U.S. Congress - Text of S.882 as Introduced in Senate Drug and Device Accountability Act of 2009
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Donate NowS.882 - Drug and Device Accountability Act of 2009
A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes.
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S 882 ISCommentsClose CommentsPermalink
111th CONGRESSCommentsClose CommentsPermalink
1st SessionCommentsClose CommentsPermalink
S. 882CommentsClose CommentsPermalink
To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes.CommentsClose CommentsPermalink
IN THE SENATE OF THE UNITED STATESCommentsClose CommentsPermalink
April 23, 2009CommentsClose CommentsPermalink
April 23, 2009CommentsClose CommentsPermalink
Mr. REID for (Mr. KENNEDY (for himself and Mr. GRASSLEY)) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsCommentsClose CommentsPermalink
A BILLCommentsClose CommentsPermalink
To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, 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 ‘Drug and Device Accountability Act of 2009’.CommentsClose CommentsPermalink
SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT.
(a) Table of Contents- The table of contents for this Act is as follows:CommentsClose CommentsPermalink
Sec. 1. Short title.CommentsClose CommentsPermalink
Sec. 2. Table of contents; references in Act.CommentsClose CommentsPermalink
TITLE I--ENSURING THE SAFETY AND QUALITY OF MEDICAL PRODUCTS AND THEIR COMPONENTS
Subtitle A--Enhanced Registration and Inspection of Drug and Device Establishments
Sec. 101. Registration of drug and device establishments.CommentsClose CommentsPermalink
Sec. 102. Registration of foreign drug and device establishments.CommentsClose CommentsPermalink
Sec. 103. Registration of establishments for drug precursor ingredients.CommentsClose CommentsPermalink
Sec. 104. Registration and licensing of drug importers.CommentsClose CommentsPermalink
Sec. 105. Inspection of drug and device establishments.CommentsClose CommentsPermalink
Sec. 106. Listing of drugs and devices; enhanced information technology system for registration and listing; inactive ingredients.CommentsClose CommentsPermalink
Sec. 107. Fees related to establishment inspections.CommentsClose CommentsPermalink
Sec. 108. Electronic submission and certification of registrations and listings.CommentsClose CommentsPermalink
Sec. 109. Technical and conforming amendments.CommentsClose CommentsPermalink
Sec. 110. Effective date.CommentsClose CommentsPermalink
Subtitle B--Ensuring Identity and Sourcing of Drug Ingredients
Sec. 111. Compendial modernization.CommentsClose CommentsPermalink
Sec. 112. Testing of drug purity and identity.CommentsClose CommentsPermalink
Sec. 113. Manufacturer responsibility for source and quality of drug ingredients.CommentsClose CommentsPermalink
Sec. 114. Current manufacturing science.CommentsClose CommentsPermalink
Sec. 115. Country of origin labeling.CommentsClose CommentsPermalink
Sec. 116. Effective date; implementation.CommentsClose CommentsPermalink
Subtitle C--Ensuring Standards for Imported Drugs
Sec. 121. Good distribution and import practices.CommentsClose CommentsPermalink
Sec. 122. Standards for admission of imported drugs and drug ingredients.CommentsClose CommentsPermalink
Sec. 123. Prohibition on use of drugs and drug ingredients not declared as drugs on importation.CommentsClose CommentsPermalink
Sec. 124. Destruction of unsafe products refused admission.CommentsClose CommentsPermalink
Sec. 125. Effective date.CommentsClose CommentsPermalink
Subtitle D--Enhanced Response to Unsafe Drugs
Sec. 131. Administrative detention of drugs.CommentsClose CommentsPermalink
Sec. 132. Mandatory recall authority for drugs.CommentsClose CommentsPermalink
Sec. 133. Records and reports of drug defects and destruction of defective drugs that cannot be reconditioned.CommentsClose CommentsPermalink
Sec. 134. Civil money penalties.CommentsClose CommentsPermalink
Subtitle E--Additional Provisions Related to Medical Products
Sec. 141. Certification of information.CommentsClose CommentsPermalink
Sec. 142. Whistleblower protections.CommentsClose CommentsPermalink
Sec. 143. Study by the Institute of Medicine regarding the review of medical devices.CommentsClose CommentsPermalink
TITLE II--GENERAL AUTHORITIES TO ENHANCE FOOD AND DRUG ADMINISTRATION OVERSIGHT OF PRODUCTS FROM A GLOBAL MARKET
Sec. 201. Dedicated foreign inspectorate.CommentsClose CommentsPermalink
Sec. 202. Authority to exchange confidential information with foreign government officials.CommentsClose CommentsPermalink
Sec. 203. Subpoena authority.CommentsClose CommentsPermalink
Sec. 204. Information reporting.CommentsClose CommentsPermalink
(b) References in Act- Except as otherwise specified, amendments made by this Act to a section or other provision of law are amendments to such section or other provision of the Federal Food, Drug, and Cosmetic Act (
TITLE I--ENSURING THE SAFETY AND QUALITY OF MEDICAL PRODUCTS AND THEIR COMPONENTSCommentsClose CommentsPermalink
TITLE I--ENSURING THE SAFETY AND QUALITY OF MEDICAL PRODUCTS AND THEIR COMPONENTSCommentsClose CommentsPermalink
Subtitle A--Enhanced Registration and Inspection of Drug and Device EstablishmentsCommentsClose CommentsPermalink
Subtitle A--Enhanced Registration and Inspection of Drug and Device EstablishmentsCommentsClose CommentsPermalink
SEC. 101. REGISTRATION OF DRUG AND DEVICE ESTABLISHMENTS.
Section 510 (
(1) by striking subsection (b) and inserting the following:CommentsClose CommentsPermalink
‘(b) Registration of Domestic Establishments- Any person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device shall--CommentsClose CommentsPermalink
‘(1) upon first engaging in any such activity, immediately submit a registration to the Secretary that includes the name of such person, places of business of such person, all such establishments, the D-U-N-S number of each such establishment, an e-mail address for use in an emergency, and payment of any inspection fee for each such establishment required under section 743;CommentsClose CommentsPermalink
‘(2) thereafter immediately submit a registration that includes the information and fee described in paragraph (1) for any additional establishment owned or operated by such person in any State in which such person begins the manufacture, preparation, propagation, compounding, or processing of a drug or device; andCommentsClose CommentsPermalink
‘(3) thereafter--CommentsClose CommentsPermalink
‘(A) with respect to such drugs, submit a registration described in paragraph (1) to the Secretary on or before December 31 of each year; andCommentsClose CommentsPermalink
‘(B) with respect to such devices, submit a registration described in paragraph (1) to the Secretary during the period beginning on October 1 and ending on December 31 of each year.’; andCommentsClose CommentsPermalink
(2) by striking subsections (c) and (d).CommentsClose CommentsPermalink
SEC. 102. REGISTRATION OF FOREIGN DRUG AND DEVICE ESTABLISHMENTS.
(a) Enforcement of Registration of Foreign Establishments- Section 502(o) (
(b) Registration of Foreign Establishments- Section 510 (U.S.C. 360), as amended by section 101, is further amended--CommentsClose CommentsPermalink
(1) by transferring subsection (i) so as to appear after subsection (b); andCommentsClose CommentsPermalink
(2) in subsection (i) (as so transferred)--CommentsClose CommentsPermalink
(A) by striking ‘(i) (1)’ and all that follows through ‘of each year.’ and inserting the following:CommentsClose CommentsPermalink
‘(c) Registration of Foreign Establishments-CommentsClose CommentsPermalink
‘(1) IN GENERAL- Any person who owns or operates any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device that is imported or offered for import into the United States shall--CommentsClose CommentsPermalink
‘(A) upon first engaging in any such activity, immediately submit a registration to the Secretary that includes the name and place of business of such person, all such establishments, the D-U-N-S number of each such establishment, an e-mail address for use in an emergency, payment of any inspection fee for each such establishment required under section 743, the name of the United States agent of each such establishment, the name of each importer of such drug or device in the United States that is known to each such establishment, and the name of each person who imports or offers for import such drug or device to the United States for purposes of importation;CommentsClose CommentsPermalink
‘(B) thereafter immediately submit a registration that includes the information and fee described in paragraph (1) for any additional establishment owned or operated by such person within any foreign country in which such person begins the manufacture, preparation, propagation, compounding, or processing of such a drug or device; andCommentsClose CommentsPermalink
‘(C) thereafter--CommentsClose CommentsPermalink
‘(i) with respect to drugs, submit a registration described in subparagraph (A) to the Secretary on or before December 31 of each year; andCommentsClose CommentsPermalink
‘(ii) with respect to devices, submit a registration described in subparagraph (A) to the Secretary during the period beginning on October 1 and ending on December 31 of each year.’;CommentsClose CommentsPermalink
(B) by striking paragraph (2);CommentsClose CommentsPermalink
(C) in paragraph (3), by striking ‘(3) The Secretary’ and inserting ‘(2) COOPERATIVE ARRANGEMENTS- The Secretary’; andCommentsClose CommentsPermalink
(D) by moving the indentation of paragraph (2), as amended, 2 ems to the right.CommentsClose CommentsPermalink
SEC. 103. REGISTRATION OF ESTABLISHMENTS FOR DRUG PRECURSOR INGREDIENTS.
(a) Registration of Establishments That Manufacture Drug Precursor Ingredients- Section 510(a) (
(1) in the matter preceding paragraph (1), by striking ‘As used’ and inserting ‘Definitions- As used’;CommentsClose CommentsPermalink
(2) by redesignating paragraphs (1) and (2) as paragraphs (2) and (3), respectively; andCommentsClose CommentsPermalink
(3) by inserting after ‘this section--’ the following:CommentsClose CommentsPermalink
‘(1) the term ‘drug’ includes a precursor ingredient;’.CommentsClose CommentsPermalink
(b) Definition of Precursor Ingredient- Section 201 (
‘(rr) The term ‘precursor ingredient’, with respect to an active ingredient of a drug, means an article that is a material--CommentsClose CommentsPermalink
‘(1) of animal origin from which such active ingredient is derived; orCommentsClose CommentsPermalink
‘(2) used in the final stage of synthesis or purification of such active ingredient, if so specified by the Secretary by regulation or in an order approving a drug that bears or contains such active ingredient.’.CommentsClose CommentsPermalink
SEC. 104. REGISTRATION AND LICENSING OF DRUG IMPORTERS.
Section 510 (
‘(d) Registration and Licensing of Drug Importers-CommentsClose CommentsPermalink
‘(1) IN GENERAL- Any person who owns or operates any establishment engaged in the importation, filing for importation, or brokering for importation of a drug into the United States shall--CommentsClose CommentsPermalink
‘(A) upon first engaging in any such activity, immediately submit a registration to the Secretary that includes the name of such person, places of business of such person, all such establishments, the D-U-N-S number of each such establishment, and an e-mail address for use in an emergency;CommentsClose CommentsPermalink
‘(B) thereafter immediately submit a registration that includes the information described in subparagraph (A) for any additional establishment owned or operated by such person in which such person begins any such activity; andCommentsClose CommentsPermalink
‘(C) thereafter submit a registration described in subparagraph (A) to the Secretary during the period beginning on October 1 and ending on December 31 of each year.CommentsClose CommentsPermalink
‘(2) LICENSING-CommentsClose CommentsPermalink
‘(A) IN GENERAL- The Secretary may require any person engaged in the importation, filing for importation, or brokering for importation of a drug into the United States, before engaging in those activities, to obtain a license to be issued by the Secretary.CommentsClose CommentsPermalink
‘(B) BOND- The Secretary may require as a condition of a license for a person under subparagraph (A) that the person post a bond subject to forfeiture if the person has, in connection with the importation, filing for importation, or brokering for importation of a drug into the United States--CommentsClose CommentsPermalink
‘(i) violated, or caused the violation, of this Act; orCommentsClose CommentsPermalink
‘(ii) made, or caused to be made, a false or misleading statement.CommentsClose CommentsPermalink
‘(C) AMOUNT OF BOND- The Secretary shall ensure that the amount of any bond required under subparagraph (B) for a person is sufficient to deter such person from, in connection with the importation, filing for importation, or brokering for importation of a drug into the United States--CommentsClose CommentsPermalink
‘(i) violating, or causing the violation of, this Act; orCommentsClose CommentsPermalink
‘(ii) making, or causing to be made, a false or misleading statement.CommentsClose CommentsPermalink
‘(D) REVOCATION- The Secretary may revoke the license for a person under subparagraph (A) if the Secretary finds that, in connection with the importation, filing for importation, or brokering for importation of a drug into the United States, such person has--CommentsClose CommentsPermalink
‘(i) violated, or caused the violation of, this Act; orCommentsClose CommentsPermalink
‘(ii) made, or caused to be made, a false or misleading statement.’.CommentsClose CommentsPermalink
SEC. 105. INSPECTION OF DRUG AND DEVICE ESTABLISHMENTS.
(a) Equal Inspection Authority for Domestic and Foreign Establishments; Refused Inspections- Section 510(h) (
(1) striking ‘Every’ and inserting: ‘Inspections-CommentsClose CommentsPermalink
‘(1) IN GENERAL- Every’;CommentsClose CommentsPermalink
(2) striking ‘in any State’; andCommentsClose CommentsPermalink
(3) striking ‘704 and every such establishment’ and inserting ‘704.CommentsClose CommentsPermalink
‘(2) REFUSED INSPECTION- Any establishment described in paragraph (1) shall not be considered duly registered under this section if an inspection of such establishment by the Secretary is refused, delayed, or limited by--CommentsClose CommentsPermalink
‘(A) the person who owns or operates such establishment, or any agent or employee of such person; orCommentsClose CommentsPermalink
‘(B) any agent of a governmental authority in the foreign country within which such establishment is located.CommentsClose CommentsPermalink
‘(3) BIENNIAL INSPECTION SCHEDULE- Except as provided in paragraph (4), and except for establishments that manufacture, prepare, propagate, compound, or process only inactive ingredients, every establishment described in paragraph (1).’.CommentsClose CommentsPermalink
(b) Providing for Risk-Based Inspections of Establishments-CommentsClose CommentsPermalink
(1) IN GENERAL- Section 510(h) (
‘(4) RISK-BASED INSPECTION SCHEDULE-CommentsClose CommentsPermalink
‘(A) IN GENERAL- The Secretary may by regulation provide for an inspection schedule for establishments described in paragraph (3) (including those establishments that manufacture, prepare, propagate, compound, or process only inactive ingredients) different from that required by such paragraph.CommentsClose CommentsPermalink
‘(B) INSPECTION FREQUENCY AND RISK-BASED FACTORS- In providing for an inspection schedule under subparagraph (A), the Secretary--CommentsClose CommentsPermalink
‘(i) may require inspections of an establishment more frequently than once in every successive 2-year period;CommentsClose CommentsPermalink
‘(ii) shall require inspections of an establishment at least once in every successive 5-year period; andCommentsClose CommentsPermalink
‘(iii) shall consider--CommentsClose CommentsPermalink
‘(I) the risks presented by the drug or drugs, or the device or devices, manufactured, prepared, propagated, compounded, or processed by an establishment (including whether the drug is a finished dosage form, an active ingredient, a precursor ingredient, or an inactive ingredient; the route of administration of the drug; whether the device is intended to be implanted, permanently implantable, life sustaining, or life supporting; and the use or uses for which the drug or device is approved or cleared under this Act or licensed under section 351 of the Public Health Service Act);CommentsClose CommentsPermalink
‘(II) whether or not an establishment is within a foreign country with a governmental authority responsible for drugs or devices, as applicable, deemed adequate by the Secretary;CommentsClose CommentsPermalink
‘(III) whether or not, and the frequency with which, an establishment is subject to inspection by a governmental authority responsible for drugs or devices, as applicable, deemed adequate by the Secretary; andCommentsClose CommentsPermalink
‘(IV) such other factors as the Secretary determines are relevant to determining an inspection schedule for establishments.CommentsClose CommentsPermalink
‘(C) RISK-BASED FACTORS FOR MODIFYING FREQUENCY OF INSPECTIONS OF AN ESTABLISHMENT- The Secretary may inspect an establishment at a frequency different than that required by the inspection schedule under subparagraph (A) by considering--CommentsClose CommentsPermalink
‘(i) the history of any safety problems with any drug or device manufactured, prepared, propagated, compounded, or processed by the establishment;CommentsClose CommentsPermalink
‘(ii) the record of inspections by the Secretary of the establishment;CommentsClose CommentsPermalink
‘(iii) with respect to a drug that is not a finished dosage form, the record of inspections by a governmental authority responsible for drugs deemed adequate by the Secretary;CommentsClose CommentsPermalink
‘(iv) with respect to a drug that is an inactive ingredient, a quality certification by a private entity, if the Secretary has agreed to accept such a certification; andCommentsClose CommentsPermalink
‘(v) such other factors as the Secretary determines are relevant to assessing the risk presented by the drug or drugs, or the device or devices, manufactured, prepared, propagated, compounded, or processed by the establishment.’.CommentsClose CommentsPermalink
(2) IMPLEMENTATION- The Secretary of Health and Human Services may issue a proposed rule to provide for a risk-based inspection schedule as described in section 510(h)(4) of the Federal Food, Drug, and Cosmetic Act, as amended by this Act, no earlier than March 31, 2011.CommentsClose CommentsPermalink
(c) Annual Report on Inspections of Establishments- Section 510(h) (
‘(5) ANNUAL REPORT ON INSPECTIONS OF ESTABLISHMENTS- Not later than February 1 of each year, the Secretary shall submit a report to the Congress about--CommentsClose CommentsPermalink
‘(A) the appropriations used to inspect establishments registered pursuant to this section in the previous fiscal year;CommentsClose CommentsPermalink
‘(B) the number of domestic and foreign establishments registered with the Secretary under this section during the previous calendar year;CommentsClose CommentsPermalink
‘(C)(i) the number of domestic and foreign establishments registered pursuant to this section that the Secretary inspected in the previous fiscal year; andCommentsClose CommentsPermalink
‘(ii) if the Secretary has provided for a schedule under paragraph (4)(A) with different frequencies of inspection for different classes of establishments, the numbers and identities for each such class;CommentsClose CommentsPermalink
‘(D)(i) the number of domestic and foreign establishments registered pursuant to this section that the Secretary did not inspect in the previous fiscal year; andCommentsClose CommentsPermalink
‘(ii) if the Secretary has provided for a schedule under paragraph (4)(A) with expected frequencies of inspection for different classes of establishments, the numbers for each such class;CommentsClose CommentsPermalink
‘(E) information on the performance in the previous fiscal year of the foreign inspectorate established under section 704(h) including--CommentsClose CommentsPermalink
‘(i) the number of inspections conducted with and without personnel who are fluent in the language used in the establishment under inspection;CommentsClose CommentsPermalink
‘(ii) the number of personnel in such inspectorate;CommentsClose CommentsPermalink
‘(iii) the countries in which such personnel conduct inspections;CommentsClose CommentsPermalink
‘(iv) the offices in foreign countries where such personnel are permanently stationed;CommentsClose CommentsPermalink
‘(v) the number of personnel conducting inspections in each country who are fluent in the language or languages used in the establishments of that country; andCommentsClose CommentsPermalink
‘(vi) the number of personnel who are permanently stationed in each in-country office who are fluent in the language or languages used in the establishments of that country; andCommentsClose CommentsPermalink
‘(F) other information deemed relevant by the Secretary.CommentsClose CommentsPermalink
‘(6) PUBLIC AVAILABILITY OF ANNUAL REPORTS- The Secretary shall make the report required under paragraph (5) available to the public on the Internet Web site of the Food and Drug Administration.’.CommentsClose CommentsPermalink
SEC. 106. LISTING OF DRUGS AND DEVICES; ENHANCED INFORMATION TECHNOLOGY SYSTEM FOR REGISTRATION AND LISTING; INACTIVE INGREDIENTS.
(a) Listing of Drugs and Devices- Section 510(j) (
(1) by striking ‘(j)(1) Every person who registers with the Secretary under subsection (b), (c), (d), or (i)’ and inserting the following:CommentsClose CommentsPermalink
‘(i) Submission of List of Drugs and Devices-CommentsClose CommentsPermalink
‘(1) IN GENERAL- Every person who registers with the Secretary under subsection (b) or (c)’;CommentsClose CommentsPermalink
(2) in paragraph (1)--CommentsClose CommentsPermalink
(A) in subparagraph (B)(i), by inserting ‘in the case of a drug, the authority under this Act that does not require such drug to be subject to section 505 and section 512,’ after ‘labeling for such drug or device,’;CommentsClose CommentsPermalink
(B) in subparagraph (B)(ii), by inserting ‘, in the case of a drug, the authority under this Act that does not require such drug to be subject to section 505 and section 512,’ after ‘insert for such drug or device’;CommentsClose CommentsPermalink
(C) by moving the indentation of subparagraphs (A) through (D) 2 ems to the right; andCommentsClose CommentsPermalink
(D) in subparagraph (B), by moving the indentation of clauses (i) and (ii) 2 ems to the right;CommentsClose CommentsPermalink
(3) in paragraph (2)--CommentsClose CommentsPermalink
(A) by striking ‘(2) Each person who registers with the Secretary under this section’ and inserting the following:CommentsClose CommentsPermalink
‘(2) REPORT TO SECRETARY- Every person who registers with the Secretary under subsection (b) or (c)’; andCommentsClose CommentsPermalink
(B) by moving the indentation of subparagraphs (A) through (D) 2 ems to the right;CommentsClose CommentsPermalink
(4) in paragraph (3), by striking ‘(3) The Secretary’ and inserting the following:CommentsClose CommentsPermalink
‘(3) ADDITIONAL LIST- The Secretary’; andCommentsClose CommentsPermalink
(5) by adding at the end the following:CommentsClose CommentsPermalink
‘(4) SUBMISSION FOR FINISHED DOSAGE FORM- Every person who files a list under paragraph (1) or reports a list under paragraph (2) shall submit with such list, for any drug that is a finished dosage form, the identity of each establishment engaged in the manufacture, preparation, propagation, compounding, or processing of--CommentsClose CommentsPermalink
‘(A) the finished dosage form;CommentsClose CommentsPermalink
‘(B) any active ingredient of the drug;CommentsClose CommentsPermalink
‘(C) any inactive ingredient of the drug; orCommentsClose CommentsPermalink
‘(D) any precursor ingredient of any such active ingredient.’.CommentsClose CommentsPermalink
(b) Enhanced Information Technology System for Registration and Listing- Section 510(j) (
‘(5) ELECTRONIC SUBMISSION AND MAINTENANCE OF INFORMATION- Not later than October 1, 2010, the Secretary shall establish and maintain--CommentsClose CommentsPermalink
‘(A) an Internet-based portal through which information to register establishments under subsection (b), (c), and (d) and to list drugs and devices under this subsection shall be submitted to the Secretary; andCommentsClose CommentsPermalink
‘(B) an electronic database (which shall not be subject to inspection under subsection (f)) populated with the information submitted under subparagraph (A) that--CommentsClose CommentsPermalink
‘(i) includes appropriate links between registered establishments and between such establishments and listed drugs and devices sufficient to enable the Secretary to track and assess the establishments and articles involved in the manufacture, preparation, propagation, compounding, or processing of each drug that is a finished dosage form or an active ingredient and each device;CommentsClose CommentsPermalink
‘(ii) includes the date of each inspection by the Secretary (with the Secretary’s report on and assessment of the inspection) for each such establishment and such other information on the inspectional record and compliance history of the establishment as the Secretary deems necessary and appropriate to assess the compliance history of the establishment and, if applicable, apply the inspection schedule under subsection (h)(4) to such establishment; andCommentsClose CommentsPermalink
‘(iii) is interoperable and communicates with other relevant databases within the Food and Drug Administration (including a database for submission of information under section 801(p)).’.CommentsClose CommentsPermalink
(c) Drugs That Are Not Approved Under Section 505 or 512- Section 510(f) (
(1) by striking ‘(f) The Secretary’ and inserting the following:CommentsClose CommentsPermalink
‘(f) Inspection by Public of Registration-CommentsClose CommentsPermalink
‘(1) IN GENERAL- The Secretary’;CommentsClose CommentsPermalink
(2) by striking ‘subsection (j)’ and inserting ‘subsection (i)’; andCommentsClose CommentsPermalink
(3) by inserting at the end the following:CommentsClose CommentsPermalink
‘(2) LIST OF DRUGS THAT ARE NOT APPROVED UNDER SECTION 505 OR 512- The Secretary shall make available to the public on the Internet Web site of the Food and Drug Administration a list that includes, for each drug described in subsection (i)(1)(B)--CommentsClose CommentsPermalink
‘(A) the drug;CommentsClose CommentsPermalink
‘(B) the person who listed such drug; andCommentsClose CommentsPermalink
‘(C) the authority under this Act that does not require such drug to be subject to section 505 and section 512, as provided by such person in such list.’.CommentsClose CommentsPermalink
(d) Inactive Ingredients-CommentsClose CommentsPermalink
(1) ASSESSMENT OF ESTABLISHMENTS THAT MANUFACTURE DRUG INACTIVE INGREDIENTS- Not later than March 31, 2011, the Secretary of Health and Human Services (referred to in this subsection as the ‘Secretary’) shall--CommentsClose CommentsPermalink
(A) use the information populating the electronic database referred to in section 510(j)(5) of the Federal, Food, Drug, and Cosmetic Act, as added by subsection (b), to identify the establishments that manufacture, prepare, propagate, compound, or process an active ingredient of any drug listed in such database; andCommentsClose CommentsPermalink
(B) complete an assessment as to whether the exemption from registration in subsection (e) of section 207.10 of title 21, Code of Federal Regulations, should be eliminated or modified.CommentsClose CommentsPermalink
(2) REGULATION TO ELIMINATE OR MODIFY THE EXEMPTION FROM REGISTRATION FOR ESTABLISHMENTS THAT MANUFACTURE DRUG INACTIVE INGREDIENTS- In the regulation provided for under section 105(b)(2), the Secretary may propose to eliminate or modify the exemption referred to in paragraph (1)(B), as the Secretary deems appropriate, after having completed the assessment under such paragraph.CommentsClose CommentsPermalink
SEC. 107. FEES RELATED TO ESTABLISHMENT INSPECTIONS.
Subchapter C of chapter VII (
‘PART 6--FEES RELATED TO ESTABLISHMENT INSPECTIONS
‘SEC. 743. AUTHORITY TO ASSESS AND USE FEES.
‘(a) Definitions- In this section:CommentsClose CommentsPermalink
‘(1) AFFILIATE- The term ‘affiliate’ means a business entity that has a relationship with a second business entity if, directly or indirectly--CommentsClose CommentsPermalink
‘(A) one business entity controls, or has the power to control, the other business entity; orCommentsClose CommentsPermalink
‘(B) a third business entity controls, or has the power to control, both of the business entities.CommentsClose CommentsPermalink
‘(2) DEVICE ESTABLISHMENT- The term ‘device establishment’ means--CommentsClose CommentsPermalink
‘(A) an establishment in any State that is--CommentsClose CommentsPermalink
‘(i) engaged in the manufacture, preparation, propagation, compounding, or processing of a device classified in class II or class III; andCommentsClose CommentsPermalink
‘(ii) subject to inspection under subsection (h)(3) or (h)(4) of section 510, as applicable; orCommentsClose CommentsPermalink
‘(B) an establishment within any foreign country that is--CommentsClose CommentsPermalink
‘(i) engaged in the manufacture, preparation, propagation, compounding, or processing of a device classified in class II or class III that is imported or offered for import into the United States; andCommentsClose CommentsPermalink
‘(ii) subject to inspection under subsection (h)(3) or (h)(4) of section 510, as applicable.CommentsClose CommentsPermalink
‘(3) DEVICE REGISTRATION AND INSPECTION ACTIVITIES- The term ‘device registration and inspection activities’ means the following activities of the Secretary:CommentsClose CommentsPermalink
‘(A) The registration of device establishments under subsections (b) and (c) of section 510.CommentsClose CommentsPermalink
‘(B) The listing of devices under section 510(i), including the activities for devices described in section 510(i)(5).CommentsClose CommentsPermalink
‘(C) The inspection of device establishments under section 510(h)(3) or, if applicable, section 510(h)(4).CommentsClose CommentsPermalink
‘(D) The review of inspection reports from such inspections.CommentsClose CommentsPermalink
‘(E) Any action under this Act pursuant to such registration, listing, inspections, or reviews.CommentsClose CommentsPermalink
‘(4) DRUG ESTABLISHMENT- The term ‘drug establishment’ means--CommentsClose CommentsPermalink
‘(A) an establishment in any State that is--CommentsClose CommentsPermalink
‘(i) engaged in the manufacture, preparation, propagation, compounding, or processing of a drug; andCommentsClose CommentsPermalink
‘(ii) subject to inspection under subsection (h)(3) or (h)(4) of section 510, as applicable; orCommentsClose CommentsPermalink
‘(B) an establishment within any foreign country that is--CommentsClose CommentsPermalink
‘(i) engaged in the manufacture, preparation, propagation, compounding, or processing of a drug; andCommentsClose CommentsPermalink
‘(ii) subject to inspection under subsection (h)(3) or (h)(4) of section 510, as applicable.CommentsClose CommentsPermalink
‘(5) DRUG REGISTRATION AND INSPECTION ACTIVITIES- The term ‘drug registration and inspection activities’ means the following activities of the Secretary:CommentsClose CommentsPermalink
‘(A) The registration of drug establishments under subsections (b) and (c) of section 510.CommentsClose CommentsPermalink
‘(B) The listing of drugs under section 510(i), including the activities for drugs described in section 510(i)(5).CommentsClose CommentsPermalink
‘(C) The inspection of drug establishments under section 510(h)(3) or, if applicable, section 510(h)(4).CommentsClose CommentsPermalink
‘(D) The review of inspection reports from such inspections.CommentsClose CommentsPermalink
‘(E) Any action under this Act pursuant to such registration, listing, inspections, or reviews.CommentsClose CommentsPermalink
‘(6) PERSON- The term ‘person’ includes an affiliate thereof.CommentsClose CommentsPermalink
‘(b) Types of Fees-CommentsClose CommentsPermalink
‘(1) DRUG INSPECTION FEES- Beginning in fiscal year 2010, the Secretary shall collect drug inspection fees in accordance with this section as follows:CommentsClose CommentsPermalink
‘(A) IN GENERAL- Except as provided under subparagraphs (B), (C), and (D), each person that during a fiscal year registers a drug establishment under subsection (b) or (c) of section 510 shall be subject to a drug inspection fee established under subsection (c)(1).CommentsClose CommentsPermalink
‘(B) REDUCTION FOR POSITRON EMISSION TOMOGRAPHY DRUGS- The drug inspection fee for a drug establishment engaged solely in the manufacture, preparation, propagation, compounding, or processing of 1 or more drugs to which section 736(a)(2)(C)(i) applies shall be one-sixth of the drug inspection fee otherwise applicable to such establishment under subsection (c)(1).CommentsClose CommentsPermalink
‘(C) EXEMPTION FOR CERTAIN POSITRON EMISSION TOMOGRAPHY DRUGS AND CERTAIN ORPHAN DRUGS- A drug establishment engaged solely in the manufacture, preparation, propagation, compounding, or processing of 1 or more drugs to which section 736(a)(2)(C)(ii) or section 736(k) applies shall not be assessed a drug inspection fee.CommentsClose CommentsPermalink
‘(D) WAIVER OR REDUCTION- The Secretary shall grant a waiver from or reduction of the drug inspection fee as provided for under section 736(d).CommentsClose CommentsPermalink
‘(2) DEVICE INSPECTION FEES- Beginning in fiscal year 2010, the Secretary shall collect device inspection fees in accordance with this section as follows:CommentsClose CommentsPermalink
‘(A) IN GENERAL- Except as provided under subparagraphs (B) and (C), each person that during a fiscal year registers a device establishment under subsection (b) or (c) of section 510 shall pay a device inspection fee established under subsection (c)(2).CommentsClose CommentsPermalink
‘(B) REDUCTION FOR SMALL BUSINESSES- The device inspection fee for a device establishment owned or operated by an entity that qualifies as a small business under section 738(d)(2) shall be one-fourth of the device inspection fee otherwise applicable to such establishment under subsection (c)(2).CommentsClose CommentsPermalink
‘(C) EXEMPTION FOR CERTAIN STATE OR FEDERAL GOVERNMENT ESTABLISHMENTS- A device establishment operated by a State or Federal Government entity shall not be assessed a device inspection fee unless a device classified in class II or class III manufactured by the establishment is to be distributed commercially.CommentsClose CommentsPermalink
‘(c) Fee Amounts-CommentsClose CommentsPermalink
‘(1) DRUG INSPECTION FEE AMOUNTS-CommentsClose CommentsPermalink
‘(A) IN GENERAL- Beginning with fiscal year 2010, the Secretary shall, not later than 30 days after the amount has been appropriated for a fiscal year in an appropriations Act as described in subsection (e)(1), establish for such fiscal year, and publish in the Federal Register, drug inspection fees, based on the amount provided for in advance in appropriations Acts for such fees as described in subsection (e)(1), considering--CommentsClose CommentsPermalink
‘(i) the requirement described under subparagraph (C);CommentsClose CommentsPermalink
‘(ii) the reductions required under subparagraphs (B) and (D) of subsection (b)(1); andCommentsClose CommentsPermalink
‘(iii) the number of drug establishments subject to such a fee, considering subparagraphs (C) and (D) of subsection (b)(1).CommentsClose CommentsPermalink
‘(B) FOREIGN DRUG ESTABLISHMENT- For a foreign drug establishment, the drug inspection fee shall be--CommentsClose CommentsPermalink
‘(i) the applicable drug inspection fee under subparagraph (A), plusCommentsClose CommentsPermalink
‘(ii) the pro rata costs, if any, of--CommentsClose CommentsPermalink
‘(I) travel to and within, and lodging in, the country in which the establishment is located for the individual or individuals who conduct the inspection of the establishment; andCommentsClose CommentsPermalink
‘(II) a translator for the inspection of the establishment.CommentsClose CommentsPermalink
‘(C) PROPORTIONAL FEES-CommentsClose CommentsPermalink
‘(i) INSPECTIONS MORE FREQUENT THAN EVERY 2 YEARS- The drug inspection fee for a drug establishment that under the inspection schedule provided for under section 510(h)(4) is to be inspected more frequently than once in every 2-year period shall be more than the drug inspection fee for a drug establishment that under such schedule is to be inspected once in every 2-year period, in proportion to the factor by which such drug establishment to be is inspected more frequently than once in every 2-year period.CommentsClose CommentsPermalink
‘(ii) INSPECTIONS LESS FREQUENT THAN EVERY 2 YEARS- The drug inspection fee for a drug establishment that under the inspection schedule provided for under section 510(h)(4) is to be inspected less frequently than once in every 2-year period shall be less than the drug inspection fee for a drug establishment that under such schedule is to be inspected once in every 2-year period, in proportion to the factor by which such establishment is to be inspected less frequently than once in every 2-year period.CommentsClose CommentsPermalink
‘(2) DEVICE INSPECTION FEE AMOUNTS-CommentsClose CommentsPermalink
‘(A) IN GENERAL- Beginning with fiscal year 2010, the Secretary shall, not later than 30 days after the amount has been appropriated for a fiscal year in an appropriations Act as described in subsection (e)(2) establish for such fiscal year, and publish in the Federal Register device inspection fees, based on the amount provided for in advance in appropriations Acts for such fees as described in subsection (e)(2) and considering--CommentsClose CommentsPermalink
‘(i) the requirement described under subparagraph (C);CommentsClose CommentsPermalink
‘(ii) the reduction required under subsection (b)(2)(B); andCommentsClose CommentsPermalink
‘(iii) the number of device establishments subject to such a fee, considering subsection (b)(2)(C).CommentsClose CommentsPermalink
‘(B) FOREIGN DEVICE ESTABLISHMENT- For a foreign device establishment, the device inspection fee shall be--CommentsClose CommentsPermalink
‘(i) the applicable device inspection fee under subparagraph (A), plusCommentsClose CommentsPermalink
‘(ii) the pro rata costs, if any, of--CommentsClose CommentsPermalink
‘(I) travel to and within, and lodging in, the country in which the establishment is located for the individual or individuals who conduct the inspection of the establishment; andCommentsClose CommentsPermalink
‘(II) a translator for the inspection of the establishment.CommentsClose CommentsPermalink
‘(C) PROPORTIONAL FEES-CommentsClose CommentsPermalink
‘(i) INSPECTIONS MORE FREQUENT THAN EVERY 2 YEARS- The device inspection fee for a device establishment that under the inspection schedule provided for under section 510(h)(4) is to be inspected more frequently than once in every 2-year period shall be more than the device inspection fee for a device establishment that under such schedule is to be inspected once in every 2-year period, in proportion to the factor by which such device establishment is to be inspected more frequently than once in every 2-year period.CommentsClose CommentsPermalink
‘(ii) INSPECTIONS LESS FREQUENT THAN EVERY 2 YEARS- The device inspection fee for a device establishment that under the inspection schedule provided for under section 510(h)(4) is to be inspected less frequently than once in every 2-year period shall be less than the device inspection fee for a device establishment that under such schedule is to be inspected once in every 2-year period, in proportion to the factor by which such establishment is to be inspected less frequently than once in every 2-year period.CommentsClose CommentsPermalink
‘(d) Effect of Failure To Pay Fees-CommentsClose CommentsPermalink
‘(1) DRUG INSPECTION FEE- An establishment subject to a drug inspection fee under subsection (b) shall be considered not to be registered under section 510 until all fees under this section owed by the person required to register such establishment have been paid.CommentsClose CommentsPermalink
‘(2) DEVICE INSPECTION FEE- An establishment subject to a device inspection fee under subsection (b) shall be considered not to be registered under section 510 until all fees under this section owed by the person required to register such establishment have been paid.CommentsClose CommentsPermalink
‘(e) Crediting and Availability of Fees-CommentsClose CommentsPermalink
‘(1) DRUG INSPECTION FEES- Drug inspection fees authorized under subsection (b) 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 drug registration and inspection activities.CommentsClose CommentsPermalink
‘(2) DEVICE INSPECTION FEES- Device inspection fees authorized under subsection (b) 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 device registration and inspection activities.CommentsClose CommentsPermalink
‘(3) AUTHORIZATION OF APPROPRIATIONS-CommentsClose CommentsPermalink
‘(A) DRUG INSPECTION FEES- Beginning in fiscal year 2010, there is authorized to be appropriated for each fiscal year for drug inspection fees under this section such sums as may be necessary to carry out drug inspection activities for such fiscal year, except that such sums may be no greater than the lesser of--CommentsClose CommentsPermalink
‘(i) the amount appropriated (excluding fees) for such activities for such fiscal year; orCommentsClose CommentsPermalink
‘(ii) the difference between the amount necessary to carry out such activities for such fiscal year (as provided in the report required by subsection (h)(2)(A)) and the amount appropriated (excluding fees) for such activities for such fiscal year.CommentsClose CommentsPermalink
‘(B) DEVICE INSPECTION FEES- Beginning in fiscal year 2010, there is authorized to be appropriated for each fiscal year for device inspection fees under this section such sums as may be necessary to carry out device registration and inspection activities for such fiscal year, except that such sums may be no greater than the lesser of--CommentsClose CommentsPermalink
‘(i) the amount appropriated (excluding fees) for such activities for such fiscal year; orCommentsClose CommentsPermalink
‘(ii) the difference between the amount necessary to carry out such activities for such fiscal year (as provided in the report required by subsection (h)(2)(B)) and the amount appropriated (excluding fees) for such activities for such fiscal year.CommentsClose CommentsPermalink
‘(f) Authority- If the Secretary does not assess fees under subsection (b) during any portion of a fiscal year and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate, at any time in such fiscal year notwithstanding the provisions of subsections (b) and (c) of section 510 relating to the date fees are to be paid.CommentsClose CommentsPermalink
‘(g) Collection of Unpaid Fees- In any case where the Secretary does not receive payment of a fee required to be paid under subsection (b) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31, United States Code.CommentsClose CommentsPermalink
‘(h) Reports-CommentsClose CommentsPermalink
‘(1) PERFORMANCE REPORTS- Beginning for fiscal year 2010, not later than 120 days after the end of each fiscal year for which fees are collected under this section, the Secretary shall prepare and 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--CommentsClose CommentsPermalink
‘(A) a report concerning the performance of the Food and Drug Administration with respect to drug registration and inspection activities during such fiscal year; andCommentsClose CommentsPermalink
‘(B) a report concerning the performance of the Food and Drug Administration with respect to device registration and inspection activities during such fiscal year.CommentsClose CommentsPermalink
‘(2) FISCAL REPORT- Beginning for fiscal year 2010, not later than 120 days after the end of each fiscal year for which fees are collected under this section, the Secretary shall prepare and 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--CommentsClose CommentsPermalink
‘(A) a report on--CommentsClose CommentsPermalink
‘(i) the implementation of the authority for drug establishment fees during such fiscal year;CommentsClose CommentsPermalink
‘(ii) the use, by the Food and Drug Administration, of such fees collected for such fiscal year; andCommentsClose CommentsPermalink
‘(iii) the amount necessary to carry out drug registration and inspection activities for the subsequent fiscal year (with a detailed explanation of the methodology used to determine such amount); andCommentsClose CommentsPermalink
‘(B) a report on--CommentsClose CommentsPermalink
‘(i) the implementation of the authority for device establishment fees during such fiscal year;CommentsClose CommentsPermalink
‘(ii) the use, by the Food and Drug Administration, of such fees collected for such fiscal year; andCommentsClose CommentsPermalink
‘(iii) the amount necessary to carry out device registration and inspection activities for the subsequent fiscal year (with a detailed explanation of the methodology used to determine such amount).CommentsClose CommentsPermalink
‘(3) PUBLIC AVAILABILITY- The Secretary shall make the reports required under paragraphs (1) and (2) available to the public on the Internet Web site of the Food and Drug Administration.’.CommentsClose CommentsPermalink
SEC. 108. ELECTRONIC SUBMISSION AND CERTIFICATION OF REGISTRATIONS AND LISTINGS.
Section 510 (
(1) inserting after subsection (i) the following:CommentsClose CommentsPermalink
‘(j) Electronic Submission and Certification- Registrations and listings under this section (including the submission of updated information) shall be submitted and certified to the Secretary through the electronic portal described in subsection (i)(5)(A) (or by other electronic means until the Secretary establishes such portal) unless the Secretary grants a request for waiver of such requirement because use of electronic means is not reasonable for the person requesting such waiver.’; andCommentsClose CommentsPermalink
(2) striking subsection (p).CommentsClose CommentsPermalink
SEC. 109. TECHNICAL AND CONFORMING AMENDMENTS.
(a) Section 510-CommentsClose CommentsPermalink
(1) LISTING NUMBERS- Section 510(e) (
(A) by striking ‘(e) The Secretary’ and all that follows through ‘Any number’ and inserting the following:CommentsClose CommentsPermalink
‘(e) Listing Number- The Secretary may assign a listing number to each drug or class of drugs listed under subsection (i). Any number’; andCommentsClose CommentsPermalink
(B) by striking ‘subsection (j)’ and inserting ‘subsection (i)’.CommentsClose CommentsPermalink
(2) EXEMPTIONS- Section 510(g) (
‘(g) Exemptions- The foregoing’.CommentsClose CommentsPermalink
(3) DEVICE REPORTS- Section 510(k) (
‘(k) Device Reports- Each person’.CommentsClose CommentsPermalink
(4) NO REPORT REQUIRED- Section 510(l) (
‘(l) No Report Required- A report’.CommentsClose CommentsPermalink
(5) EXEMPTIONS FOR CLASS II DEVICES- Section 510(m) (
(A) by striking ‘(m)(1) Not later than’ and inserting the following:CommentsClose CommentsPermalink
‘(m) Exemptions for Class II Devices-CommentsClose CommentsPermalink
‘(1) LIST OF EXEMPTED DEVICES- Not later than’; andCommentsClose CommentsPermalink
(B) by striking ‘(2) Beginning’ and inserting the following:CommentsClose CommentsPermalink
‘(2) OTHER EXEMPTED DEVICES- Beginning’.CommentsClose CommentsPermalink
(6) REVIEW OF REPORT- Section 510(n) (
21 U.S.C. 360(n) ) is amended by striking ‘(n) The Secretary’ and inserting the following:CommentsClose CommentsPermalink‘(n) Review of Report- The Secretary’.CommentsClose CommentsPermalink
(7) REPROCESSED SINGLE-USE DEVICES- Section 510(o) (
(A) by striking ‘(o)(1) With respect to’ and inserting the following:CommentsClose CommentsPermalink
‘(o) Reprocessed Single-Use Devices-CommentsClose CommentsPermalink
‘(1) REPROCESSED SINGLE-USE DEVICES FOR WHICH REPORTS ARE REQUIRED- With respect to’;CommentsClose CommentsPermalink
(B) in paragraph (1), by moving the indentation of subparagraphs (A) through (D) 2 ems to the right;CommentsClose CommentsPermalink
(C) by striking ‘(2) With respect to’ and inserting the following:CommentsClose CommentsPermalink
‘(2) CRITICAL AND SEMICRITICAL REPROCESSED SINGLE-USE DEVICES- With respect to’; andCommentsClose CommentsPermalink
(D) in paragraph (2), by moving the indentation of subparagraphs (A) through (E) 2 ems to the right.CommentsClose CommentsPermalink
(b) Other Provisions- The Federal Food, Drug, and Cosmetic Act (
(1) by striking ‘510(i)’ each place it appears and inserting ‘510(c)’;CommentsClose CommentsPermalink
(2) in section 301(p)--CommentsClose CommentsPermalink
(A) by striking ‘510(j)’ and inserting ‘510(i)’; andCommentsClose CommentsPermalink
(B) by striking ‘510(j)(2)’ and inserting ‘510(i)(2)’;CommentsClose CommentsPermalink
(3) in section 502(o), by striking ‘510(j)’ and inserting ‘510(i)’; andCommentsClose CommentsPermalink
(4) in section 801(a), by striking ‘subsection (i) of section 510’ and inserting ‘subsection (c) of section 510’.CommentsClose CommentsPermalink
SEC. 110. EFFECTIVE DATE.
Except as otherwise provided in this subtitle, this subtitle, and the amendments made by this subtitle, shall take effect on October 1, 2009.CommentsClose CommentsPermalink
Subtitle B--Ensuring Identity and Sourcing of Drug IngredientsCommentsClose CommentsPermalink
Subtitle B--Ensuring Identity and Sourcing of Drug IngredientsCommentsClose CommentsPermalink
SEC. 111. COMPENDIAL MODERNIZATION.
(a) In General- Section 501(b) (
(1) inserting ‘or of the appropriate body charged with the revision of such compendium’ after ‘are, in the judgment of the Secretary’;CommentsClose CommentsPermalink
(2) inserting ‘(1)’ after ‘insufficient for the making of such determination,’;CommentsClose CommentsPermalink
(3) striking ‘attention of the appropriate body charged with the revision of such compendium’ and inserting ‘attention of such body’; andCommentsClose CommentsPermalink
(4) inserting ‘, or (2) such body shall bring such fact to the attention of the Secretary, and the Secretary shall work with such body to develop approaches that will allow such body to establish sufficient standards’ after ‘purity shall be made’.CommentsClose CommentsPermalink
(b) Rulemaking- Section 701(e)(1) (
(c) Assessment- The Secretary of Health and Human Services, in consultation with the United States Pharmacopeia, other drug regulatory agencies, academic experts, and industry, shall periodically assess the tests and methods of assay for drugs found in official compendia to--CommentsClose CommentsPermalink
(1) identify, considering current scientific methods, which tests and methods of assay are no longer scientifically sound and appropriate and of sufficient analytical precision and specificity for their purpose; andCommentsClose CommentsPermalink
(2) prioritize which such tests and methods of assay should be revised, considering--CommentsClose CommentsPermalink
(A) the risks posed by a drug if its strength differs, or its quality or purity falls below, the compendia standards for such drug; andCommentsClose CommentsPermalink
(B) whether such tests and methods of assay are sufficient to distinguish such drug from contaminants or adulterants reasonably likely to be present in or on such drug.CommentsClose CommentsPermalink
SEC. 112. TESTING OF DRUG PURITY AND IDENTITY.
Section 501 (
‘(j) If it is a drug and it bears or contains an article, unless the manufacturer of such drug verifies the purity and identity of such article using scientifically sound and appropriate methods of sufficient analytical precision and specificity to detect and quantify the article separate from--CommentsClose CommentsPermalink
‘(1) impurities; andCommentsClose CommentsPermalink
‘(2) contaminants and adulterants reasonably likely to be present in or on such article.’.CommentsClose CommentsPermalink
SEC. 113. MANUFACTURER RESPONSIBILITY FOR SOURCE AND QUALITY OF DRUG INGREDIENTS.
Section 501 (
‘(k) If it is a drug and the manufacturer or importer fails to establish and maintain for a period of time determined by the Secretary documentation adequate to--CommentsClose CommentsPermalink
‘(1) identify each establishment that manufactured, processed, packed, or held each article that is a component of the drug or a precursor ingredient of such a component; andCommentsClose CommentsPermalink
‘(2) establish, including through appropriate and periodic audits of the establishments described in paragraph (1), that the drug and each such article is not adulterated under this section or misbranded under section 502.’.CommentsClose CommentsPermalink
SEC. 114. CURRENT MANUFACTURING SCIENCE.
Section 501(a) (
SEC. 115. COUNTRY OF ORIGIN LABELING.
Section 502 (
‘(d) If it is a drug in final dosage form or device for use on or by patients unless the Internet Web site of the manufacturer or distributor of the drug or device (whichever is identified on the label of the drug or device) lists, for each lot of such drug or device, the identity of--CommentsClose CommentsPermalink
‘(1) the country of manufacture of the drug or device; andCommentsClose CommentsPermalink
‘(2) if it is a drug, the country of manufacture of each active ingredient of the drug.’.CommentsClose CommentsPermalink
SEC. 116. EFFECTIVE DATE; IMPLEMENTATION.
(a) Effective Date- Sections 112, 113, 114, and 115, and the amendments made by such sections, shall take effect on the date that is 2 years after the date of enactment of this Act.CommentsClose CommentsPermalink
(b) Implementation- Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue a guidance for industry about how a drug may comply with the requirements of subsections (a)(2)(D), (j), and (k) of section 501 of the Federal Food, Drug, and Cosmetic Act (as added by this subtitle) and section 501(a)(2)(B) of such Act (
Subtitle C--Ensuring Standards for Imported DrugsCommentsClose CommentsPermalink
Subtitle C--Ensuring Standards for Imported DrugsCommentsClose CommentsPermalink
SEC. 121. GOOD DISTRIBUTION AND IMPORT PRACTICES.
(a) Good Distribution and Import Practices- Section 501(a) (
(b) Inspection of Importers and Distributors of Drugs- Section 704 (
(1) in subsection (a)--CommentsClose CommentsPermalink
(A) in paragraph (1)(A), by inserting ‘(and in the case of drugs, distributed, shipped, warehoused, or conveyed),’ after ‘or held,’; andCommentsClose CommentsPermalink
(B) in the third sentence--CommentsClose CommentsPermalink
(i) by inserting ‘(and in the case of drugs, distributed, shipped, warehoused, or conveyed),’ after ‘packed, or held,’; andCommentsClose CommentsPermalink
(ii) by inserting ‘, (and in the case of drugs, distributed, shipped, warehoused, or conveyed),’ after ‘transported, or held’; andCommentsClose CommentsPermalink
(2) in subsection (e), by striking ‘519 or’ and inserting ‘502(a)(2)(E), 519, or’.CommentsClose CommentsPermalink
SEC. 122. STANDARDS FOR ADMISSION OF IMPORTED DRUGS AND DRUG INGREDIENTS.
(a) In General- Section 801 (
(1) in subsection (o), by striking ‘drug or’; andCommentsClose CommentsPermalink
(2) by adding at the end the following:CommentsClose CommentsPermalink
‘(p)(1) Except as provided in paragraph (2), a drug, or an article that appears to be a drug, in finished dosage form, an article that is intended to be a component of a drug, or an article that is intended to be a precursor ingredient of such a component that is being imported or offered for import into the United States shall be refused admission unless the person importing or offering for import such drug or article provides to the Secretary, at the time of being imported or offered for import (and through an electronic portal as provided by the Secretary)--CommentsClose CommentsPermalink
‘(A) all information submitted to U.S. Customs and Border Protection in the entry declaration for such drug or such article;CommentsClose CommentsPermalink
‘(B) for a drug, or an article that appears to be a drug, in finished dosage form--CommentsClose CommentsPermalink
‘(i) the listing number under section 510(e) of such drug;CommentsClose CommentsPermalink
‘(ii) the D-U-N-S number of each establishment in which such drug was manufactured, prepared, propagated, compounded, or processed;CommentsClose CommentsPermalink
‘(iii) the new drug application number, the biologics license application number, the abbreviated new drug application number, the number of the investigational new drug exemption for the drug, or the drug monograph number, as applicable;CommentsClose CommentsPermalink
‘(iv) the label required by the new drug application, the biologics license application number, abbreviated new drug application, investigational new drug exemption, or drug monograph, as applicable; andCommentsClose CommentsPermalink
‘(v) the record of inspections by the Secretary;CommentsClose CommentsPermalink
‘(C) for an article that is an active ingredient of a drug, or an article that is a precursor ingredient of an active ingredient--CommentsClose CommentsPermalink
‘(i) the listing number under section 510(e) of such article;CommentsClose CommentsPermalink
‘(ii) the D-U-N-S number of each establishment in which such article was manufactured, prepared, propagated, compounded, or processed;CommentsClose CommentsPermalink
‘(iii) the new drug application number, the biologics license application number, the abbreviated new drug application number, the number of the investigational new drug exemption for the drug, or the drug monograph number, as applicable, of the finished dosage form for which such article is intended;CommentsClose CommentsPermalink
‘(iv) the label under a regulatory exemption from section 502(f)(1); andCommentsClose CommentsPermalink
‘(v) the record of inspections by the Secretary or by a governmental authority responsible for drugs deemed adequate by the Secretary; andCommentsClose CommentsPermalink
‘(D) for an article (other than an active ingredient) that is intended to be a component of a drug, or an article that is a precursor ingredient of any such component--CommentsClose CommentsPermalink
‘(i) the listing number under section 510(e) of such article;CommentsClose CommentsPermalink
‘(ii) the D-U-N-S number of each establishment in which such article was manufactured, prepared, propagated, compounded, or processed;CommentsClose CommentsPermalink
‘(iii) the new drug application number, the biologics license application number, the abbreviated new drug application number, the number of the investigational new drug exemption for the drug, or the drug monograph number, as applicable, of the finished dosage form for which such article is intended; andCommentsClose CommentsPermalink
‘(iv)(I) the record of inspections by the Secretary or by a governmental authority responsible for drugs deemed adequate by the Secretary;CommentsClose CommentsPermalink
‘(II) a quality certification by a private entity, if the Secretary has agreed to accept such a certification; andCommentsClose CommentsPermalink
‘(III) other evidence of quality that the Secretary has deemed acceptable by regulation.CommentsClose CommentsPermalink
‘(2) Paragraph (1) shall not apply to--CommentsClose CommentsPermalink
‘(A) a drug to which subsection (g) applies; orCommentsClose CommentsPermalink
‘(B) an article that--CommentsClose CommentsPermalink
‘(i) is intended to be subject to further manufacturing for export as a drug, a device, or a component of a drug or a device; andCommentsClose CommentsPermalink
‘(ii) is not deemed to be adulterated or misbranded under subsection (e)(1).’.CommentsClose CommentsPermalink
(b) Implementation- Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall provide for an electronic portal for submission of the information required to be submitted under section 801(p) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).CommentsClose CommentsPermalink
SEC. 123. PROHIBITION ON USE OF DRUGS AND DRUG INGREDIENTS NOT DECLARED AS DRUGS ON IMPORTATION.
Section 502 (
‘(aa) If it is a drug and it is, bears, or contains an article that, when imported or offered for import into the United States is intended to be a drug or a component of a drug, unless--CommentsClose CommentsPermalink
‘(1) the label of such article, when so imported or offered for import, contains the statement ‘for drug use’; andCommentsClose CommentsPermalink
‘(2) the article is declared when so imported or offered for import as ‘for drug use’.’.CommentsClose CommentsPermalink
SEC. 124. DESTRUCTION OF UNSAFE PRODUCTS REFUSED ADMISSION.
Section 801(a) (
SEC. 125. EFFECTIVE DATE.
This subtitle, and the amendments made by this subtitle, shall take effect on the date that is 30 days after the date of enactment of this Act.CommentsClose CommentsPermalink
Subtitle D--Enhanced Response to Unsafe DrugsCommentsClose CommentsPermalink
Subtitle D--Enhanced Response to Unsafe DrugsCommentsClose CommentsPermalink
SEC. 131. ADMINISTRATIVE DETENTION OF DRUGS.
(a) In General- Section 304(g) (
(1) in paragraph (1)--CommentsClose CommentsPermalink
(A) by inserting ‘drug or’ before ‘device’ each place it appears; andCommentsClose CommentsPermalink
(B) by inserting ‘, or, in the case of a drug, which the officer or employee making the inspection has reason to believe is in violation of section 505,’ after ‘or misbranded’; andCommentsClose CommentsPermalink
(2) in paragraph (2), by inserting ‘drug or’ before ‘device’ each place it appears.CommentsClose CommentsPermalink
(b) Technical Amendments- Section 304(g)(1) (
(1) striking ‘(1) If’ and inserting ‘(1)(A) If’;CommentsClose CommentsPermalink
(2) striking ‘thirty days. Regulations’ and inserting the following: ‘thirty days.CommentsClose CommentsPermalink
‘(B) Regulations’;CommentsClose CommentsPermalink
(3) striking ‘such order. A detention’ and inserting the following: ‘such order.CommentsClose CommentsPermalink
‘(C) A detention’; andCommentsClose CommentsPermalink
(4) striking ‘as detained. Any person’ and inserting the following: ‘as detained.CommentsClose CommentsPermalink
‘(D) Any person’.CommentsClose CommentsPermalink
(c) Regulations- Until the date that the Secretary of Health and Human Services issues a final regulation to implement the amendments to section 304(g) of the Federal Food, Drug, and Cosmetic Act (as made by subsection (a)), the regulations on administrative detention in section 800.55 of title 21, Code of Federal Regulations, shall apply to any administrative detention of a drug under such section 304(g).CommentsClose CommentsPermalink
SEC. 132. MANDATORY RECALL AUTHORITY FOR DRUGS.
(a) In General- Chapter V (
‘SEC. 507. MANDATORY RECALL AUTHORITY FOR DRUGS.
‘(a) Order To Cease Distribution; Notification; Process-CommentsClose CommentsPermalink
‘(1) ORDER TO CEASE DISTRIBUTION; NOTIFICATION- If the Secretary finds that there is a reasonable probability that a drug intended for human use would cause serious, adverse health consequences or death, the Secretary shall issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the drug)--CommentsClose CommentsPermalink
‘(A) to immediately cease distribution of such drug; andCommentsClose CommentsPermalink
‘(B) to immediately notify health professionals and hospitals and other health care facilities of the order and to instruct such professionals and facilities to cease use of such drug.CommentsClose CommentsPermalink
‘(2) PROCESS- The order under paragraph (1) shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than 10 days after the date of the issuance of the order, on the actions required by the order and on whether the order should be amended to require a recall of such drug. If, after providing an opportunity for such a hearing, the Secretary determines that inadequate grounds exist to support the actions required by the order, the Secretary shall vacate the order.CommentsClose CommentsPermalink
‘(b) Order To Recall-CommentsClose CommentsPermalink
‘(1) IN GENERAL- If, after providing an opportunity for an informal hearing under subsection (a), the Secretary determines that the order should be amended to include a recall of the drug with respect to which the order was issued, the Secretary shall, except as provided in paragraph (2), amend the order to require a recall. The Secretary shall specify a timetable in which the drug recall will occur and shall require periodic reports to the Secretary describing the progress of the recall.CommentsClose CommentsPermalink
‘(2) AMENDED ORDER- An amended order under paragraph (1)--CommentsClose CommentsPermalink
‘(A) shall--CommentsClose CommentsPermalink
‘(i) not include recall of a drug from individuals; andCommentsClose CommentsPermalink
‘(ii) not include recall of a drug from hospitals and other health care facilities if the Secretary determines that the risk of recalling such drug from the facilities presents a greater health risk than the health risk of not recalling the drug from use; andCommentsClose CommentsPermalink
‘(B) shall provide for notice to individuals subject to the risks associated with the use of such drug.CommentsClose CommentsPermalink
‘(3) ASSISTANCE- In providing the notice required by paragraph (2), the Secretary may use the assistance of health professionals who prescribed or used such a drug for individuals. If a significant number of such individuals cannot be identified, the Secretary shall notify such individuals pursuant to section 705(b).’.CommentsClose CommentsPermalink
(b) Regulations- Until the date that the Secretary of Health and Human Services issues a final regulation to implement section 507 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)), the regulations on medical device recall authority in part 810 of title 21, Code of Federal Regulations, shall apply to any recall of a drug under such section 507.CommentsClose CommentsPermalink
SEC. 133. RECORDS AND REPORTS OF DRUG DEFECTS AND DESTRUCTION OF DEFECTIVE DRUGS THAT CANNOT BE RECONDITIONED.
(a) In General- Section 503 (
‘(h) Drug Defects-CommentsClose CommentsPermalink
‘(1) RECORDS- The manufacturer of a drug shall make and maintain records about any defect of the drug.CommentsClose CommentsPermalink
‘(2) REPORTS- The manufacturer of a drug shall submit reports to the Secretary about any defect of the drug that the Secretary specifies in guidance in accordance with a schedule specified by the Secretary in such guidance.CommentsClose CommentsPermalink
‘(3) INVESTIGATION AND CORRECTIVE ACTION- The manufacturer of a drug shall--CommentsClose CommentsPermalink
‘(A) investigate the cause of any defect of the drug; andCommentsClose CommentsPermalink
‘(B) take appropriate corrective action.CommentsClose CommentsPermalink
‘(4) DESTRUCTION- If a drug may cause injury or death because of a defect, the manufacturer shall, after the investigation of the defect required under paragraph (3), destroy the drug and shall not recondition the drug.CommentsClose CommentsPermalink
‘(5) DEFECT- For purposes of this subsection, a defect of a drug shall include--CommentsClose CommentsPermalink
‘(A) microbiological or other contamination;CommentsClose CommentsPermalink
‘(B) significant chemical, physical, or other change or deterioration;CommentsClose CommentsPermalink
‘(C) any deviation from purity or identity identified under section 501(j); andCommentsClose CommentsPermalink
‘(D) any failure of 1 or more batches of the drug to meet a specification established for it.’.CommentsClose CommentsPermalink
(b) Prohibited Acts- Section 301 (
(1) in subsection (d), by striking ‘505’ and inserting ‘503(h), 505’; andCommentsClose CommentsPermalink
(2) in subsection (e), by striking ‘504’ and inserting ‘503(h), 504’.CommentsClose CommentsPermalink
(c) Effective Date- The amendments made by this section shall take effect on the date that is 180 days after the date of enactment of this Act.CommentsClose CommentsPermalink
SEC. 134. CIVIL MONEY PENALTIES.
(a) In General- Section 303(f) (
(1) by redesignating paragraphs (5), (6), and (7) as paragraphs (6), (7), and (8), respectively;CommentsClose CommentsPermalink
(2) in paragraph (4), by striking ‘or 505-1’ each place it appears and inserting ‘505-1, 505A, or 523A’;CommentsClose CommentsPermalink
(3) by inserting after paragraph (4) the following:CommentsClose CommentsPermalink
‘(5)(A)(i) Any manufacturer, distributor, importer, broker, or filer that violates a requirement of this Act that relates to drugs for human use (except a requirement referred to in paragraph (4) or subsection (g)) shall be liable to the United States for a civil penalty not to exceed $100,000 per violation.CommentsClose CommentsPermalink
‘(ii) Each day during which a violation continues shall be considered a separate violation under clause (i).CommentsClose CommentsPermalink
‘(B)(i) Any manufacturer, distributor, importer, broker, or filer that knowingly reports or enters false or misleading data on documents related to the importation of a drug shall be liable to the United States for a civil penalty not to exceed $150,000.CommentsClose CommentsPermalink
‘(ii) Each act of reporting or entering false data shall be considered a separate violation under clause (i).’;CommentsClose CommentsPermalink
(4) in paragraph (6), as so redesignated, by striking ‘, or (4)’ each place it appears and inserting ‘(4), or (5)’;CommentsClose CommentsPermalink
(5) in paragraph (7), as so redesignated, by striking ‘(5)(A)’ and inserting ‘(6)(A)’; andCommentsClose CommentsPermalink
(6) in paragraph (8), as so redesignated, by striking ‘paragraph (6)’ each place it appears and inserting ‘paragraph (7)’.CommentsClose CommentsPermalink
(b) Applicability- Section 303(f)(5), as amended by subsection (a), shall apply to violations described in such section that occur after the date of enactment of this Act.CommentsClose CommentsPermalink
Subtitle E--Additional Provisions Related to Medical ProductsCommentsClose CommentsPermalink
Subtitle E--Additional Provisions Related to Medical ProductsCommentsClose CommentsPermalink
SEC. 141. CERTIFICATION OF INFORMATION.
(a) Drugs- Chapter V (
‘SEC. 505E. CERTIFICATION OF DRUG INFORMATION.
‘(a) Certification-CommentsClose CommentsPermalink
‘(1) IN GENERAL- A submission, when submitted to the Secretary, shall include a certification, in writing (which may be in electronic form) and under penalty of perjury, by the responsible person that--CommentsClose CommentsPermalink
‘(A) such person has actual knowledge of the requirements under this Act and, if applicable, such section 351, with respect to the drug that is the subject of such submission;CommentsClose CommentsPermalink
‘(B) such person has actual knowledge of the information related to such drug;CommentsClose CommentsPermalink
‘(C) such person has actual knowledge of the information in such submission (and, if such submission is an annual report, in any submission of any other information with respect to such application or report for which a certification under this paragraph is not otherwise required);CommentsClose CommentsPermalink
‘(D) the information in such submission (and, if such submission is an annual report, in any submission of any other information with respect to such application or report for which a certification under this paragraph is not otherwise required) complies with such requirements;CommentsClose CommentsPermalink
‘(E) the information in such submission (and, if such submission is an annual report, in any submission of any other information with respect to such application or report for which a certification under this paragraph is not otherwise required) is not false or misleading; andCommentsClose CommentsPermalink
‘(F) full reports of all clinical trials and postmarket studies (whether conducted within or outside the United States) related to the safety or effectiveness of the drug under review that were funded by the sponsor of such submission, or the full reports of which the sponsor of such submission had access, have been submitted to the Food and Drug Administration.CommentsClose CommentsPermalink
‘(2) DEFINITIONS- In this section:CommentsClose CommentsPermalink
‘(A) RESPONSIBLE PERSON- The term ‘responsible person’ means, with respect to a submission, a senior officer or director of the sponsor of such submission with knowledge of, and management responsibility for, such submission.CommentsClose CommentsPermalink
‘(B) SUBMISSION- The term ‘submission’ means--CommentsClose CommentsPermalink
‘(i) new drug application under section 505(b);CommentsClose CommentsPermalink
‘(ii) an abbreviated new drug application under section 505(j);CommentsClose CommentsPermalink
‘(iii) a biologics license application under section 351 of the Public Health Service Act;CommentsClose CommentsPermalink
‘(iv) an application for an investigational new drug exemption under section 505(i);CommentsClose CommentsPermalink
‘(v) a new animal drug application under section 512(b);CommentsClose CommentsPermalink
‘(vi) an abbreviated new animal drug application under section 512(b);CommentsClose CommentsPermalink
‘(vii) an application under section 571;CommentsClose CommentsPermalink
‘(viii) a request under section 572;CommentsClose CommentsPermalink
‘(ix) or a major amendment, supplement, or an annual report submitted to the Secretary with respect to any application or request described in clauses (i) through (viii);CommentsClose CommentsPermalink
‘(x) a record or report related to the safety or effectiveness of a drug subject to section 505 or such section 351, to an adverse event under section 505(k) or 760, or to a postapproval study or postapproval clinical trial under section 505(o); orCommentsClose CommentsPermalink
‘(xi) a list under section 510(i) including a drug.CommentsClose CommentsPermalink
‘(b) Inspections-CommentsClose CommentsPermalink
‘(1) IN GENERAL- If the Secretary determines, after notice and opportunity for an informal hearing, that a sponsor described in subsection (a)(2) knew or should have known that the information in a submission described in subsection (a)(1) did not comply with the requirements of this Act or was false or misleading, the Secretary may provide that any factory, warehouse, establishment, or consulting laboratory related to such noncompliance or such false or misleading information shall be inspected periodically by officers or employees duly designated by the Secretary for a period of time determined by the Secretary, not to exceed 5 years.CommentsClose CommentsPermalink
‘(2) COSTS- The Secretary shall assess the costs of such inspections to such sponsor.’.CommentsClose CommentsPermalink
(b) Devices- Chapter V (
21 U.S.C. 351 et seq.) is amended by inserting after section 523 the following:CommentsClose CommentsPermalink
‘SEC. 523A. CERTIFICATION OF DEVICE INFORMATION.
‘(a) Certification-CommentsClose CommentsPermalink
‘(1) CERTIFICATION BY SPONSOR- A submission, when submitted to the Secretary, shall include a certification, in writing and under penalty of perjury, by the responsible person that--CommentsClose CommentsPermalink
‘(A) such person has actual knowledge of the requirements under this Act with respect to the device that is the subject of such submission;CommentsClose CommentsPermalink
‘(B) such person has actual knowledge of the information related to such device;CommentsClose CommentsPermalink
‘(C) such person has actual knowledge of the information in such submission (and, if such submission is an annual report, in any submission of any other information with respect to such application or report for which a certification under this paragraph is not otherwise required);CommentsClose CommentsPermalink
‘(D) the information in such submission (and, if such submission is an annual report, in any submission of any other information with respect to such application or report for which a certification under this paragraph is not otherwise required) complies with such requirements;CommentsClose CommentsPermalink
‘(E) the information in such submission (and, if such submission is an annual report, in any submission of any other information with respect to such application or report for which a certification under this paragraph is not otherwise required) is not false or misleading; andCommentsClose CommentsPermalink
‘(F) full reports of all clinical trials and postmarket studies (whether conducted within or outside the United States) related to the safety or effectiveness of the device under review that were funded by the sponsor of such submission, or the full reports of which the sponsor of such submission had access, have been submitted to the Food and Drug Administration.CommentsClose CommentsPermalink
‘(2) DEFINITIONS- In this section:CommentsClose CommentsPermalink
‘(A) RESPONSIBLE PERSON- The term ‘responsible person’ means, with respect to a submission, a senior officer or director of the sponsor of such submission with knowledge of, and management responsibility for, such submission.CommentsClose CommentsPermalink
‘(B) SUBMISSION- The term ‘submission’ means--CommentsClose CommentsPermalink
‘(i) an application or report for premarket approval under section 515;CommentsClose CommentsPermalink
‘(ii) an application for an investigational device exemption under section 520(g);CommentsClose CommentsPermalink
‘(iii) a report under section 510(k);CommentsClose CommentsPermalink
‘(iv) an application for a humanitarian device exemption under section 520(m);CommentsClose CommentsPermalink
‘(v) a major amendment, supplement, or an annual report submitted to the Secretary with respect to any application or report described in clauses (i) through (iv);CommentsClose CommentsPermalink
‘(vi) a record or report related to an adverse event, a report, or postmarket surveillance under section 519 or 522; orCommentsClose CommentsPermalink
‘(vii) a list under section 510(i) including a device,CommentsClose CommentsPermalink
‘(b) Inspections-CommentsClose CommentsPermalink
‘(1) IN GENERAL- If the Secretary determines, after notice and opportunity for an informal hearing, that a sponsor described in subsection (a)(2) knew or should have known that the information in a submission described in subsection (a)(1) did not comply with the requirements of this Act or was false or misleading, the Secretary may provide that any factory, warehouse, establishment, or consulting laboratory related to such noncompliance or such false or misleading information shall be inspected periodically by officers or employees duly designated by the Secretary for a period of time determined by the Secretary, not to exceed 5 years.CommentsClose CommentsPermalink
‘(2) COSTS- The Secretary shall assess the costs of such inspections to such sponsor.’.CommentsClose CommentsPermalink
(c) Criminal Penalties- Chapter 47 of title 18, United States Code, is amended by adding at the end the following:CommentsClose CommentsPermalink
‘Sec. 1041. Certifications related to drug and device information
‘(a) If a responsible person--CommentsClose CommentsPermalink
‘(1) certifies any submission as set forth in section 505E or 523A of the Federal Food, Drug, and Cosmetic Act knowing that a component of such certification is false or misleading, then--CommentsClose CommentsPermalink
‘(A) the sponsor of such submission shall be fined not more than $1,000,000; andCommentsClose CommentsPermalink
‘(B) such responsible person shall be fined not more than $1,000,000, imprisoned for not more than 10 years, or both; orCommentsClose CommentsPermalink
‘(2) willfully certifies any submission as set forth in section 505E or 523A of the Federal Food, Drug, and Cosmetic Act knowing that a component of such certification is false or misleading, then--CommentsClose CommentsPermalink
‘(A) the sponsor of such submission shall be fined not more than $5,000,000; andCommentsClose CommentsPermalink
‘(B) such responsible person shall be fined not more than $5,000,000, imprisoned not more than 20 years, or both.CommentsClose CommentsPermalink
‘(b) In this section:CommentsClose CommentsPermalink
‘(1) The term ‘responsible person’--CommentsClose CommentsPermalink
‘(A) with respect to a submission related to a drug, has the meaning given that term in section 505E(a)(2) of the Federal Food, Drug, and Cosmetic Act; andCommentsClose CommentsPermalink
‘(B) with respect to a submission related to device, has the meaning given that term in section 523A(a)(2) of such Act.CommentsClose CommentsPermalink
‘(2) The term ‘submission’ means--CommentsClose CommentsPermalink
‘(A) with respect to a drug--CommentsClose CommentsPermalink
‘(i) a new drug application under section 505(b) of the Federal Food, Drug, and Cosmetic Act;CommentsClose CommentsPermalink
‘(ii) an abbreviated new drug application under section 505(j) of such Act;CommentsClose CommentsPermalink
‘(iii) a biologics license application under section 351 of the Public Health Service Act;CommentsClose CommentsPermalink
‘(iv) an application for an investigational new drug exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act;CommentsClose CommentsPermalink
‘(v) a new animal drug application under section 512(b) of the Federal Food, Drug, and Cosmetic Act;CommentsClose CommentsPermalink
‘(vi) an abbreviated new animal drug application under section 512(b) of such Act;CommentsClose CommentsPermalink
‘(vii) an application under section 571 of such Act;CommentsClose CommentsPermalink
‘(viii) a request under section 572 of such Act;CommentsClose CommentsPermalink
‘(ix) a major amendment, supplement, or other information submitted to the Secretary with respect to any application or request described in clauses (i) through (viii);CommentsClose CommentsPermalink
‘(x) a record or report related to the safety or effectiveness of a drug subject to section 505 of such Act or section 351 of the Public Health Service Act, to an adverse event under section 505(k) or 760 of the Federal Food, Drug, and Cosmetic Act, or to a postapproval study or postapproval clinical trial under section 505(o) of such Act; orCommentsClose CommentsPermalink
‘(xi) a list under section 510(i) including the drug; andCommentsClose CommentsPermalink
‘(B) with respect to a device--CommentsClose CommentsPermalink
‘(i) an application or report for premarket approval under section 515 of the Federal Food, Drug, and Cosmetic Act;CommentsClose CommentsPermalink
‘(ii) an application for an investigational device exemption under section 520(g) of such Act;CommentsClose CommentsPermalink
‘(iii) a report under section 510(k) of such Act;CommentsClose CommentsPermalink
‘(iv) an application for a humanitarian device exemption under section 520(m) of such Act;CommentsClose CommentsPermalink
‘(v) a major amendment, supplement, or other information submitted to the Secretary with respect to any application or report described in clauses (i) through (iv);CommentsClose CommentsPermalink
‘(vi) a record or report related to an adverse event, a report, or postmarket surveillance under section 519 or 522 of such Act; orCommentsClose CommentsPermalink
‘(vii) a list under section 510(i) including the device.’.CommentsClose CommentsPermalink
(d) Conforming Amendment- The table of sections for chapter 47 of title 18, United States Code, is amended by inserting after the item relating to section 1040 the following:CommentsClose CommentsPermalink
‘1041. Certification of drug and device information.’.CommentsClose CommentsPermalink
SEC. 142. WHISTLEBLOWER PROTECTIONS.
Chapter IX (
‘SEC. 911. PROTECTIONS FOR EMPLOYEES WHO REFUSE TO VIOLATE, OR WHO DISCLOSE VIOLATIONS OF, THIS ACT OR SECTION 351 OF THE PUBLIC HEALTH SERVICE ACT.
‘(a) In General-CommentsClose CommentsPermalink
‘(1) PROTECTIONS FOR EMPLOYEES- No person that submits, or is required to submit to the Secretary a submission described in paragraph (2), or any officer, employee, contractor, subcontractor, or agent of such a person, may discharge, demote, suspend, threaten, harass, or in any other manner discriminate against an employee in the terms and conditions of employment because of any lawful act done by the employee, including within the ordinary course of the job duties of such employee--CommentsClose CommentsPermalink
‘(A) to provide information, cause information to be provided, or otherwise assist in any investigation regarding any conduct which the employee reasonably believes constitutes a violation of any section of this Act or the Public Health Service Act described under paragraph (2), any other provision of Federal law relating to the safety or effectiveness of a drug, biological product, or device, or any provision of Federal law prohibiting fraud against the Food and Drug Administration, if the information or assistance is provided to, or an investigation stemming from the provided information is conducted by--CommentsClose CommentsPermalink
‘(i) a Federal regulatory or law enforcement agency;CommentsClose CommentsPermalink
‘(ii) any Member of Congress or any committee of Congress; orCommentsClose CommentsPermalink
‘(iii) a person with supervisory authority over the employee (or such other person working for the employer who has the authority to investigate, discover, or terminate the misconduct);CommentsClose CommentsPermalink
‘(B) to file, cause to be filed, testify, participate in, or otherwise assist in a proceeding filed or about to be filed (with any knowledge of the employer) relating to an alleged violation of any section of this Act or the Public Health Service Act described under paragraph (2), any other provision of Federal law relating to the safety or effectiveness of a drug, biological product, or device, or any provision of Federal law prohibiting fraud against the Food and Drug Administration; orCommentsClose CommentsPermalink
‘(C) to refuse to violate or assist in the violation of any section of this Act or the Public Health Service Act listed described paragraph (2), any other provision of Federal law relating to the safety or effectiveness of a drug, biological product, or device, or any provision of Federal law prohibiting fraud against the Food and Drug Administration.CommentsClose CommentsPermalink
‘(2) SUBMISSION- A submission described in this paragraph is--CommentsClose CommentsPermalink
‘(A) a new drug application under section 505(b);CommentsClose CommentsPermalink
‘(B) an abbreviated new drug application under section 505(j);CommentsClose CommentsPermalink
‘(C) a biologics license application under section 351 of the Public Health Service Act;CommentsClose CommentsPermalink
‘(D) an application for an investigational new drug exemption under section 505(i);CommentsClose CommentsPermalink
‘(E) a new animal drug application under section 512(b);CommentsClose CommentsPermalink
‘(F) an abbreviated new animal drug application under section 512(b);CommentsClose CommentsPermalink
‘(G) an application under section 571;CommentsClose CommentsPermalink
‘(H) a request under section 572;CommentsClose CommentsPermalink
‘(I) an application or report for premarket approval under section 515;CommentsClose CommentsPermalink
‘(J) an application for an investigational device exemption under section 520(g);CommentsClose CommentsPermalink
‘(K) a report under section 510(k);CommentsClose CommentsPermalink
‘(L) an application for a humanitarian device exemption under section 520(m);CommentsClose CommentsPermalink
‘(M) an amendment, supplement, or other submission with respect to any such application or report described in subparagraphs (A) through (L); orCommentsClose CommentsPermalink
‘(N) a record or report related to an adverse event, a postapproval study, a postapproval clinical trial, a report, or postmarket surveillance under section 505(k), 505(o), 519, 522, or 760.CommentsClose CommentsPermalink
‘(b) Enforcement Action-CommentsClose CommentsPermalink
‘(1) IN GENERAL- An employee who alleges discharge, or other discrimination in violation of subsection (a), may seek relief in accordance with the provisions of subsection (c), by--CommentsClose CommentsPermalink
‘(A) filing a complaint with the Secretary of Labor; orCommentsClose CommentsPermalink
‘(B) if the Secretary of Labor has not issued a final decision within 210 days of the filing of the complaint and there is no showing that such delay is due to the bad faith of the claimant, bringing an action at law or equity for de novo review in the appropriate district court of the United States, which shall have jurisdiction over such an action without regard to the amount in controversy.CommentsClose CommentsPermalink
‘(2) PROCEDURE-CommentsClose CommentsPermalink
‘(A) IN GENERAL- Any action under paragraph (1) shall be governed under the rules and procedures set forth in
section 42121(b) of title 49, United States Code .CommentsClose CommentsPermalink‘(B) EXCEPTION- Notification in an action under paragraph (1) shall be made in accordance with
section 42121(b)(1) of title 49, United States Code , except that such notification shall be made to the person named in the complaint and to the employer.CommentsClose CommentsPermalink‘(C) BURDENS OF PROOF- An action brought under paragraph (1)(B) shall be governed by the legal burdens of proof set forth in
section 42121(b) of title 49, United States Code .CommentsClose CommentsPermalink‘(D) STATUTE OF LIMITATIONS- An action under paragraph (1) shall be commenced not later than 180 days after the date on which the violation occurs.CommentsClose CommentsPermalink
‘(c) Remedies-CommentsClose CommentsPermalink
‘(1) IN GENERAL- An employee prevailing in any action under subsection (b)(1) shall be entitled to all relief necessary to make the employee whole.CommentsClose CommentsPermalink
‘(2) COMPENSATORY DAMAGES- Relief in an action under subsection (b) shall include--CommentsClose CommentsPermalink
‘(A) reinstatement with the same seniority status that the employee would have had, but for the discrimination;CommentsClose CommentsPermalink
‘(B) the amount of backpay owed to the employee, with interest; andCommentsClose CommentsPermalink
‘(C) compensation for any special damages sustained as a result of the discrimination, including litigation costs, expert witness fees, and reasonable attorney fees.CommentsClose CommentsPermalink
‘(d) Rights Retained by Employee- Nothing in this section shall be deemed to diminish the rights, privileges, or remedies of any employee under any Federal or State law or under any collective bargaining agreement. The rights and remedies in this section may not be waived by any agreement, policy, form, or condition of employment.’.CommentsClose CommentsPermalink
SEC. 143. STUDY BY THE INSTITUTE OF MEDICINE REGARDING THE REVIEW OF MEDICAL DEVICES.
(a) In General- The Secretary of Health and Human Services shall enter into a contract with the Institute of Medicine to conduct a study to--CommentsClose CommentsPermalink
(1) evaluate the organizational structure and operations of the Food and Drug Administration with respect to the review of medical devices for clearance under section 510(k) of the Federal Food, Drug, and Cosmetic Act (
(2) evaluate the analytical and methodological tools used by such Administration to conduct such reviews; andCommentsClose CommentsPermalink
(3) identify strengths, weaknesses, and limitations of the system used by such Administration to conduct such reviews.CommentsClose CommentsPermalink
(b) Report- Not later than September 31, 2010, the Institute of Medicine shall complete the study described under subsection (a) and submit to the Secretary of Health and Human Services, the Committee on Health, Education, Labor, and Pensions and the Committee on Finance of the Senate, and the Committee on Energy and Commerce of the House of Representatives a report that--CommentsClose CommentsPermalink
(1) describes the findings of such study; andCommentsClose CommentsPermalink
(2) makes recommendations regarding the organization structure and operations of the Food and Drug Administration, legislation, and regulation to improve or enhance the review of medical devices by such Administration.CommentsClose CommentsPermalink
TITLE II--GENERAL AUTHORITIES TO ENHANCE FOOD AND DRUG ADMINISTRATION OVERSIGHT OF PRODUCTS FROM A GLOBAL MARKETCommentsClose CommentsPermalink
TITLE II--GENERAL AUTHORITIES TO ENHANCE FOOD AND DRUG ADMINISTRATION OVERSIGHT OF PRODUCTS FROM A GLOBAL MARKETCommentsClose CommentsPermalink
SEC. 201. DEDICATED FOREIGN INSPECTORATE.
Section 704 (
‘(h) Foreign Inspectorate-CommentsClose CommentsPermalink
‘(1) IN GENERAL- The Secretary shall establish and maintain a corps of inspectors dedicated to inspections of foreign establishments registered under section 510 and foreign facilities registered under section 415. Such corps shall include personnel, in numbers sufficient to act as inspectors or translators for inspectors on each inspection by such corps, who are able to understand and speak the language used in the establishment or facility under inspection.CommentsClose CommentsPermalink
‘(2) ORGANIZATION- The corps established under paragraph (1) shall be organized into the following 4 units:CommentsClose CommentsPermalink
‘(A) A unit with expertise in inspections of food facilities.CommentsClose CommentsPermalink
‘(B) A unit with expertise in inspections of human drug establishments.CommentsClose CommentsPermalink
‘(C) A unit with expertise in inspections of animal drug establishments.CommentsClose CommentsPermalink
‘(D) A unit with expertise in inspections of medical device establishments.CommentsClose CommentsPermalink
‘(3) STAFFING AND FUNDING- Each unit shall be staffed and funded by the Secretary at a level sufficient to allow the unit to conduct inspections, as applicable--CommentsClose CommentsPermalink
‘(A) of foreign establishments registered under section 510 at a frequency, considering risk, that is comparable to the inspection rate of domestic establishments registered under section 510; orCommentsClose CommentsPermalink
‘(B) of foreign facilities registered under section 415 at a frequency, considering risk, that is comparable to the inspection rate of domestic facilities registered under section 415.CommentsClose CommentsPermalink
‘(4) DISTRIBUTION- The Secretary shall distribute the staff of each unit described in paragraph (2) in countries, and may modify such distribution over time, considering--CommentsClose CommentsPermalink
‘(A) the volume of product exported from such country to the United States;CommentsClose CommentsPermalink
‘(B) an assessment of the effectiveness of the regulatory oversight provided by such country for such products;CommentsClose CommentsPermalink
‘(C) an assessment of the risk posed by such products; andCommentsClose CommentsPermalink
‘(D) such other factors as the Secretary determines are relevant to such distribution.’.CommentsClose CommentsPermalink
SEC. 202. AUTHORITY TO EXCHANGE CONFIDENTIAL INFORMATION WITH FOREIGN GOVERNMENT OFFICIALS.
(a) Authority To Exchange Confidential Information With Foreign Government Officials- Section 803 (
‘(d) Exchange of Confidential Information-CommentsClose CommentsPermalink
‘(1) DISCLOSURE BY SECRETARY- The Secretary may disclose information about food, drugs, devices, and cosmetics to officials of a foreign government if--CommentsClose CommentsPermalink
‘(A) such government is able, and agrees, to guard the confidentiality and guarantee nondisclosure of such information; andCommentsClose CommentsPermalink
‘(B) the Secretary determines that such disclosure is necessary to promote a regulatory, enforcement, or other public health function.CommentsClose CommentsPermalink
‘(2) DISCLOSURE TO SECRETARY- The Secretary may receive information from officials of foreign governments under conditions of confidentiality. Such information shall be exempt from disclosure under
section 552 of title 5, United States Code .’.CommentsClose CommentsPermalink
(b) Conforming Amendment- Section 301(j) (
SEC. 203. SUBPOENA AUTHORITY.
Section 702 (
‘(f)(1) The Secretary may conduct investigations as the Secretary deems necessary--CommentsClose CommentsPermalink
‘(A) to carry out the authority of the Secretary under this Act or section 351 of the Public Health Service Act; orCommentsClose CommentsPermalink
‘(B) to determine whether any person has engaged or is about to engage in any act that constitutes or will constitute a violation of this Act or such section 351.CommentsClose CommentsPermalink
‘(2) For the purpose of any investigation conducted under paragraph (1), the Secretary may administer oaths and affirmations, subpoena witnesses, compel the attendance of such witnesses, take evidence, and require the production of any books, papers, documents, or other materials that are relevant to the investigation.CommentsClose CommentsPermalink
‘(3)(A) In case of contumacy or refusal to obey a subpoena issued under paragraph (2), the district court of the United States for the judicial district in which such investigation or proceeding is conducted, or in which the subpoenaed person resides or conducts business, may issue an order requiring such person to appear before the Secretary, testify, or produce books, papers, documents, or other materials that are relevant to the investigation. All process in any such case may be served in the judicial district in which such person resides or may be found.CommentsClose CommentsPermalink
‘(B) Any failure to obey an order issued under subparagraph (A) may be punished by the court as contempt of court.’.CommentsClose CommentsPermalink
SEC. 204. INFORMATION REPORTING.
Subchapter G of chapter VII (
‘SEC. 757. INFORMATION REPORTING.
‘(a) Notification of Settlements or Judgments- If a particular product regulated by the Secretary under this Act or section 351 of the Public Health Service Act is the subject of at least 3 civil actions that have been filed in Federal or State court alleging death, serious injury, or serious illness caused in whole or in part by such product which, in any 24-month period, result in either a final settlement involving the manufacturer or a court judgment in favor of the plaintiff, the manufacturer of such product shall, in accordance with subsection (b), report to the Secretary each such civil action not later than 30 days after the final settlement or court judgment in the third of such civil actions, and report to the Secretary any other such action not later than 30 days after any subsequent such settlement or judgment that--CommentsClose CommentsPermalink
‘(1) occurs within 24 months of any other 2 such settlements or judgments; andCommentsClose CommentsPermalink
‘(2) has not been previously reported to the Secretary under this section.CommentsClose CommentsPermalink
‘(b) Information To Be Reported-CommentsClose CommentsPermalink
‘(1) REQUIRED INFORMATION- The information required by subsection (a) to be reported to the Secretary, with respect to each civil action described in such subsection, shall include and, in addition to any voluntary information provided under paragraph (2), shall be limited to the following:CommentsClose CommentsPermalink
‘(A) The name and address of the manufacturer.CommentsClose CommentsPermalink
‘(B) The name or model of the product subject to the civil action.CommentsClose CommentsPermalink
‘(C) A statement as to whether the civil action alleged death, injury, or illness and in the case of an allegation of injury, a statement of the category of such injury.CommentsClose CommentsPermalink
‘(D) A statement as to whether the civil action resulted in a final settlement or a judgment in favor of the plaintiff.CommentsClose CommentsPermalink
‘(E) In the case of a judgment in favor of the plaintiff, the name of the civil action, the number assigned the civil action, and the court in which the civil action was filed.CommentsClose CommentsPermalink
‘(2) VOLUNTARY INFORMATION- A manufacturer furnishing the report required by paragraph (1) may include--CommentsClose CommentsPermalink
‘(A) a statement as to whether any judgment in favor of the plaintiff is under appeal or is expected to be appealed; orCommentsClose CommentsPermalink
‘(B) any other information which the manufacturer chooses to provide.CommentsClose CommentsPermalink
‘(c) Safety Report- A report of a civil action described in subsection (a) shall be considered a safety report under section 756 and may be accompanied by a statement, which shall be part of any report released for public disclosure, that denies that the report constitutes an admission that the product involved caused or contributed to a death, serious injury, or serious illness.CommentsClose CommentsPermalink
‘(d) Admission- A report of a civil action described in subsection (a) shall not be considered an admission that the product involved is adulterated or caused or contributed to a death, serious injury, or serious illness.CommentsClose CommentsPermalink
‘(e) Definitions- The terms ‘serious illness’ and ‘serious injury’ mean illness or injury, respectively, that--CommentsClose CommentsPermalink
‘(1) is life threatening,CommentsClose CommentsPermalink
‘(2) results in permanent impairment of a body function or permanent damage to a body structure, orCommentsClose CommentsPermalink
‘(3) necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.’.CommentsClose CommentsPermalink
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