HR 2273 IHCommentsClose CommentsPermalink

To amend the Federal Food, Drug, and Cosmetic Act to provide for the deposit in the general fund of the Treasury of fees that are collected from manufacturers of drugs and devices under chapter VII of such Act, to terminate the authority of the Food and Drug Administration to negotiate with the manufacturers on particular uses of the fees, to establish a Center for Postmarket Drug Safety and Effectiveness, to establish additional authorities to ensure the safe and effective use of drugs, and for other purposes.CommentsClose CommentsPermalink

May 10, 2007

Mr. HINCHEY (for himself, Mr. STUPAK, and Mr. GRIJALVA) introduced the following bill; which was referred to the Committee on Energy and CommerceCommentsClose CommentsPermalink

To amend the Federal Food, Drug, and Cosmetic Act to provide for the deposit in the general fund of the Treasury of fees that are collected from manufacturers of drugs and devices under chapter VII of such Act, to terminate the authority of the Food and Drug Administration to negotiate with the manufacturers on particular uses of the fees, to establish a Center for Postmarket Drug Safety and Effectiveness, to establish additional authorities to ensure the safe and effective use of drugs, 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

SECTION 1. SHORT TITLE.

This Act may be cited as the `Food and Drug Administration Improvement Act of 2007'.CommentsClose CommentsPermalink

SEC. 2. FEES PAID BY MANUFACTURERS TO FOOD AND DRUG ADMINISTRATION; DEPOSIT IN GENERAL FUND OF TREASURY; DIRECT SPENDING.

(a) In General- Subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379f et seq.) is amended by adding at the end the following part:CommentsClose CommentsPermalink

`PART 5--MODIFICATIONS REGARDING USER-FEE PROGRAMS

`SEC. 740A. DEPOSIT OF FEES IN GENERAL FUND OF TREASURY; DIRECT SPENDING.

`(a) Deposit in General Fund- Notwithstanding any other provision of this Act related to the collection of fees related to drugs, devices, or animal drugs, all such fees collected under this Act shall be deposited in the general fund of the Treasury.CommentsClose CommentsPermalink





`(b) Direct Spending-CommentsClose CommentsPermalink





`(1) IN GENERAL- Notwithstanding any other provision of this Act related to the collection of such fees, amounts are available to the Secretary for obligation in accordance with the following:CommentsClose CommentsPermalink





`(A) The amount authorized to be appropriated under this Act for fees related to drugs is, to the extent described in section 736(g)(2)(A)(ii) (as in effect on September 30, 2007), available to the Secretary for obligation solely for the process for the review of human drug applications (within the meaning given to such term in section 735, as in effect on September 30, 2007).CommentsClose CommentsPermalink





`(B) The amount authorized to be appropriated under this Act for fees related to devices is, to the extent described in section 738(h)(2)(A)(ii) (as in effect on September 30, 2007), available to the Secretary for obligation solely for the process for the review of device applications (within the meaning given to such terms in section 737, as in effect on September 30, 2007).CommentsClose CommentsPermalink





`(C) The amount authorized to be appropriated under this Act for fees related to animal drugs is, to the extent described in section 740(g)(2)(A)(ii) (as in effect on September 30, 2007), available to the Secretary for obligation solely for the process for the review of animal drug applications (within the meaning given to such terms in section 739, as in effect on September 30, 2007).CommentsClose CommentsPermalink





`(2) LIST OF MANDATORY APPROPRIATIONS- The program of spending established in paragraph (1) shall be considered entitlement authority within the meaning of section 250(17) of the Balanced Budget and Emergency Deficit Control Act of 1985.CommentsClose CommentsPermalink

`SEC. 740B. TERMINATION OF AUTHORITY FOR NEGOTIATIONS WITH MANUFACTURERS ON USE OF FEES.

`(a) In General- With respect to persons from whom fees related to drugs, devices, or animal drugs are collected under this Act and notwithstanding any other provision of this Act related to the collection of such fees:CommentsClose CommentsPermalink





`(1) On and after the date of the enactment of the Food and Drug Administration Improvement Act of 2007:CommentsClose CommentsPermalink





`(A) The Secretary may not enter into agreements with such persons on particular uses of the fees, including agreements on priorities, performance goals, or other commitments relating to--CommentsClose CommentsPermalink





`(i) review times for human drug applications or supplements (within the meaning given to such terms in section 735, as in effect on September 30, 2007);CommentsClose CommentsPermalink





`(ii) review times for premarket applications, premarket reports, premarket notification submissions, or supplements (within the meaning given to such terms in section 737, as in effect on September 30, 2007); orCommentsClose CommentsPermalink





`(iii) review times for animal drug applications or supplements (within the meaning given to such terms in section 739, as in effect on September 30, 2007).CommentsClose CommentsPermalink





`(B) The Secretary may not otherwise negotiate understandings with such persons on particular uses of the fees.CommentsClose CommentsPermalink





`(2) On and after October 1, 2007:CommentsClose CommentsPermalink





`(A) Any such agreement or understanding that was in effect on the day before the date of the Food and Drug Administration Improvement Act of 2007 is terminated, including agreements or understandings pursuant to letters referred to in section 502(4) of Public Law 107-188 (116 Stat. 688), section 101(3) of Public Law 107-250 (116 Stat. 1589), and section 2(3) of Public Law 108-130 (117 Stat. 1361).CommentsClose CommentsPermalink





`(B) The Secretary is relieved of responsibility for meeting any particular goals concerning such review times that were established in such letters.CommentsClose CommentsPermalink





`(b) Rules of Construction- Subsection (a) may not be construed--CommentsClose CommentsPermalink





`(1) as affecting the responsibility of the Secretary to work toward the general goal of administering this Act efficiently, including the review of applications, reports, supplements and other submissions referred to in subsection (a)(1)(A); orCommentsClose CommentsPermalink





`(2) as terminating requirements for the collection of fees under any other provision of this Act.'.CommentsClose CommentsPermalink





(b) Applicability- Section 740A of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a) of this section, applies with respect to fiscal year 2008 and subsequent fiscal years.CommentsClose CommentsPermalink

SEC. 3. ESTABLISHMENT OF CENTER FOR POSTMARKET DRUG SAFETY AND EFFECTIVENESS.

(a) In General- Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 505B the following sections:CommentsClose CommentsPermalink

`SEC. 505C. CENTER FOR POSTMARKET DRUG SAFETY AND EFFECTIVENESS.

`(a) Establishment- Not later than 180 days after the date of the enactment of the Food and Drug Administration Improvement Act of 2007, the Secretary shall establish within the Food and Drug Administration a center to be known as the Center for Postmarket Drug Safety and Effectiveness (referred to in this section as the `Center'), which shall be headed by a director appointed by the Secretary (without regard to the delegation to the Commissioner of Food and Drugs under section 903(d)(2)). The Center shall be established as a separate center at the organizational level immediately below the Office of the Commissioner. The Director of the Center shall report directly to the Commissioner.CommentsClose CommentsPermalink





`(b) Duties-CommentsClose CommentsPermalink





`(1) IN GENERAL- The Director of the Center shall have the principal responsibility within the Food and Drug Administration, below the Office of the Commissioner, for assisting the Commissioner in regulating approved drugs, other than with respect to section 501. Such assistance includes assistance with the following:CommentsClose CommentsPermalink





`(A) Administering enforcement authorities under chapter III, including civil penalties under section 303(f).CommentsClose CommentsPermalink





`(B) Administering section 502.CommentsClose CommentsPermalink





`(C) Administering requirements for studies that were required as conditions for the approval of applications under section 505 (which studies are conducted after such approval).CommentsClose CommentsPermalink





`(D) Administering authorities under sections 505D and 505E.CommentsClose CommentsPermalink





`(E) Monitoring approved drugs to determine whether there are any issues regarding safety and effectiveness.CommentsClose CommentsPermalink





`(F) With respect to issues identified under subparagraph (E), taking action under the provisions referred to in subparagraphs (A) through (D), including as appropriate the following:CommentsClose CommentsPermalink





`(i) Establishing requirements for advertising under section 502(n).CommentsClose CommentsPermalink





`(ii) Establishing requirements for modifications in labeling under section 502(x), including the specification of a date by which the modifications are required to be made.CommentsClose CommentsPermalink





`(iii) Withdrawing the approval of drugs under section 505(e).CommentsClose CommentsPermalink





`(iv) Requiring reports under section 505(k) on clinical experience with approved drugs, including reports on the number of individuals using the drugs as indicated by sales of the drugs at retail and reports on information possessed by manufacturers on usage of the drugs.CommentsClose CommentsPermalink





`(v) Requiring notifications under section 505D(a)(1) to eliminate unreasonable risks of substantial harm to the public health.CommentsClose CommentsPermalink





`(vi) Establishing restrictions under section 505D(a)(2) to ensure the safe use of approved drugs, including requirements for--CommentsClose CommentsPermalink





`(I) the specific manner of obtaining the informed consent of patients to undergo treatment with the drugs;CommentsClose CommentsPermalink





`(II) providing education to physicians;CommentsClose CommentsPermalink





`(III) providing education to patients; andCommentsClose CommentsPermalink





`(IV) the establishment of risk-management plans by manufacturers.CommentsClose CommentsPermalink





`(vii) Requiring the conduct of studies under section 505E.CommentsClose CommentsPermalink





`(2) TRANSFERS- The Secretary shall transfer to the Center all responsibilities for the matters referred to in paragraph (1) that, on the day before the date of the enactment of the Food and Drug Administration Improvement Act of 2007, were vested in the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.CommentsClose CommentsPermalink





`(c) Interactions With Other Centers-CommentsClose CommentsPermalink





`(1) CONSULTATION- The Director of the Center shall carry out this section in consultation with the Directors of the Centers referred to in subsection (b)(2).CommentsClose CommentsPermalink





`(2) ACCESS TO INFORMATION- The Secretary shall ensure that the Director of the Center has full access to all information possessed by the Food and Drug Administration that relates to the safety and effectiveness of approved drugs, including information possessed by the Centers referred to in subsection (b)(2).CommentsClose CommentsPermalink





`(d) Definition- For purposes of this section, the term `approved drug' means a drug for which an approved application under section 505 is in effect or for which a biologics license under section 351 of the Public Health Service Act is in effect.CommentsClose CommentsPermalink





`(e) Funding- For the purpose of carrying out this section, the Secretary shall make available for a fiscal year, from the amount appropriated for the Food and Drug Administration for such year, the following amount, as applicable to such year:CommentsClose CommentsPermalink





`(1) For fiscal year 2008, $100,000,000.CommentsClose CommentsPermalink





`(2) For fiscal year 2009, $125,000,000.CommentsClose CommentsPermalink





`(3) For fiscal year 2010, $150,000,000.CommentsClose CommentsPermalink





`(4) For fiscal year 2011, $175,000,000.CommentsClose CommentsPermalink





`(5) For fiscal year 2012, $200,000,000.CommentsClose CommentsPermalink

`SEC. 505D. CERTAIN POSTMARKET AUTHORITIES.

`(a) In General- Effective on and after the date of the enactment of the Food and Drug Administration Improvement Act of 2007, the Secretary has with respect to approved drugs the same authorities as the Secretary has with respect to devices under the following provisions:CommentsClose CommentsPermalink





`(1) Section 518(a) (relating to notifications to eliminate an unreasonable risk of substantial harm to the public health).CommentsClose CommentsPermalink





`(2) Section 520(e)(1)(B) (relating to restrictions on sale, distribution, or use).CommentsClose CommentsPermalink





`(3) Section 520(h) (relating to making available to the public summaries of information respecting safety and effectiveness).CommentsClose CommentsPermalink





`(b) Definition- For purposes of this section, the term `approved drug' has the meaning given such term in section 505C(d).CommentsClose CommentsPermalink

`SEC. 505E. POSTMARKET STUDIES REGARDING SAFETY OF DRUGS.

`(a) Phase 4 Studies- The Secretary may require that the manufacturer of an approved drug conduct one or more studies to confirm or refute an empirical or theoretical hypothesis of a significant safety issue with the drug (whether raised with respect to the product directly or with respect to the class of the product) that has been identified pursuant to--CommentsClose CommentsPermalink





`(1) the MedWatch postmarket surveillance system;CommentsClose CommentsPermalink





`(2) a clinical or epidemiological study;CommentsClose CommentsPermalink





`(3) the scientific literature;CommentsClose CommentsPermalink





`(4) a foreign government that regulates drugs or devices;CommentsClose CommentsPermalink





`(5) an international organization concerned with the safety or effectiveness of drugs or devices; orCommentsClose CommentsPermalink





`(6) such other sources as the Secretary determines to be appropriate.CommentsClose CommentsPermalink





`(b) Approval of Protocol; Timeframe- A study under subsection (a) shall be conducted in accordance with a protocol approved by the Secretary. In requiring such a study, the Secretary shall specify a timeframe for completing the study.CommentsClose CommentsPermalink





`(c) Public Disclosure-CommentsClose CommentsPermalink





`(1) INTERNET SITE- Notwithstanding section 506B, the Secretary shall maintain on the Internet site of the Food and Drug Administration a database that provides information on each study required under subsection (a), including a description of and the reason for the study, the required completion date, and whether the study has been completed. The Secretary shall update the database not less frequently than once each quarter.CommentsClose CommentsPermalink





`(2) FEDERAL REGISTER- Not later than 30 days after first establishing the database under paragraph (1), the Secretary shall, with respect to studies required under subsection (a), publish in the Federal Register the same information as is included in such database as of the date of such publication. Thereafter, the Secretary shall publish in the Federal Register, not less frequently than once each quarter, updates that reflect the updates made under paragraph (1).CommentsClose CommentsPermalink





`(d) Definition- For purposes of this section, the term `approved drug' has the meaning given such term in section 505C(d).'.CommentsClose CommentsPermalink





(b) Certain Studies-CommentsClose CommentsPermalink





(1) IN GENERAL- With respect to section 505E(c) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a) of this section), each study described in paragraph (2) is deemed to be a study to which such section applies.CommentsClose CommentsPermalink





(2) RELEVANT STUDIES- For purposes of paragraph (1), a study described in this paragraph is a study that--CommentsClose CommentsPermalink





(A) relates to the safety or effectiveness of a drug;CommentsClose CommentsPermalink





(B) was in progress as of the date of the enactment of this Act; andCommentsClose CommentsPermalink





(C) was conducted pursuant to an agreement that, on or after January 1, 2003, was entered into with the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs.CommentsClose CommentsPermalink

SEC. 4. ORDER REGARDING POSTMARKET LABELING.

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





`(y) If it is a drug and the Secretary determines that its labeling fails to provide information, including specific wording, required by the Secretary by order on the basis that the information is necessary to ensure its safe and effective use.'.CommentsClose CommentsPermalink

SEC. 5. ADDITIONAL ENFORCEMENT PROVISIONS.

(a) Postmarket Authorities- Section 502 of the Federal Food, Drug, and Cosmetic Act, as amended by section 4 of this Act, is amended by adding at the end the following:CommentsClose CommentsPermalink





`(y) If it is a drug with respect to which there is a failure to comply with any requirement under section 505D or 505E.'.CommentsClose CommentsPermalink





(b) Civil Penalties for Violations of Requirements Relating to Drugs- 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) through (5) as paragraphs (4) through (6), respectively;CommentsClose CommentsPermalink





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





`(3) Any person who violates a requirement of this Act which relates to drugs shall be liable to the United States for a civil penalty in an amount not exceeding $50,000 per day for each such violation, not to exceed $50,000,000 for all such violations adjudicated in a single proceeding.';CommentsClose CommentsPermalink





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





(4) in paragraph (5) (as so redesignated), by striking `paragraph (3)(A)' and inserting `paragraph (4)(A)'; andCommentsClose CommentsPermalink





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

SEC. 6. PREEMPTION.

(a) In General- With respect to the issue of whether a provision of chapter V of the Federal Food, Drug, and Cosmetic Act or of section 351 of the Public Health Service Act (or regulations or orders under such a provision) supersedes the law of a State, the Secretary of Health and Human Services (referred to in this section as the `Secretary') shall follow, without change, the interpretation that was followed by the Food and Drug Administration in 1999, including the interpretation that such Administration `does not believe that the evolution of state tort law will cause the development of standards that would be at odds with the agency's regulations' and that such regulations `establish minimal standards' but are not intended to preclude the States from imposing additional requirements (63 FR 66384).CommentsClose CommentsPermalink





(b) Product Liability Cases- In the case of civil actions regarding product liability that are brought in State courts against manufacturers of drugs or devices, policies of the Secretary required under subsection (a) include the policy that the Secretary cease intervening in such actions to argue any interpretation contrary to such subsection.CommentsClose CommentsPermalink

SEC. 7. ADDITIONAL PROVISIONS.

(a) Requirements Regarding Membership of Advisory Committees- Subchapter A of 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 section:CommentsClose CommentsPermalink

`SEC. 712. REQUIREMENTS REGARDING MEMBERSHIP OF ADVISORY COMMITTEES.

`(a) In General- Notwithstanding any other provision of law, the Secretary shall comply with the following with respect to any meeting of an advisory committee convened by the Secretary under this Act:CommentsClose CommentsPermalink





`(1) Not later than 30 days before such meeting, the Secretary shall post on the Internet site of the Food and Drug Administration the agenda for the meeting and the tentative list of all proposed advisory committee members, together with a short biography of each such prospective member.CommentsClose CommentsPermalink





`(2) After compliance with paragraph (1), the Secretary shall provide the public not fewer than 20 days to submit to the Secretary comments on the proposed membership of the advisory committee.CommentsClose CommentsPermalink





`(3) The Secretary shall consider the public comments to determine whether any adjustment to the roster of the advisory committee is necessary to make the committee fairly balanced.CommentsClose CommentsPermalink





`(4) Not later than three days before the start of the meeting, the Secretary shall post on such Internet site the final membership of the advisory committee.CommentsClose CommentsPermalink





`(b) Conflicts of Interest- Notwithstanding any other provision of law, a member of an advisory committee under this Act may not, with respect to service on such committee, be granted an exemption under section 208(b) of title 18, United States Code (relating to personal financial interests).CommentsClose CommentsPermalink





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





`(1) The term `advisory committee' has the same meaning given such term in section 3(2) of the Federal Advisory Committee Act.CommentsClose CommentsPermalink





`(2) The term `fairly balanced' has the same meaning as applies to such term under section 5(b)(2) of the Federal Advisory Committee Act.'.CommentsClose CommentsPermalink





(b) Certain Uses of Approved Drugs- 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 section:CommentsClose CommentsPermalink

`SEC. 910. REQUIREMENT REGARDING INFORMED CONSENT FOR CERTAIN TREATMENTS.

`With respect to the prescribing of a drug for a use not included in the approved labeling for the drug under section 505 or under section 351 of the Public Health Service Act, the Secretary shall promulgate regulations requiring that, before prescribing the drug--CommentsClose CommentsPermalink





`(1) the physician inform the patient that the use for which the physician intends to prescribe the drug has not been approved by the Food and Drug Administration; andCommentsClose CommentsPermalink





`(2) the physician obtain from the patient an acknowledgment of such fact and the consent of the patient to use the drug for such use notwithstanding such fact.'.CommentsClose CommentsPermalink