink





`(I) $50(aa) for fiscal year 2008, $25,000,000;CommentsClose CommentsPermalink





`(bb) for fiscal year 2009, $35,000,000;CommentsClose CommentsPermalink





`(cc) for fiscal year 2010, $45,000,000;CommentsClose CommentsPermalink





`(dd) for fiscal year 2011, $55,000,000; andCommentsClose CommentsPermalink





`(ee) for fiscal year 2012, $65,000,000; minusCommentsClose CommentsPermalink





`(II) the amount equal to one-fifth of the amount by which the appropriations for salaries and expenses ofexcess amount in item (bb), provided that--CommentsClose CommentsPermalink





`(aa) the amount of the total appropriation for the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) exceed the amount of appropriations for the salaries and expenses of the Food and Drug Administration for thes the amount of the total appropriation for the Food and Drug Administration for fiscal year 2007 (excluding the amount of fees appropriated for such fiscal year), adjusted as provided under subsection (c)(1); andCommentsClose CommentsPermalink





`(bb) the amount of the total appropriations for the process of human drug review at the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) exceeds the amount of appropriations for the process of human drug review at the Food and Drug Administration for fiscal year 2007 (excluding the amount of fees appropriated for such fiscal year), adjusted as provided under subsection (c)(1).CommentsClose CommentsPermalink





In making the adjustment under subclause (II) for any fiscal year 2008 through 2012, subsection (c)(1) shall be applied by substituting `2007' for `2008'.`(C) .'CommentsClose CommentsPermalink





`(C) LIMITATION- This paragraph shall not apply for any fiscal year if the amount described under subparagraph (B)(ii) is less than 0.'.CommentsClose CommentsPermalink





(dc) Strategic Plan for Information Technology- Not later than 1 year after the date of enactment of this title, the Secretary of Health and Human Services (referred to in this title as the `Secretary') shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, a strategic plan on information technology that includes--CommentsClose CommentsPermalink





(1) an assessment of the information technology infrastructure, including systems for data collection, access to data in external health care databases, data mining capabilities, personnel, and personnel training programs, needed by the Food and Drug Administration to--CommentsClose CommentsPermalink





(A) comply with the requirements of this subtitle (and the amendments made by this subtitle);CommentsClose CommentsPermalink





(B) achieve interoperability within and among the centers of the Food and Drug Administration and between the Food and Drug Administration and product application sponsors;CommentsClose CommentsPermalink





(C) utilize electronic health records;CommentsClose CommentsPermalink





and(D) (D) implement routine active safety monitoring under section urveillance under section 505(k)(3)(including other (including complementary approaches under subsection (c) of such section) of the Federal Food, Drug, and Cosmetic Act, as added by section 201 of this Act; andCommentsClose CommentsPermalink





(E) communicate drug safety information to physicians and other health care providers;CommentsClose CommentsPermalink





(2) an assessment of the extent to which the current information technology assets of the Food and Drug Administration are sufficient to meet the needs assessments under paragraph (1);CommentsClose CommentsPermalink





(3) a plan for enhancing the information technology assets of the Food and Drug Administration toward meeting the needs assessments under paragraph (1); andCommentsClose CommentsPermalink





(4) an assessment of additional resources needed to so enhance the information technology assets of the Food and Drug Administration.CommentsClose CommentsPermalink

SEC. 208. SAFETY LABELING CHANGES.

(a) In General- Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506C the following:CommentsClose CommentsPermalink

`SEC. 506D. SAFETY LABELING CHANGES.

`(a) New Safety Information-CommentsClose CommentsPermalink





`(1) NOTIFICATION- The holder of an approved application under section 505 of this Act or a license under section 351 of the Public Health Service Act (referred to in this section as a `holder') shall promptly notify the Secretary if the holder becomes aware of new safety information that the holder believes should be included in the labeling of the drug. The Secretary shall promptly notify the holder if the Secretary becomes aware of new safety information that the Secretary believes should be included in the labeling of the drug.CommentsClose CommentsPermalink





`(2) DISCUSSION REGARDING LABELING CHANGES- Following notification pursuant to paragraph (1), the Secretary and holder shall initiate discussions of the new safety information in order to reach agreement on whether the labeling for the drug should be modified to reflect the new safety information and, if so, on the contents of such labeling changes.CommentsClose CommentsPermalink





`(3) SUPPLEMENT- If the Secretary determines that there is reasonable scientific evidence that an adverse event is associated with use of the drug, the Secretary may request the holder to submit a supplement to an application under section 505 of this Act or to a license under section 351 of the Public Health Service Act (referred to in this section as a `supplement') proposing changes to the approved labeling to reflect the new safety information, including changes to boxed warnings, contraindications, warnings, precautions, or adverse reactions (referred to in this section as a `safety labeling change'). If the Secretary determines that no safety labeling change is necessary or appropriate based upon the new safety information, the Secretary shall notify the holder of this determination in writing.CommentsClose CommentsPermalink





`(b) Labeling Supplements-CommentsClose CommentsPermalink





`(1) IN GENERAL- The holder shall submit a supplement whenever the holder seeks, either at the holder's own initiative or at the request of the Secretary, to make a safety labeling change.CommentsClose CommentsPermalink





`(2) NONACCELERATED PROCESS- Unless the accelerated labeling review process described in subsection (c) is initiated, any supplement proposing a safety labeling change shall be reviewed and acted upon by the Secretary not later than 30 days after the date the Secretary receives the supplement. Until the Secretary acts on such a supplement proposing a safety labeling change, the existing approved labeling shall remain in effect and be distributed by the holder without change.CommentsClose CommentsPermalink





`(3) NEW SAFETY INFORMATION- Nothing in this section shall prohibit the Secretary from informing health care professionals or the public about new safety information prior to approval of a supplement proposing a safety labeling change.CommentsClose CommentsPermalink





`(c) Accelerated Labeling Review Process- An accelerated labeling review process shall be available to resolve disagreements in a timely manner between the Secretary and a holder about the need for, or content of, a safety labeling change, as follows:CommentsClose CommentsPermalink





`(1) REQUEST TO INITIATE ACCELERATED PROCESS- The accelerated labeling review process shall be initiated upon the written request of either the Secretary or the holder. Such request may be made at any time after the notification described in subsection (a)(1), including during the Secretary's review of a supplement proposing a safety labeling change.CommentsClose CommentsPermalink





`(2) SCIENTIFIC DISCUSSION AND MEETINGS-CommentsClose CommentsPermalink





`(A) IN GENERAL- Following initiation of the accelerated labeling review process, the Secretary and holder shall immediately initiate discussions to review and assess the new safety information and to reach agreement on whether safety labeling changes are necessary and appropriate and, if so, the content of such safety labeling changes.CommentsClose CommentsPermalink





`(B) TIME PERIOD- The discussions under this paragraph shall not extend for more than 45 calendar days after the initiation of the accelerated labeling review process.CommentsClose CommentsPermalink





`(C) DISPUTE PROCEEDINGS- If the Secretary and holder do not reach an agreement regarding the safety labeling changes by not later than 25 calendar days after the initiation of the accelerated labeling review process, the dispute automatically shall be referred to the director of the drug evaluation office responsible for the drug under consideration, who shall be required to take an active role in such discussions.CommentsClose CommentsPermalink





`(3) REQUEST FOR SAFETY LABELING CHANGE AND FAILURE TO AGREE- If the Secretary and holder fail to reach an agreement on appropriate safety labeling changes by not later than 45 calendar days after the initiation of the accelerated labeling review process--CommentsClose CommentsPermalink





`(A) on the next calendar day (other than a weekend or Federal holiday) after such period, the Secretary shall--CommentsClose CommentsPermalink





`(i) request in writing that the holder make any safety labeling change that the Secretary determines to be necessary and appropriate based upon the new safety information; orCommentsClose CommentsPermalink





`(ii) notify the holder in writing that the Secretary has determined that no safety labeling change is necessary or appropriate; andCommentsClose CommentsPermalink





`(B) if the Secretary fails to act within the specified time, or if the holder does not agree to make a safety labeling change requested by the Secretary or does not agree with the Secretary's determination that no labeling change is necessary or appropriate, the Secretary (on his own initiative or upon request by the holder) shall refer the matter for expedited review to the Drug Safety Oversight Board.CommentsClose CommentsPermalink





`(4) ACTION BY THE DRUG SAFETY OVERSIGHT BOARD- Not later than 45 days after receiving a referral under paragraph (3)(B), the Drug Safety Oversight Board shall--CommentsClose CommentsPermalink





`(A) review the new safety information;CommentsClose CommentsPermalink





`(B) review all written material submitted by the Secretary and the holder;CommentsClose CommentsPermalink





`(C) convene a meeting to hear oral presentations and arguments from the Secretary and holder; andCommentsClose CommentsPermalink





`(D) make a written recommendation to the Secretary--CommentsClose CommentsPermalink





`(i) concerning appropriate safety labeling changes, if any; orCommentsClose CommentsPermalink





`(ii) stating that no safety labeling changes are necessary or appropriate based upon the new safety information.CommentsClose CommentsPermalink





`(5) CONSIDERATION OF RECOMMENDATIONS-CommentsClose CommentsPermalink





`(A) ACTION BY THE SECRETARY- The Secretary shall consider the recommendation of the Drug Safety Oversight Board made under paragraph (4)(D) and, not later than 20 days after receiving the recommendation--CommentsClose CommentsPermalink





`(i) issue an order requiring the holder to make any safety labeling change that the Secretary determines to be necessary and appropriate; orCommentsClose CommentsPermalink





`(ii) if the Secretary determines that no safety labeling change is necessary or appropriate, the Secretary shall notify the holder of this determination in writing.CommentsClose CommentsPermalink





`(B) FAILURE TO ACT- If the Secretary fails to act by not later than 20 days after receiving the recommendation of the Drug Safety Oversight Board, the written recommendation of the Drug Safety Oversight Board shall be considered the order of the Secretary under this paragraph.CommentsClose CommentsPermalink





`(C) NONDELEGATION- The Secretary's authority under this paragraph shall not be redelegated to an individual below the level of the Director of the Center for Drug Evaluation and Research, or the Director of the Center for Biologics Evaluation and Research, of the Food and Drug Administration.CommentsClose CommentsPermalink





`(6) MISBRANDING- If the holder, not later than 10 days after receiving an order under subparagraph (A) or (B) of paragraph (5), does not agree to make a safety labeling change ordered by the Secretary, the Secretary may deem the drug that is the subject of the request to be misbranded.CommentsClose CommentsPermalink





`(d) Rule of Construction- Nothing in this section shall be construed to change the standards in existence on the date of enactment of this section for determining whether safety labeling changes are necessary or appropriate.'.CommentsClose CommentsPermalink





(b) Conforming Amendment- Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352 et seq.), as amended by section 203, is further amended by adding at the end the following:CommentsClose CommentsPermalink





`(y) If it is a drug and the holder does not agree to make a safety labeling change ordered by the Secretary under section 506D(c) within 10 days after issuance of such an order.'.CommentsClose CommentsPermalink

SEC. 209. DRUG LABELING.(a) Accessible Repository of Drug Labeling- Not later than the effective date of this subtitle, the Secretary, through the Commissioner of Food and Drugs, and the Director of the National Institutes of Health, shall establish a searchable repository of structured, electronic product information, including the approved professional labeling and any required patient labeling of each drug approved under sectionPOSTMARKET DRUG SAFETY INFORMATION FOR PATIENTS AND PROVIDERS.

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by section 251, is amended by adding at the end the following:CommentsClose CommentsPermalink





`(r) Postmarket Drug Safety Information for Patients and Providers-CommentsClose CommentsPermalink





`(1) ESTABLISHMENT- Not later than 1 year after the date of enactment of the Enhancing Drug Safety and Innovation Act of 2007, the Secretary shall improve the transparency of pharmaceutical data and allow patients and health care providers better access to pharmaceutical data by developing and maintaining an Internet website that--CommentsClose CommentsPermalink





`(A) provides comprehensive drug safety information for prescription drugs that are approved by the Secretary under this section or licensed under section 351 of the Public Health Service Act (42 U.S.C. 262) in order to improve patient safety through accessible product information, support initiatives to improve patient care by better management of health care information, and provide standards for drug information. Such repository shall be made publicly accessible on the Internet website of the; andCommentsClose CommentsPermalink





`(B) improves communication of drug safety information to patients and providers.CommentsClose CommentsPermalink





`(2) INTERNET WEBSITE- The Secretary shall carry out paragraph (1) by--CommentsClose CommentsPermalink





`(A) developing and maintaining an accessible, consolidated Internet website with easily searchable drug safety information, including the information found on United States Government Internet websites, such as the United States National Library of Medicine and through a link on the homepage of the Internet website of the Food and Drug Administration.(b) Posting Upon Approval- The Secretary shall post in the repository under subsection (a) the approved professional labeling and any required patient labeling of a drug approved under such section 505 or licensed under such section 351 not later than 21 days after the date the drug is approved, including in a supplemental application with respect to a labeling change.(c) Report- The Secretary shall report annually to the Committee on Health, Education, Labor and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on the status of the repository under subsection (a), and on progress in posting structured electronic product information, including posting of information regarding drugs approved prior to the effective date of this subtitle.(d) Medication Guides- Not later than the effective date of this subtitle, the Secretary, through the Commissioner of Food and Drugs, shall establish on the Internet website for the repository under subsection (a), a link to a list of each drug, whether approved under such section 505's Daily Med and Medline Plus websites, in addition to other such websites maintained by the Secretary;CommentsClose CommentsPermalink





`(B) ensuring that the information provided on the Internet website is comprehensive and includes, when available and appropriate--CommentsClose CommentsPermalink





`(i) patient labeling and patient packaging inserts;CommentsClose CommentsPermalink





`(ii) a link to a list of each drug, whether approved under this section or licensed under such section 351, for which a Medication Guide, as provided for under part 208 of title 21, Code of Federal Regulations (or any successor regulations), is required;CommentsClose CommentsPermalink





`(iii) a link to the clinical trial registry data bank provided for under subsections (i) and (j) of section 402 of the Public Health Service Act;CommentsClose CommentsPermalink





`(iv) the most recent safety information and alerts issued by the Food and Drug Administration for drugs approved by the Secretary under this section, such as product recalls, warning letters, and import alerts;CommentsClose CommentsPermalink





`(v) publicly available information about implemented RiskMAPs and risk evaluation and mitigation strategies under subsection (o);CommentsClose CommentsPermalink





`(vi) guidance documents and regulations related to drug safety; andCommentsClose CommentsPermalink





`(vii) other material determined appropriate by the Secretary;CommentsClose CommentsPermalink





`(C) including links to non-Food and Drug Administration Internet resources that provide access to relevant drug safety information, such as medical journals and studies;CommentsClose CommentsPermalink





`(D) providing access to summaries of the assessed and aggregated data collected from the active surveillance infrastructure under subsection (k)(3) to provide information of known and serious side-effects for drugs approved by the Secretary under this section or licensed under such section 351;CommentsClose CommentsPermalink





`(E) enabling patients, providers, and drug sponsors to submit adverse event reports through the Internet website;CommentsClose CommentsPermalink





`(F) providing educational materials for patients and providers about the appropriate means of disposing of expired, damaged, or unusable medications; andCommentsClose CommentsPermalink





`(G) supporting initiatives that the Secretary determines to be useful to fulfill the purposes of the Internet website.CommentsClose CommentsPermalink





`(3) POSTING OF DRUG LABELING- The Secretary shall post on the Internet website established under paragraph (1) the approved professional labeling and any required patient labeling of a drug approved under this section or licensed under such section 351 not later than 21 days after the date the drug is approved or licensed, including in a supplemental application with respect to a labeling change.CommentsClose CommentsPermalink





`(4) PRIVATE SECTOR RESOURCES- To ensure development of the Internet website by the date described in paragraph (1), the Secretary may, on a temporary or permanent basis, implement systems or products developed by private entities.CommentsClose CommentsPermalink





`(5) AUTHORITY FOR CONTRACTS- The Secretary may enter into contracts with public and private entities to fulfill the requirements of this subsection.CommentsClose CommentsPermalink





`(6) REVIEW- The Advisory Committee on Risk Communication under section 566 shall, on a regular basis, perform a comprehensive review and evaluation of the types of risk communication information provided on the Internet website established under paragraph (1) and, through other means, shall identify, clarify, and define the purposes and types of information available to facilitate the efficient flow of information to patients and providers, and shall recommend ways for the Food and Drug Administration to work with outside entities to help facilitate the dispensing of risk communication information to patients and providers.'.CommentsClose CommentsPermalink

SEC. 210. ACTION PACKAGE FOR APPROVAL.

Section 505(l) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(l)) is amended by--CommentsClose CommentsPermalink





(1) redesignating paragraphs (1), (2), (3), (4), and (5) as subparagraphs (A), (B), (C), (D), and (E), respectively;CommentsClose CommentsPermalink





(2) striking `(l) Safety and' and inserting `(l)(1) Safety and'; andCommentsClose CommentsPermalink





(3) adding at the end the following:CommentsClose CommentsPermalink





`(2) Action Package for Approval-CommentsClose CommentsPermalink





`(A) ACTION PACKAGE- The Secretary shall publish the action package for approval of an application under subsection (b) or section 351 of the Public Health Service Act on the Internet website of the Food and Drug Administration--CommentsClose CommentsPermalink





`(i) not later than 30 days after the date of approval of such application for a drug no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under this section or section 351 of the Public Health Service Act; andCommentsClose CommentsPermalink





`(ii) not later than 30 days after the third request for such action package for approval received under section 552 of title 5, United States Code, for any other drug.CommentsClose CommentsPermalink





`(B) IMMEDIATE PUBLICATION OF SUMMARY REVIEW- Notwithstanding subparagraph (A), the Secretary shall publish, on the Internet website of the Food and Drug Administration, the materials described in subparagraph (C)(iv) not later than 48 hours after the date of approval of the drug, except where such materials require redaction by the Secretary.CommentsClose CommentsPermalink





`(C) CONTENTS- An action package for approval of an application under subparagraph (A) shall be dated and shall include the following:CommentsClose CommentsPermalink





`(i) Documents generated by the Food and Drug Administration related to review of the application.CommentsClose CommentsPermalink





`(ii) Documents pertaining to the format and content of the application generated during drug development.CommentsClose CommentsPermalink





`(iii) Labeling submitted by the applicant.CommentsClose CommentsPermalink





`(iv) A summary review that documents conclusions from all reviewing disciplines about the drug, noting any critical issues and disagreements with the applicant and how they were resolved, recommendation for action, and an explanation of any nonconcurrence with review conclusions.CommentsClose CommentsPermalink





`(v) If applicable, a separate review from a supervisor who does not concur with the summary review.CommentsClose CommentsPermalink





`(vi) Identification by name of each officer or employee of the Food and Drug Administration who--CommentsClose CommentsPermalink





`(I) participated in the decision to approve the application; andCommentsClose CommentsPermalink





`(II) consents to have his or her name included in the package.CommentsClose CommentsPermalink





`(D) DISAGREEMENTS- A scientific review of an application is considered the work of the reviewer and shall not be altered by management or the reviewer once final. Disagreements by team leaders, division directors, or office directors with any or all of the major conclusions of a reviewer shall be document in a separate review or in an addendum to the review.CommentsClose CommentsPermalink





`(E) CONFIDENTIAL INFORMATION- This paragraph does not authorize the disclosure of any trade secret or confidential commercial or financial information described in section 552(b)(4) of title 5, United States Code, unless the Secretary declares an emergency under section 319 of the Public Health Service Act and such disclosure is necessary to mitigate the effects of such emergency.'.CommentsClose CommentsPermalink

SEC. 211. RISK COMMUNICATION.

Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end the following:CommentsClose CommentsPermalink

`SEC. 566. ADVISORY COMMITTEE ON RISK COMMUNICATION.

`(a) In GeneralAdvisory Committee on Risk Communication-CommentsClose CommentsPermalink





`(1) IN GENERAL- The Secretary shall establish an advisory committee to be known as the `Advisory Committee on Risk Communication' (referred to in this section as the `Committee').CommentsClose CommentsPermalink





`(b) Duties of Committee2) DUTIES OF COMMITTEE- The Committee shall advise the Commissioner on methods to effectively communicate risks associated with the products regulated by the Food and Drug Administration.CommentsClose CommentsPermalink





`(c) Members3) MEMBERS- The Secretary shall ensure that the Committee is composed of experts on risk communication, experts on the risks described in subsection (b), and representatives of patient, consumer, and health professional organizations.CommentsClose CommentsPermalink





`(d) Permanence of Committee4) PERMANENCE OF COMMITTEE- Section 14 of the Federal Advisory Committee Act shall not apply to the Committee established under this secubsection.CommentsClose CommentsPermalink





`(b) Partnerships for Risk Communication-CommentsClose CommentsPermalink





`(1) IN GENERAL- The Secretary shall partner with professional medical societies, medical schools, academic medical centers, and other stakeholders to develop robust and multi-faceted systems for communication to health care providers about emerging postmarket drug risks.CommentsClose CommentsPermalink





`(2) PARTNERSHIPS- The systems developed under paragraph (1) shall--CommentsClose CommentsPermalink





`(A) account for the diversity among physicians in terms of practice, affinity for technology, and focus; andCommentsClose CommentsPermalink





`(B) include the use of existing communication channels, including electronic communications, in place at the Food and Drug Administration.'.CommentsClose CommentsPermalink

SEC. 212. REFERRAL TO ADVISORY COMMITTEE.

Section 505 of the Federal Food, Drug, and Cosmetic Act, as amended by this sectionsection 202, is further amended by adding at the end the following:CommentsClose CommentsPermalink





`(p) Referral to Advisory Committee-CommentsClose CommentsPermalink





`(1) IN GENERAL- Prior to the approval of a drug no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under this section or section 351 of the Public Health Service Act, the Secretary shall refer such drug to a Food and Drug Administration advisory committee for review at a meeting of such advisory committee.CommentsClose CommentsPermalink





`(2) EXCEPTION- Notwithstanding paragraph (1), an advisory committee review of a drug described under such paragraph may occur within 1 year after approval of such a drug if--CommentsClose CommentsPermalink





`(A) the clinical trial that formed the primary basis of the safety and efficacy determination was halted by a drug safety monitoring board or an Institutional Review Board before its scheduled completion due to early unanticipated therapeutic results; orCommentsClose CommentsPermalink





`(B) the Secretary determines that it would be beneficial to the public health.'.CommentsClose CommentsPermalink

SEC. 213. RESPONSE TO THE INSTITUTE OF MEDICINE.

(a) In General- Not later than 1 year after the date of enactment of this title, the Secretary shall issue a report responding to the 2006 report of the Institute of Medicine entitled `The Future of Drug Safety--Promoting and Protecting the Health of the Public'.CommentsClose CommentsPermalink





(b) Content of Report- The report issued by the Secretary under subsection (a) shall include--CommentsClose CommentsPermalink





(1) an update on the implementation by the Food and Drug Administration of its plan to respond to the Institute of Medicine report described under such subsection; andCommentsClose CommentsPermalink





(2) an assessment of how the Food and Drug Administration has implemented--CommentsClose CommentsPermalink





(A) the recommendations described in such Institute of Medicine report; andCommentsClose CommentsPermalink





(B) the requirement under paragraph (7) of section 505(o) of the Federal Food, Drug, and Cosmetic Act (as added by this title), that the appropriate office responsible for reviewing a drug and the office responsible for postapproval safety with respect to the drug act together to assess, implement, and ensure compliance with the requirements of such section 505(o).CommentsClose CommentsPermalink

SEC. 214. EFFECTIVE DATE AND APPLICABILITY.

(a) Effective Dates-CommentsClose CommentsPermalink





(1) IN GENERAL- Except as provided in paragraph (2), this subtitle shall take effect 180 days after the date of enactment of this title.CommentsClose CommentsPermalink





(2) USER FEES- The amendments made by subsections (a) through (c) of section 207 shall take effect on October 1, 2007.CommentsClose CommentsPermalink





(b) Drugs Deemed To Have Risk Evaluation and Mitigation Strategies-CommentsClose CommentsPermalink





(1) IN GENERAL- A drug that was approved before the effective date of this subtitle shall be deemed to have an approved risk evaluation and mitigation strategy under section 505(o) of the Federal Food, Drug, and Cosmetic Act (as added by this subtitle) if there are in effect on the effective date of this subtitle restrictions on distribution or use--CommentsClose CommentsPermalink





(A) required under section 314.520 or section 601.42 of title 21, Code of Federal Regulations; orCommentsClose CommentsPermalink





(B) otherwise agreed to by the applicant and the Secretary for such drug.CommentsClose CommentsPermalink





(2) RISK EVALUATION AND MITIGATION STRATEGY- The approved risk evaluation and mitigation strategy deemed in effect for a drug under paragraph (1) shall consist of the elements described in subparagraphs (A) and (B) of paragraph (3) of such section 505(o) and any other additional elements under paragraphs (4), (5), and (6) in effect for such drug on the effective date of this subtitle.CommentsClose CommentsPermalink





(3) NOTIFICATION- Not later than 30 days after the effective date of this subtitle, the Secretary shall notify the applicant for each drug described in paragraph (1)--CommentsClose CommentsPermalink





(A) that such drug is deemed to have an approved risk evaluation and mitigation strategy pursuant to such paragraph; andCommentsClose CommentsPermalink





(B) of the date, which, unless a safety issue with the drug arises, shall be no earlier than 6 months after the applicant is so notified, by which the applicant shall submit to the Secretary an assessment of such approved strategy under paragraph (7)(B) of such section 505(o), except with respect to the drug Mifeprex (mifepristone), such assessment shall be submitted 6 months after the applicant is so notified.CommentsClose CommentsPermalink





(4) ENFORCEMENT ONLY AFTER ASSESSMENT AND REVIEW- Neither the Secretary nor the Attorney General may seek to enforce a requirement of a risk evaluation and mitigation strategy deemed in effect under paragraph (1) before the Secretary has completed review of, and acted on, the first assessment of such strategy under such section 505(o).CommentsClose CommentsPermalink





(c) No Effect on Veterinary Medicine- This subtitle, and the amendments made by this subtitle, shall have no effect on the use of drugs approved under section 505 of the Federal Food, Drug, and Cosmetic Act by, or on the lawful written or oral order of, a licensed veterinarian within the context of a veterinarian-client-patient relationship, as provided for under section 512(a)(5) of such Act.CommentsClose CommentsPermalink

Subtitle B--Reagan-Udall Foundation for the Food and Drug Administration

SEC. 221. THE REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION.

(a) In General- Chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at the end the following:CommentsClose CommentsPermalink

`Subchapter I--Reagan-Udall Foundation for the Food and Drug Administration

`SEC. 770. ESTABLISHMENT AND FUNCTIONS OF THE FOUNDATION.

`(a) In General- A nonprofit corporation to be known as the Reagan-Udall Foundation for the Food and Drug Administration (referred to in this subchapter as the `Foundation') shall be established in accordance with this section. The Foundation shall be headed by an Executive Director, appointed by the members of the Board of Directors under subsection (e). The Foundation shall not be an agency or instrumentality of the United States Government.CommentsClose CommentsPermalink





`(b) Purpose of Foundation- The purpose of the Foundation is to advance the mission of the Food and Drug Administration to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.CommentsClose CommentsPermalink





`(c) Duties of the Foundation- The Foundation shall--CommentsClose CommentsPermalink





`(1) taking into consideration the Critical Path reports and priorities published by the Food and Drug Administration, identify unmet needs in the development, manufacture, and evaluation of the safety and effectiveness, including postapproval, of devices, including diagnostics, biologics, and drugs, and the safety of food, food ingredients, and cosmetics;CommentsClose CommentsPermalink





`(2) establish goals and priorities in order to meet the unmet needs identified in paragraph (1);CommentsClose CommentsPermalink





`(3) in consultation with the Secretary, identify existing and proposed Federal intramural and extramural research and development programs relating to the goals and priorities established under paragraph (2), coordinate Foundation activities with such programs, and minimize Foundation duplication of existing efforts;CommentsClose CommentsPermalink





`(4) award grants to, or enter into contracts, memoranda of understanding, or cooperative agreements with, scientists and entities, which may include the Food and Drug Administration, university consortia, public-private partnerships, institutions of higher education, entities described in section 501(c)(3) of the Internal Revenue Code (and exempt from tax under section 501(a) of such Code), and industry, to efficiently and effectively advance the goals and priorities established under paragraph (2);CommentsClose CommentsPermalink





`(5) recruit meeting participants and hold or sponsor (in whole or in part) meetings as appropriate to further the goals and priorities established under paragraph (2);CommentsClose CommentsPermalink





`(6) release and publish information and data and, to the extent practicable, license, distribute, and release material, reagents, and techniques to maximize, promote, and coordinate the availability of such material, reagents, and techniques for use by the Food and Drug Administration, nonprofit organizations, and academic and industrial researchers to further the goals and priorities established under paragraph (2);CommentsClose CommentsPermalink





`(7) ensure that--CommentsClose CommentsPermalink





`(A) action is taken as necessary to obtain patents for inventions developed by the Foundation or with funds from the Foundation;CommentsClose CommentsPermalink





`(B) action is taken as necessary to enable the licensing of inventions developed by the Foundation or with funds from the Foundation; andCommentsClose CommentsPermalink





`(C) executed licenses, memoranda of understanding, material transfer agreements, contracts, and other such instruments, promote, to the maximum extent practicable, the broadest conversion to commercial and noncommercial applications of licensed and patented inventions of the Foundation to further the goals and priorities established under paragraph (2);CommentsClose CommentsPermalink





`(8) provide objective clinical and scientific information to the Food and Drug Administration and, upon request, to other Federal agencies to assist in agency determinations of how to ensure that regulatory policy accommodates scientific advances and meets the agency's public health mission;CommentsClose CommentsPermalink





`(9) conduct annual assessments of the unmet needs identified in paragraph (1); andCommentsClose CommentsPermalink





`(10) carry out such other activities consistent with the purposes of the Foundation as the Board determines appropriate.CommentsClose CommentsPermalink





`(d) Board of Directors-CommentsClose CommentsPermalink





`(1) ESTABLISHMENT-CommentsClose CommentsPermalink





`(A) IN GENERAL- The Foundation shall have a Board of Directors (referred to in this subchapter as the `Board'), which shall be composed of ex officio and appointed members in accordance with this subsection. All appointed members of the Board shall be voting members.CommentsClose CommentsPermalink





`(B) EX OFFICIO MEMBERS- The ex officio members of the Board shall be the following individuals or their designees:CommentsClose CommentsPermalink





`(i) The Commissioner.CommentsClose CommentsPermalink





`(ii) The Director of the National Institutes of Health.CommentsClose CommentsPermalink





`(iii) The Director of the Centers for Disease Control and Prevention.CommentsClose CommentsPermalink





`(iv) The Director of the Agency for Healthcare Research and Quality.CommentsClose CommentsPermalink





`(C) APPOINTED MEMBERS-CommentsClose CommentsPermalink





`(i) IN GENERAL- The ex officio members of the Board under subparagraph (B) shall, by majority vote, appoint to the Board 12 individuals, from a list of candidates to be provided by the National Academy of Sciences. Of such appointed members--CommentsClose CommentsPermalink





`(I) 4 shall be representatives of the general pharmaceutical, device, food, cosmetic, and biotechnology industries;CommentsClose CommentsPermalink





`(II) 3 shall be representatives of academic research organizations;CommentsClose CommentsPermalink





`(III) 2 shall be representatives of Government agencies, including the Food and Drug Administration and the National Institutes of Health;CommentsClose CommentsPermalink





`(IV) 2 shall be representatives of patient or consumer advocacy organizations; andCommentsClose CommentsPermalink





`(V) 1 shall be a representative of health care providers.CommentsClose CommentsPermalink





`(ii) REQUIREMENT- The ex officio members shall ensure the Board membership includes individuals with expertise in areas including the sciences of developing, manufacturing, and evaluating the safety and effectiveness of devices, including diagnostics, biologics, and drugs, and the safety of food, food ingredients, and cosmetics.CommentsClose CommentsPermalink





`(D) INITIAL MEETING-CommentsClose CommentsPermalink





`(i) IN GENERAL- Not later than 30 days after the date of the enactment of the Enhancing Drug Safety and Innovation Act of 2007, the Secretary shall convene a meeting of the ex officio members of the Board to--CommentsClose CommentsPermalink





`(I) incorporate the Foundation; andCommentsClose CommentsPermalink





`(II) appoint the members of the Board in accordance with subparagraph (C).CommentsClose CommentsPermalink





`(ii) SERVICE OF EX OFFICIO MEMBERS- Upon the appointment of the members of the Board under clause (i)(II), the terms of service of the ex officio members of the Board as members of the Board shall terminate.CommentsClose CommentsPermalink





`(iii) CHAIR- The ex officio members of the Board under subparagraph (B) shall designate an appointed member of the Board to serve as the Chair of the Board.CommentsClose CommentsPermalink





`(2) DUTIES OF BOARD- The Board shall--CommentsClose CommentsPermalink





`(A) establish bylaws for the Foundation that--CommentsClose CommentsPermalink





`(i) are published in the Federal Register and available for public comment;CommentsClose CommentsPermalink





`(ii) establish policies for the selection of the officers, employees, agents, and contractors of the Foundation;CommentsClose CommentsPermalink





`(iii) establish policies, including ethical standards, for the acceptance, solicitation, and disposition of donations and grants to the Foundation and for the disposition of the assets of the Foundation, including strict appropriate limits on the ability of donors to include stipulations or restrictions on the use ofdesignate, by stipulation or restriction, the use or recipient of donated funds;CommentsClose CommentsPermalink





`(iv) establish policies that would subject all employees, fellows, and trainees of the Foundation to the conflict of interest standards under section 208 of title 18, United States Code;CommentsClose CommentsPermalink





`(v) establish licensing, distribution, and publication policies that support the widest and least restrictive use by the public of information and inventions developed by the Foundation or with Foundation funds to carry out the duties described in paragraphs (6) and (7) of subsection (c), and may include charging cost-based fees for published material produced by the Foundation;CommentsClose CommentsPermalink





`(vi) specify principles for the review of proposals and awarding of grants and contracts that include peer review and that are consistent with those of the Foundation for the National Institutes of Health, to the extent determined practicable and appropriate by the Board;CommentsClose CommentsPermalink





`(vii) specify a cap on administrative expenses for recipients of a grant, contract, or cooperative agreement from the Foundation;CommentsClose CommentsPermalink





`(viii) establish policies for the execution of memoranda of understanding and cooperative agreements between the Foundation and other entities, including the Food and Drug Administration;CommentsClose CommentsPermalink





`(ix) establish policies for funding training fellowships, whether at the Foundation, academic or scientific institutions, or the Food and Drug Administration, for scientists, doctors, and other professionals who are not employees of regulated industry, to foster greater understanding of and expertise in new scientific tools, diagnostics, manufacturing techniques, and potential barriers to translating basic research into clinical and regulatory practice;CommentsClose CommentsPermalink





`(x) specify a process for annual Board review of the operations of the Foundation; andCommentsClose CommentsPermalink





`(xi) establish specific duties of the Executive Director;CommentsClose CommentsPermalink





`(B) prioritize and provide overall direction to the activities of the Foundation;CommentsClose CommentsPermalink





`(C) evaluate the performance of the Executive Director; andCommentsClose CommentsPermalink





`(D) carry out any other necessary activities regarding the functioning of the Foundation.CommentsClose CommentsPermalink





`(3) TERMS AND VACANCIES-CommentsClose CommentsPermalink





`(A) TERM- The term of office of each member of the Board appointed under paragraph (1)(C) shall be 4 years, except that the terms of offices for the initial appointed members of the Board shall expire on a staggered basis as determined by the ex officio members.CommentsClose CommentsPermalink





`(B) VACANCY- Any vacancy in the membership of the Board--CommentsClose CommentsPermalink





`(i) shall not affect the power of the remaining members to execute the duties of the Board; andCommentsClose CommentsPermalink





`(ii) shall be filled by appointment by the appointed members described in paragraph (1)(C) by majority vote.CommentsClose CommentsPermalink





`(C) PARTIAL TERM- If a member of the Board does not serve the full term applicable under subparagraph (A), the individual appointed under subparagraph (B) to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual.CommentsClose CommentsPermalink





`(D) SERVING PAST TERM- A member of the Board may continue to serve after the expiration of the term of the member until a successor is appointed.CommentsClose CommentsPermalink





`(4) COMPENSATION- Members of the Board may not receive compensation for service on the Board. Such members may be reimbursed for travel, subsistence, and other necessary expenses incurred in carrying out the duties of the Board, as set forth in the bylaws issued by the Board.CommentsClose CommentsPermalink





`(e) Incorporation- The ex officio members of the Board shall serve as incorporators and shall take whatever actions necessary to incorporate the Foundation.CommentsClose CommentsPermalink





`(f) Nonprofit Status- The Foundation shall be considered to be a corporation under section 501(c) of the Internal Revenue Code of 1986, and shall be subject to the provisions of such section.CommentsClose CommentsPermalink





`(g) Executive Director-CommentsClose CommentsPermalink





`(1) IN GENERAL- The Board shall appoint an Executive Director who shall serve at the pleasure of the Board. The Executive Director shall be responsible for the day-to-day operations of the Foundation and shall have such specific duties and responsibilities as the Board shall prescribe.CommentsClose CommentsPermalink





`(2) COMPENSATION- The compensation of the Executive Director shall be fixed by the Board but shall not be greater than the compensation of the Commissioner.CommentsClose CommentsPermalink





`(h) Administrative Powers- In carrying out this subchapter, the Board, acting through the Executive Director, may--CommentsClose CommentsPermalink





`(1) adopt, alter, and use a corporate seal, which shall be judicially noticed;CommentsClose CommentsPermalink





`(2) hire, promote, compensate, and discharge 1 or more officers, employees, and agents, as may be necessary, and define their duties;CommentsClose CommentsPermalink





`(3) prescribe the manner in which--CommentsClose CommentsPermalink





`(A) real or personal property of the Foundation is acquired, held, and transferred;CommentsClose CommentsPermalink





`(B) general operations of the Foundation are to be conducted; andCommentsClose CommentsPermalink





`(C) the privileges granted to the Board by law are exercised and enjoyed;CommentsClose CommentsPermalink





`(4) with the consent of the applicable executive department or independent agency, use the information, services, and facilities of such department or agencies in carrying out this section;CommentsClose CommentsPermalink





`(5) enter into contracts with public and private organizations for the writing, editing, printing, and publishing of books and other material;CommentsClose CommentsPermalink





`(6) hold, administer, invest, and spend any gift, devise, or bequest of real or personal property made to the Foundation under subsection (i);CommentsClose CommentsPermalink





`(7) enter into such other contracts, leases, cooperative agreements, and other transactions as the Board considers appropriate to conduct the activities of the Foundation;CommentsClose CommentsPermalink





`(8) modify or consent to the modification of any contract or agreement to which it is a party or in which it has an interest under this subchapter;CommentsClose CommentsPermalink





`(9) take such action as may be necessary to obtain patents and licenses for devices and procedures developed by the Foundation and its employees;CommentsClose CommentsPermalink





`(10) sue and be sued in its corporate name, and complain and defend in courts of competent jurisdiction;CommentsClose CommentsPermalink





`(11) appoint other groups of advisors as may be determined necessary to carry out the functions of the Foundation; andCommentsClose CommentsPermalink





`(12) exercise other powers as set forth in this section, and such other incidental powers as are necessary to carry out its powers, duties, and functions in accordance with this subchapter.CommentsClose CommentsPermalink





`(i) Acceptance of Funds From Other Sources- The Executive Director may solicit and accept on behalf of the Foundation, any funds, gifts, grants, devises, or bequests of real or personal property made to the Foundation, including from private entities, for the purposes of carrying out the duties of the Foundation.CommentsClose CommentsPermalink





`(j) Service of Federal Employees- Federal Government employees may serve on committees advisory to the Foundation and otherwise cooperate with and assist the Foundation in carrying out its functions, so long as such employees do not direct or control Foundation activities.CommentsClose CommentsPermalink





`(k) Detail of Government Employees; Fellowships-CommentsClose CommentsPermalink





`(1) DETAIL FROM FEDERAL AGENCIES- Federal Government employees may be detailed from Federal agencies with or without reimbursement to those agencies to the Foundation at any time, and such detail shall be without interruption or loss of civil service status or privilege. Each such employee shall abide by the statutory, regulatory, ethical, and procedural standards applicable to the employees of the agency from which such employee is detailed and those of the Foundation.CommentsClose CommentsPermalink





`(2) VOLUNTARY SERVICE; ACCEPTANCE OF FEDERAL EMPLOYEES-CommentsClose CommentsPermalink





`(A) FOUNDATION- The Executive Director of the Foundation may accept the services of employees detailed from Federal agencies with or without reimbursement to those agencies.CommentsClose CommentsPermalink





`(B) FOOD AND DRUG ADMINISTRATION- The Commissioner may accept the uncompensated services of Foundation fellows or trainees. Such services shall be considered to be undertaking an activity under contract with the Secretary as described in section 708.CommentsClose CommentsPermalink





`(l) Annual Reports-CommentsClose CommentsPermalink





`(1) REPORTS TO FOUNDATION- Any recipient of a grant, contract, fellowship, memorandum of understanding, or cooperative agreement from the Foundation under this section shall submit to the Foundation a report on an annual basis for the duration of such grant, contract, fellowship, memorandum of understanding, or cooperative agreement, that describes the activities carried out under such grant, contract, fellowship, memorandum of understanding, or cooperative agreement.CommentsClose CommentsPermalink





`(2) REPORT TO CONGRESS AND THE FDA- Beginning with fiscal year 2009, the Executive Director shall submit to Congress and the Commissioner an annual report that--CommentsClose CommentsPermalink





`(A) describes the activities of the Foundation and the progress of the Foundation in furthering the goals and priorities established under subsection (c)(2), including the practical impact of the Foundation on regulated product development;CommentsClose CommentsPermalink





`(B) provides a specific accounting of the source and use of all funds used by the Foundation to carry out such activities; andCommentsClose CommentsPermalink





`(C) provides information on how the results of Foundation activities could be incorporated into the regulatory and product review activities of the Food and Drug Administration.CommentsClose CommentsPermalink





`(m) Separation of Funds- The Executive Director shall ensure that the funds received from the Treasury are held in separate accounts from funds received from entities under subsection (i).CommentsClose CommentsPermalink





`(n) Funding- From amounts appropriated to the Food and Drug Administration for each fiscal year, the Commissioner shall transfer not less than $500,000 and not more than $1,250,000, to the Foundation to carry out subsections (a), (b), and (d) through (m).'.CommentsClose CommentsPermalink





(b) Other Foundation Provisions- Chapter VII (21 U.S.C. 371 et seq.) (as amended by subsection (a)) is amended by adding at the end the following:CommentsClose CommentsPermalink

`SEC. 771. LOCATION OF FOUNDATION.

`The Foundation shall, if practicable, be located not more than 20 miles from the District of Columbia.CommentsClose CommentsPermalink

`SEC. 772. ACTIVITIES OF THE FOOD AND DRUG ADMINISTRATION.

`(a) In General- The Commissioner shall receive and assess the report submitted to the Commissioner by the Executive Director of the Foundation under section 770(l)(2).CommentsClose CommentsPermalink





`(b) Report to Congress- Beginning with fiscal year 2009, the Commissioner shall submit to Congress an annual report summarizing the incorporation of the information provided by the Foundation in the report described under section 770(l)(2) and by other recipients of grants, contracts, memoranda of understanding, or cooperative agreements into regulatory and product review activities of the Food and Drug Administration.CommentsClose CommentsPermalink





`(c) Extramural Grants- The provisions of this subchapter shall have no effect on any grant, contract, memorandum of understanding, or cooperative agreement between the Food and Drug Administration and any other entity entered into before, on, or after the date of enactment of the Enhancing Drug Safety and Innovation Act of 2007.'.CommentsClose CommentsPermalink





(c) Conforming Amendment- Section 742(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379l(b)) is amended by adding at the end the following: `Any such fellowships and training programs under this section or under section 770(d)(2)(A)(ix) may include provision by such scientists and physicians of services on a voluntary and uncompensated basis, as the Secretary determines appropriate. Such scientists and physicians shall be subject to all legal and ethical requirements otherwise applicable to officers or employees of the Department of Health and Human Services.'.CommentsClose CommentsPermalink

SEC. 222. OFFICE OF THE CHIEF SCIENTIST.

Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended by adding at the end the following:CommentsClose CommentsPermalink

`SEC. 910. OFFICE OF THE CHIEF SCIENTIST.

`(a) Establishment; Appointment- The Secretary shall establish within the Office of the Commissioner an office to be known as the Office of the Chief Scientist. The Secretary shall appoint a Chief Scientist to lead such Office.CommentsClose CommentsPermalink





`(b) Duties of the Office- The Office of the Chief Scientist shall--CommentsClose CommentsPermalink





`(1) oversee, coordinate, and ensure quality and regulatory focus of the intramural research programs of the Food and Drug Administration;CommentsClose CommentsPermalink





`(2) track and, to the extent necessary, coordinate intramural research awards made by each center of the Administration or science-based office within the Office of the Commissioner, and ensure that there is no duplication of research efforts supported by the Reagan-Udall Foundation for the Food and Drug Administration;CommentsClose CommentsPermalink





`(3) develop and advocate for a budget to support intramural research;CommentsClose CommentsPermalink





`(4) develop a peer review process by which intramural research can be evaluated; andCommentsClose CommentsPermalink





`(5) identify and solicit intramural research proposals from across the Food and Drug Administration through an advisory board composed of employees of the Administration that shall include--CommentsClose CommentsPermalink





`(A) representatives of each of the centers and the science-based offices within the Office of the Commissioner; andCommentsClose CommentsPermalink





`(B) experts on trial design, epidemiology, demographics, pharmacovigilance, basic science, and public health.'.CommentsClose CommentsPermalink

Subtitle C--Clinical Trials

SEC. 231. EXPANDED CLINICAL TRIAL REGISTRY DATA BANK.

(a) In General- Section 402 of the Public Health Service Act (42 U.S.C. 282) is amended by--CommentsClose CommentsPermalink





(1) redesignating subsections (j) and (k) as subsections (k) and (l), respectively; andCommentsClose CommentsPermalink





(2) inserting after subsection (i) the following:CommentsClose CommentsPermalink





`(j) Expanded Clinical Trial Registry Data Bank-CommentsClose CommentsPermalink





`(1) DEFINITIONS; REQUIREMENT-CommentsClose CommentsPermalink





`(A) DEFINITIONS- In this subsection:CommentsClose CommentsPermalink





`(i) APPLICABLE DEVICE CLINICAL TRIAL- The term `applicable device clinical trial' means--CommentsClose CommentsPermalink





`(I) a prospective study of health outcomes comparing an intervention against a control in human subjects intended to support an application under section 515 or 520(m), or a report under section 510(k), of the Federal Food, Drug, and Cosmetic Act (other than a limited study to gather essential information used to refine the device or design a pivotal trial and that is not intended to determine safety and effectiveness of a device); andCommentsClose CommentsPermalink





`(II) a pediatric postmarket surveillance as required under section 522 of the Federal Food, Drug, and Cosmetic Act.CommentsClose CommentsPermalink





`(ii) APPLICABLE DRUG CLINICAL TRIAL-CommentsClose CommentsPermalink





`(I) IN GENERAL- The term `applicable drug clinical trial' means a controlled clinical investigation, other than a phase I clinical investigation, of a product subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to section 351 of this Act.CommentsClose CommentsPermalink





`(II) CLINICAL INVESTIGATION- For purposes of subclause (I), the term `clinical investigation' has the meaning given that term in section 312.3 of title 21, Code of Federal Regulations.CommentsClose CommentsPermalink





`(III) PHASE I- The term `phase I' has the meaning given that term in section 312.21 of title 21, Code of Federal Regulations.CommentsClose CommentsPermalink





`(iii) CLINICAL TRIAL INFORMATION- The term `clinical trial information' means those data elements that are necessary to complete an entry in the clinical trial registry data bank under paragraph (2).CommentsClose CommentsPermalink





`(iv) COMPLETION DATE- The term `completion date' means, with respect to an applicable drug clinical trial or an applicable device clinical trial, the date on which the last patient enrolled in the clinical trial has completed his or her last medical visit of the clinical trial, whether the clinical trial concluded according to the prespecified protocol plan or was terminated.CommentsClose CommentsPermalink





`(v) DEVICE- The term `device' means a device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act.CommentsClose CommentsPermalink





`(vi) DRUG- The term `drug' means a drug as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act or a biological product as defined in section 351 of this Act.CommentsClose CommentsPermalink





`(vii) RESPONSIBLE PARTY- The term `responsible party', with respect to a clinical trial of a drug or device, means--CommentsClose CommentsPermalink





`(I) the sponsor of the clinical trial (as defined in section 50.3 of title 21, Code of Federal Regulations (or any successor regulations)) or the principal investigator of such clinical trial if so designated by such sponsor; orCommentsClose CommentsPermalink





`(II) if no sponsor exists, the grantee, contractor, or awardee for a trial funded by a Federal agency or the principal investigator of such clinical trial if so designated by such grantee, contractor, or awardee.CommentsClose CommentsPermalink





`(B) REQUIREMENT- The Secretary shall develop a mechanism by which--CommentsClose CommentsPermalink





`(i) the responsible party for each applicable drug clinical trial and applicable device clinical trial shall submit the identity and contact information of such responsible party to the Secretary at the time of submission of clinical trial information under paragraph (2); andCommentsClose CommentsPermalink





`(ii) other Federal agencies may identify the responsible party for an applicable drug clinical trial or applicable device clinical trial.CommentsClose CommentsPermalink





`(2) EXPANSION OF CLINICAL TRIAL REGISTRY DATA BANK WITH RESPECT TO CLINICAL TRIAL INFORMATION-CommentsClose CommentsPermalink





`(A) IN GENERAL-CommentsClose CommentsPermalink





`(i) EXPANSION OF DATA BANK- To enhance patient enrollment and provide a mechanism to track subsequent progress of clinical trials, the Secretary, acting through the Director of NIH, shall expand, in accordance with this subsection, the clinical trials registry of the data bank described under subsection (i)(3)(A) (referred to in this subsection as the `registry data bank'). The Director of NIH shall ensure that the registry data bank is made publicly available through the Internet.CommentsClose CommentsPermalink





`(ii) CONTENT- Not later than 18 months after the date of enactment of the Enhancing Drug Safety and Innovation Act of 2007, and after notice and comment, the Secretary shall promulgate regulations to expand the registry data bank to require the submission to the registry data bank of clinical trial information for applicable drug clinical trials and applicable device clinical trials that--CommentsClose CommentsPermalink





`(I) conforms to the International Clinical Trials Registry Platform trial registration data set of the World Health Organization;CommentsClose CommentsPermalink





`(II) includes the city, State, and zip code for each clinical trial location, or a toll-free number through which such location information may be accessed;CommentsClose CommentsPermalink





`(III) if the drug is not approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act, specifies whether or not there is expanded access to the drug under section 561 of the Federal Food, Drug, and Cosmetic Act for those who do not qualify for enrollment in the clinical trial and how to obtain information about such access;CommentsClose CommentsPermalink





`(IV) requires the inclusion of such other data elements to the registry data bank as appropriate; andCommentsClose CommentsPermalink





`(V) becomes effective 90 days after issuance of the final rule.CommentsClose CommentsPermalink





`(B) FORMAT AND STRUCTURE-