I 

110TH CONGRESS 

1ST SESSION H. R. 1561 

To amend the Public Health Service Act and the Federal Food, Drug, 

and Cosmetic Act to improve drug safety and oversight, and for other 

purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 19, 2007 

Mr. WAXMAN (for himself and Mr. MARKEY) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Public Health Service Act and the Federal 

Food, Drug, and Cosmetic Act to improve drug safety 

and oversight, 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 ‘‘Enhancing Drug Safe5 ty and Innovation Act of 2007’’. 

6 SEC. 2. TABLE OF CONTENTS. 

7 The table of contents for this Act is as follows: 

Sec. 1. Short title. 

Sec. 2. Table of contents. 

TITLE I—RISK EVALUATION AND MITIGATION STRATEGIES 


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Sec. 101. Risk evaluation and mitigation strategies. 

Sec. 102. Enforcement. 

Sec. 103. Regulation of biological products. 

Sec. 104. No effect on withdrawal or suspension of approval. 

Sec. 105. Drugs subject to an abbreviated new drug application. 

Sec. 106. Conforming amendments. 

Sec. 107. Resources. 

Sec. 108. Drug labeling. 

Sec. 109. Factory inspections. 

Sec. 110. Study on integration of expertise of Office of Surveillance and Epidemiology. 

Sec. 111. Benefit-risk assessments. 

Sec. 112. Effective date and applicability. 

Sec. 113. Rule of construction regarding pediatric studies. 

Sec. 114. Authorization of appropriations. 

TITLE II—REAGAN-UDALL INSTITUTE FOR APPLIED BIOMEDICAL 

RESEARCH 

Sec. 201. The Reagan-Udall Institute for Applied Biomedical Research. 

TITLE III—CLINICAL TRIALS 

Sec. 301. Clinical trial registry database and clinical trial results database. 

TITLE IV—CONFLICTS OF INTEREST 

Sec. 401. Conflicts of interest. 

1 TITLE I—RISK EVALUATION AND 

2 MITIGATION STRATEGIES 

3 SEC. 101. RISK EVALUATION AND MITIGATION STRATEGIES. 

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

5 Act (21 U.S.C. 355) is amended by adding at the end the 

6 following: 

7 ‘‘(o) RISK EVALUATION AND MITIGATION STRAT8 EGY.— 

9 ‘‘(1) IN GENERAL.—In the case of any drug 

10 subject to subsection (b) or to section 351 of the 

11 Public Health Service Act for which a risk evalua12 tion and mitigation strategy is approved as provided 


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1 for in this subsection, the applicant shall comply 

2 with the requirements of such strategy. 

3 ‘‘(2) DEFINITIONS.—In this subsection: 

4 ‘‘(A) ADVERSE DRUG EXPERIENCE.—The 

5 term ‘adverse drug experience’ means any ad6 verse event associated with the use of a drug in 

7 humans, whether or not considered drug re8 lated, including— 

9 ‘‘(i) an adverse event occurring in the 

10 course of the use of the drug in profes11 sional practice; 

12 ‘‘(ii) an adverse event occurring from 

13 an overdose of the drug, whether acci14 dental or intentional; 

15 ‘‘(iii) an adverse event occurring from 

16 abuse of the drug; 

17 ‘‘(iv) an adverse event occurring from 

18 withdrawal of the drug; and 

19 ‘‘(v) any failure of expected pharma20 cological action of the drug. 

21 ‘‘(B) SERIOUS ADVERSE DRUG EXPERI22 ENCE.—The term ‘serious adverse drug experi23 ence’ is an adverse event that— 

24 ‘‘(i) results in— 

25 ‘‘(I) death; 


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1 ‘‘(II) an adverse drug experience 

2 that places the patient at immediate 

3 risk of death from the adverse drug 

4 experience as it occurred (not includ5 ing an adverse drug experience that 

6 might have caused death had it oc7 curred in a more severe form); 

8 ‘‘(III) inpatient hospitalization or 

9 prolongation of existing hospitaliza10 tion; 

11 ‘‘(IV) a persistent or significant 

12 incapacity or substantial disruption of 

13 the ability to conduct normal life 

14 functions; or 

15 ‘‘(V) a congenital anomaly or 

16 birth defect; or 

17 ‘‘(ii) based on appropriate medical 

18 judgment, may jeopardize the patient and 

19 may require a medical or surgical interven20 tion to prevent an outcome described under 

21 clause (i). 

22 ‘‘(C) SERIOUS RISK.—The term ‘serious 

23 risk’ means a risk of a serious adverse drug ex24 perience. 


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1 ‘‘(D) UNEXPECTED SERIOUS RISK.—The 

2 term ‘unexpected serious risk’ means a serious 

3 adverse drug experience that is not listed in the 

4 labeling of a drug, or that may be sympto5 matically and pathophysiologically related to an 

6 adverse drug experience identified in the label7 ing, but differs from such adverse drug experi8 ence because of greater severity, specificity, or 

9 prevalence. 

10 ‘‘(E) SIGNAL OF A SERIOUS RISK.—The 

11 term ‘signal of a serious risk’ means informa12 tion related to a serious adverse drug experi13 ence associated with use of a drug and derived 

14 from— 

15 ‘‘(i) a clinical trial; 

16 ‘‘(ii) adverse event reports; 

17 ‘‘(iii) a post-approval study, including 

18 a study under paragraph (4)(D); or 

19 ‘‘(iv) peer-reviewed biomedical lit20 erature. 

21 ‘‘(F) NEW SAFETY INFORMATION.—The 

22 term ‘new safety information’ with respect to a 

23 drug means information about— 

24 ‘‘(i) a serious risk or an unexpected 

25 serious risk associated with use of the drug 


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1 that the Secretary has become aware of 

2 since the last assessment of the approved 

3 risk evaluation and mitigation strategy for 

4 the drug; or 

5 ‘‘(ii) the effectiveness of the approved 

6 risk evaluation and mitigation strategy for 

7 the drug obtained since the last assessment 

8 of such strategy. 

9 ‘‘(3) REQUIRED ELEMENTS OF ARISK EVALUA10 TION AND MITIGATION STRATEGY.—The risk evalua11 tion and mitigation strategy for a drug shall re12 quire— 

13 ‘‘(A)(i) labeling for the drug for use by 

14 health care providers as approved under sub15 section (c); and 

16 ‘‘(ii) for the first 2 years (or for such pe17 riod as the Secretary determines on a case-by18 case basis to be appropriate) after the drug or 

19 a new indication for the drug is approved, inclu20 sion in the labeling and any direct-to-consumer 

21 advertisements of a unique symbol indicating 

22 the newly approved status of the drug or indica23 tion; 

24 ‘‘(B)(i) submission of reports for the drug 

25 as required under subsection (k); and 


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1 ‘‘(ii) for a drug that is a vaccine— 

2 ‘‘(I) analysis of reports to the Vaccine 

3 Adverse Event Reporting Systems 

4 (VAERS); or 

5 ‘‘(II) surveillance using the Vaccine 

6 Safety Datalink (VSD) or successor data7 bases; 

8 ‘‘(C) a pharmacovigilance statement— 

9 ‘‘(i) as to whether the reports under 

10 subparagraph (B)(i) or, for a vaccine, the 

11 analysis and surveillance under subpara12 graph (B)(ii), and the periodic assessment 

13 under subparagraph (E), are sufficient to 

14 assess the serious risks and to identify un15 expected serious risks of the drug; and 

16 ‘‘(ii) if such reports, such analysis and 

17 surveillance, and such periodic assessment 

18 are not sufficient to assess the serious 

19 risks and to identify unexpected serious 

20 risks of the drug, that describes what 

21 study or studies of the drug are required 

22 under paragraph (4)(D) or what clinical 

23 trial or trials of the drug are required 

24 under paragraph (4)(E); 


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1 ‘‘(D) a justification for the 

2 pharmacovigilance statement in subparagraph 

3 (C) that takes into consideration— 

4 ‘‘(i) the estimated size of the treat5 ment population for the drug; 

6 ‘‘(ii) the seriousness of the disease or 

7 condition that the drug is used to treat or 

8 prevent; 

9 ‘‘(iii) the expected or actual duration 

10 of treatment with the drug; 

11 ‘‘(iv) the availability and safety of a 

12 drug or other treatment, if any, for such 

13 disease or condition to which the safety of 

14 the drug may be compared; and 

15 ‘‘(v) the seriousness of the risk at 

16 issue and its background incidence in the 

17 population; and 

18 ‘‘(E) a timetable for submission of assess19 ments of the strategy, that— 

20 ‘‘(i) shall be no less frequently than 

21 once annually for the first 3 years after 

22 the drug is initially approved under sub23 section (c) or licensed under section 351 of 

24 the Public Health Service Act; 


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1 ‘‘(ii) shall include an assessment in 

2 the seventh year after the drug is so ap3 proved; and 

4 ‘‘(iii) subject to clause (ii), for subse5 quent years— 

6 ‘‘(I) shall be at a frequency speci7 fied in the strategy; 

8 ‘‘(II) may be increased or re9 duced in frequency as necessary as 

10 provided for in paragraph 

11 (6)(B)(iv)(VI); and 

12 ‘‘(III) may be eliminated after 

13 the 3-year period described in clause 

14 (i) if the Secretary determines that se15 rious risks of the drug have been ade16 quately identified and assessed and 

17 are being adequately managed. 

18 ‘‘(4) ADDITIONAL POTENTIAL ELEMENTS OF A

19 RISK EVALUATION AND MITIGATION STRATEGY.— 

20 ‘‘(A) IN GENERAL.—The Secretary may re21 quire that the risk evaluation and mitigation 

22 strategy for a drug include 1 or more of the ad23 ditional elements described in this paragraph, 

24 so long as the Secretary makes the determinaVerDate Aug 31 2005 23:40 Mar 22, 2007 Jkt 059200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H1561.IH H1561

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1 tion required with respect to each additional in2 cluded element. 

3 ‘‘(B) MEDGUIDE; PATIENT PACKAGE IN4 SERT.—The risk evaluation and mitigation 

5 strategy for a drug may require that the appli6 cant develop for distribution to each patient 

7 when the drug is dispensed— 

8 ‘‘(i) a Medication Guide, as provided 

9 for under part 208 of title 21, Code of 

10 Federal Regulations (or any successor reg11 ulations); or 

12 ‘‘(ii) a patient package insert, if the 

13 Secretary determines that such insert may 

14 help mitigate a serious risk of the drug. 

15 ‘‘(C) COMMUNICATION PLAN.—The risk 

16 evaluation and mitigation strategy for a drug 

17 may require that the applicant conduct a com18 munication plan to health care providers, if, 

19 with respect to such drug, the Secretary deter20 mines that such plan may support implementa21 tion of an element of the strategy. Such plan 

22 may include— 

23 ‘‘(i) sending letters to health care pro24 viders; 


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1 ‘‘(ii) disseminating information about 

2 the elements of the risk evaluation and 

3 mitigation strategy to encourage implemen4 tation by health care providers of compo5 nents that apply to such health care pro6 viders, or to explain certain safety proto7 cols (such as medical monitoring by peri8 odic laboratory tests); or 

9 ‘‘(iii) disseminating information to 

10 health care providers through professional 

11 societies about any serious risks of the 

12 drug and any protocol to assure safe use. 

13 ‘‘(D) POST-APPROVAL STUDIES.—The risk 

14 evaluation and mitigation strategy for a drug 

15 may require that the applicant conduct, or pro16 vide that the Secretary will conduct, an appro17 priate post-approval study, such as a prospec18 tive or retrospective observational study (includ19 ing through the systematic use of established 

20 health care networks and databases), of the 

21 drug (with a target schedule for completing the 

22 study and reporting the results to the Sec23 retary), if the Secretary determines the reports, 

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1 ments referred to in paragraph (3)(C) are not 

2 sufficient to— 

3 ‘‘(i) assess evidence of a serious risk 

4 related to the safety or effectiveness of the 

5 drug; or 

6 ‘‘(ii) identify unexpected serious risks 

7 in domestic populations who use the drug, 

8 including populations not included in stud9 ies used to approve the drug (such as older 

10 people, people with comorbidities, pregnant 

11 women, or children). 

12 ‘‘(E) POST-APPROVAL CLINICAL TRIALS.— 

13 The risk evaluation and mitigation strategy for 

14 a drug may require that the applicant for a 

15 drug for which there is no effective approved 

16 application under subsection (j) of this section 

17 as of the date that the requirement is first im18 posed conduct an appropriate post-approval 

19 clinical trial of the drug (with a target schedule 

20 for completing the clinical trial and reporting 

21 the results to the Secretary) to be included in 

22 the clinical trial registry database and clinical 

23 trial results database provided for under section 

24 402(i) of the Public Health Service Act, if the 

25 Secretary determines that a study or studies 


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1 under subparagraph (D) will likely be inad2 equate to assess evidence of a serious risk re3 lated to the safety or effectiveness of the drug. 

4 ‘‘(F) PRECLEARANCE.— 

5 ‘‘(i) IN GENERAL.—The risk evalua6 tion and mitigation strategy for a drug 

7 may require that the applicant submit to 

8 the Secretary advertisements of the drug 

9 for preclearance, if the Secretary deter10 mines that such preclearance is necessary 

11 to ensure compliance with section 502(n) 

12 with respect to the disclosure of informa13 tion about a serious risk listed in the label14 ing of the drug. The advertisements re15 quired to be submitted under the preceding 

16 sentence shall be reviewed and cleared by 

17 the Secretary within 45 days of submis18 sion. 

19 ‘‘(ii) SPECIFICATION OF ADVERTISE20 MENTS.—The Secretary may specify the 

21 advertisements required to be submitted 

22 under clause (i). 

23 ‘‘(G) SPECIFIC DISCLOSURES.— 

24 ‘‘(i) IN GENERAL.—The risk evalua25 tion and mitigation strategy for a drug 


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1 may require that the applicant include in 

2 advertisements of the drug a specific dis3 closure— 

4 ‘‘(I) of the date the drug was ap5 proved and that the existing informa6 tion may not have identified or al7 lowed for full assessment of all serious 

8 risks of using the drug, if the Sec9 retary determines that such disclosure 

10 is necessary to protect public health 

11 and safety; or 

12 ‘‘(II) about a serious adverse 

13 event listed in the labeling of the drug 

14 or a protocol to ensure safe use de15 scribed in the labeling of the drug, if 

16 the Secretary determines that such 

17 advertisements lacking such disclosure 

18 would be false or misleading. 

19 ‘‘(ii) SPECIFICATION OF ADVERTISE20 MENTS.—The Secretary may specify the 

21 advertisements required to include a spe22 cific disclosure under clause (i). 

23 ‘‘(H) TEMPORARY MORATORIUM.—The 

24 risk evaluation and mitigation strategy for a 

25 drug may require that for a fixed period after 


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1 initial approval, not to exceed 3 years, the ap2 plicant not issue or cause to be issued direct3 to-consumer advertisements of the drug, if the 

4 Secretary determines that disclosure under sub5 paragraph (G) is inadequate to protect public 

6 health and safety, and that such prohibition is 

7 necessary to protect public health and safety 

8 while additional information about serious risks 

9 of the drug is collected, considering— 

10 ‘‘(i) the number of patients who may 

11 be treated with the drug; 

12 ‘‘(ii) the seriousness of the condition 

13 for which the drug will be used; 

14 ‘‘(iii) the serious adverse events listed 

15 in the labeling of the drug; 

16 ‘‘(iv) the extent to which patients have 

17 access to other approved drugs in the 

18 pharmacological class of the drug and with 

19 the same intended use as the drug; and 

20 ‘‘(v) the extent to which clinical trials 

21 used to approve the drug may not have 

22 identified serious risks that might occur 

23 among patients expected to be treated with 

24 the drug. 


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1 ‘‘(5) RESTRICTIONS ON DISTRIBUTION OR

2 USE.— 

3 ‘‘(A) IN GENERAL.—If the Secretary deter4 mines that a drug shown to be effective can be 

5 safely used only if distribution or use of such 

6 drug is restricted, the Secretary may require as 

7 elements of the risk evaluation and mitigation 

8 strategy such restrictions on distribution or use 

9 as are needed to ensure safe use of the drug. 

10 ‘‘(B) LIMITS ON RESTRICTIONS.—Such re11 strictions under subparagraph (A) shall— 

12 ‘‘(i) be commensurate with the spe13 cific risk presented by the drug; 

14 ‘‘(ii) not be unduly burdensome on pa15 tient access to the drug, particularly for 

16 patients with serious or life-threatening 

17 diseases or conditions; and 

18 ‘‘(iii) to the extent practicable, con19 form with restrictions on distribution or 

20 use for other drugs with similar risks, so 

21 as to minimize the burden on the health 

22 care delivery system. 

23 ‘‘(C) ELEMENTS.—The restrictions on dis24 tribution or use described in subparagraph (A) 

25 shall include 1 or more goals to evaluate or 


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1 mitigate a serious risk listed in the labeling of 

2 the drug and may require that— 

3 ‘‘(i) health care providers that pre4 scribe the drug have special training or ex5 perience, or are specially certified; 

6 ‘‘(ii) pharmacies, practitioners, or 

7 health care settings that dispense the drug 

8 are specially certified; 

9 ‘‘(iii) the drug be dispensed to pa10 tients only in certain health care settings, 

11 such as hospitals; 

12 ‘‘(iv) the drug be dispensed to pa13 tients with evidence or other documenta14 tion of safe-use conditions, such as labora15 tory test results; 

16 ‘‘(v) each patient using the drug be 

17 subject to certain monitoring; or 

18 ‘‘(vi) each patient using the drug be 

19 enrolled in a registry. 

20 ‘‘(D) IMPLEMENTATION SYSTEM.—The re21 strictions on distribution or use described in 

22 subparagraph (A) may require a system 

23 through which the applicant is able to— 

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1 viders, pharmacists, patients, and other 

2 parties in the health care system who are 

3 responsible for implementing the restric4 tions; 

5 ‘‘(ii) work to improve implementation 

6 of the restrictions by health care providers, 

7 pharmacists, patients, and other parties in 

8 the health care system who are responsible 

9 for implementing the restrictions; and 

10 ‘‘(iii) stop distribution of the drug to 

11 those health care providers, pharmacists, 

12 and other parties in the health care sys13 tem— 

14 ‘‘(I) who are responsible for im15 plementing the restrictions; and 

16 ‘‘(II) whom the applicant knows 

17 have failed to meet their responsibil18 ities for implementing the restrictions, 

19 after the applicant has informed such 

20 party of such failure and such party 

21 has not remedied such failure. 

22 ‘‘(E) PATENTS.—The Secretary shall not 

23 approve a risk evaluation and mitigation strat24 egy for a drug, or any modification to the strat25 egy, under paragraph (6) if— 


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1 ‘‘(i) the strategy includes a restriction 

2 on distribution or use described in sub3 paragraph (A) that is protected by a pat4 ent; 

5 ‘‘(ii) such patent was issued after the 

6 date of the enactment of this subsection; 

7 and 

8 ‘‘(iii) such patent would prohibit or 

9 impair the application of such restriction 

10 under section 505(j)(2)(E)(i)(VII) to a 

11 drug that is the subject of an abbreviated 

12 new drug application. 

13 ‘‘(6) SUBMISSION AND REVIEW OF RISK EVAL14 UATION AND MITIGATION STRATEGY.— 

15 ‘‘(A) PROPOSED RISK EVALUATION AND

16 MITIGATION STRATEGY.— 

17 ‘‘(i) INITIAL APPROVAL.—An appli18 cant shall include a proposed risk evalua19 tion and mitigation strategy in an applica20 tion under subsection (b) or section 351 of 

21 the Public Health Service Act for initial 

22 approval of the drug. 

23 ‘‘(ii) APPROVAL OF NEW INDICA24 TION.—If no risk evaluation and mitiga25 tion strategy for the drug is in effect under 


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1 this subsection and the drug may not be 

2 dispensed without a prescription, the appli3 cant shall include a proposed risk evalua4 tion and mitigation strategy in an applica5 tion, including in a supplemental applica6 tion, seeking a new indication for such 

7 drug. 

8 ‘‘(iii) CONTENTS.—A proposed risk 

9 evaluation and mitigation strategy— 

10 ‘‘(I) shall include the minimal 

11 elements required under paragraph 

12 (3); and 

13 ‘‘(II) may also include additional 

14 elements as provided for under para15 graphs (4) and (5). 

16 ‘‘(B) ASSESSMENT AND MODIFICATION OF

17 A RISK EVALUATION AND MITIGATION STRAT18 EGY.— 

19 ‘‘(i) VOLUNTARY ASSESSMENTS.—The 

20 applicant may submit to the Secretary an 

21 assessment of, and propose a modification 

22 to, the approved risk evaluation and miti23 gation strategy for a drug at any time. 

24 ‘‘(ii) REQUIRED ASSESSMENTS.—The 

25 applicant shall submit an assessment of, 


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1 and may propose a modification to, the ap2 proved risk evaluation and mitigation 

3 strategy for a drug— 

4 ‘‘(I) when submitting a supple5 mental application for a new indica6 tion under subsection (b) or section 

7 351 of the Public Health Service Act, 

8 unless the drug may be dispensed 

9 without a prescription and the risk 

10 evaluation and mitigation strategy for 

11 the drug includes only the elements 

12 under paragraph (3); 

13 ‘‘(II) when required by the strat14 egy, as provided for in the timetable 

15 under paragraph (3)(E); 

16 ‘‘(III) within a time specified by 

17 the Secretary, not to be less than 45 

18 days, when ordered by the Secretary, 

19 if the Secretary determines that new 

20 safety or effectiveness information in21 dicates that an element under para22 graph (3) or (4) should be modified or 

23 included in the strategy; 

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1 retary determines that new safety or 

2 effectiveness information indicates 

3 that an element under paragraph (5) 

4 should be modified or included in the 

5 strategy; or 

6 ‘‘(V) within 15 days when or7 dered by the Secretary, if the Sec8 retary determines that there may be a 

9 cause for action by the Secretary 

10 under subsection (e). 

11 ‘‘(iii) ASSESSMENT.—An assessment 

12 of the approved risk evaluation and mitiga13 tion strategy for a drug shall include— 

14 ‘‘(I) with respect to any goal 

15 under paragraph (5), an assessment 

16 of how well the restrictions on dis17 tribution or use are meeting the goal 

18 or whether the goal or such restric19 tions should be modified; 

20 ‘‘(II) with respect to any post-ap21 proval study required under para22 graph (4)(D), the status of such 

23 study, including whether any difficul24 ties completing the study have been 

25 encountered; and 


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1 ‘‘(III) with respect to any post2 approval clinical trial required under 

3 paragraph (4)(E), the status of such 

4 clinical trial, including whether enroll5 ment has begun, the number of par6 ticipants enrolled, the expected com7 pletion date, whether any difficulties 

8 completing the clinical trial have been 

9 encountered, and registration informa10 tion with respect to requirements 

11 under section 402(i) of the Public 

12 Health Service Act. 

13 ‘‘(iv) MODIFICATION.—A modification 

14 (whether an enhancement or a reduction) 

15 to the approved risk evaluation and mitiga16 tion strategy for a drug may include the 

17 addition or modification of any element 

18 under subparagraph (A), (C), or (D) of 

19 paragraph (3) or the addition, modifica20 tion, or removal of any element under 

21 paragraph (4) or (5), such as— 

22 ‘‘(I) a labeling change, including 

23 the addition of a boxed warning; 

24 ‘‘(II) adding a post-approval 

25 study or clinical trial requirement; 


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1 ‘‘(III) modifying a post-approval 

2 study or clinical trial requirement 

3 (such as a change in trial design due 

4 to legitimate difficulties recruiting 

5 participants); 

6 ‘‘(IV) adding, modifying, or re7 moving a restriction on advertising 

8 under subparagraph (F), (G), and 

9 (H) of paragraph (4); 

10 ‘‘(V) adding, modifying, or re11 moving a restriction on distribution or 

12 use under paragraph (5); or 

13 ‘‘(VI) modifying the timetable for 

14 assessments of the strategy under 

15 paragraph (3)(E), including to elimi16 nate assessments. 

17 ‘‘(C) REVIEW.— 

18 ‘‘(i) IN GENERAL.—The Secretary 

19 shall promptly review the proposed risk 

20 evaluation and mitigation strategy for a 

21 drug submitted under subparagraph (A), 

22 or an assessment of the approved risk eval23 uation and mitigation strategy for a drug 

24 submitted under subparagraph (B). 


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1 ‘‘(ii) MARKETING PLAN.—As part of a 

2 review conducted under this subparagraph, 

3 the Secretary may require the applicant to 

4 submit its marketing plan for the drug, so 

5 as to allow the Secretary to determine 

6 whether any of the proposed or ongoing 

7 marketing activities undermine any of the 

8 requirements of the risk evaluation and 

9 mitigation strategy. 

10 ‘‘(D) DISCUSSION.—The Secretary shall 

11 initiate discussions of the proposed risk evalua12 tion and mitigation strategy for a drug sub13 mitted under subparagraph (A), or of an as14 sessment of the approved risk evaluation and 

15 mitigation strategy for a drug submitted under 

16 subparagraph (B), with the applicant to deter17 mine a strategy— 

18 ‘‘(i) if the proposed strategy or assess19 ment is submitted as part of an application 

20 or supplemental application under subpara21 graph (A) or (B)(ii)(I), not less than 60 

22 days before the action deadline for the ap23 plication that has been agreed to by the 

24 Secretary and that has been set forth in 

25 goals identified in letters of the Secretary 


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1 (relating to the use of fees collected under 

2 section 736 to expedite the drug develop3 ment process and the review of human 

4 drug applications); 

5 ‘‘(ii) if the assessment is submitted 

6 under subclause (II) or (III) of subpara7 graph (B)(ii), not later than 20 days after 

8 such submission; 

9 ‘‘(iii) if the assessment is submitted 

10 under subparagraph (B)(i) or under sub11 paragraph (B)(ii)(IV), not later than 30 

12 days after such submission; or 

13 ‘‘(iv) if the assessment is submitted 

14 under subparagraph (B)(ii)(V), not later 

15 than 10 days after such submission. 

16 ‘‘(E) ACTION.— 

17 ‘‘(i) IN GENERAL.—Unless the appli18 cant requests the dispute resolution proc19 ess described under subparagraph (F), the 

20 Secretary shall approve and describe the 

21 risk evaluation and mitigation strategy for 

22 a drug, or any modification to the strat23 egy— 

24 ‘‘(I) as part of the action letter 

25 on the application, when a proposed 


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1 strategy is submitted under subpara2 graph (A) or an assessment of the 

3 strategy is submitted under subpara4 graph (B)(ii)(I); or 

5 ‘‘(II) in an order issued not later 

6 than 50 days after the date discus7 sions of such modification begin under 

8 subparagraph (C), when an assess9 ment of the strategy is under sub10 paragraph (B)(i) or under subclause 

11 (II), (III), (IV), or (V) of subpara12 graph (B)(ii). 

13 ‘‘(ii) INACTION.—An approved risk 

14 evaluation and mitigation strategy shall re15 main in effect until the Secretary acts, if 

16 the Secretary fails to act as provided under 

17 clause (i). 

18 ‘‘(iii) PUBLIC AVAILABILITY.—Any ac19 tion letter described in clause (i)(I) or 

20 order described in clause (i)(II) shall be 

21 made publicly available. 

22 ‘‘(F) DISPUTE RESOLUTION.— 

23 ‘‘(i) REQUEST FOR REVIEW.—Not 

24 earlier than 15 days, and not later than 35 

25 days, after discussions under subparagraph 


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1 (D) have begun, the applicant may request 

2 in writing that a dispute about the strat3 egy be reviewed by the Drug Safety Over4 sight Board. Upon receipt of such a re5 quest, the Secretary shall schedule the dis6 pute for review under clause (ii) and, not 

7 later than 5 business days of scheduling 

8 the dispute for review, shall publish by 

9 posting on the Internet or otherwise a no10 tice that the dispute will be reviewed by 

11 the Drug Safety Oversight Board. 

12 ‘‘(ii) SCHEDULING REVIEW.—If the 

13 applicant requests review under clause (i), 

14 the Secretary— 

15 ‘‘(I) shall schedule the dispute 

16 for review at 1 of the next 2 regular 

17 meetings of the Drug Safety Over18 sight Board, whichever meeting date 

19 is more practicable; or 

20 ‘‘(II) may convene a special 

21 meeting of the Drug Safety Oversight 

22 Board to review the matter more 

23 promptly, including to meet an action 

24 deadline on an application (including 

25 a supplemental application). 


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1 ‘‘(iii) AGREEMENT AFTER DISCUSSION

2 OR ADMINISTRATIVE APPEALS.— 

3 ‘‘(I) FURTHER DISCUSSION OR

4 ADMINISTRATIVE APPEALS.—A re5 quest for review under clause (i) shall 

6 not preclude further discussions to 

7 reach agreement on the risk evalua8 tion and mitigation strategy, and such 

9 a request shall not preclude the use of 

10 administrative appeals within the 

11 Food and Drug Administration to 

12 reach agreement on the strategy, in13 cluding appeals as described in letters 

14 of the Secretary (relating to the use of 

15 fees collected under section 736 to ex16 pedite the drug development process 

17 and the review of human drug appli18 cations) for procedural or scientific 

19 matters involving the review of human 

20 drug applications and supplemental 

21 applications that cannot be resolved at 

22 the divisional level. 

23 ‘‘(II) AGREEMENT TERMINATES

24 DISPUTE RESOLUTION.—At any time 

25 before a decision and order is issued 


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1 under clause (vii), the Secretary and 

2 the applicant may reach an agreement 

3 on the risk evaluation and mitigation 

4 strategy through further discussion or 

5 administrative appeals, terminating 

6 the dispute resolution process, and the 

7 Secretary shall issue an action letter 

8 or order, as appropriate, that de9 scribes the strategy. 

10 ‘‘(iv) MEETING OF THE BOARD.—At 

11 the meeting of the Drug Safety Oversight 

12 Board described in clause (ii), the Board 

13 shall— 

14 ‘‘(I) hear from both parties; and 

15 ‘‘(II) review the dispute. 

16 ‘‘(v) RECORD OF PROCEEDINGS.—The 

17 Secretary shall ensure that the proceedings 

18 of any such meeting are recorded, tran19 scribed, and made public within 30 days of 

20 the meeting. The Secretary shall redact the 

21 transcript to protect any trade secrets or 

22 other confidential information described in 

23 section 552(b)(4) of title 5, United States 

24 Code. 


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1 ‘‘(vi) RECOMMENDATION OF THE

2 BOARD.—Not later than 5 days after any 

3 such meeting, the Drug Safety Oversight 

4 Board shall provide a written recommenda5 tion on resolving the dispute to the Sec6 retary. Not later than 5 days after the 

7 Board provides such written recommenda8 tion to the Secretary, the Secretary shall 

9 make the recommendation available to the 

10 public. 

11 ‘‘(vii) ACTION BY THE SECRETARY.— 

12 ‘‘(I) ACTION LETTER.—With re13 spect to a proposed risk evaluation 

14 and mitigation strategy submitted 

15 under subparagraph (A) or to an as16 sessment of the strategy submitted 

17 under subparagraph (B)(ii)(I), the 

18 Secretary shall issue an action letter 

19 that resolves the dispute not later 

20 than the later of— 

21 ‘‘(aa) the action deadline re22 ferred to in subparagraph (D)(i); 

23 or 


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1 ‘‘(bb) 7 days after receiving 

2 the recommendation of the Drug 

3 Safety Oversight Board. 

4 ‘‘(II) ORDER.—With respect to 

5 an assessment of the risk evaluation 

6 and mitigation strategy under sub7 paragraph (B)(i) or under subclause 

8 (II), (III), (IV), or (V) of subpara9 graph (B)(ii), the Secretary shall 

10 issue an order, which shall be made 

11 public, that resolves the dispute not 

12 later than 7 days after receiving the 

13 recommendation of the Drug Safety 

14 Oversight Board. 

15 ‘‘(viii) INACTION.—An approved risk 

16 evaluation and mitigation strategy shall re17 main in effect until the Secretary acts, if 

18 the Secretary fails to act as provided for 

19 under clause (vii). 

20 ‘‘(ix) EFFECT ON ACTION DEAD21 LINE.—With respect to the application or 

22 supplemental application in which a pro23 posed risk evaluation and mitigation strat24 egy is submitted under subparagraph (A) 

25 or in which an assessment of the strategy 


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1 is submitted under subparagraph 

2 (B)(ii)(I), the Secretary shall be considered 

3 to have met the action deadline referred to 

4 in subparagraph (D)(i) with respect to 

5 such application if the applicant requests 

6 the dispute resolution process described in 

7 this subparagraph and if the Secretary— 

8 ‘‘(I) has initiated the discussions 

9 described under subparagraph (D) not 

10 less than 60 days before such action 

11 deadline; and 

12 ‘‘(II) has complied with the tim13 ing requirements of scheduling review 

14 by the Drug Safety Oversight Board, 

15 providing a written recommendation, 

16 and issuing an action letter under 

17 clauses (ii), (vi), and (vii), respec18 tively. 

19 ‘‘(x) DISQUALIFICATION.—No indi20 vidual who is an employee of the Food and 

21 Drug Administration and who reviews a 

22 drug or who participated in an administra23 tive appeal under clause (iii)(I) with re24 spect to such drug may serve on the Drug 

25 Safety Oversight Board at a meeting under 


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1 clause (iv) to review a dispute about the 

2 risk evaluation and mitigation strategy for 

3 such drug. 

4 ‘‘(xi) ADDITIONAL EXPERTISE.—The 

5 Drug Safety Oversight Board may add 

6 members with relevant expertise from the 

7 Food and Drug Administration, including 

8 the Office of Pediatrics, the Office of 

9 Women’s Health, or the Office of Rare 

10 Diseases, or from other Federal public 

11 health or health care agencies, for a meet12 ing under clause (iv) of the Drug Safety 

13 Oversight Board. 

14 ‘‘(G) USE OF ADVISORY COMMITTEES.— 

15 The Secretary may convene a meeting of 1 or 

16 more advisory committees of the Food and 

17 Drug Administration to— 

18 ‘‘(i) review a concern about the safety 

19 of a drug or class of drugs, including be20 fore an assessment of the risk evaluation 

21 and mitigation strategy or strategies of 

22 such drug or drugs is required to be sub23 mitted under subclause (II), (III), (IV), or 

24 (V) of subparagraph (B)(ii); 


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1 ‘‘(ii) review the risk evaluation and 

2 mitigation strategy or strategies of a drug 

3 or group of drugs; or 

4 ‘‘(iii) review a dispute under subpara5 graph (F). 

6 ‘‘(H) PROCESS FOR ADDRESSING DRUG

7 CLASS EFFECTS.— 

8 ‘‘(i) IN GENERAL.—When a concern 

9 about a serious risk of a drug may be re10 lated to the pharmacological class of the 

11 drug, the Secretary may defer assessments 

12 of the approved risk evaluation and mitiga13 tion strategies for such drugs until the 

14 Secretary has convened 1 or more public 

15 meetings to consider possible responses to 

16 such concern. If the Secretary defers an 

17 assessment under this clause, the Sec18 retary shall give notice to the public of the 

19 deferral not later than 5 days of the defer20 ral. 

21 ‘‘(ii) PUBLIC MEETINGS.—Such public 

22 meetings may include— 

23 ‘‘(I) 1 or more meetings of the 

24 applicants for such drugs; 


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1 ‘‘(II) 1 or more meetings of 1 or 

2 more advisory committees of the Food 

3 and Drug Administration, as provided 

4 for under subparagraph (G); or 

5 ‘‘(III) 1 or more workshops of 

6 scientific experts and other stake7 holders. 

8 ‘‘(iii) ACTION.—After considering the 

9 discussions from any meetings under 

10 clause (ii), the Secretary may— 

11 ‘‘(I) announce in the Federal 

12 Register a planned regulatory action, 

13 including a modification to each risk 

14 evaluation and mitigation strategy, for 

15 drugs in the pharmacological class; 

16 ‘‘(II) seek public comment about 

17 such action; and 

18 ‘‘(III) after seeking such com19 ment, issue an order addressing such 

20 regulatory action. 

21 ‘‘(I) INTERNATIONAL COORDINATION.— 

22 The Secretary may coordinate the timetable for 

23 submission of assessments under paragraph 

24 (3)(E), a study under paragraph (4)(D), or a 

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1 forts to identify and assess the serious risks of 

2 such drug by the marketing authorities of other 

3 countries whose drug approval and risk man4 agement processes the Secretary deems com5 parable to the drug approval and risk manage6 ment processes of the United States. If the Sec7 retary takes action to coordinate such time8 table, the Secretary shall give notice to the pub9 lic of the action not later than 5 days after the 

10 action. 

11 ‘‘(J) EFFECT.—Use of the processes de12 scribed in subparagraphs (H) and (I) shall not 

13 delay action on an application or a supplement 

14 to an application for a drug. 

15 ‘‘(K) NO EFFECT ON LABELING CHANGES

16 THAT DO NOT REQUIRE PREAPPROVAL.—In the 

17 case of a labeling change to which section 

18 314.70 of title 21, Code of Federal Regulations 

19 (or any successor regulation), applies for which 

20 the submission of a supplemental application is 

21 not required or for which distribution of the 

22 drug involved may commence upon the receipt 

23 by the Secretary of a supplemental application 

24 for the change, the submission of an assessment 

25 of the approved risk evaluation and mitigation 


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1 strategy for the drug under this subsection is 

2 not required. 

3 ‘‘(7) DRUG SAFETY OVERSIGHT BOARD.— 

4 ‘‘(A) IN GENERAL.—There is established a 

5 Drug Safety Oversight Board. 

6 ‘‘(B) COMPOSITION; MEETINGS.—The 

7 Drug Safety Oversight Board shall— 

8 ‘‘(i) be composed of scientists and 

9 health care practitioners appointed by the 

10 Secretary, each of whom is an employee of 

11 the Federal Government; 

12 ‘‘(ii) include representatives from of13 fices throughout the Food and Drug Ad14 ministration; 

15 ‘‘(iii) include at least 1 representative 

16 from each of the National Institutes of 

17 Health, the Department of Health and 

18 Human Services (other than the Food and 

19 Drug Administration), and the Veterans 

20 Health Administration; and 

21 ‘‘(iv) meet at least monthly to provide 

22 oversight and advice to the Secretary on 

23 the management of important drug safety 

24 issues.’’. 


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1 SEC. 102. ENFORCEMENT. 

2 (a) MISBRANDING.—Section 502 of the Federal 

3 Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend4 ed by adding at the end the following: 

5 ‘‘(y) If it is a drug subject to an approved risk evalua6 tion and mitigation strategy under section 505(o) and the 

7 applicant for such drug fails to— 

8 ‘‘(1) make a labeling change required by such 

9 strategy after the Secretary has completed review of, 

10 and acted on, an assessment of such strategy under 

11 paragraph (6) of such section; or 

12 ‘‘(2) comply with a requirement of such strat13 egy provided for under paragraph (3), (4), or (5) of 

14 such section. 

15 ‘‘(z) Failure to conduct a postmarket study required 

16 under section 506 (or any regulation thereunder).’’. 

17 (b) CIVIL PENALTIES.—Section 303(f) of the Federal 

18 Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)) is 

19 amended— 

20 (1) by redesignating paragraphs (3), (4), and 

21 (5) as paragraphs (4), (5), and (6), respectively; 

22 (2) by inserting after paragraph (2) the fol23 lowing: 

24 ‘‘(3) Any person who violates a requirement of this 

25 Act which relates to drugs shall be liable to the United 

26 States for a civil penalty in an amount not less than 


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1 $50,000 for each such violation and, for all such violations 

2 adjudicated in a single proceeding, in an amount not to 

3 exceed the following: 

4 ‘‘(A) For drugs on the market for at least one year, 

5 10 percent of the annual United States sales revenue dur6 ing the year prior to which the person is subject to the 

7 civil penalty, based upon data from IMS Health Inc.’s Re8 tail and Provider Prospective Combined Purchases on the 

9 United States sales revenue of the drug or, in the event 

10 IMS data is not available, based upon any comparable 

11 data. 

12 ‘‘(B) For drugs on the market for less than one year, 

13 $1,000,000.’’; 

14 (3) in paragraph (2)(C), by striking ‘‘paragraph 

15 (3)(A)’’ and inserting ‘‘paragraph (4)(A)’’; 

16 (4) in paragraph (4), as so redesignated, by 

17 striking ‘‘paragraph (1) or (2)’’ each place it ap18 pears and inserting ‘‘paragraph (1), (2), or (3)’’; 

19 and 

20 (5) in paragraph (6), as so redesignated, by 

21 striking ‘‘paragraph (4)’’ each place it appears and 

22 inserting ‘‘paragraph (5)’’. 

23 SEC. 103. REGULATION OF BIOLOGICAL PRODUCTS. 

24 Section 351 of the Public Health Service Act (42 

25 U.S.C. 262) is amended— 


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1 (1) in subsection (a)(2), by adding at the end 

2 the following: 

3 ‘‘(D) RISK EVALUATION AND MITIGATION STRAT4 EGY.—A person that submits an application for a license 

5 under this paragraph shall submit to the Secretary as part 

6 of the application a proposed risk evaluation and mitiga7 tion strategy as described under section 505(o) of the Fed8 eral Food, Drug, and Cosmetic Act.’’; and 

9 (2) in subsection (j), by inserting ‘‘, including 

10 the requirements under section 505(o) of such Act,’’ 

11 after ‘‘, and Cosmetic Act’’. 

12 SEC. 104. NO EFFECT ON WITHDRAWAL OR SUSPENSION OF 

13 APPROVAL. 

14 Section 505(e) of the Federal Food, Drug, and Cos15 metic Act (21 U.S.C. 355(e)) is amended by adding at 

16 the end the following: ‘‘The Secretary may withdraw the 

17 approval of an application submitted under this section, 

18 or suspend the approval of such an application, as pro19 vided under this subsection, without first ordering the ap20 plicant to submit an assessment of the approved risk eval21 uation and mitigation strategy for the drug under sub22 section (o)(6)(B)(ii)(V).’’. 


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1 SEC. 105. DRUGS SUBJECT TO AN ABBREVIATED NEW DRUG 

2 APPLICATION. 

3 Section 505(j)(2) of the Federal Food, Drug, and 

4 Cosmetic Act (21 U.S.C. 355(j)(2)) is amended by adding 

5 at the end the following: 

6 ‘‘(E) RISK EVALUATION AND MITIGATION STRATEGY

7 REQUIREMENT.— 

8 ‘‘(i) IN GENERAL.—A drug that is the subject 

9 of an abbreviated new drug application under this 

10 subsection shall be subject to only the following ele11 ments of the risk evaluation and mitigation strategy 

12 required under subsection (o) for the applicable list13 ed drug: 

14 ‘‘(I) Labeling, as required under subsection 

15 (o)(3)(A) for the applicable listed drug. 

16 ‘‘(II) Submission of reports, as required 

17 under subsection (o)(3)(B)(i) for the applicable 

18 listed drug. 

19 ‘‘(III) A Medication Guide or patient pack20 age insert, if required under subsection 

21 (o)(4)(B) for the applicable listed drug. 

22 ‘‘(IV) Preclearance of advertising, if re23 quired under subsection (o)(4)(F) for the appli24 cable listed drug. 


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1 ‘‘(V) Specific disclosures in advertising, if 

2 required under subsection (o)(4)(G) for the ap3 plicable listed drug. 

4 ‘‘(VI) A temporary moratorium on direct5 to-consumer advertising, if required under sub6 section (o)(4)(H) for the applicable listed drug. 

7 ‘‘(VII) Restrictions on distribution or use, 

8 if required under subsection (o)(5) for the listed 

9 drug. A drug that is the subject of an abbre10 viated new drug application and the listed drug 

11 shall use a single, shared system under sub12 section (o)(5)(D). The Secretary may waive the 

13 requirement under the preceding sentence for a 

14 drug that is the subject of an abbreviated new 

15 drug application if the Secretary determines 

16 that (aa) it is not practical for the drug to use 

17 such single, shared system or (bb) the burden 

18 of using the single, shared system outweighs 

19 the benefit of using the single system. 

20 ‘‘(ii) ACTION BY SECRETARY.—For an applica21 ble listed drug for which a drug is approved under 

22 this subsection, the Secretary— 

23 ‘‘(I) shall undertake any communication 

24 plan to health care providers required under 

25 section (o)(4)(C) for the applicable listed drug; 


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1 ‘‘(II) shall conduct any post-approval study 

2 required under subsection (o)(4)(D) for the ap3 plicable listed drug; and 

4 ‘‘(III) shall inform the applicant for a drug 

5 approved under this subsection if the risk eval6 uation and mitigation strategy for the applica7 ble listed drug is modified.’’. 

8 SEC. 106. CONFORMING AMENDMENTS. 

9 (a) PRECLEARANCE OF ADVERTISEMENTS.—Section 

10 502(n)(3)(A) of the Federal Food, Drug, and Cosmetic 

11 Act (21 U.S.C. 352(n)(3)(A)) is amended by inserting 

12 ‘‘(or when required under section 505(o)(4)(F))’’ after 

13 ‘‘except in extraordinary circumstances’’. 

14 (b) CONTENT OF NEW DRUG APPLICATION.—Section 

15 505(b)(1) of the Federal Food, Drug, and Cosmetic Act 

16 (21 U.S.C. 355(b)) is amended— 

17 (1) in subparagraph (F), by striking ‘‘and’’; 

18 and 

19 (2) in subparagraph (G), by striking the period 

20 and inserting the following: ‘‘, and (H) a proposed 

21 risk evaluation and mitigation strategy as described 

22 under subsection (o).’’. 


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1 SEC. 107. RESOURCES. 

2 (a) USER FEES.—Subparagraph (F) of section 

3 735(6) of the Federal Food, Drug, and Cosmetic Act (21 

4 U.S.C. 379g(6)) is amended to read as follows: 

5 ‘‘(F) Reviewing and implementing risk 

6 evaluation and mitigation strategies, and col7 lecting, developing, and reviewing safety or ef8 fectiveness information on drugs, including ad9 verse event reports.’’. 

10 (b) WORKLOAD ADJUSTMENT.—Subparagraph (A) of 

11 section 736(c)(2) of the Federal Food, Drug, and Cos12 metic Act (21 U.S.C. 379h(c)(2)) is amended to read as 

13 follows: 

14 ‘‘(A) The adjustment shall be determined 

15 by the Secretary based on a weighted average 

16 of the change in the total number of human 

17 drug applications; commercial investigational 

18 new drug applications; efficacy supplements; 

19 manufacturing supplements; implementation, 

20 assessment, review, and enforcement activities 

21 for risk evaluation and mitigation strategies; 

22 and uses of dispute resolution under the process 

23 for reviewing and assessing risk evaluation and 

24 mitigation strategies. The Secretary shall pub25 lish in the Federal Register the fee revenues 


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1 and fees resulting from the adjustment and 

2 supporting methodologies.’’. 

3 (c) STRATEGIC PLAN FOR INFORMATION TECH4 NOLOGY.—Not later than 1 year after the date of enact5 ment of this title, the Secretary of Health and Human 

6 Services (referred to in this Act as the ‘‘Secretary’’) shall 

7 submit to the Committee on Health, Education, Labor, 

8 and Pensions and the Committee on Appropriations of the 

9 Senate and the Committee on Energy and Commerce and 

10 the Committee on Appropriations of the House of Rep11 resentatives, a strategic plan on information technology 

12 that includes— 

13 (1) an assessment of the information technology 

14 infrastructure, including systems for data collection, 

15 access to data in external health care databases (in16 cluding databases of the Centers for Medicare & 

17 Medicaid Services and the Department of Veterans 

18 Affairs), data mining capabilities, personnel, and 

19 personnel training programs, needed by the Food 

20 and Drug Administration to— 

21 (A) comply with the requirements of this 

22 title (and the amendments made by this title); 

23 (B) achieve interoperability within and 

24 among the Centers of the Food and Drug Ad25 ministration and between the Food and Drug 


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1 Administration and product application spon2 sors; and 

3 (C) utilize electronic health records; 

4 (2) an assessment of the extent to which the 

5 current information technology assets of the Food 

6 and Drug Administration are sufficient to meet the 

7 needs assessments under paragraph (1); 

8 (3) a plan for enhancing the information tech9 nology assets of the Food and Drug Administration 

10 toward meeting the needs assessments under para11 graph (1); and 

12 (4) an assessment of additional resources need13 ed to so enhance the information technology assets 

14 of the Food and Drug Administration. 

15 SEC. 108. DRUG LABELING. 

16 (a) ACCESSIBLE REPOSITORY OF DRUG LABEL17 ING.—Not later than the effective date of this title, the 

18 Secretary, through the Commissioner of Food and Drugs, 

19 and the Director of the National Institutes of Health, shall 

20 establish a searchable repository of structured, electronic 

21 product information (including health warnings, Dear 

22 Doctor letters, and the approved professional labeling and 

23 any required patient labeling of each drug approved under 

24 section 505 of the Federal Food, Drug, and Cosmetic Act 

25 (21 U.S.C. 355) or licensed under section 351 of the PubVerDate Aug 31 2005 23:40 Mar 22, 2007 Jkt 059200 PO 00000 Frm 00047 Fmt 6652 Sfmt 6201 E:\BILLS\H1561.IH H1561

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1 lic Health Service Act (42 U.S.C. 262)) in order to im2 prove patient safety through accessible product informa3 tion, support initiatives to improve patient care by better 

4 management of health care information, and provide 

5 standards for drug information. Such repository shall be 

6 made publicly accessible on the Internet website of the Na7 tional Library of Medicine and through a link on the 

8 homepage of the Internet website of the Food and Drug 

9 Administration. 

10 (b) POSTING UPON APPROVAL.—The Secretary shall 

11 post in the repository under subsection (a) the approved 

12 professional labeling and any required patient labeling of 

13 a drug approved under such section 505 or licensed under 

14 such section 351 not later than 21 days after the date 

15 the drug is approved, including in a supplemental applica16 tion with respect to a labeling change. 

17 (c) REPORT.—The Secretary shall report annually to 

18 the Committee on Health, Education, Labor and Pensions 

19 of the Senate and the Committee on Energy and Com20 merce of the House of Representatives on the status of 

21 the repository under subsection (a), and on progress in 

22 posting structured electronic product information, includ23 ing posting of information regarding drugs approved prior 

24 to the effective date of this title. 


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1 (d) MEDICATION GUIDES.—Not later than the effec2 tive date of this title, the Secretary, through the Commis3 sioner of Food and Drugs, shall establish on the Internet 

4 website for the repository under subsection (a), a link to 

5 a list of each drug, whether approved under such section 

6 505 or licensed under such section 351, for which a Medi7 cation Guide, as provided for under part 208 of title 21, 

8 Code of Federal Regulations (or any successor regula9 tions), is required. 

10 SEC. 109. FACTORY INSPECTIONS. 

11 Paragraph (1) of section 704(a) of the Federal Food, 

12 Drug, and Cosmetic Act (21 U.S.C. 374(a)) is amended 

13 by inserting ‘‘or marketing data’’ after ‘‘No inspection au14 thorized by the preceding sentence or by paragraph (3) 

15 shall extend to financial data, sales data other than ship16 ment data’’. 

17 SEC. 110. STUDY ON INTEGRATION OF EXPERTISE OF OF18 FICE OF SURVEILLANCE AND EPIDEMI19 OLOGY. 

20 Not later than 1 year after the date of the enactment 

21 of this Act, the Commissioner of Food and Drugs shall 

22 submit a report to the Congress on the Commissioner’s 

23 efforts to integrate the expertise of the Office of Surveil24 lance and Epidemiology into the Food and Drug AdminisVerDate Aug 31 2005 23:40 Mar 22, 2007 Jkt 059200 PO 00000 Frm 00049 Fmt 6652 Sfmt 6201 E:\BILLS\H1561.IH H1561

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1 tration’s approval, labeling, and post-approval safety deci2 sions. 

3 SEC. 111. BENEFIT-RISK ASSESSMENTS. 

4 Not later than 1 year after the date of the enactment 

5 of this Act, the Commissioner of Food and Drugs shall 

6 submit to the Congress a report on how best to commu7 nicate to the public the risks and benefits of new drugs 

8 and the role of the risk evaluation and mitigation strategy 

9 in assessing such risks and benefits. 

10 SEC. 112. EFFECTIVE DATE AND APPLICABILITY. 

11 (a) EFFECTIVE DATE.—This title shall take effect 

12 180 days after the date of enactment of this Act. 

13 (b) DRUGS DEEMED TO HAVE RISK EVALUATION

14 AND MITIGATION STRATEGIES.— 

15 (1) IN GENERAL.—A drug that was approved 

16 before the effective date of this title shall be deemed 

17 to have an approved risk evaluation and mitigation 

18 strategy under section 505(o) of the Federal Food, 

19 Drug, and Cosmetic Act (as added by this title) if 

20 there are in effect on the effective date of this title 

21 restrictions on distribution or use— 

22 (A) required under section 314.520 or sec23 tion 601.42 of title 21, Code of Federal Regula24 tions; or 


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1 (B) otherwise agreed to by the applicant 

2 and the Secretary for such drug. 

3 (2) RISK EVALUATION AND MITIGATION STRAT4 EGY.—The approved risk evaluation and mitigation 

5 strategy deemed in effect for a drug under para6 graph (1) shall consist of the elements described in 

7 subparagraphs (A) and (B) of paragraph (3) of such 

8 section 505(o) and any other additional elements 

9 under paragraphs (4) and (5) in effect for such drug 

10 on the effective date of this title. 

11 (3) NOTIFICATION.—Not later than 30 days 

12 after the effective date of this title, the Secretary 

13 shall notify the applicant for each drug described in 

14 paragraph (1)— 

15 (A) that such drug is deemed to have an 

16 approved risk evaluation and mitigation strat17 egy pursuant to such paragraph; and 

18 (B) of the date, which shall be no earlier 

19 than 6 months after the applicant is so notified, 

20 by which the applicant shall submit to the Sec21 retary an assessment of such approved strategy 

22 under paragraph (6)(B) of such section 505(o). 

23 (c) OTHER DRUGS APPROVED BEFORE THE EFFEC24 TIVE DATE.—The Secretary, on a case-by-case basis, may 

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1 tive date of this title to which subsection (b) does not 

2 apply to submit a proposed risk evaluation and mitigation 

3 strategy in accordance with the timeframes provided for 

4 in subclause (III), (IV), or (V), as applicable, of paragraph 

5 (6)(B)(ii) of such section 505(o) if the Secretary deter6 mines (with respect to such drug or with respect to the 

7 group of drugs to which such drug belongs) that— 

8 (1) an element described under paragraph 

9 (3)(A) of such section 505(o) may require modifica10 tion; or 

11 (2) a standard for adding an element described 

12 in paragraph (4) or (5) of such section 505(o) that 

13 is not in effect with respect to such drug or class of 

14 drugs may apply. 

15 (d) USE OF ADVISORY COMMITTEES; PROCESS FOR

16 ADDRESSING DRUG CLASS EFFECTS.—In imposing a re17 quirement under subsection (c), the Secretary— 

18 (1) may convene a meeting of 1 or more advi19 sory committees of the Food and Drug Administra20 tion in accordance with paragraph (6)(G) of such 

21 section 505(o); and 

22 (2) may use the process described in paragraph 

23 (6)(H) of such section 505(o) (relating to addressing 

24 drug class effects). 


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1 SEC. 113. RULE OF CONSTRUCTION REGARDING PEDIATRIC 

2 STUDIES. 

3 Nothing in this Act or the amendments made by this 

4 Act shall be construed to affect the authority of the Sec5 retary or the Commissioner of Food and Drugs to require 

6 pediatric studies under section 505A of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 355a). 

8 SEC. 114. AUTHORIZATION OF APPROPRIATIONS. 

9 (a) IN GENERAL.—For carrying out this title and the 

10 amendments made by this title, there is authorized to be 

11 appropriated $25,000,000 for each of fiscal years 2008 

12 through 2012. 

13 (b) RELATION TO OTHER FUNDING.—The authoriza14 tion of appropriations under subsection (a) is in addition 

15 to any other funds available for carrying out this title and 

16 the amendments made by this title. 

17 TITLE II—REAGAN-UDALL INSTI18 TUTE FOR APPLIED BIO19 MEDICAL RESEARCH 

20 SEC. 201. THE REAGAN-UDALL INSTITUTE FOR APPLIED 

21 BIOMEDICAL RESEARCH. 

22 (a) IN GENERAL.—Chapter VII of the Federal Food, 

23 Drug, and Cosmetic Act (21 U.S.C. 371 et seq.), as 

24 amended by Public Law 109–462, is amended by adding 

25 at the end the following: 


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1 ‘‘Subchapter I—Reagan-Udall Institute for 

2 Applied Biomedical Research 

3 ‘‘SEC. 770. ESTABLISHMENT AND FUNCTIONS OF THE INSTI4 TUTE. 

5 ‘‘(a) IN GENERAL.—The Secretary shall establish a 

6 nonprofit corporation to be known as the Reagan-Udall 

7 Institute for Applied Biomedical Research (referred to in 

8 this subchapter as the ‘Institute’). The Institute shall be 

9 headed by an Executive Director, appointed by the mem10 bers of the Board of Directors under subsection (e). The 

11 Institute shall not be an agency or instrumentality of the 

12 United States Government. 

13 ‘‘(b) PURPOSE OF INSTITUTE.—The purpose of the 

14 Institute is to advance the Critical Path Initiative of the 

15 Food and Drug Administration to modernize medical 

16 product development, accelerate innovation, and enhance 

17 product safety. 

18 ‘‘(c) DUTIES OF THE INSTITUTE.—The Institute 

19 shall— 

20 ‘‘(1) taking into consideration the 2004 report 

21 published by the Food and Drug Administration en22 titled ‘Innovation or Stagnation? Challenge and Op23 portunity on the Critical Path to New Medical Prod24 ucts’, identify unmet needs in the sciences of devel25 oping, manufacturing, and evaluating the safety and 


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1 effectiveness of diagnostics, devices, biologics, and 

2 drugs, including— 

3 ‘‘(A) the identification and validation of 

4 biomarkers for use in diagnostic, device, bio5 logic, and drug development; 

6 ‘‘(B) the development and validation of 

7 animal models for human disease and medical 

8 product safety; 

9 ‘‘(C) pharmacogenomics and inter-indi10 vidual variability in drug, biologic, and device 

11 response; 

12 ‘‘(D) the development of data analysis 

13 technology and methodology for use in device, 

14 biologic, drug, and diagnostic development; 

15 ‘‘(E) advancing improvements to the de16 sign and conduct of clinical trials; 

17 ‘‘(F) toxicological quality assessment tech18 nologies; 

19 ‘‘(G) diagnostic, device, biologic, and drug 

20 manufacturing, design, and materials science; 

21 ‘‘(H) failure mode assessment for medical 

22 product development; 

23 ‘‘(I) improving adverse event reporting and 

24 analysis; 


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1 ‘‘(J) bridging engineering data and clinical 

2 performance for devices; and 

3 ‘‘(K) computer modeling; 

4 ‘‘(2) establish goals and priorities in order to 

5 meet the unmet needs identified in paragraph (1); 

6 ‘‘(3) in consultation with the Secretary, assess 

7 existing and proposed Federal intramural and extra8 mural research and development programs relating 

9 to the goals and priorities established under para10 graph (2) and facilitate and encourage interagency 

11 coordination of such programs; 

12 ‘‘(4) award grants to, or enter into contracts or 

13 cooperative agreements with, scientists and entities 

14 to advance the goals and priorities established under 

15 paragraph (2); 

16 ‘‘(5) recruit meeting participants and hold or 

17 sponsor (in whole or in part) meetings as appro18 priate to further the goals and priorities established 

19 under paragraph (2); 

20 ‘‘(6) release and publish information and data 

21 and, to the extent practicable, license, distribute, 

22 and release material, reagents, and techniques to 

23 maximize, promote, and coordinate the availability of 

24 such material, reagents, and techniques for use by 

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1 nizations, and academic and industrial researchers 

2 to further the goals and priorities established under 

3 paragraph (2); 

4 ‘‘(7) ensure that— 

5 ‘‘(A) action is taken as necessary to obtain 

6 patents for inventions developed by the Insti7 tute or with funds from the Institute; 

8 ‘‘(B) action is taken as necessary to enable 

9 the licensing of inventions developed by the In10 stitute or with funds from the Institute; and 

11 ‘‘(C) executed licenses, memoranda of un12 derstanding, material transfer agreements, con13 tracts, and other such instruments promote, to 

14 the maximum extent practicable, the broadest 

15 conversion to commercial and noncommercial 

16 applications of licensed and patented inventions 

17 of the Institute to further the goals and prior18 ities established under paragraph (2); 

19 ‘‘(8) provide objective clinical and scientific in20 formation to the Food and Drug Administration 

21 and, upon request, to other Federal agencies to as22 sist in agency determinations of how to ensure that 

23 regulatory policy accommodates scientific advances; 

24 ‘‘(9) conduct annual assessments of the unmet 

25 needs identified in paragraph (1); and 


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1 ‘‘(10) carry out such other activities consistent 

2 with the purposes of the Institute as the Board de3 termines appropriate. 

4 ‘‘(d) BOARD OF DIRECTORS.— 

5 ‘‘(1) ESTABLISHMENT.— 

6 ‘‘(A) IN GENERAL.—The Institute shall 

7 have a Board of Directors (referred to in this 

8 subchapter as the ‘Board’), which shall be com9 posed of ex officio and appointed members in 

10 accordance with this subsection. All appointed 

11 members of the Board shall be voting members. 

12 ‘‘(B) EX OFFICIO MEMBERS.—The ex offi13 cio members of the Board shall be— 

14 ‘‘(i) the immediate past Chair of the 

15 Board of Directors of the Institute; 

16 ‘‘(ii) the Commissioner of Food and 

17 Drugs; 

18 ‘‘(iii) the Director of the National In19 stitutes of Health; 

20 ‘‘(iv) the Director of the Centers for 

21 Disease Control and Prevention; and 

22 ‘‘(v) the Director of the Agency for 

23 Healthcare Research and Quality. 

24 ‘‘(C) APPOINTED MEMBERS.— 


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1 ‘‘(i) IN GENERAL.—The ex officio 

2 members of the Board under subparagraph 

3 (B) shall, by majority vote, appoint to the 

4 Board 12 individuals. Of such appointed 

5 members— 

6 ‘‘(I) 3 shall be representatives of 

7 the general pharmaceutical, device, 

8 and biotechnology industries; 

9 ‘‘(II) 3 shall be representatives of 

10 academic research organizations; 

11 ‘‘(III) 2 shall be representatives 

12 of Government agencies, including the 

13 Food and Drug Administration and 

14 the National Institutes of Health; 

15 ‘‘(IV) 3 shall be representatives 

16 of patient advocacy and consumer or17 ganizations; and 

18 ‘‘(V) 1 shall be a representative 

19 of health care providers. 

20 ‘‘(ii) REQUIREMENT.—The ex officio 

21 members shall ensure the Board member22 ship includes individuals with expertise in 

23 areas including clinical pharmacology, bio24 medical informatics, product safety, proc25 ess improvement and pharmaceutical 


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1 sciences, and medical device and bio2 medical engineering. 

3 ‘‘(D) INITIAL MEETING.— 

4 ‘‘(i) IN GENERAL.—Not later than 30 

5 days after the date of the enactment of the 

6 Enhancing Drug Safety and Innovation 

7 Act of 2007, the Secretary shall convene a 

8 meeting of the ex officio members of the 

9 Board to— 

10 ‘‘(I) incorporate the Institute; 

11 and 

12 ‘‘(II) appoint the members of the 

13 Board in accordance with subpara14 graph (C). 

15 ‘‘(ii) SERVICE OF EX OFFICIO MEM16 BERS.—Upon the appointment of the 

17 members of the Board under clause (i)(II), 

18 the terms of service of the ex officio mem19 bers of the Board as members of the 

20 Board shall terminate. 

21 ‘‘(iii) CHAIR.—The ex officio members 

22 of the Board under subparagraph (B) shall 

23 designate an appointed member of the 

24 Board to serve as the Chair of the Board. 

25 ‘‘(2) DUTIES OF BOARD.—The Board shall— 


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1 ‘‘(A) establish bylaws for the Institute 

2 that— 

3 ‘‘(i) are published in the Federal Reg4 ister and available for public comment; 

5 ‘‘(ii) establish policies for the selection 

6 of the officers, employees, agents, and con7 tractors of the Institute; 

8 ‘‘(iii) establish policies, including eth9 ical standards, for the acceptance, solicita10 tion, and disposition of donations and 

11 grants to the Institution and for the dis12 position of the assets of the Institute; 

13 ‘‘(iv) establish policies whereby any 

14 individual who is an officer, employee, or 

15 member of the Board of the Institute may 

16 not personally or substantially participate 

17 in the consideration or determination by 

18 the Institute of any matter that would di19 rectly or predictably affect any financial 

20 interest of the individual or a relative (as 

21 such term is defined in section 109(16) of 

22 the Ethics in Government Act of 1978) of 

23 the individual, of any business organization 

24 or other entity, or of which the individual 

25 is an officer or employee or is negotiating 


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1 for employment, or in which the individual 

2 has any other financial interest; 

3 ‘‘(v) establish licensing, distribution, 

4 and publication policies that support the 

5 widest and least restrictive use by the pub6 lic of information and inventions developed 

7 by the Institute or with Institute funds to 

8 carry out the duties described in para9 graphs (6) and (7) of subsection (c); 

10 ‘‘(vi) specify principles for the review 

11 of proposals and awarding of grants and 

12 contracts that include peer review and that 

13 are substantially consistent with those of 

14 the Foundation for the National Institutes 

15 of Health; 

16 ‘‘(vii) specify a process for annual 

17 Board review of the operations of the Insti18 tute; and 

19 ‘‘(viii) establish specific duties of the 

20 Executive Director; 

21 ‘‘(B) prioritize and provide overall direc22 tion to the activities of the Institute; 

23 ‘‘(C) evaluate the performance of the Exec24 utive Director; and 


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1 ‘‘(D) carry out any other necessary activi2 ties regarding the functioning of the Institute. 

3 ‘‘(3) ADDITIONAL BOARD FUNCTIONS.—The 

4 Board may coordinate and collaborate with other en5 tities to conduct research, education, and outreach, 

6 and to modernize the sciences of developing, manu7 facturing, and evaluating the safety and effective8 ness of diagnostics, devices, biologics, and drugs. 

9 ‘‘(4) TERMS AND VACANCIES.— 

10 ‘‘(A) TERM.—The term of office of each 

11 member of the Board appointed under para12 graph (1)(C) shall be 4 years, except that the 

13 terms of offices for the initial appointed mem14 bers of the Board shall expire on a staggered 

15 basis as determined by the ex officio members. 

16 ‘‘(B) VACANCY.—Any vacancy in the mem17 bership of the Board— 

18 ‘‘(i) shall not affect the power of the 

19 remaining members to execute the duties 

20 of the Board; and 

21 ‘‘(ii) shall be filled by appointment by 

22 the individuals described in clauses (i) 

23 through (v) of paragraph (1)(B) by major24 ity vote. 


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1 ‘‘(C) PARTIAL TERM.—If a member of the 

2 Board does not serve the full term applicable 

3 under subparagraph (A), the individual ap4 pointed under subparagraph (B) to fill the re5 sulting vacancy shall be appointed for the re6 mainder of the term of the predecessor of the 

7 individual. 

8 ‘‘(D) SERVING PAST TERM.—A member of 

9 the Board may continue to serve after the expi10 ration of the term of the member until a suc11 cessor is appointed. 

12 ‘‘(5) COMPENSATION.—Members of the Board 

13 may not receive compensation for service on the 

14 Board. Such members may be reimbursed for travel, 

15 subsistence, and other necessary expenses incurred 

16 in carrying out the duties of the Board, as set forth 

17 in the bylaws issued by the Board. 

18 ‘‘(e) INCORPORATION.—The ex officio members of the 

19 Board shall serve as incorporators and shall take whatever 

20 actions necessary to incorporate the Institute. 

21 ‘‘(f) NONPROFIT STATUS.—The Institute shall be 

22 considered to be a corporation under section 501(c) of the 

23 Internal Revenue Code of 1986, and shall be subject to 

24 the provisions of such section. 

25 ‘‘(g) EXECUTIVE DIRECTOR.— 


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1 ‘‘(1) IN GENERAL.—The Board shall appoint an 

2 Executive Director who shall serve at the pleasure of 

3 the Board. The Executive Director shall be respon4 sible for the day-to-day operations of the Institute 

5 and shall have such specific duties and responsibil6 ities as the Board shall prescribe. 

7 ‘‘(2) COMPENSATION.—The compensation of 

8 the Executive Director shall be fixed by the Board 

9 but shall not be greater than the compensation of 

10 the Commissioner of Food and Drugs. 

11 ‘‘(h) ADMINISTRATIVE POWERS.—In carrying out 

12 this subchapter, the Board, acting through the Executive 

13 Director, may— 

14 ‘‘(1) adopt, alter, and use a corporate seal, 

15 which shall be judicially noticed; 

16 ‘‘(2) hire, promote, compensate, and discharge 

17 1 or more officers, employees, and agents, as may be 

18 necessary, and define their duties; 

19 ‘‘(3) prescribe the manner in which— 

20 ‘‘(A) real or personal property of the Insti21 tute is acquired, held, and transferred; 

22 ‘‘(B) general operations of the Institute 

23 are to be conducted; and 

24 ‘‘(C) the privileges granted to the Board 

25 by law are exercised and enjoyed; 


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1 ‘‘(4) with the consent of the applicable executive 

2 department or independent agency, use the informa3 tion, services, and facilities of such department or 

4 agencies in carrying out this section; 

5 ‘‘(5) enter into contracts with public and pri6 vate organizations for the writing, editing, printing, 

7 and publishing of books and other material; 

8 ‘‘(6) hold, administer, invest, and spend any 

9 gift, devise, or bequest of real or personal property 

10 made to the Institute under subsection (i); 

11 ‘‘(7) enter into such other contracts, leases, co12 operative agreements, and other transactions as the 

13 Board considers appropriate to conduct the activities 

14 of the Institute; 

15 ‘‘(8) modify or consent to the modification of 

16 any contract or agreement to which it is a party or 

17 in which it has an interest under this subchapter; 

18 ‘‘(9) take such action as may be necessary to 

19 obtain patents and licenses for devices and proce20 dures developed by the Institute and its employees; 

21 ‘‘(10) sue and be sued in its corporate name, 

22 and complain and defend in courts of competent ju23 risdiction; 


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1 ‘‘(11) appoint other groups of advisors as may 

2 be determined necessary to carry out the functions 

3 of the Institute; and 

4 ‘‘(12) exercise other powers as set forth in this 

5 section, and such other incidental powers as are nec6 essary to carry out its powers, duties, and functions 

7 in accordance with this subchapter. 

8 ‘‘(i) ACCEPTANCE OF FUNDS FROM OTHER

9 SOURCES.—The Executive Director may solicit and accept 

10 on behalf of the Institute, any funds, gifts, grants, devises, 

11 or bequests of real or personal property made to the Insti12 tute, including from private entities, for the purposes of 

13 carrying out the duties of the Institute. 

14 ‘‘(j) SERVICE OF FEDERAL EMPLOYEES.—Federal 

15 Government employees may serve on committees advisory 

16 to the Institute and otherwise cooperate with and assist 

17 the Institute in carrying out its functions, so long as such 

18 employees do not direct or control Institute activities. 

19 ‘‘(k) DETAIL OF GOVERNMENT EMPLOYEES.—Fed20 eral Government employees may be detailed from Federal 

21 agencies with or without reimbursement to those agencies 

22 to the Institute at any time, and such detail shall be with23 out interruption or loss of civil service status or privilege. 

24 Each such employee shall abide by the statutory, regu25 latory, ethical, and procedural standards applicable to the 


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1 employees of the agency from which such employee is de2 tailed and those of the Institute. 

3 ‘‘(l) ANNUAL REPORTS.— 

4 ‘‘(1) REPORTS TO INSTITUTE.—Any recipient of 

5 a grant, contract, or cooperative agreement from the 

6 Institute under this section shall submit to the Insti7 tute a report on an annual basis for the duration of 

8 such grant, contract, or cooperative agreement, that 

9 describes the activities carried out under such grant, 

10 contract, or cooperative agreement. 

11 ‘‘(2) REPORT TO FDA.—Beginning with fiscal 

12 year 2009, the Executive Director shall submit to 

13 the Commissioner an annual report that— 

14 ‘‘(A) details the progress of the Institute in 

15 furthering the goals and priorities established 

16 under subsection (c)(2); and 

17 ‘‘(B) provides recommendations for incor18 porating such progress into regulatory and 

19 product review activities of the Food and Drug 

20 Administration. 

21 ‘‘(3) REPORT TO CONGRESS.—Beginning with 

22 fiscal year 2009, the Executive Director shall submit 

23 to the Committee on Health, Education, Labor, and 

24 Pensions and the Committee on Appropriations of 

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1 merce and the Committee on Appropriations of the 

2 House of Representatives an annual report that— 

3 ‘‘(A) describes the activities of the Insti4 tute and of the recipients of a grant, contract, 

5 or cooperative agreement under this section, in6 cluding the practical impact of the Institute on 

7 medical product development; 

8 ‘‘(B) provides a specific accounting of the 

9 source of all funds used by the Institute to 

10 carry out such activities; and 

11 ‘‘(C) describes how such funds were used 

12 by the Institute. 

13 ‘‘(m) SEPARATION OF FUNDS.—The Executive Di14 rector shall ensure that the funds received from the Treas15 ury are held in separate accounts from funds received 

16 from entities under subsection (i). 

17 ‘‘(n) AUTHORIZATION OF APPROPRIATIONS.—There 

18 are authorized to be appropriated such sums as may be 

19 necessary for each of fiscal years 2008 through 2013 to 

20 carry out subsections (a), (b), and (d) through (m).’’. 

21 (b) OTHER INSTITUTE PROVISIONS.—Chapter VII 

22 (21 U.S.C. 371 et seq.) (as amended by subsection (a)) 

23 is amended by adding at the end the following: 


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1 ‘‘SEC. 771. LOCATION OF INSTITUTE. 

2 ‘‘(a) IN GENERAL.—The Institute shall, if prac3 ticable, be located not more than 20 miles from the Dis4 trict of Columbia. 

5 ‘‘(b) USE OF SPACE.—The Secretary shall consult 

6 with the Administrator of General Services to ensure the 

7 most cost-efficient arrangement for the leasing or pur8 chase of real property for adequate facilities which, if 

9 practicable, shall be located at the Food and Drug Admin10 istration, to meet the needs of the Institute in carrying 

11 out this subchapter. 

12 ‘‘SEC. 772. ACTIVITIES OF THE FOOD AND DRUG ADMINIS13 TRATION. 

14 ‘‘(a) IN GENERAL.—The Commissioner shall receive 

15 and assess the report submitted to the Commissioner by 

16 the Executive Director of the Institute under section 

17 770(l)(2). 

18 ‘‘(b) REPORT TO CONGRESS.—The Commissioner 

19 shall submit to the Committee on Health, Education, 

20 Labor, and Pensions and the Committee on Appropria21 tions of the Senate and the Committee on Energy and 

22 Commerce and the Committee on Appropriations of the 

23 House of Representatives an annual report that describes 

24 the implementation of any recommendations included in 

25 the report described under subsection (a).’’. 


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1 TITLE III—CLINICAL TRIALS 

2 SEC. 301. CLINICAL TRIAL REGISTRY DATABASE AND CLIN3 ICAL TRIAL RESULTS DATABASE. 

4 (a) IN GENERAL.—Subsection (i) of section 402 of 

5 the Public Health Service Act (42 U.S.C. 282), as amend6 ed by Public Law 109–482, is amended to read as follows: 

7 ‘‘(i) CLINICAL TRIAL REGISTRY DATABASE; CLIN8 ICAL TRIAL RESULTS DATABASE.— 

9 ‘‘(1) DEFINITIONS.—In this subsection: 

10 ‘‘(A) APPLICABLE CLINICAL TRIAL.—The 

11 term ‘applicable clinical trial’— 

12 ‘‘(i) means a clinical trial that is con13 ducted to test the safety or effectiveness 

14 (including comparative effectiveness) of a 

15 drug or device (irrespective of whether the 

16 clinical trial is federally or privately fund17 ed, and whether the clinical trial involves 

18 an approved or unapproved drug or de19 vice); 

20 ‘‘(ii) includes such a clinical trial that 

21 is conducted outside of the United States 

22 if— 

23 ‘‘(I) there is an application or 

24 premarket notification pending before 

25 the Food and Drug Administration 


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1 for approval or clearance of the drug 

2 or device involved under section 505, 

3 510(k), or 515 of the Federal Food, 

4 Drug, and Cosmetic Act or section 

5 351 of this Act; or 

6 ‘‘(II) the drug or device involved 

7 is so approved or cleared; and 

8 ‘‘(iii) notwithstanding subclauses (I) 

9 and (II), excludes— 

10 ‘‘(I) a clinical trial to determine 

11 the safety of a use of a drug that is 

12 designed solely to detect major 

13 toxicities in the drug or to investigate 

14 pharmacokinetics, unless the clinical 

15 trial is designed to investigate phar16 macokinetics in a special population 

17 or populations; and 

18 ‘‘(II) a small clinical trial to de19 termine the feasibility of a device, or 

20 a clinical trial to test prototype de21 vices where the primary focus is feasi22 bility. 

23 ‘‘(B) CLINICAL TRIAL INFORMATION.—The 

24 term ‘clinical trial information’ means those 

25 data elements that are necessary to complete an 


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1 entry in the clinical trial registry database 

2 under paragraph (2) or the clinical trial results 

3 database under paragraph (3), as applicable. 

4 ‘‘(C) COMPLETION DATE.—The term ‘com5 pletion date’ means the date of the final collec6 tion of data from subjects in the clinical trial 

7 for the primary and secondary outcomes to be 

8 examined in the trial. 

9 ‘‘(D) DEVICE.—The term ‘device’ has the 

10 meaning given to that term in section 201(h) of 

11 the Federal Food, Drug, and Cosmetic Act. 

12 ‘‘(E) DRUG.—The term ‘drug’ means a 

13 drug as defined in section 201(g) of the Federal 

14 Food, Drug, and Cosmetic Act or a biological 

15 product as defined in section 351 of this Act. 

16 ‘‘(F) RESPONSIBLE PARTY.—The term ‘re17 sponsible party’, with respect to an applicable 

18 clinical trial, means— 

19 ‘‘(i) the primary sponsor (as defined 

20 in the International Clinical Trials Reg21 istry Platform trial registration data set of 

22 the World Health Organization) of the 

23 clinical trial; or 

24 ‘‘(ii) the principal investigator of such 

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1 sor, so long as the principal investigator is 

2 responsible for conducting the trial, has ac3 cess to and control over the data, has the 

4 right to publish the results of the trial, and 

5 has the responsibility to meet all of the re6 quirements under this section that are ap7 plicable to responsible parties. 

8 ‘‘(2) CLINICAL TRIALS REGISTRY DATABASE.— 

9 ‘‘(A) ESTABLISHMENT.—To enhance pa10 tient enrollment and provide a mechanism to 

11 track subsequent progress of clinical trials, the 

12 Secretary, acting through the Director of NIH, 

13 shall establish and administer a clinical trial 

14 registry database in accordance with this sub15 section (referred to in this subsection as the 

16 ‘registry database’). The Director of NIH shall 

17 ensure that the registry database is made pub18 licly available through the Internet. 

19 ‘‘(B) CONTENT.—The Secretary shall pro20 mulgate regulations for the submission to the 

21 registry database of clinical trial information 

22 that— 

23 ‘‘(i) conforms to the International 

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1 istration data set of the World Health Or2 ganization; 

3 ‘‘(ii) includes the city, State, and zip 

4 code for each clinical trial location; 

5 ‘‘(iii) includes a statement of the esti6 mated completion date for the clinical trial; 

7 ‘‘(iv) includes the identity and contact 

8 information of the responsible party; 

9 ‘‘(v) if the drug is not approved under 

10 section 505 of the Federal Food, Drug, 

11 and Cosmetic Act or licensed under section 

12 351 of this Act, or the device is not cleared 

13 under section 510(k) or approved under 

14 section 515 of the Federal Food, Drug, 

15 and Cosmetic Act, specifies whether or not 

16 there is expanded access to the drug or de17 vice under section 561 of the Federal 

18 Food, Drug, and Cosmetic Act for those 

19 who do not qualify for enrollment in the 

20 clinical trial and how to obtain information 

21 about such access; 

22 ‘‘(vi) includes, with respect to any in23 dividual who is not an employee of the re24 sponsible party for the clinical trial or of 

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1 volved, information on any agreement that 

2 the responsible party or manufacturer has 

3 entered into with such individual that re4 stricts in any manner the ability of the in5 dividual— 

6 ‘‘(I) to discuss the results of the 

7 trial at a scientific meeting or any 

8 other public or private forum; or 

9 ‘‘(II) to publish the results of the 

10 trial, or a description or discussion of 

11 the results of the trial, in a scientific 

12 or academic journal; and 

13 ‘‘(vii) requires the inclusion of such 

14 other data elements to the registry data15 base as appropriate. 

16 ‘‘(C) FORMAT AND STRUCTURE.— 

17 ‘‘(i) SEARCHABLE CATEGORIES.—The 

18 Director of NIH shall ensure that the pub19 lic may search the entries in the registry 

20 database by 1 or more of the following cri21 teria: 

22 ‘‘(I) The indication being studied 

23 in the clinical trial, using Medical 

24 Subject Headers (MeSH) descriptors. 


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1 ‘‘(II) The safety issue being stud2 ied in the clinical trial. 

3 ‘‘(III) The enrollment status of 

4 the clinical trial. 

5 ‘‘(IV) The sponsor of the clinical 

6 trial. 

7 ‘‘(ii) FORMAT.—The Director of the 

8 NIH shall ensure that the registry data9 base is easily used by patients, and that 

10 entries are easily compared. 

11 ‘‘(D) DATA SUBMISSION.—The responsible 

12 party for an applicable clinical trial shall submit 

13 to the Director of NIH for inclusion in the reg14 istry database the clinical trial information de15 scribed in subparagraph (B). 

16 ‘‘(E) TRUTHFUL CLINICAL TRIAL INFOR17 MATION.— 

18 ‘‘(i) IN GENERAL.—The clinical trial 

19 information submitted by a responsible 

20 party under this paragraph shall not be 

21 false or misleading in any particular. 

22 ‘‘(ii) EFFECT.—Clause (i) shall not 

23 have the effect of requiring clinical trial in24 formation to include information from any 

25 source other than the clinical trial involved. 


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1 ‘‘(F) TIMING OF SUBMISSION.—Except as 

2 provided in subparagraph (G), the clinical trial 

3 information for a clinical trial required to be 

4 submitted under this paragraph shall be sub5 mitted not later than 14 days after the first pa6 tient is enrolled in such clinical trial. 

7 ‘‘(G) UPDATES.—The responsible party for 

8 an applicable clinical trial shall submit to the 

9 Director of NIH for inclusion in the registry 

10 database periodic updates to reflect changes to 

11 the clinical trial information submitted under 

12 this paragraph. Such updates— 

13 ‘‘(i) shall be provided not less than 

14 once every six months until information on 

15 the results of the trial is submitted under 

16 paragraph (3); 

17 ‘‘(ii) shall include identification of the 

18 dates of any such changes; 

19 ‘‘(iii) not later than 30 days after the 

20 enrollment status of such clinical trial 

21 changes, shall include an update of the en22 rollment status; and 

23 ‘‘(iv) not later than 30 days after the 

24 completion date of the clinical trial, shall 


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1 include a report to the Director that such 

2 clinical trial is complete. 

3 ‘‘(3) CLINICAL TRIALS RESULTS DATABASE.— 

4 ‘‘(A) ESTABLISHMENT.—To ensure that 

5 results of clinical trials are made public and 

6 that patients and providers have current infor7 mation regarding the results of clinical trials, 

8 the Secretary, acting through the Director of 

9 NIH, shall establish and administer a clinical 

10 trial results database in accordance with this 

11 subsection (referred to in this subsection as the 

12 ‘results database’). 

13 ‘‘(B) SEARCHABLE CATEGORIES.—The Di14 rector of NIH shall ensure that the public may 

15 search the entries in the results database by 1 

16 or more of the following: 

17 ‘‘(i) The indication studied in the clin18 ical trial, using Medical Subject Headers 

19 (MeSH) descriptors. 

20 ‘‘(ii) The safety issue studied in the 

21 clinical trial. 

22 ‘‘(iii) Whether an application for the 

23 tested indication is approved, pending ap24 proval, withdrawn, or not submitted. 

25 ‘‘(iv) The phase of the clinical trial. 


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1 ‘‘(v) The name of the drug or device 

2 that is the subject of the clinical trial. 

3 ‘‘(vi) Within the documents described 

4 in subclauses (II) and (III) of subpara5 graph (C)(ii), the following information, as 

6 applicable: 

7 ‘‘(I) The sponsor of the clinical 

8 trial. 

9 ‘‘(II) Each financial sponsor of 

10 the clinical trial. 

11 ‘‘(C) CONTENTS.— 

12 ‘‘(i) IN GENERAL.—The responsible 

13 party for an applicable clinical trial shall 

14 submit to the Director of NIH for inclu15 sion in the results database the clinical 

16 trial information described in clause (ii). 

17 ‘‘(ii) REQUIRED ELEMENTS.—In sub18 mitting clinical trial information for a clin19 ical trial to the Director of NIH for inclu20 sion in the results database, the respon21 sible party shall include, with respect to 

22 such clinical trial, the following informa23 tion: 


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1 ‘‘(I) The information described in 

2 clauses (i) through (v) of subpara3 graph (B). 

4 ‘‘(II) A non-promotional sum5 mary document that is written in non6 technical, understandable language for 

7 patients that includes the following: 

8 ‘‘(aa) The purpose of the 

9 clinical trial. 

10 ‘‘(bb) The sponsor of the 

11 clinical trial. 

12 ‘‘(cc) A point of contact for 

13 information about the clinical 

14 trial. 

15 ‘‘(dd) A description of the 

16 patient population tested in the 

17 clinical trial. 

18 ‘‘(ee) A general description 

19 of the clinical trial and results, 

20 including a description of and the 

21 reasons for any changes in the 

22 clinical trial design that occurred 

23 since the date of submission of 

24 clinical trial information for in25 clusion in the registry database 


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1 established under paragraph (2) 

2 and a description of any signifi3 cant safety information. 

4 ‘‘(III) A non-promotional sum5 mary document that is technical in 

6 nature that includes the following: 

7 ‘‘(aa) The purpose of the 

8 clinical trial. 

9 ‘‘(bb) The sponsor of the 

10 clinical trial. 

11 ‘‘(cc) Each financial sponsor 

12 of the clinical trial. 

13 ‘‘(dd) A point of contact for 

14 scientific information about the 

15 clinical trial. 

16 ‘‘(ee) A description of the 

17 patient population tested in the 

18 clinical trial. 

19 ‘‘(ff) A general description 

20 of the clinical trial and results, 

21 including a description of and the 

22 reasons for any changes in the 

23 clinical trial design that occurred 

24 since the date of submission of 

25 clinical trial information for the 


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1 clinical trial in the registry data2 base established under paragraph 

3 (2). 

4 ‘‘(gg) Summary data de5 scribing the results, including— 

6 ‘‘(AA) whether the pri7 mary endpoint was achieved, 

8 including relevant statistics; 

9 ‘‘(BB) an assessment of 

10 any secondary endpoints, if 

11 applicable, including relevant 

12 statistics; and 

13 ‘‘(CC) any significant 

14 safety information, including 

15 a summary of the incidence 

16 of serious adverse events ob17 served in the clinical trial 

18 and a summary of the most 

19 common adverse events ob20 served in the clinical trial 

21 and the frequencies of such 

22 events. 

23 ‘‘(IV) With respect to the group 

24 of subjects receiving the drug or de25 vice involved, and each comparison 


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1 group of subjects, the percentage of 

2 individuals who ceased participation 

3 as subjects and their reasons for ceas4 ing participation. 

5 ‘‘(V) With respect to an indi6 vidual who is not an employee of the 

7 responsible party for the clinical trial 

8 or of the manufacturer of the drug or 

9 device involved, information (to the 

10 extent not submitted under paragraph 

11 (2)(B)(vi)) on any agreement that the 

12 responsible party or manufacturer has 

13 entered into with such individual that 

14 restricts in any manner the ability of 

15 the individual— 

16 ‘‘(aa) to discuss the results 

17 of the trial at a scientific meeting 

18 or any other public or private 

19 forum; or 

20 ‘‘(bb) to publish the results 

21 of the trial, or a description or 

22 discussion of the results of the 

23 trial, in a scientific or academic 

24 journal. 


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1 ‘‘(VI) A link to available peer-re2 viewed publications based on the re3 sults of the clinical trial. 

4 ‘‘(VII) The completion date of 

5 the clinical trial. 

6 ‘‘(VIII) A link to the Internet 

7 web posting of any adverse regulatory 

8 actions taken by the Food and Drug 

9 Administration, such as a warning let10 ter, that was substantively based on 

11 the clinical trial design, outcome, or 

12 representation made by the applicant 

13 about the design or outcome of the 

14 clinical trial. 

15 ‘‘(D) TIMING.— 

16 ‘‘(i) IN GENERAL.—Except as pro17 vided in clauses (ii) and (iii), a responsible 

18 party shall submit to the Director of NIH 

19 for inclusion in the results database clin20 ical trial information for an applicable clin21 ical trial not later than 1 year after the 

22 earlier of— 

23 ‘‘(I) the estimated completion 

24 date of the trial, as submitted under 

25 paragraph (2)(B); or 


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1 ‘‘(II) the actual date of the com2 pletion, or termination before comple3 tion, of the trial, as applicable. 

4 ‘‘(ii) EXTENSIONS.—The Director of 

5 NIH may provide an extension of the 

6 deadline for submission of clinical trial in7 formation under clause (i) if the respon8 sible party for the trial submits to the Di9 rector a written request that demonstrates 

10 good cause for the extension and provides 

11 an estimate of the date on which the infor12 mation will be submitted. The Director of 

13 NIH may grant more than one such exten14 sion for the clinical trial involved. 

15 ‘‘(iii) UPDATES.—The responsible 

16 party for an applicable clinical trial shall 

17 submit to the Director of NIH for inclu18 sion in the results database periodic up19 dates to reflect changes in the clinical trial 

20 information submitted under this para21 graph. Such updates— 

22 ‘‘(I) shall be provided not less 

23 frequently than once every six months 

24 during the 10-year period beginning 


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1 on the date on which information is 

2 due under clause (i); and 

3 ‘‘(II) shall identify the dates on 

4 which the changes were made; and 

5 ‘‘(III) shall include, not later 

6 than 30 days after any change in the 

7 regulatory status of the drug or device 

8 involved, an update informing the Di9 rector of NIH of such change. 

10 ‘‘(E) TRUTHFUL CLINICAL TRIAL INFOR11 MATION.— 

12 ‘‘(i) IN GENERAL.—The clinical trial 

13 information submitted by a responsible 

14 party under this paragraph shall not be 

15 false or misleading in any particular. 

16 ‘‘(ii) EFFECT.—Clause (i) shall not 

17 have the effect of requiring clinical trial in18 formation with respect to a clinical trial to 

19 include information from any source other 

20 than such clinical trial. 

21 ‘‘(F) PUBLIC AVAILABILITY OF RE22 SULTS.— 

23 ‘‘(i) PRE-APPROVAL STUDIES.—Ex24 cept as provided in clause (v), with respect 

25 to an applicable clinical trial that is comVerDate Aug 31 2005 23:40 Mar 22, 2007 Jkt 059200 PO 00000 Frm 00087 Fmt 6652 Sfmt 6201 E:\BILLS\H1561.IH H1561

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1 pleted before the drug is initially approved 

2 under section 505 of the Federal Food, 

3 Drug, and Cosmetic Act or initially li4 censed under section 351 of this Act, or 

5 the device is initially cleared under section 

6 510(k) or approved under section 515 of 

7 the Federal Food, Drug, and Cosmetic 

8 Act, the Director of NIH shall make pub9 licly available on the results database the 

10 clinical trial information submitted for 

11 such clinical trial not later than 30 days 

12 after— 

13 ‘‘(I) the drug or device is ap14 proved under such section 505, li15 censed under such section 351, 

16 cleared under such section 510(k), or 

17 approved under such section 515, as 

18 applicable; or 

19 ‘‘(II) the Secretary issues a not 

20 approvable letter or a not substan21 tially equivalent letter for the drug or 

22 device under such section 505, 351, 

23 510(k), or 515, as applicable. 

24 ‘‘(ii) MEDICAL AND CLINICAL PHAR25 MACOLOGY REVIEWS OF PRE-APPROVAL


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1 STUDIES.—Not later than 90 days after 

2 the date applicable under subclause (I) or 

3 (II) of clause (i) with respect to an appli4 cable clinical trial, the Director of NIH 

5 shall make publicly available on the results 

6 database a summary of the available med7 ical and clinical pharmacology reviews con8 ducted by the Food and Drug Administra9 tion for such trial. 

10 ‘‘(iii) POST-APPROVAL STUDIES.—Ex11 cept as provided in clauses (iv) and (v), 

12 with respect to an applicable clinical trial 

13 that is completed after the drug is initially 

14 approved under such section 505 or li15 censed under such section 351, or the de16 vice is initially cleared under such section 

17 510(k) or approved under such section 

18 515, the Director of NIH shall make pub19 licly available on the results database the 

20 clinical trial information submitted for 

21 such clinical trial not later than 30 days 

22 after the date of such submission. 

23 ‘‘(iv) SEEKING APPROVAL OF A NEW

24 USE FOR THE DRUG OR DEVICE.— 


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1 ‘‘(I) IN GENERAL.—If the manu2 facturer of the drug or device is the 

3 sponsor or a financial sponsor of an 

4 applicable clinical trial, and such man5 ufacturer certifies to the Director of 

6 NIH that such manufacturer has 

7 filed, or will file within 1 year, an ap8 plication seeking approval under such 

9 section 505, licensing under such sec10 tion 351, clearance under such section 

11 510(k), or approval under such sec12 tion 515 for the use studied in such 

13 clinical trial (which use is not included 

14 in the labeling of the approved drug 

15 or device), then the Director of NIH 

16 shall make publicly available on the 

17 results database the clinical trial in18 formation submitted for such clinical 

19 trial on the earlier of the date that is 

20 30 days after the date— 

21 ‘‘(aa) the new use of the 

22 drug or device is approved under 

23 such section 505, licensed under 

24 such section 351, cleared under 


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1 such section 510(k), or approved 

2 under such section 515; 

3 ‘‘(bb) the Secretary issues a 

4 not approvable letter or a not 

5 substantially equivalent letter for 

6 the new use of the drug or device 

7 under such section 505, 351, 

8 510(k), or 515; or 

9 ‘‘(cc) the application or pre10 market notification under such 

11 section 505, 351, 510(k), or 515 

12 is withdrawn. 

13 ‘‘(II) LIMITATION ON CERTIFI14 CATION.—If a manufacturer makes a 

15 certification under subclause (I) with 

16 respect to a clinical trial, the manu17 facturer shall make such a certifi18 cation with respect to each applicable 

19 clinical trial that is required to be 

20 submitted in an application for ap21 proval of the use studied in the clin22 ical trial. 

23 ‘‘(III) 2-YEAR LIMITATION.—The 

24 clinical trial information subject to 

25 subclause (I) shall be made publicly 


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1 available on the results database on 

2 the date that is 2 years after the date 

3 the certification referred to in sub4 clause (I) was made to the Director of 

5 NIH, if a regulatory action referred to 

6 in item (aa), (bb), or (cc) of subclause 

7 (I) has not occurred by such date. 

8 ‘‘(IV) MEDICAL AND CLINICAL

9 PHARMACOLOGY REVIEWS.—Not later 

10 than 90 days after the date applicable 

11 under item (aa), (bb), or (cc) of sub12 clause (I) or subclause (III) with re13 spect to an applicable clinical trial, 

14 the Director of NIH shall make pub15 licly available on the results database 

16 a summary of the available medical 

17 and clinical pharmacology reviews 

18 conducted by the Food and Drug Ad19 ministration for such trial. 

20 ‘‘(v) SEEKING PUBLICATION.— 

21 ‘‘(I) IN GENERAL.—If the prin22 cipal investigator of an applicable clin23 ical trial is seeking publication in a 

24 peer-reviewed biomedical journal of a 

25 manuscript based on the results of the 


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1 clinical trial and the responsible party 

2 so certifies to the Director of NIH— 

3 ‘‘(aa) the responsible party 

4 shall notify the Director of NIH 

5 of the publication date of such 

6 manuscript not later than 15 

7 days after such date; and 

8 ‘‘(bb) the Director of NIH 

9 shall make publicly available on 

10 the results database the clinical 

11 trial information submitted for 

12 such clinical trial on the date 

13 that is 30 days after the publica14 tion date of such manuscript. 

15 ‘‘(II) LIMITATIONS.—The clinical 

16 trial information subject to subclause 

17 (I)— 

18 ‘‘(aa) shall be made publicly 

19 available on the results database 

20 on the date that is 2 years after 

21 the date that the clinical trial in22 formation was required to be 

23 submitted to the Director of NIH 

24 if the manuscript referred to in 


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1 such subclause has not been pub2 lished by such date; and 

3 ‘‘(bb) shall not be required 

4 to be made publicly available 

5 under section 552 of title 5, 

6 United States Code (commonly 

7 known as the ‘Freedom of Infor8 mation Act’), prior to the date 

9 applicable to such clinical trial 

10 information under this clause. 

11 ‘‘(G) VERIFICATION OF SUBMISSION PRIOR

12 TO PUBLIC AVAILABILITY.—In the case of clin13 ical trial information that is submitted under 

14 this paragraph, but is not made publicly avail15 able pending either regulatory action or publica16 tion under clause (iv) or (v) of subparagraph 

17 (F), as applicable, the Director of NIH shall re18 spond to inquiries from other Federal agencies 

19 and peer-reviewed journals to confirm that such 

20 clinical trial information has been submitted 

21 but has not yet been made publicly available on 

22 the results database. 

23 ‘‘(4) UPDATES; TRACKING OF CHANGES IN SUB24 MITTED INFORMATION.—The Director of NIH shall 

25 ensure that updates submitted to the Director under 


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1 paragraphs (2)(G) and (3)(D) do not result in the 

2 removal from the registry database or the results 

3 database of the original submissions or of any pre4 ceding updates, and that information in such data5 bases is presented in a manner that enables users to 

6 readily access each original submission and to track 

7 the changes made by the updates. 

8 ‘‘(5) COORDINATION AND COMPLIANCE.— 

9 ‘‘(A) CLINICAL TRIALS SUPPORTED BY

10 GRANTS FROM FEDERAL AGENCIES.— 

11 ‘‘(i) IN GENERAL.—No Federal agen12 cy may release funds under a research 

13 grant to a person who has not complied 

14 with paragraphs (2) and (3) for any appli15 cable clinical trial for which such person is 

16 the responsible party. 

17 ‘‘(ii) GRANTS FROM CERTAIN FED18 ERAL AGENCIES.—If an applicable clinical 

19 trial is funded in whole or in part by a 

20 grant from the National Institutes of 

21 Health, the Agency for Healthcare Re22 search and Quality, or the Department of 

23 Veterans Affairs, any grant or progress re24 port forms required under such grant shall 

25 include a certification that the responsible 


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1 party has made all required submissions to 

2 the Director of NIH under paragraphs (2) 

3 and (3). 

4 ‘‘(iii) VERIFICATION BY FEDERAL

5 AGENCIES.—The heads of the agencies re6 ferred to in clause (ii), as applicable, shall 

7 verify that the clinical trial information for 

8 each applicable clinical trial for which a 

9 grantee is the responsible party has been 

10 submitted under paragraph (2) and (3), as 

11 applicable, before releasing funding for a 

12 grant to such grantee. 

13 ‘‘(iv) NOTICE AND OPPORTUNITY TO

14 REMEDY.—If the head of an agency re15 ferred to in clause (ii), as applicable, 

16 verifies that a grantee has not submitted 

17 clinical trial information as described in 

18 clause (iii), such agency head shall provide 

19 notice to such grantee of such noncompli20 ance and allow such grantee 30 days to 

21 correct such noncompliance and submit the 

22 required clinical trial information. 

23 ‘‘(v) CONSULTATION WITH OTHER

24 FEDERAL AGENCIES.—The Secretary 

25 shall— 


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1 ‘‘(I) consult with other agencies 

2 that conduct human studies in accord3 ance with part 46 of title 45, Code of 

4 Federal Regulations (or any successor 

5 regulations), to determine if any such 

6 studies are applicable clinical trials; 

7 and 

8 ‘‘(II) develop with such agencies 

9 procedures comparable to those de10 scribed in clauses (ii), (iii), and (iv) to 

11 ensure that clinical trial information 

12 for such applicable clinical trials is 

13 submitted under paragraphs (2) and 

14 (3). 

15 ‘‘(B) COORDINATION OF REGISTRY DATA16 BASE AND RESULTS DATABASE.— 

17 ‘‘(i) IN GENERAL.—Each entry in the 

18 registry database under paragraph (2) or 

19 the results database under paragraph (3) 

20 shall include a link to the corresponding 

21 entry in the results database or the reg22 istry database, respectively. 

23 ‘‘(ii) MISSING ENTRIES.— 

24 ‘‘(I) IN GENERAL.—If, based on 

25 a review of the entries in the registry 


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1 database under paragraph (2), the Di2 rector of NIH determines that a re3 sponsible party has failed to submit 

4 required clinical trial information to 

5 the results database under paragraph 

6 (3), the Director of NIH shall inform 

7 the responsible party involved of such 

8 failure and permit the responsible 

9 party to correct the failure within 30 

10 days. 

11 ‘‘(II) FAILURE TO CORRECT.—If 

12 the responsible party does not correct 

13 a failure to submit required clinical 

14 trial information within the 30-day 

15 period described under subclause (I), 

16 the Director of NIH shall report such 

17 noncompliance to the scientific peer 

18 review committees of the Federal re19 search agencies and to the Office of 

20 Human Research Protections. 

21 ‘‘(III) PUBLIC NOTICE OF FAIL22 URE TO CORRECT.—The Director of 

23 NIH shall include in the clinical trial 

24 registry database entry and the clin25 ical trial results database entry for 


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1 each applicable clinical trial a notice 

2 of any uncorrected failure to submit 

3 required clinical trial information and 

4 shall provide that the public may eas5 ily search for such entries. 

6 ‘‘(C) ACTION ON APPLICATIONS.— 

7 ‘‘(i) VERIFICATION PRIOR TO FIL8 ING.—The Secretary, acting through the 

9 Commissioner of Food and Drugs, shall 

10 verify that the clinical trial information re11 quired under paragraphs (2) and (3) for 

12 an applicable clinical trial is submitted 

13 pursuant to such paragraphs, as applica14 ble— 

15 ‘‘(I) when considering a drug or 

16 device for an exemption under section 

17 505(i) or section 520(g) of the Fed18 eral Food, Drug, and Cosmetic Act; 

19 and 

20 ‘‘(II) prior to filing an applica21 tion or premarket notification under 

22 section 505, 510(k), or 515 of the 

23 Federal Food, Drug, and Cosmetic 

24 Act or section 351 of this Act, that 


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1 includes information from such clin2 ical trial. 

3 ‘‘(ii) NOTIFICATION.—If the Secretary 

4 determines under clause (i) that clinical 

5 trial information has not been submitted 

6 as required by paragraph (2) or (3), the 

7 Secretary shall notify the applicant and the 

8 responsible party of such noncompliance 

9 and require submission of such information 

10 within 30 days. 

11 ‘‘(iii) REFUSAL TO FILE.—If the re12 sponsible party does not remedy such non13 compliance within 30 days of receipt of no14 tification under clause (ii), the Secretary 

15 shall refuse to file, approve, or clear such 

16 application or premarket notification. 

17 ‘‘(D) CONTENT REVIEW.— 

18 ‘‘(i) IN GENERAL.—To ensure that 

19 the summary documents described in para20 graph (3)(C) are non-promotional, and are 

21 not false or misleading in any particular 

22 under paragraph (3)(E), the Secretary 

23 shall compare such documents to the re24 sults data of the clinical trial for a repVerDate Aug 31 2005 23:40 Mar 22, 2007 Jkt 059200 PO 00000 Frm 00100 Fmt 6652 Sfmt 6201 E:\BILLS\H1561.IH H1561

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1 resentative sample of applicable clinical 

2 trials by— 

3 ‘‘(I) acting through the Commis4 sioner of Food and Drugs to examine 

5 the results data for such clinical trials 

6 submitted to Secretary when such 

7 data are submitted— 

8 ‘‘(aa) for review as part of 

9 an application under section 505 

10 or 515 of the Federal Food, 

11 Drug, and Cosmetic Act or under 

12 section 351 of this Act or a pre13 market notification under section 

14 510(k) of the Federal Food, 

15 Drug, and Cosmetic Act; or 

16 ‘‘(bb) in an annual status 

17 report on the drug or device 

18 under such application; 

19 ‘‘(II) acting with the Federal 

20 agency that funds such clinical trial in 

21 whole or in part by a grant to exam22 ine the results data for such clinical 

23 trials; and 

24 ‘‘(III) acting through inspections 

25 under section 704 of the Federal 


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1 Food, Drug, and Cosmetic Act to ex2 amine results data for such clinical 

3 trials not described in subclause (I) or 

4 (II). 

5 ‘‘(ii) NOTICE OF NONCOMPLIANCE.— 

6 If the Secretary determines that the clin7 ical trial information submitted in such a 

8 summary document is promotional, or false 

9 or misleading in any particular, the Sec10 retary shall notify the responsible party 

11 and give such party an opportunity to rem12 edy such noncompliance by submitting the 

13 required revised clinical trial information 

14 within 30 days of such notification. 

15 ‘‘(6) PENALTIES FOR NONCOMPLIANCE.— 

16 ‘‘(A) IN GENERAL.—The following acts 

17 and the causing thereof are deemed to be pro18 hibited by section 301 of the Federal Food, 

19 Drug, and Cosmetic Act: 

20 ‘‘(i) The failure to submit clinical trial 

21 information as required by this section. 

22 ‘‘(ii) The submission of clinical trial 

23 information under this section that is pro24 motional or false or misleading in any parVerDate Aug 31 2005 23:40 Mar 22, 2007 Jkt 059200 PO 00000 Frm 00102 Fmt 6652 Sfmt 6201 E:\BILLS\H1561.IH H1561

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1 ticular in violation of paragraph (2)(E) or 

2 (3)(E). 

3 ‘‘(B) CONSIDERATIONS.—In determining 

4 whether to apply a penalty under the Federal 

5 Food, Drug, and Cosmetic Act or under sub6 paragraph (C) of this paragraph for a violation 

7 described in subparagraph (A), the Secretary, 

8 acting through the Commissioner of Food and 

9 Drugs, shall consider— 

10 ‘‘(i) whether the responsible party 

11 promptly corrects the noncompliance when 

12 provided notice; 

13 ‘‘(ii) whether the responsible party 

14 has engaged in a pattern or practice of 

15 noncompliance; and 

16 ‘‘(iii) the extent to which the non17 compliance involved may have significantly 

18 misled health care providers or patients 

19 concerning the safety or effectiveness of 

20 the drug involved. 

21 ‘‘(C) CIVIL PENALTIES.— 

22 ‘‘(i) IN GENERAL.—A person is sub23 ject to a civil penalty in accordance with 

24 this subparagraph if the person commits a 

25 violation described in subparagraph (A) 


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1 and fails to correct the violation by the end 

2 of the 30-day period described in clause 

3 (ii). 

4 ‘‘(ii) NOTIFICATION.—If a person is 

5 in violation of subparagraph (A), the Sec6 retary shall notify the person of such non7 compliance and give the person a 30-day 

8 period to correct such violation before im9 posing a civil penalty under this subpara10 graph. 

11 ‘‘(iii) AMOUNT OF PENALTY.—The 

12 amount of a civil penalty under this para13 graph shall be not more than a total of 

14 $15,000 for all violations adjudicated in a 

15 single proceeding in the case of an indi16 vidual, and not more than $10,000 per day 

17 until the violation is corrected in the case 

18 of any other person, except that if the per19 son is a nonprofit entity the penalty may 

20 not exceed a total of $15,000 for all viola21 tions adjudicated in a single proceeding. 

22 ‘‘(iv) PROCEDURES.—The provisions 

23 of paragraphs (4) through (6) of section 

24 303(f) of the Federal Food, Drug, and 

25 Cosmetic Act apply to the imposition of a 


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1 penalty under this paragraph to the same 

2 extent and in the same manner as such 

3 provisions apply to a penalty imposed 

4 under such section 303(f). 

5 ‘‘(7) AUTHORIZATION OF APPROPRIATIONS.— 

6 There are authorized to be appropriated to carry out 

7 this subsection $10,000,000 for each fiscal year.’’. 

8 (b) CONFORMING AMENDMENTS.— 

9 (1) INVESTIGATIONAL NEW DRUGS.—Section 

10 505(i) of the Federal Food, Drug, and Cosmetic Act 

11 (21 U.S.C. 355(i)) is amended— 

12 (A) in paragraph (1)— 

13 (i) in subparagraph (C), by striking 

14 ‘‘and’’ after the semicolon; 

15 (ii) in subparagraph (D)— 

16 (I) by aligning the indentation of 

17 such subparagraph with the indenta18 tion of subparagraphs (A), (B), and 

19 (C); and 

20 (II) by striking the period at the 

21 end and inserting ‘‘; and’’; and 

22 (iii) by adding at the end the fol23 lowing: 

24 ‘‘(E) the submission to the Director of NIH of 

25 clinical trial information for the clinical investigation 


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1 at issue required under section 402(i) of the Public 

2 Health Service Act for inclusion in the registry data3 base and the results database described in such sec4 tion.’’; 

5 (B) in paragraph (3)(B)— 

6 (i) in clause (i), by striking ‘‘or’’ after 

7 the semicolon; 

8 (ii) in clause (ii), by striking the pe9 riod at the end and inserting ‘‘; or’’; and 

10 (iii) by adding at the end the fol11 lowing: 

12 ‘‘(iii) clinical trial information for the clinical 

13 investigation at issue was not submitted in compli14 ance with section 402(i) of the Public Health Service 

15 Act.’’; and 

16 (C) in paragraph (4), by adding at the end 

17 the following: ‘‘The Secretary shall update such 

18 regulations to require inclusion in the informed 

19 consent form a statement that clinical trial in20 formation for such clinical investigation will be 

21 submitted for inclusion in the registry database 

22 and results database, as applicable, described in 

23 section 402(i) of the Public Health Service 

24 Act.’’. 


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1 (2) REFUSAL TO APPROVE NEW DRUG APPLICA2 TION.—Section 505(d) of the Federal Food, Drug, 

3 and Cosmetic Act (21 U.S.C. 355(d)) is amended— 

4 (A) in the first sentence, by inserting after 

5 ‘‘or any particular;’’ the following: ‘‘or (8) the 

6 applicant failed to submit the clinical trial in7 formation for any applicable clinical trial as re8 quired by section 402(i) of the Public Health 

9 Service Act;’’; and 

10 (B) in the second sentence, by striking 

11 ‘‘clauses (1) through (6)’’ and inserting ‘‘para12 graphs (1) through (8)’’. 

13 (3) INVESTIGATIONAL NEW DEVICES.—Sub14 paragraph (B) of section 520(g)(2) of the Federal 

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

16 360j(g)(2)) is amended— 

17 (A) by redesignating clause (iii) as clause 

18 (iv); and 

19 (B) by inserting after clause (ii) the fol20 lowing: 

21 ‘‘(iii) A requirement that the person 

22 applying for an exemption for a device as23 sure that such person is in compliance with 

24 the requirements of section 402(i) of the 

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1 sion of clinical trial information for inclu2 sion in the registry database and the re3 sults database described in such section.’’. 

4 (4) REFUSAL TO CLEAR NEW DEVICE PRE5 MARKET NOTIFICATION REPORT.—Subsection (k) of 

6 section 510 of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 360) is amended— 

8 (A) in paragraph (1), by striking ‘‘and’’ at 

9 the end; and 

10 (B) in paragraph (2), by striking the pe11 riod at the end and inserting ‘‘, and’’; and 

12 (C) by adding at the end the following: 

13 ‘‘(3) action taken by such person to comply 

14 with requirements under section 402(i) of the Public 

15 Health Service Act for the submission of clinical 

16 trial information for inclusion in the registry data17 base and the results database described in such sec18 tion.’’. 

19 (5) REFUSAL TO APPROVE NEW DEVICE APPLI20 CATION.—Paragraph (2) of section 515(d) of the 

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

22 360e(d)) is amended— 

23 (A) in subparagraph (D), by striking ‘‘or’’ 

24 at the end; 


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1 (B) in subparagraph (E), by striking the 

2 period at the end and inserting ‘‘; or’’; and 

3 (C) by adding at the end the following: 

4 ‘‘(F) the applicant is in violation of the re5 quirements under section 402(i) of the Public 

6 Health Service Act for the submission of clin7 ical trial information for inclusion in the reg8 istry database or the results database described 

9 in such section.’’. 

10 (c) GUIDANCE.—Not later than 180 days after the 

11 date of enactment of this Act, the Commissioner of Food 

12 and Drugs, in consultation with the Director of the Na13 tional Institutes of Health, shall issue guidance to clarify 

14 which clinical trials are applicable clinical trials (as de15 fined in section 402(i)(2) of the Public Health Service Act, 

16 as amended by this section) and required to be submitted 

17 for inclusion in the clinical trial registry database de18 scribed in such section. 

19 (d) PREEMPTION.— 

20 (1) IN GENERAL.—No State or political subdivi21 sion of a State may establish or continue in effect 

22 any requirement for the registration of clinical trials 

23 or for the inclusion of information relating to the re24 sults of clinical trials in a database. 


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1 (2) RULE OF CONSTRUCTION.—The fact of sub2 mission of clinical trial information, if submitted in 

3 compliance with section 402(i) of the Public Health 

4 Service Act (as amended by this section), that re5 lates to a use of a drug or device not included in the 

6 official labeling of the approved drug or device shall 

7 not be construed by the Secretary or in any adminis8 trative or judicial proceeding, as evidence of a new 

9 intended use of the drug or device that is different 

10 from the intended use of the drug or device set forth 

11 in the official labeling of the drug or device. The 

12 availability of clinical trial information through the 

13 databases under paragraphs (2) and (3) of such sec14 tion 402(i), if submitted in compliance with such 

15 section 402(i), shall not be considered as labeling, 

16 adulteration, or misbranding of the drug or device 

17 under the Federal Food, Drug, and Cosmetic Act 

18 (21 U.S.C. 301 et seq.). 

19 (e) EFFECTIVE DATES.— 

20 (1) ESTABLISHMENT OF REGISTRY DATABASE

21 AND RESULTS DATABASE.—Not later than 1 year 

22 after the date of enactment of this Act, the Director 

23 of NIH shall establish the registry database and the 

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1 vices in accordance with section 402(i) of the Public 

2 Health Service Act (as amended by subsection (a)). 

3 (2) CLINICAL TRIALS INITIATED PRIOR TO OP4 ERATION OF REGISTRY DATABASE.—The responsible 

5 party (as defined in such section 402(i)) for an ap6 plicable clinical trial (as defined in such section 

7 402(i)) that is initiated after the date of enactment 

8 of this Act and before the date such registry data9 base is established under paragraph (1) of this sub10 section, shall submit required clinical trial informa11 tion not later than 120 days after the date such reg12 istry database is established. 

13 (3) CLINICAL TRIALS INITIATED AFTER OPER14 ATION OF REGISTRY DATABASE.—The responsible 

15 party (as defined in such section 402(i)) for an ap16 plicable clinical trial (as defined in such section 

17 402(i)) that is initiated after the date such registry 

18 database is established under paragraph (1) of this 

19 subsection shall submit required clinical trial infor20 mation in accordance with paragraph (2) of such 

21 section 402(i). 

22 (4) TRIALS COMPLETED BEFORE OPERATION

23 OF RESULTS DATABASE.— 

24 (A) IN GENERAL.—Paragraph (3) of such 

25 section 402(i) shall take effect 90 days after 


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1 the date the results database is established 

2 under paragraph (1) of this subsection with re3 spect to any applicable clinical trial (as defined 

4 in such section 402(i)) that— 

5 (i) involves a drug to treat a serious 

6 or life-threatening condition; and 

7 (ii) is completed between the date of 

8 enactment of this Act and such date of es9 tablishment under paragraph (1) of this 

10 subsection. 

11 (B) OTHER TRIALS.—Except as provided 

12 in subparagraph (A), paragraph (3) of such 

13 section 402(i) shall take effect 180 days after 

14 the date that the results database is established 

15 under paragraph (1) of this subsection with re16 spect to any applicable clinical trial that is com17 pleted between the date of enactment of this 

18 Act and such date of establishment under para19 graph (1). 

20 (5) TRIALS COMPLETED AFTER ESTABLISH21 MENT OF RESULTS DATABASE.—Paragraph (3) of 

22 such section 402(i) shall apply to any clinical trial 

23 that is completed after the date that the results 

24 database is established under paragraph (1) of this 

25 subsection. 


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1 (6) RETROACTIVITY OF DATABASE.— 

2 (A) VOLUNTARY SUBMISSIONS.—The Sec3 retary of Health and Human Services (referred 

4 to in this paragraph as the ‘‘Secretary’’) shall 

5 establish procedures and mechanisms to allow 

6 for the voluntary submission to the Secretary— 

7 (i) of clinical trial information for in8 clusion in the registry database (as defined 

9 in such section 402(i)) on applicable clin10 ical trials (as defined in such section 

11 402(i)) initiated before the date of the en12 actment of this Act; and 

13 (ii) of clinical trial information for in14 clusion in the results database (as defined 

15 in such section 402(i)) on applicable clin16 ical trials (as defined in such section 

17 402(i)) completed before the date of the 

18 enactment of this Act. 

19 (B) REQUIRED SUBMISSIONS.—Notwith20 standing the preceding paragraphs of this sub21 section, in any case in which the Secretary de22 termines that submission of clinical trial infor23 mation for an applicable clinical trial (as de24 fined in such section 402(i)) described in clause 


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1 (i) or (ii) of subparagraph (A) is in the interest 

2 of the public health— 

3 (i) the Secretary may require that 

4 such information be submitted to the Sec5 retary in accordance with such section 

6 402(i); and 

7 (ii) failure to comply with such a re8 quirement shall be treated as a violation of 

9 the corresponding requirement of such sec10 tion 402(i). 

11 (7) FUNDING RESTRICTIONS.—Subparagraph 

12 (A) of paragraph (5) of such section 402(i) shall 

13 take effect 210 days after the date that the clinical 

14 trial registry database and the clinical trial results 

15 database are established under paragraph (1) of this 

16 subsection. 

17 (8) STATUS OF CLINICALTRIALS.GOV

18 WEBSITE.— 

19 (A) IN GENERAL.—After receiving public 

20 comment and not later than 90 days after the 

21 date of enactment of this Act, the Secretary 

22 shall publish in the Federal Register a notice 

23 determining the more efficient approach to es24 tablishing the registry database described in 


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1 paragraph (2) of such section 402(i) and 

2 whether such approach is— 

3 (i) that such registry database should 

4 expand and build upon the database de5 scribed in section 402(i) of the Public 

6 Health Service Act (as in effect on the day 

7 before the date of enactment of this Act); 

8 or 

9 (ii) that such registry database should 

10 supplant the database described in such 

11 section 402(i) (as in effect on the day be12 fore the date of enactment of this Act). 

13 (B) CLINICALTRIALS.GOV SUPPLANTED.— 

14 If the Secretary determines to apply the ap15 proach described under subparagraph (A)(ii), 

16 the Secretary shall maintain an archive of the 

17 database described in such section 402(i) (as in 

18 effect on the day before the date of enactment 

19 of this Act) on the Internet website of the Na20 tional Library of Medicine. 


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1 TITLE IV—CONFLICTS OF 

2 INTEREST 

3 SEC. 401. CONFLICTS OF INTEREST. 

4 (a) IN GENERAL.—Subchapter A of chapter VII of 

5 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 

6 et seq.) is amended by inserting at the end the following: 

7 ‘‘SEC. 712. CONFLICTS OF INTEREST. 

8 ‘‘(a) DEFINITIONS.—For purposes of this section: 

9 ‘‘(1) ADVISORY COMMITTEE.—The term ‘advi10 sory committee’ means an advisory committee under 

11 the Federal Advisory Committee Act that provides 

12 advice or recommendations to the Secretary regard13 ing activities of the Food and Drug Administration. 

14 ‘‘(2) FINANCIAL INTEREST.—The term ‘finan15 cial interest’ means a financial interest under section 

16 208(a) of title 18, United States Code. 

17 ‘‘(3) INDUSTRY FINANCIAL INTEREST.—The 

18 term ‘industry financial interest’, with respect to ap19 pointment for a term to an advisory committee, 

20 means an interest in a company that is a member 

21 of the relevant industry that would be a financial in22 terest were an advisory committee to consider a par23 ticular matter involving such company. 

24 ‘‘(4) RELEVANT INDUSTRY.—The term ‘rel25 evant industry’ means— 


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1 ‘‘(A) with respect to an advisory committee 

2 that advises the Secretary on human drugs, bio3 logics, or devices, the pharmaceutical, bio4 technology, and device industries; 

5 ‘‘(B) with respect to an advisory committee 

6 that advises the Secretary on animal drugs or 

7 devices, the animal drug and the animal device 

8 industries; and 

9 ‘‘(C) with respect to an advisory committee 

10 that advises the Secretary on foods, the food in11 dustry. 

12 ‘‘(b) APPOINTMENTS TO ADVISORY COMMITTEES.— 

13 ‘‘(1) DISCLOSURE OF INDUSTRY FINANCIAL IN14 TERESTS.—Each individual under consideration for 

15 a term appointment to an advisory committee shall 

16 disclose to the Secretary all industry financial inter17 ests. 

18 ‘‘(2) DISCLOSURES NOT PUBLICLY AVAIL19 ABLE.—No disclosure required under paragraph (1) 

20 shall be made available to the public. 

21 ‘‘(3) EVALUATION AND CRITERIA.—When con22 sidering a term appointment to an advisory com23 mittee, the Secretary— 

24 ‘‘(A) shall review the expertise and the in25 dustry financial interests, as disclosed under 


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1 paragraph (1), of each individual under consid2 eration for the appointment, so as to appoint 

3 the individuals, from among those individuals 

4 under consideration for appointment, who are 

5 the most qualified relative to their industry fi6 nancial interests that could require a written 

7 determination as referred to in section 

8 208(b)(1) of title 18, United States Code, a 

9 written certification as referred to in section 

10 208(b)(3) of title 18, United States Code, or a 

11 waiver as referred to in subsection (c)(3) for 

12 service on the committee at a meeting of the 

13 committee; and 

14 ‘‘(B) may appoint 2 or more qualified indi15 viduals with similar expertise and whose indus16 try financial interests are nonoverlapping or 

17 minimally overlapping, so as to minimize the 

18 likelihood that an advisory committee will need 

19 the expertise of an appointed individual who re20 quires a written determination as referred to in 

21 section 208(b)(1) of title 18, United States 

22 Code, a written certification as referred to in 

23 section 208(b)(3) of title 18, United States 

24 Code, or a waiver as referred to in subsection 


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1 (c)(3) for service on the committee at a meeting 

2 of the committee. 

3 ‘‘(c) GRANTING AND DISCLOSURE OF WAIVERS.— 

4 ‘‘(1) IN GENERAL.—Not later then 45 days be5 fore a meeting of an advisory committee, each mem6 ber of the committee shall disclose to the Secretary 

7 all financial interests in accordance with section 

8 208(b) of title 18, United States Code. 

9 ‘‘(2) FINANCIAL GAIN OF ADVISORY COMMITTEE

10 MEMBER OR FAMILY MEMBER.—No member of an 

11 advisory committee may vote with respect to any 

12 matter considered by the advisory committee if such 

13 member or an immediate family member of such 

14 member could gain financially from the advice given 

15 to the Secretary with respect to such matter. 

16 ‘‘(3) WAIVER.—In addition to considerations 

17 under section 208(b) of title 18, United States Code, 

18 the Secretary may grant a waiver of a conflict of in19 terest requirement if such waiver is necessary to af20 ford the advisory committee essential expertise. 

21 ‘‘(4) LIMITATION.—In no case may the Sec22 retary grant a waiver under paragraph (3) for a 

23 member of an advisory committee if the scientific 

24 work of such member is under consideration by the 

25 committee. 


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1 ‘‘(5) DISCLOSURE OF WAIVER.— 

2 ‘‘(A) MORE THAN 15 DAYS IN ADVANCE.— 

3 As soon as practicable, but in no case later 

4 than 15 days prior to a meeting of an advisory 

5 committee to which a written determination as 

6 referred to in section 208(b)(1) of title 18, 

7 United States Code, a written certification as 

8 referred to in section 208(b)(3) of title 18, 

9 United States Code, or a waiver as referred to 

10 in paragraph (3) applies, the Secretary shall 

11 disclose (other than information exempted from 

12 disclosure under section 552 of title 5, United 

13 States Code, and section 552a of title 5, United 

14 States Code (popularly known as the Freedom 

15 of Information Act and the Privacy Act of 

16 1974, respectively)) on the Internet website of 

17 the Food and Drug Administration— 

18 ‘‘(i) the financial interests of the advi19 sory committee member to which such de20 termination, certification, or waiver ap21 plies; and 

22 ‘‘(ii) the reasons of the Secretary for 

23 such determination, certification, or waiv24 er. 


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1 ‘‘(B) LESS THAN 15 DAYS IN ADVANCE.— 

2 In the case of a financial interest that becomes 

3 known to the Secretary less than 30 days prior 

4 to a meeting of an advisory committee to which 

5 a written determination as referred to in section 

6 208(b)(1) of title 18, United States Code, a 

7 written certification as referred to in section 

8 208(b)(3) of title 18, United States Code, or a 

9 waiver as referred to in paragraph (3) applies, 

10 the Secretary shall disclose (other than infor11 mation exempted from disclosure under section 

12 552 of title 5, United States Code, and section 

13 552a of title 5, United States Code) on the 

14 Internet website of the Food and Drug Admin15 istration, the information described in clauses 

16 (i) and (ii) of subparagraph (A) as soon as the 

17 Secretary makes such determination, certifi18 cation, or waiver, but in no event later than the 

19 date of such meeting. 

20 ‘‘(d) PUBLIC RECORD.—The Secretary shall ensure 

21 that the public record and transcript of each meeting of 

22 an advisory committee includes the disclosure required 

23 under subsection (c)(5) (other than information exempted 

24 from disclosure under section 552 of title 5, United States 

25 Code, and section 552a of title 5, United States Code). 


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1 ‘‘(e) ANNUAL REPORT.—Not later than January 15 

2 of each year, the Secretary shall submit a report to the 

3 Inspector General of the Department of Health and 

4 Human Services, the Committee on Appropriations and 

5 the Committee on Health, Education, Labor, and Pen6 sions of the Senate, and the Committee on Appropriations 

7 and the Committee on Energy and Commerce of the 

8 House of Representatives— 

9 ‘‘(1) with respect to the fiscal year that ended 

10 on September 30 of the previous year, the number 

11 of vacancies on each advisory committee, the number 

12 of nominees received for each committee, and the 

13 number of such nominees willing to serve; 

14 ‘‘(2) with respect to such year, the aggregate 

15 number of disclosures required under subsection 

16 (c)(5) for each meeting of each advisory committee 

17 and the percentage of individuals to whom such dis18 closures did not apply who served on such committee 

19 for each such meeting; 

20 ‘‘(3) with respect to such year, the number of 

21 times the disclosures required under subsection 

22 (c)(5) occurred under subparagraph (B) of such sub23 section; and 


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1 ‘‘(4) how the Secretary plans to reduce the 

2 number of vacancies reported under paragraph (1) 

3 during the fiscal year following such year.’’. 

4 (b) GUIDANCE.— 

5 (1) NOMINATIONS.—Not later than 270 days 

6 after the date of enactment of this Act, and after 

7 seeking input from professional medical and sci8 entific societies, the Secretary shall publish in the 

9 Federal Register for public comment a proposed 

10 mechanism for encouraging the nomination of indi11 viduals who are classified by the Food and Drug Ad12 ministration as academicians or practitioners for 

13 service on an advisory committee. 

14 (2) WAIVER DETERMINATIONS.—Not later than 

15 270 days after the date of enactment of this Act the 

16 Secretary shall issue or revise guidance— 

17 (A) that clarifies the circumstances in 

18 which the Secretary may make a written deter19 mination as referred to in section 208(b)(1) of 

20 title 18, United States Code, make a written 

21 certification as referred to in section 208(b)(3) 

22 of title 18, United States Code, or grant a waiv23 er as referred to section 712(c)(3) of the Fed24 eral Food, Drug, and Cosmetic Act (as added 


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1 by this section), including those circumstances 

2 that— 

3 (i) favor the inclusion of an individual 

4 on an advisory committee; 

5 (ii) favor making such a determina6 tion, certification, or waiver for an indi7 vidual on an advisory committee; 

8 (iii) favor limitations on an individ9 ual’s ability to act when making such a de10 termination, certification, or waiver for the 

11 individual on an advisory committee; and 

12 (iv) disfavor the inclusion of an indi13 vidual on an advisory committee; 

14 (B) that defines how financial interests im15 puted to an individual bear upon his or her eli16 gibility for service on an advisory committee or 

17 for service at a meeting of an advisory com18 mittee; and 

19 (C) to ensure consistency within and 

20 among the centers of the Food and Drug Ad21 ministration in applying section 208(b) of title 

22 18, United States Code, and such section 

23 712(c)(3). 

24 (3) PERIODIC REVIEW.—At least once every 5 

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1 scribed under paragraph (2) and update such guid2 ance as necessary. 

3 (c) REVIEW BY INSPECTOR GENERAL.— 

4 (1) IN GENERAL.—The Inspector General of 

5 the Department of Health and Human Services shall 

6 conduct a review, which may include surveys of past 

7 or current members of advisory committees, of the 

8 processes of the Food and Drug Administration 

9 for— 

10 (A) evaluating the financial interests of a 

11 member of such an advisory committee while 

12 the member serves on such a committee and 

13 after the member has served on such a com14 mittee; and 

15 (B) assuring the completeness and accu16 racy of information contained in the disclosures 

17 described in subsections (b)(1) and (c)(1) of 

18 such section 712 of the Federal Food, Drug, 

19 and Cosmetic Act (as added by this section). 

20 (2) SUBMISSION OF REPORT.—Not later than 

21 18 months after the effective date of this section, 

22 the Inspector General of the Department of Health 

23 and Human Services shall submit to Congress a re24 port based on the review required under paragraph 


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1 (1), and include any recommendations for the im2 provement of such processes. 

3 (d) DEFINITIONS.—For purposes of this section, the 

4 terms ‘‘advisory committee’’ and ‘‘financial interest’’ have 

5 the meaning given such terms in section 712 of the Fed6 eral Food, Drug, and Cosmetic Act (as added by this sec7 tion). 

8 (e) CONFORMING AMENDMENT.—Section 505(n) of 

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

10 355(n)) is amended by— 

11 (1) striking paragraph (4); and 

12 (2) redesignating paragraphs (5), (6), (7), and 

13 (8) as paragraphs (4), (5), (6), and (7), respectively. 

14 (f) EFFECTIVE DATE.—The amendments made by 

15 this section shall take effect on October 1, 2007. 

Æ 


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