I 

110TH CONGRESS 

1ST SESSION H. R. 1165 

To amend the Federal Food, Drug, and Cosmetic Act to establish additional 

authorities to ensure the safe and effective use of drugs, to establish 

whistleblower protections for certain individuals, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 16, 2007 

Mr. MARKEY introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

establish additional authorities to ensure the safe and 

effective use of drugs, to establish whistleblower protections for certain individuals, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Swift Approval, Full 

5 Evaluation Drug Act’’ or the ‘‘SAFE Drug Act’’. 


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1 SEC. 2. POSTMARKET STUDIES REGARDING DRUG SAFETY; 

2 POSTMARKET LABELING CHANGES. 

3 (a) POSTMARKET ORDERS REGARDING STUDIES.— 

4 Chapter V of the Federal Food, Drug, and Cosmetic Act 

5 (21 U.S.C. 351 et seq.) is amended by inserting after sec6 tion 505B the following section: 

7 ‘‘SEC. 505C. POSTMARKET STUDIES REGARDING DRUG 

8 SAFETY. 

9 ‘‘(a) POSTMARKET ORDERS.—Within 30 days after 

10 receiving evidence of a significant issue regarding the safe11 ty or lack of effectiveness of an approved drug, including 

12 reports of adverse events, studies conducted or reports re13 leased by the Food and Drug Administration, the National 

14 Institutes of Health, the Agency for Healthcare Research 

15 and Quality, or another relevant agency, actions or reports 

16 by regulatory agencies in foreign countries, or studies or 

17 case reports published in scientific or academic journals, 

18 the Secretary, after providing public notice of the signifi19 cant safety or effectiveness issue, may order the holder 

20 of the approved application to conduct a study or studies 

21 to address the issues involved. Each such notice and order 

22 shall be published in the Federal Register. 

23 ‘‘(b) RESTRICTIONS ON USE.— 

24 ‘‘(1) IN GENERAL.—An order under subsection 

25 (a) with respect to an approved drug may, during 

26 the period in which the study involved is conducted, 


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1 establish restrictions on the distribution or use of 

2 the drug if the Secretary determines that such re3 strictions are necessary to ensure the safe and effec4 tive use of the drug during such period. 

5 ‘‘(2) CERTAIN AUTHORITIES.—Restrictions that 

6 may be established by the Secretary under para7 graph (1) with respect to a drug include the fol8 lowing: 

9 ‘‘(A) Restricting distribution to certain fa10 cilities or physicians with special training or ex11 perience. 

12 ‘‘(B) Conditioning distribution on the per13 formance of specified medical procedures. 

14 ‘‘(C) Restricting direct-to-consumer adver15 tisements for the drug. 

16 ‘‘(3) TERMINATION.—The Secretary may, on 

17 the basis of the results of a study ordered pursuant 

18 to subsection (a) or other evidence, continue the re19 strictions under paragraph (1), terminate restric20 tions established, or establish different restrictions, 

21 as necessary to ensure the safe use of the drug. The 

22 Secretary shall notify the sponsor of the decision to 

23 extend, terminate, or change the restrictions no later 

24 than 30 days after the date on which the results of 

25 the study involved are submitted to the Secretary. 


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1 ‘‘(c) DEFINITION.—For purposes of this section, the 

2 term ‘approved drug’ means a drug for which an approved 

3 application under section 505 is in effect or for which a 

4 biologics license under section 351 of the Public Health 

5 Service Act is in effect.’’. 

6 (b) NEW DRUG APPLICATIONS; POSTMARKET STUD7 IES PURSUANT TO ACCELERATED APPROVAL.—Section 

8 505 of the Federal Food, Drug, and Cosmetic Act (21 

9 U.S.C. 355) is amended by adding at the end the following 

10 subsection: 

11 ‘‘(o)(1) The Secretary shall amend subpart H of part 

12 314 of title 21, Code of Federal Regulations, to establish 

13 the following policies: 

14 ‘‘(A) As a condition of the approval under such 

15 subpart of a new drug on or after the date of the 

16 enactment of the SAFE Drug Act, the Secretary 

17 shall require that one or more postmarket studies of 

18 the drug be conducted. 

19 ‘‘(B) The Secretary may not approve the appli20 cation involved unless— 

21 ‘‘(i) the sponsor has submitted to the Sec22 retary the protocols for each such study; 

23 ‘‘(ii) the Secretary has approved the proto24 cols; and 


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1 ‘‘(iii) the Secretary and the sponsor have 

2 agreed on a timeframe, including designated 

3 milestones, for the prompt completion of the 

4 study, which timeframe assumes due diligence 

5 by the sponsor in conducting the study. 

6 ‘‘(C) The Secretary shall require that, after the 

7 application is approved under such subpart and the 

8 drug enters commercial distribution, the drug be 

9 marketed in accordance with the following: 

10 ‘‘(i) The distribution and use of the drug 

11 shall be restricted in accordance with such sub12 part. 

13 ‘‘(ii) Until the Secretary determines that 

14 the sponsor has fulfilled its commitments under 

15 subparagraphs (A) and (B), the labeling of the 

16 drug shall bear— 

17 ‘‘(I) a statement that the Food and 

18 Drug Administration is requiring a study 

19 or studies to confirm the safety and effec20 tiveness of the drug; and 

21 ‘‘(II) a statement providing a clear 

22 and concise summary of the outstanding 

23 issues or questions to be addressed in such 

24 required studies. 


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1 ‘‘(iii) Until the Secretary determines that 

2 the sponsor has fulfilled its commitments under 

3 subparagraphs (A) and (B), the labeling of the 

4 drug shall bear a statement providing as fol5 lows: ‘This product received conditional ap6 proval from the FDA under its accelerated ap7 proval process. It will not receive full approval 

8 until completion of further testing to confirm 

9 safety and/or efficacy. For further information 

10 please contact your physician.’. 

11 ‘‘(iv) Direct-to-consumer advertisements 

12 for the drug shall be restricted until— 

13 ‘‘(I) the Secretary determines that the 

14 sponsor has fulfilled its commitments 

15 under subparagraphs (A) and (B); and 

16 ‘‘(II) the drug has been approved 

17 under such part 314 independently of sub18 part H of such part. 

19 ‘‘(2) The Secretary shall amend part 314 of title 21, 

20 Code of Federal Regulations, to establish the following 

21 policies regarding postmarket studies that, on or after the 

22 date of the enactment of the SAFE Drug Act, are required 

23 pursuant to approval of a new drug under subpart H of 

24 such part or under section 506(b)(2) of this Act: 


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1 ‘‘(A) If a required study is not completed by 

2 two years after the date on which the new drug was 

3 so approved, the Secretary shall, promptly after the 

4 expiration of such period, convene a public meeting 

5 of the appropriate advisory committee to review the 

6 progress of the study. Such review shall include the 

7 assessment of compliance with the timeframe for 

8 prompt completion of the study as agreed to by the 

9 company and the Secretary under paragraph 

10 (1)(B)(iii) or under section 506(b)(2) (as the case 

11 may be), the quality of study conduct, rates of en12 rollment overall and by institution, the barriers to 

13 progress, and whether the sponsor is acting with due 

14 diligence. At the meeting, the advisory committee 

15 shall determine whether it is in the best interest of 

16 the public to allow the sponsor to continue mar17 keting the drug until the study is completed or 

18 whether it is in the best interest of the public to sus19 pend the commercial marketing of the drug until the 

20 study is completed. 

21 ‘‘(B) If the drug was approved on the basis of 

22 animal efficacy data because human efficacy studies 

23 are not ethical or feasible, the holder of the ap24 proved application shall conduct studies when ethical 


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1 and feasible to verify and describe clinical benefit 

2 and to assess the product’s safety and effectiveness. 

3 ‘‘(C) If the results of a completed study that 

4 was so required are inconclusive or the risk-to-ben5 efit profile cannot be positively established, the Sec6 retary shall withdraw the product for commercial 

7 distribution. If a required study is not completed by 

8 five years after the date of approval, the results of 

9 the study are presumed to be inconclusive. The prod10 uct may only be made available to a patient who— 

11 ‘‘(i) according to a health care professional 

12 has previously benefitted from the product; and 

13 ‘‘(ii) has signed a statement of informed 

14 consent that— 

15 ‘‘(I) states that the patient has re16 ceived notice from the sponsor that the re17 sults of completed studies on the product 

18 have proven to be inconclusive or the risk19 to-benefit profile cannot be positively es20 tablished; and 

21 ‘‘(II) identifies the risks of continuing 

22 the product. 

23 Otherwise the product shall be unavailable except in 

24 a research setting until the product can meet the 


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1 same standard of safety and effectiveness that exists 

2 for full approval.’’. 

3 (c) ENFORCEMENT REGARDING POSTMARKET STUD4 IES.— 

5 (1) MISBRANDING.—Section 502 of the Federal 

6 Food, Drug, and Cosmetic Act (21 U.S.C. 352) is 

7 amended by adding at the end the following: 

8 ‘‘(y) If it is a drug with respect to which there is 

9 a failure to comply with a requirement under section 

10 505(o)(1), an order under section 505C, or a requirement 

11 under section 506(b)(2).’’. 

12 (2) CIVIL PENALTIES.—Section 303 of the Fed13 eral Food, Drug, and Cosmetic Act (21 U.S.C. 331) 

14 is amended by adding at the end the following: 

15 ‘‘(g)(1)(A) Any person who violates section 301(a), 

16 301(b), or 301(c) by reason of section 502(y) shall be sub17 ject to a civil penalty of not more than 100 percent of 

18 the gross profits received by the sponsor from sales of the 

19 drug, or $1,000,000, whichever is greater, subject to sub20 paragraph (B). 

21 ‘‘(B) If any harm to a consumer occurs as a result 

22 of a violation referred to in subparagraph (A), the person 

23 involved may be subject to a civil penalty of not more than 

24 an amount equal to 300 percent of the gross profits re25 ceived by the person, or $3,000,000, whichever is greater. 


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1 ‘‘(2) Any person who fails to act with due diligence 

2 to complete a postmarket study required under section 

3 506(b)(2), or under subpart H of part 314 of title 21, 

4 Code of Federal Regulations, shall be subject to a civil 

5 penalty of not more than the amount that applies under 

6 subparagraph (A) or subparagraph (B) of paragraph (1) 

7 (as the case may be) for a violation referred to in such 

8 paragraph. The Secretary shall by regulation define the 

9 term ‘due diligence’ for purposes of this paragraph. 

10 ‘‘(3) The provisions of paragraphs (3) through (5) 

11 of subsection (f) apply to a civil penalty under subpara12 graph (A) or (B) of paragraph (1) or under paragraph 

13 (2) to the same extent and in the same manner as such 

14 provisions apply to a civil penalty under paragraph (1) or 

15 (2) of such subsection.’’. 

16 (d) POSTMARKET LABELING CHANGES.—Section 

17 502 of the Federal Food, Drug, and Cosmetic Act, as 

18 amended by subsection (c)(1) of this section, is amended 

19 by adding at the end the following: 

20 ‘‘(z) If it is a drug and the manufacturer of the 

21 drug or product fails to make changes to a product’s 

22 labeling in compliance with an order of the Sec23 retary, issued on the basis of clinical evidence (in24 cluding studies submitted to the Secretary, an anal25 ysis of adverse events reports, studies conducted or 


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1 reports released by the Food and Drug Administra2 tion, the National Institutes of Health, the Agency 

3 for Healthcare Research and Quality, or another rel4 evant agency, actions or reports by regulatory agen5 cies in foreign countries, or studies published in sci6 entific or academic journals), that the labeling of the 

7 drug be modified to include specific wording re8 quired by the Secretary to ensure the safe and effec9 tive use of the drug.’’. 

10 (e) RULE OF CONSTRUCTION REGARDING CERTAIN

11 PEDIATRIC STUDIES.—The amendments made by this 

12 section establish authorities in addition to, and not in lieu 

13 of— 

14 (1) the program under section 505A of the 

15 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

16 355a); and 

17 (2) authorities under section 505B of such Act 

18 (21 U.S.C. 355b). 

19 SEC. 3. WHISTLEBLOWER PROTECTIONS. 

20 (a) PROHIBITION.—It shall be unlawful for any per21 son to discharge, demote, suspend, reprimand, investigate, 

22 or take or fail to take any other personnel action that in 

23 any manner discriminates against any covered individual, 

24 or in any other manner discriminate against any covered 

25 individual (including by a denial, suspension, or revocation 


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1 of a security clearance or by any other security access de2 termination, or by denial of award of a Federal contract 

3 or subcontract), or to threaten or recommend the dis4 charge, demotion, suspension, reprimand, investigation, 

5 other personnel action (or rejection of such action) that 

6 in any manner discriminates against any covered indi7 vidual, or other manner of discrimination if such action, 

8 discrimination, or recommendation is due, in whole or in 

9 part, to any lawful act done, perceived to have been done, 

10 or intended to be done by the covered individual— 

11 (1) to provide information, cause information to 

12 be provided, or otherwise assist in an investigation 

13 or proceeding regarding any conduct which the cov14 ered individual reasonably believes constitutes evi15 dence of a violation of any law, rule, or regulation, 

16 a substantial and specific threat to public health or 

17 safety, an abuse of authority, fraud, waste, or mis18 management of public funds, censorship, distortion, 

19 or suppression of scientific information, research, or 

20 analysis, or the willful disclosure of false, mis21 leading, or incomplete scientific information, if the 

22 information or assistance is provided to or the inves23 tigation or proceeding is conducted by— 

24 (A) a Federal, State, or local regulatory or 

25 law enforcement agency (including an office of 


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1 Inspector General under the Inspector General 

2 Act of 1978); 

3 (B) any Member of Congress, any com4 mittee of Congress, or the Government Ac5 countability Office; 

6 (C) any person with supervisory or mana7 gerial authority over the covered individual (or 

8 any other person who has the authority to in9 vestigate, discover, or terminate misconduct); or 

10 (D) a potential witness to or other person 

11 affected by or aware of the conduct described in 

12 this section who has the authority to inves13 tigate, discover, or terminate misconduct; 

14 (2) to file, cause to be filed, testify, participate 

15 in, or otherwise assist in a proceeding or action filed 

16 or about to be filed relating to an alleged violation 

17 of any law, rule, or regulation; or 

18 (3) to refuse to violate or assist in the violation 

19 of any law, rule, or regulation. 

20 (b) ENFORCEMENT ACTION.— 

21 (1) IN GENERAL.—A covered individual who al22 leges discharge or other discrimination by any per23 son in violation of subsection (a) may seek relief 

24 under paragraph (3) by— 


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1 (A) filing a complaint with the Secretary of 

2 Labor; or 

3 (B) if the Secretary has not issued a final 

4 decision within 180 days after the filing of the 

5 complaint and there is no showing that such 

6 delay is due to the bad faith of the claimant, 

7 bringing an action at law or equity for de novo 

8 review in the appropriate district court of the 

9 United States, which shall have jurisdiction 

10 over such an action without regard to the 

11 amount in controversy. 

12 (2) PROCEDURE.— 

13 (A) IN GENERAL.—An action under para14 graph (1)(A) shall be governed under the rules 

15 and procedures set forth in section 42121(b) of 

16 title 49, United States Code. 

17 (B) EXCEPTION.—Notification made under 

18 section 42121(b)(1) of title 49, United States 

19 Code, shall be made— 

20 (i) to the person named in the com21 plaint; and 

22 (ii) to the person’s employer. 

23 (C) BURDENS OF PROOF.—An action 

24 brought under paragraph (1)(B) shall be gov25 erned by the legal burdens of proof set forth in 


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1 section 42121(b) of title 49, United States 

2 Code. 

3 (D) STATUTE OF LIMITATIONS.—An action 

4 under paragraph (1) shall be commenced not 

5 later than 6 years after the date on which the 

6 violation occurs. 

7 (3) REMEDIES.— 

8 (A) IN GENERAL.—A covered individual 

9 prevailing in any action under this subsection 

10 shall be entitled to all relief appropriate to 

11 make the covered individual whole. 

12 (B) DAMAGES.—Relief for any action 

13 under this subsection shall include— 

14 (i) reinstatement with the same se15 niority status and employment grade or 

16 pay level (or the equivalent) that the cov17 ered individual would have had, but for the 

18 discrimination; 

19 (ii) compensatory damages, including 

20 the amount of any back pay, with interest; 

21 (iii) compensation for any special 

22 damages sustained as a result of the dis23 crimination, including litigation costs, ex24 pert witness fees, and reasonable attorney 

25 fees; and 


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1 (iv) punitive damages in an amount 

2 not to exceed the greater of 3 times the 

3 amount of any monetary damages awarded 

4 under this section (apart from this para5 graph) or $5,000,000. 

6 (c) CRIMINAL PENALTIES.— 

7 (1) IN GENERAL.—Any person who violates 

8 subsection (a) shall be fined under title 18 of the 

9 United States Code, imprisoned not more than 10 

10 years, or both. 

11 (2) REPORTING REQUIREMENTS.—The Attor12 ney General of the United States shall (based on 

13 such periodic reports and other information from the 

14 Department of Labor as the Attorney General may 

15 require) submit to the Congress an annual report on 

16 the enforcement of paragraph (1). Each such report 

17 shall— 

18 (A) identify each case in which formal 

19 charges under paragraph (1) were brought; 

20 (B) describe the status or disposition of 

21 each such case; and 

22 (C) in any action under subsection (b) in 

23 which the covered individual was the prevailing 

24 party or the substantially prevailing party, indi25 cate whether or not any formal charges under 


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1 paragraph (1) have been brought and, if not, 

2 the reasons therefor. 

3 (d) RIGHTS RETAINED BY COVERED INDIVIDUAL.— 

4 Nothing in this section shall be deemed to diminish the 

5 rights, privileges, or remedies of any covered individual 

6 under any Federal or State law, or under any collective 

7 bargaining agreement. The rights and remedies in this 

8 section may not be waived by any agreement, policy, form, 

9 or condition of employment. 

10 (e) NOTIFICATION.—The provisions of this section 

11 shall be prominently posted in any place of employment 

12 to which this section applies. 

13 (f) DEFINITIONS.—For purposes of this section: 

14 (1) The term ‘‘covered individual’’ means an 

15 employee or a contractor or subcontractor of the 

16 Food and Drug Administration. 

17 (2) The term ‘‘lawful’’ means not specifically 

18 prohibited by law. 

19 SEC. 4. RIGHT TO PUBLISH. 

20 Subchapter E of chapter V of the Federal Food, 

21 Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is 

22 amended by adding at the end the following section: 

23 ‘‘SEC. 565. RIGHT TO PUBLISH. 

24 ‘‘Officers and employees of the Food and Drug Ad25 ministration, and individuals sponsored by such AdminisVerDate Aug 31 2005 03:50 Feb 22, 2007 Jkt 059200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\H1165.IH H1165

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1 tration, may publish in peer-reviewed journals and other 

2 scientific publications, and make oral presentations at pro3 fessional society meetings and other meetings of their 

4 peers, unless publication or presentation of the data is 

5 subject to Federal export control or national security laws 

6 or regulations, or is proprietary information. The right to 

7 publish or present such data cannot be waived by any 

8 agreement, policy, form, or condition of employment.’’. 

9 SEC. 5. PROVIDING FDA ADVISORY COMMITTEES WITH 

10 COMPLETE INFORMATION. 

11 Subchapter E of chapter V of the Federal Food, 

12 Drug, and Cosmetic Act, as amended by section 4 of this 

13 Act, is amended by adding at the end the following section: 

14 ‘‘SEC. 566. PROVIDING ADVISORY COMMITTEES WITH COM15 PLETE INFORMATION. 

16 ‘‘(a) IN GENERAL.—In conjunction with any hearing 

17 of an advisory committee of the Food and Drug Adminis18 tration, the Secretary shall, at the request of any officer 

19 or employee of the Administration whose employment du20 ties relate to the topic of the hearing, allow the officer 

21 or employee a reasonable amount of time to present to 

22 the advisory committee information on such topic. 

23 ‘‘(b) TIMING OF PRESENTATION.—An advisory com24 mittee shall provide a period of time to an officer or em25 ployee for a presentation under subsection (a) that is sepaVerDate Aug 31 2005 03:50 Feb 22, 2007 Jkt 059200 PO 00000 Frm 00018 Fmt 6652 Sfmt 6201 E:\BILLS\H1165.IH H1165

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1 rate from the period of time allotted to the public for the 

2 hearing involved.’’. 

3 SEC. 6. PRESERVING SCIENTIFIC INTEGRITY. 

4 Subchapter E of chapter V of the Federal Food, 

5 Drug, and Cosmetic Act, as amended by section 5 of this 

6 Act, is amended by adding at the end the following section: 

7 ‘‘SEC. 567. PRESERVING SCIENTIFIC INTEGRITY. 

8 ‘‘(a) PROHIBITION.—An officer or employee of the 

9 Food and Drug Administration shall not direct any other 

10 officer or employee of the Administration— 

11 ‘‘(1) to censor, distort, or suppress any sci12 entific research, analysis, opinion, or recommenda13 tion; or 

14 ‘‘(2) to willfully disclose scientific information 

15 that is false, misleading, or incomplete. 

16 ‘‘(b) APPROPRIATE DISCIPLINARY ACTION.—The 

17 Secretary shall subject any officer or employee who vio18 lates subsection (a) to appropriate disciplinary action 

19 (which may include dismissal). 

20 ‘‘(c) REPORTING BY IG.—Not less than 1 year after 

21 the date of the enactment of this section, and annually 

22 thereafter, the Inspector General of the Department of 

23 Health and Human Services shall submit a report to the 

24 Congress— 


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1 ‘‘(1) identifying each disciplinary action under 

2 subsection (b) during the preceding 12 months; and 

3 ‘‘(2) describing the circumstances of each such 

4 disciplinary action.’’. 

5 SEC. 7. TRANSPARENCY OF APPROVAL DECISIONS. 

6 Section 505 of the Federal Food, Drug, and Cosmetic 

7 Act, as amended by section 2(b) of this Act, is further 

8 amended by adding at the end the following: 

9 ‘‘(p) TRANSPARENCY OF APPROVAL DECISIONS.— 

10 ‘‘(1) SUMMARY STATEMENT.—Not later than 

11 48 hours after the approval of an application filed 

12 under subsection (b) or (j), the Secretary shall pub13 lish a summary statement of the scientific basis for 

14 such approval and how the final decision balanced 

15 the risks and benefits. 

16 ‘‘(2) CONTENTS.—A summary statement under 

17 paragraph (1) shall be dated and shall include the 

18 following: 

19 ‘‘(A) A summary of the factual, scientific, 

20 and related issues considered during the ap21 proval process, including— 

22 ‘‘(i) an explanation of the risks and 

23 the benefits of the drug involved; and 

24 ‘‘(ii) the scientific rationale for the 

25 final decision. 


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1 ‘‘(B) Identification by name of each officer 

2 or employee of the Food and Drug Administra3 tion who participated in the decision to approve 

4 the application. 

5 ‘‘(C) A description of— 

6 ‘‘(i) any significant controversy or dif7 ference of opinion between two or more of8 ficers or employees described in subpara9 graph (B) relating to the decision to ap10 prove the application; and 

11 ‘‘(ii) the resolution of each such con12 troversy or difference of opinion. 

13 ‘‘(3) DISSENTING AND OTHER VIEWS.—Any of14 ficer or employee of the Food and Drug Administra15 tion who participates in the decision to approve an 

16 application filed under subsection (b) or (j) may sub17 mit a statement of views on the matter for inclusion 

18 in the applicable summary statement. Upon receipt 

19 of such a statement of views, the Secretary shall at20 tach the statement of views, without alteration, as 

21 an addendum to the summary statement. 

22 ‘‘(4) SUBSEQUENT CHANGES.—After publica23 tion of a summary statement under this subsection, 

24 the Secretary— 


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1 ‘‘(A) shall not alter the text of the sum2 mary statement; and 

3 ‘‘(B) may prepare a description of changes 

4 to the summary statement in a separate docu5 ment and attach the document as an addendum 

6 to the summary statement. 

7 ‘‘(5) CONFIDENTIAL INFORMATION.—This sub8 section does not authorize the disclosure of any 

9 trade secret or privileged or confidential commercial 

10 or financial information described in section 

11 552(b)(4) of title 5, United States Code, unless the 

12 Secretary determines that such disclosure is nec13 essary to protect the public health.’’. 

14 SEC. 8. BIENNIAL REPORTS ON APPROVED APPLICATIONS 

15 SUPPORTED BY NON-INFERIORITY STUDIES. 

16 Section 505 of the Federal Food, Drug, and Cosmetic 

17 Act, as amended by section 7 of this Act, is amended by 

18 adding at the end the following subsection: 

19 ‘‘(q) BIENNIAL REPORTS ON APPROVED APPLICA20 TIONS SUPPORTED BY NON-INFERIORITY STUDIES.—The 

21 Secretary shall submit to the Congress biennial reports on 

22 approved applications under subsection (b) (including sup23 plemental applications) that have been supported by data 

24 from one or more non-inferiority studies. For each such 


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1 application, the report shall include the following informa2 tion: 

3 ‘‘(1) The name of the drug listed in application. 

4 ‘‘(2) The name of the sponsor. 

5 ‘‘(3) The date of the approval. 

6 ‘‘(4) The name of each drug used as an active 

7 control in the non-inferiority studies used to support 

8 the application. 

9 ‘‘(5) The indication studied. 

10 ‘‘(6) The primary and secondary endpoints of 

11 the non-inferiority studies. 

12 ‘‘(7) The margins used in such studies. 

13 ‘‘(8) The explanation required by section 

14 314.l26(b)(2)(iv) of title 21, Code of Federal Regu15 lations, as to why the drugs should be considered ef16 fective in the study.’’. 

17 SEC. 9. BIANNUAL REPORTS REGARDING POSTMARKET 

18 STUDIES. 

19 Section 505 of the Federal Food, Drug, and Cosmetic 

20 Act, as amended by section 8 of this Act, is amended by 

21 adding at the end the following subsection: 

22 ‘‘(r) BIANNUAL REPORTS REGARDING POSTMARKET

23 STUDIES.—The Secretary shall submit to the Congress bi24 annual reports that provide the following information: 


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1 ‘‘(1) The number of enforcement actions taken 

2 to ensure that sponsors are complying with the re3 quirements to complete postmarketing studies under 

4 subsection (o) and sections 505C and 506(b)(2), to5 gether with a description of each such action. 

6 ‘‘(2) The measures taken by the Secretary to 

7 establish a system to ensure effective monitoring of 

8 the status of all such postmarketing studies, to9 gether with a description of the status of that sys10 tem. 

11 ‘‘(3) The measures taken by the Secretary to 

12 develop a system to track information about ongoing 

13 postmarketing safety issues, together with a descrip14 tion of the status of that system.’’. 

Æ 


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