II 

109TH CONGRESS 

2D SESSION S. 3807 

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 SENATE OF THE UNITED STATES 

AUGUST 3, 2006 

Mr. ENZI (for himself and Mr. KENNEDY) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

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 2006’’. 


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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 (j) or section 351 of the 

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

13 for in this subsection, the applicant shall comply 

14 with the requirements of such strategy, which— 

15 ‘‘(A) shall require the elements under 

16 paragraph (3); and 

17 ‘‘(B) may require one or more additional 

18 elements under paragraph (4) or (5), so long as 

19 the Secretary makes the determination required 

20 with respect to each such element. 

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

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

23 risk’ means a risk of a serious adverse drug ex24 perience as defined in section 314.80 of title 21, 


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1 Code of Federal Regulations (or any successor 

2 regulation). 

3 ‘‘(B) UNEXPECTED SERIOUS RISK.—The 

4 term ‘unexpected serious risk’ means a serious 

5 adverse drug experience as defined in section 

6 314.80 of title 21, Code of Federal Regulations 

7 (or any successor regulation) that is not listed 

8 in the labeling of a drug, or that may be symp9 tomatically and pathophysiologically related to 

10 an adverse drug experience identified in the la11 beling, but differs from such adverse drug expe12 rience because of greater severity or specificity. 

13 ‘‘(C) EMPIRICAL SIGNAL OF A SERIOUS

14 RISK.—The term ‘empirical signal of a serious 

15 risk’ means information related to a serious ad16 verse drug experience as defined in section 

17 314.80 of title 21, Code of Federal Regulations 

18 (or any successor regulation) associated with 

19 use of a drug and derived from— 

20 ‘‘(i) a clinical trial; 

21 ‘‘(ii) adverse event reports; 

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

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

24 ‘‘(iv) peer-reviewed biomedical lit25 erature. 


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1 ‘‘(D) NEW SAFETY INFORMATION.—The 

2 term ‘new safety information’ with respect to a 

3 drug means information about— 

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

5 serious risk associated with use of the drug 

6 that the Secretary has become aware of 

7 since the last assessment of the approved 

8 risk evaluation and mitigation strategy for 

9 the drug; or 

10 ‘‘(ii) the effectiveness of the approved 

11 risk evaluation and mitigation strategy for 

12 the drug. 

13 ‘‘(E) DRUG SAFETY OVERSIGHT BOARD.— 

14 The term ‘Drug Safety Oversight Board’ means 

15 a body of scientists who have been appointed to 

16 serve from offices throughout the Food and 

17 Drug Administration and other Federal agen18 cies to provide oversight and advice to the Sec19 retary through the Director of the Center for 

20 Drug Evaluation and Research of the Food and 

21 Drug Administration on the management of im22 portant drug safety issues and which meets 

23 monthly. 

24 ‘‘(3) REQUIRED ELEMENTS OF A RISK EVALUA25 TION AND MITIGATION STRATEGY.—The risk evaluaVerDate Aug 31 2005 02:17 Aug 09, 2006 Jkt 049200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3807.IS S3807

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1 tion and mitigation strategy for a drug shall re2 quire— 

3 ‘‘(A) labeling for the drug for use by 

4 health care providers as approved under sub5 section (c); 

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

7 as required under subsection (k); and 

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

9 ‘‘(I) analysis by the Secretary of re10 ports to the Vaccine Adverse Event Re11 porting Systems (VAERS); or 

12 ‘‘(II) surveillance by the Secretary 

13 using the Vaccine Safety Datalink (VSD) 

14 or successor databases; 

15 ‘‘(C) a pharmacovigilance statement as to 

16 whether— 

17 ‘‘(i) the reports under subparagraph 

18 (B)(i) or, for a vaccine, the analysis and 

19 surveillance under subparagraph (B)(ii), 

20 and the periodic assessment under sub21 paragraph (E), are sufficient to assess the 

22 serious risks and to identify unexpected se23 rious risks of the drug; or 

24 ‘‘(ii) studies under paragraph (4)(D) 

25 or clinical trials under paragraph (4)(E) 


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1 are needed to assess the serious risks and 

2 identify unexpected serious risks of the 

3 drug; 

4 ‘‘(D) a justification for the 

5 pharmacovigilance statement in subparagraph 

6 (C) that takes into consideration— 

7 ‘‘(i) the estimated size of the treat8 ment population for the drug; 

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

10 condition that the drug is used to treat; 

11 ‘‘(iii) the expected or actual duration 

12 of treatment with the drug; 

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

14 drug or other treatment, if any, for such 

15 disease or condition to which the drug may 

16 be compared; and 

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

18 issue and its background incidence in the 

19 population; and 

20 ‘‘(E) a timetable for submission of assess21 ments of the strategy, that— 

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

23 once annually for the first 3 years after 

24 the drug is initially approved under sub25 section (c) or licensed under section 351 of 


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1 the Public Health Service Act, and at a 

2 frequency determined by the Secretary for 

3 subsequent years; 

4 ‘‘(ii) may be increased or reduced by 

5 the Secretary in frequency as necessary; 

6 and 

7 ‘‘(iii) may be eliminated after the first 

8 3 years if the Secretary determines that 

9 serious risks of the drug have been ade10 quately identified and assessed and are 

11 being adequately managed. 

12 ‘‘(4) ADDITIONAL POTENTIAL ELEMENTS OF A

13 RISK EVALUATION AND MITIGATION STRATEGY.— 

14 ‘‘(A) IN GENERAL.—The risk evaluation 

15 and mitigation strategy for a drug may require 

16 one or more of the additional elements de17 scribed in this paragraph, so long as the Sec18 retary makes the determination required with 

19 respect to each such element. 

20 ‘‘(B) MEDGUIDE.—The risk evaluation and 

21 mitigation strategy for a drug may require that 

22 the applicant develop for distribution to each 

23 patient when the drug is dispensed— 

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

25 for under part 208 of title 21, Code of 


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1 Federal Regulations (or any successor reg2 ulations); or 

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

4 Secretary determines that such insert may 

5 help minimize a serious risk of the drug. 

6 ‘‘(C) COMMUNICATION PLAN.—The risk 

7 evaluation and mitigation strategy for a drug 

8 may require that the applicant conduct a com9 munication plan to health care providers, if, 

10 with respect to such drug, the Secretary deter11 mines that such plan may support implementa12 tion of an element of the strategy under sub13 paragraph (D) or (E) or under paragraph (5), 

14 which may include— 

15 ‘‘(i) sending letters to health care pro16 viders; 

17 ‘‘(ii) disseminating information about 

18 the elements of the risk evaluation and 

19 mitigation strategy to encourage compli20 ance by health care providers with compo21 nents that apply to such health care pro22 viders, or to explain certain safety proto23 cols (such as medical monitoring by peri24 odic laboratory tests); or 


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1 ‘‘(iii) disseminating information to 

2 health care providers through professional 

3 societies about any serious risks of the 

4 drug and how to prescribe and use the 

5 drug safely. 

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

7 evaluation and mitigation strategy for a drug 

8 may require that the applicant or the Secretary 

9 conduct an appropriate post-approval study of 

10 the drug (with target commencement and com11 pletion dates), if the Secretary determines the 

12 study is necessary to assess an empirical signal 

13 of a serious risk with use of the drug or to 

14 identify unexpected serious risks in domestic 

15 populations who use the drug but were not in16 cluded in studies used to approve the drug 

17 (such as older people, people with comorbidities, 

18 pregnant women, or children), such as a pro19 spective or retrospective observational study. 

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

21 The risk evaluation and mitigation strategy for 

22 a drug may require that the applicant for a 

23 drug for which there is no effective approved 

24 application under subsection (j) as of the date 

25 that the requirement is first imposed conduct 


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1 an appropriate post-approval clinical trial of the 

2 drug (with target commencement and comple3 tion dates), to be included in the clinical trial 

4 registry database and clinical trial results data5 base provided for under section 402(j) of the 

6 Public Health Service Act, if the Secretary de7 termines that the clinical trial is necessary, and 

8 that a study under subparagraph (D) will likely 

9 be inadequate, to assess an empirical signal of 

10 a serious risk with use of the drug; 

11 ‘‘(F) PRECLEARANCE.—The risk evalua12 tion and mitigation strategy for a drug may re13 quire that the applicant submit to the Secretary 

14 advertisements of the drug for preclearance, if 

15 the Secretary determines that such preclearance 

16 is necessary to ensure compliance with section 

17 502(n) with respect to the disclosure of infor18 mation about a serious risk listed in the label19 ing of the drug, so long as advertisements re20 quired to be submitted under this subparagraph 

21 are reviewed and cleared within 30 days by the 

22 Secretary. 

23 ‘‘(G) SPECIFIC DISCLOSURES.—The risk 

24 evaluation and mitigation strategy for a drug 

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1 cific disclosure in advertisements of the drug, if 

2 the Secretary determines that advertisements 

3 lacking such disclosure would be false or mis4 leading or that such disclosure is necessary to 

5 protect public health and safety— 

6 ‘‘(i) of the date the drug was ap7 proved and that the existing information 

8 may not have identified or fully assessed 

9 all serious risks of using the drug; 

10 ‘‘(ii) about a serious adverse event 

11 listed in the labeling of the drug; or 

12 ‘‘(iii) about a protocol to ensure safe 

13 use described in the labeling of the drug; 

14 or 

15 ‘‘(H) TEMPORARY MORATORIUM.—The 

16 risk evaluation and mitigation strategy for a 

17 drug may require that for a fixed period after 

18 initial approval, not to exceed 2 years, the ap19 plicant not issue or cause to be issued direct20 to-consumer advertisements of the drug, if the 

21 Secretary determines that disclosure under sub22 paragraph (G) is inadequate to protect public 

23 health and safety, and that such prohibition is 

24 necessary to protect public health and safety 


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1 while additional information about serious risks 

2 of the drug is collected, considering— 

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

4 be treated with the drug; 

5 ‘‘(ii) the seriousness of the condition 

6 for which the drug will be used; 

7 ‘‘(iii) the serious adverse events listed 

8 in the labeling of the drug; 

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

10 access to other approved drugs in the 

11 pharmacological class of the drug and with 

12 the same intended use as the drug; and 

13 ‘‘(v) the extent to which studies used 

14 to approve the drug may not have identi15 fied serious risks that might occur among 

16 patients expected to be treated with the 

17 drug. 

18 ‘‘(5) RESTRICTIONS ON DISTRIBUTION AND

19 USE.— 

20 ‘‘(A) IN GENERAL.—If the Secretary deter21 mines that a drug presents a significant risk to 

22 public health, and provides significant benefits 

23 to patients, the risk evaluation and mitigation 

24 strategy may require restrictions on distribution 

25 and use to address such risk of the drug, so 


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1 long as application of elements under paragraph 

2 (4) are insufficient to manage such risk. 

3 ‘‘(B) LIMITS ON RESTRICTIONS.—Such re4 strictions under subparagraph (A) shall be— 

5 ‘‘(i) commensurate with the risk; 

6 ‘‘(ii) necessary to ensure safe use of 

7 the drug given the risk; and 

8 ‘‘(iii) not unduly burdensome on pa9 tient access to the drug, particularly for 

10 patients with serious or life-threatening 

11 diseases or conditions. 

12 ‘‘(C) ELEMENTS.—The restrictions on dis13 tribution and use described under subparagraph 

14 (A) shall include one or more goals to evaluate 

15 or mitigate a serious risk listed in the labeling 

16 of the drug and may require that— 

17 ‘‘(i) health care providers that pre18 scribe the drug have particular training or 

19 experience, or elect to be specially certified; 

20 ‘‘(ii) pharmacies, practitioners, or 

21 health care settings that dispense the drug 

22 elect to be specially certified; 

23 ‘‘(iii) the drug be dispensed to pa24 tients only in certain health care settings, 

25 such as hospitals; 


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1 ‘‘(iv) the drug be dispensed to pa2 tients with evidence or other documenta3 tion of safe-use conditions, such as labora4 tory test results; 

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

6 subject to certain monitoring; or 

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

8 enrolled in a registry. 

9 ‘‘(D) COMPLIANCE SYSTEM.—The restric10 tions on distribution and use described under 

11 subparagraph (A) may require a compliance 

12 system through which the applicant is able to— 

13 ‘‘(i) monitor and evaluate compliance 

14 with the restrictions by health care pro15 viders, pharmacists, patients, and other 

16 parties in the health care system who are 

17 responsible for implementing the restric18 tions; 

19 ‘‘(ii) work to improve implementation 

20 of the restrictions by health care providers, 

21 pharmacists, patients, and other parties in 

22 the health care system who are responsible 

23 for implementing the restrictions; and 


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1 ‘‘(iii) limit participation by those 

2 health care providers, pharmacists, and 

3 other parties in the health care system— 

4 ‘‘(I) who are responsible for im5 plementing the restrictions; and 

6 ‘‘(II) whom the applicant knows 

7 have failed to meet their responsibil8 ities for implementing the restrictions, 

9 after the applicant has informed such 

10 party of such failure and such party 

11 has not remedied such failure. 

12 ‘‘(6) SUBMISSION AND REVIEW OF RISK EVAL13 UATION AND MITIGATION STRATEGY.— 

14 ‘‘(A) PROPOSED RISK EVALUATION AND

15 MITIGATION STRATEGY.—An applicant shall in16 clude in an application under subsection (b) or 

17 section 351 of the Public Health Service Act 

18 (including in a supplemental application seeking 

19 a new indication if no risk evaluation and miti20 gation strategy for the drug is in effect under 

21 this subsection) a proposed risk evaluation and 

22 mitigation strategy, which— 

23 ‘‘(i) shall include the minimal ele24 ments required under paragraph (3); and 


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1 ‘‘(ii) may also include additional ele2 ments as provided for under paragraphs 

3 (4) and (5). 

4 ‘‘(B) ASSESSMENT AND MODIFICATION OF

5 A RISK EVALUATION AND MITIGATION STRAT6 EGY.— 

7 ‘‘(i) IN GENERAL.—The applicant may 

8 submit to the Secretary an assessment of, 

9 and propose a modification to, the ap10 proved risk evaluation and mitigation 

11 strategy for a drug at any time, and shall 

12 submit such an assessment, which may 

13 propose such a modification— 

14 ‘‘(I) when submitting a supple15 mental application for a new indica16 tion under subsection (b) or section 

17 351 of the Public Health Service Act; 

18 ‘‘(II) when required by the strat19 egy, as provided for in the timetable 

20 under paragraph (3)(E); 

21 ‘‘(III) within a time specified by 

22 the Secretary, not to be less than 45 

23 days, when ordered by the Secretary if 

24 the Secretary determines that new 

25 safety information indicates that an 


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1 element under paragraph (3) or (4) 

2 should be modified or included in the 

3 strategy; 

4 ‘‘(IV) within 90 days when or5 dered by the Secretary if the Sec6 retary determines that new safety in7 formation indicates that an element 

8 under paragraph (5) should be modi9 fied or included in the strategy; or 

10 ‘‘(V) within 15 days when or11 dered by the Secretary if the Sec12 retary determines that there may be a 

13 cause for action by the Secretary 

14 under subsection (e). 

15 ‘‘(ii) ASSESSMENT.—An assessment of 

16 the performance and adequacy of the ap17 proved risk evaluation and mitigation 

18 strategy for a drug shall include— 

19 ‘‘(I) with respect to any goal 

20 under paragraph (5), an assessment 

21 of whether the restrictions on dis22 tribution and use are meeting the goal 

23 or whether the goal or such restric24 tions should be modified; 


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1 ‘‘(II) with respect to any post-ap2 proval study required under para3 graph (4)(D), the status of such 

4 study, the expected completion date, 

5 and whether any difficulties com6 pleting the study have been encoun7 tered; and 

8 ‘‘(III) with respect to any post9 approval clinical trial required under 

10 paragraph (4)(E), whether enrollment 

11 has begun, the number of participants 

12 enrolled, the expected completion date, 

13 and whether any difficulties com14 pleting the clinical trial have been en15 countered. 

16 ‘‘(iii) MODIFICATION.—A modification 

17 (whether an enhancement or a reduction) 

18 to the approved risk evaluation and mitiga19 tion strategy for a drug may include the 

20 addition or modification of any element 

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

22 paragraph (3) or the addition, modifica23 tion, or removal of any element under 

24 paragraph (4) or (5), such as— 


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1 ‘‘(I) a labeling change, including 

2 the addition of a boxed warning; 

3 ‘‘(II) adding a post-approval 

4 study or clinical trial requirement; 

5 ‘‘(III) modifying a post-approval 

6 study or clinical trial requirement 

7 (such as a change in trial design due 

8 to legitimate difficulties recruiting 

9 participants); 

10 ‘‘(IV) adding, modifying, or re11 moving a restriction on advertising 

12 under subparagraph (F), (G), or (H) 

13 of paragraph (4); 

14 ‘‘(V) adding, modifying, or re15 moving a restriction on distribution or 

16 use under paragraph (5); or 

17 ‘‘(VI) modifying the timetable for 

18 assessments of the strategy under 

19 paragraph (3)(E). 

20 ‘‘(C) REVIEW.—The Secretary shall 

21 promptly review the proposed risk evaluation 

22 and mitigation strategy for a drug submitted 

23 under paragraph (A), or an assessment of the 

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1 egy for a drug submitted under subparagraph 

2 (B). 

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

4 initiate discussions of the proposed risk evalua5 tion and mitigation strategy for a drug sub6 mitted under subparagraph (A), or of an as7 sessment of the approved risk evaluation and 

8 mitigation strategy for a drug submitted under 

9 subparagraph (B), with the applicant to deter10 mine a mutually agreeable strategy— 

11 ‘‘(i) when submitted as part of an ap12 plication or supplemental application under 

13 subparagraph (A) or (B)(i)(I), not less 

14 than 60 days before the action deadline for 

15 the application that has been agreed to by 

16 the Secretary and that has been set forth 

17 in goals identified in letters of the Sec18 retary (relating to the use of fees collected 

19 under section 736 to expedite the drug de20 velopment process and the review of 

21 human drug applications); 

22 ‘‘(ii) when submitted under subpara23 graph (B)(i)(II) or (III), not later than 20 

24 days after such submission; 


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1 ‘‘(iii) when submitted voluntarily by 

2 the applicant or under subparagraph 

3 (B)(i)(IV), not later than 30 days after 

4 such submission; or 

5 ‘‘(iv) when submitted under subpara6 graph (B)(i)(V), not later than 10 days 

7 after such submission. 

8 ‘‘(E) ACTION.— 

9 ‘‘(i) IN GENERAL.—Unless the appli10 cant requests the dispute resolution proc11 ess described under subparagraph (F), the 

12 Secretary shall approve and describe the 

13 risk evaluation and mitigation strategy for 

14 a drug, or any modification to the strat15 egy— 

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

17 on the application, when a proposed 

18 strategy is submitted under subpara19 graph (A) or an assessment of the 

20 strategy is submitted under subpara21 graph (B)(i)(I); or 

22 ‘‘(II) in an order, which shall be 

23 made public, issued not later than 50 

24 days after the date discussions of such 

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1 graph (C), when an assessment of the 

2 strategy is submitted voluntarily by 

3 the applicant or under subclause (II), 

4 (III), (IV), or (V) of subparagraph 

5 (B)(i). 

6 ‘‘(ii) INACTION.—An approved risk 

7 evaluation and mitigation strategy shall re8 main in effect until the Secretary acts, if 

9 the Secretary fails to act as provided under 

10 clause (i). 

11 ‘‘(F) DISPUTE RESOLUTION.— 

12 ‘‘(i) REQUEST FOR REVIEW.—Not 

13 earlier than 15 days, and not later than 35 

14 days, after discussions under subparagraph 

15 (D) have begun to determine a mutually 

16 agreeable risk evaluation and mitigation 

17 strategy, the applicant may request in 

18 writing that a dispute about the strategy 

19 be reviewed by the Drug Safety Oversight 

20 Board. 

21 ‘‘(ii) SCHEDULING REVIEW.—If the 

22 applicant requests review under clause (i), 

23 the Secretary— 

24 ‘‘(I) shall schedule the dispute 

25 for review at 1 of the next 2 regular 


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1 meetings of the Drug Safety Over2 sight Board, whichever meeting date 

3 is more practicable; or 

4 ‘‘(II) may convene a special 

5 meeting of the Drug Safety Oversight 

6 Board to review the matter more 

7 promptly, including to meet an action 

8 deadline on an application (including 

9 a supplemental application). 

10 ‘‘(iii) AGREEMENT TERMINATES DIS11 PUTE RESOLUTION.—At any time before a 

12 decision and order is issued under clause 

13 (vi), the Secretary and the applicant may 

14 reach an agreement on the risk evaluation 

15 and mitigation strategy, terminating the 

16 dispute resolution process, and the Sec17 retary shall issue an action letter or order, 

18 as appropriate, that describes the mutually 

19 agreeable strategy. 

20 ‘‘(iv) MEETING OF THE BOARD.—At 

21 the meeting of the Drug Safety Oversight 

22 Board described in clause (ii), the Board 

23 shall— 

24 ‘‘(I) hear from both parties; and 

25 ‘‘(II) review the dispute. 


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1 ‘‘(v) RECOMMENDATION OF THE

2 BOARD.—Not later than 5 days after such 

3 meeting of the Drug Safety Oversight 

4 Board, the Board shall provide a written 

5 recommendation on resolving the dispute 

6 to the Secretary. 

7 ‘‘(vi) ACTION BY THE SECRETARY.— 

8 ‘‘(I) ACTION LETTER.—With re9 spect to a proposed risk evaluation 

10 and mitigation strategy submitted 

11 under subparagraph (A) or to an as12 sessment of the strategy submitted 

13 under subparagraph (B)(i)(I), the 

14 Secretary shall issue an action letter 

15 that resolves the dispute not later 

16 than the later of— 

17 ‘‘(aa) the action deadline re18 ferred to in subparagraph (D)(i); 

19 or 

20 ‘‘(bb) 7 days after receiving 

21 the recommendation of the Drug 

22 Safety Oversight Board. 

23 ‘‘(II) ORDER.—With respect to 

24 an assessment of the risk evaluation 

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1 untarily by the applicant or under 

2 subclause (II), (III), (IV), or (V) of 

3 subparagraph (B)(i), the Secretary 

4 shall issue an order, which shall be 

5 made public, that resolves the dispute 

6 not later than 7 days after receiving 

7 the recommendation of the Drug Safe8 ty Oversight Board. 

9 ‘‘(vii) INACTION.—An approved risk 

10 evaluation and mitigation strategy shall re11 main in effect until the Secretary acts, if 

12 the Secretary fails to act as provided for 

13 under clause (vi). 

14 ‘‘(viii) EFFECT ON ACTION DEAD15 LINE.—With respect to the application or 

16 supplemental application in which a pro17 posed risk evaluation and mitigation strat18 egy is submitted under subparagraph (A) 

19 or in which an assessment of the strategy 

20 is submitted under subparagraph (B)(i)(I), 

21 the Secretary shall be considered to have 

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1 pute resolution process described in this 

2 subparagraph and if the Secretary— 

3 ‘‘(I) has initiated the discussions 

4 described under such subparagraph 

5 not less than 60 days before such ac6 tion deadline; and 

7 ‘‘(II) has complied with the tim8 ing requirements of scheduling review, 

9 providing a written recommendation, 

10 and issuing an action letter under 

11 clauses (ii), (v), and (vi), respectively. 

12 ‘‘(ix) OTHER DISPUTE RESOLUTION.— 

13 Procedural or scientific matters involving 

14 the review of human drug applications and 

15 supplements that cannot be resolved at the 

16 divisional level may in addition be appealed 

17 as described in letters of the Secretary (re18 lating to the use of fees collected under 

19 section 736 to expedite the drug develop20 ment process and the review of human 

21 drug applications). 

22 ‘‘(x) DISQUALIFICATION.—No indi23 vidual who is an employee of the Food and 

24 Drug Administration and who reviews the 

25 application for a drug or who participated 


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1 in other dispute resolution under clause 

2 (ix) with respect to such drug may serve 

3 on the Drug Safety Oversight Board at a 

4 meeting under clause (iv) to review a dis5 pute about the risk evaluation and mitiga6 tion strategy for such drug. 

7 ‘‘(xi) ADDITIONAL EXPERTISE.—The 

8 Drug Safety Oversight Board may add 

9 members from offices within the Food and 

10 Drug Administration with relevant exper11 tise, including the Office of Pediatrics, the 

12 Office of Women’s Health, or the Office of 

13 Rare Diseases, for a meeting under clause 

14 (iv) of the Drug Safety Oversight Board. 

15 ‘‘(G) PROCESS FOR ADDRESSING DRUG

16 CLASS EFFECTS.— 

17 ‘‘(i) IN GENERAL.—When a concern 

18 about a serious risk of a drug may be re19 lated to the pharmacological class of the 

20 drug, the Secretary may defer assessments 

21 of the approved risk evaluation and mitiga22 tion strategies for such drugs until the 

23 Secretary has convened, after appropriate 

24 public notice, one or more public meetings 


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1 to consider possible responses to such con2 cern. 

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

4 meetings may include— 

5 ‘‘(I) one or more meetings of the 

6 applicants for such drugs; 

7 ‘‘(II) one or more meetings of an 

8 appropriate advisory committee of the 

9 Food and Drug Administration; or 

10 ‘‘(III) one or more workshops of 

11 scientific experts and other stake12 holders. 

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

14 discussions from any meetings under 

15 clause (ii), the Secretary may— 

16 ‘‘(I) announce in the Federal 

17 Register a planned regulatory action, 

18 including a modification to each risk 

19 evaluation and mitigation strategy, for 

20 drugs in the pharmacological class; 

21 ‘‘(II) seek public comment about 

22 such action; and 

23 ‘‘(III) after seeking such com24 ment, issue an order addressing such 

25 regulatory action. 


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1 ‘‘(H) INTERNATIONAL COORDINATION.— 

2 To the extent practicable, the Secretary shall 

3 coordinate elements of the risk evaluation and 

4 mitigation strategy for a drug, such as the 

5 timetable for submission of assessments under 

6 paragraph (3)(E), a study under paragraph 

7 (4)(D), or a clinical trial under paragraph 

8 (4)(E), with efforts to manage the serious risks 

9 of such drug by the marketing authorities of 

10 other countries whose drug approval and risk 

11 management processes the Secretary deems 

12 comparable to the drug approval and risk man13 agement processes of the United States. 

14 ‘‘(I) EFFECT.—Use of the processes de15 scribed in subparagraphs (G) and (H) shall not 

16 delay action on an application or a supplement 

17 to an application for a drug. 

18 ‘‘(J) NO EFFECT ON LABELING CHANGES

19 THAT DO NOT REQUIRE PREAPPROVAL.—In the 

20 case of a labeling change to which section 

21 314.70 of title 21, Code of Federal Regulations 

22 (or any successor regulation), applies for which 

23 the submission of a supplemental application is 

24 not required or for which distribution of the 

25 drug involved may commence upon the receipt 


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1 by the Secretary of a supplemental application 

2 for the change, the submission of an assessment 

3 of the approved risk evaluation and mitigation 

4 strategy for the drug under this subsection is 

5 not required.’’. 

6 SEC. 102. ENFORCEMENT. 

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

8 Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend9 ed by adding at the end the following: 

10 ‘‘(x) If it is a drug subject to an approved risk evalua11 tion and mitigation strategy under section 505(o) and the 

12 applicant for such drug fails to— 

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

14 strategy after the Secretary has completed review of, 

15 and acted on, an assessment of such strategy under 

16 paragraph (6) of such section; or 

17 ‘‘(2) comply with a requirement of such strat18 egy with respect to advertising as provided for under 

19 subparagraph (F), (G), or (H) of paragraph (4) of 

20 such section.’’. 

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

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

23 amended— 

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

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


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1 (2) by inserting after paragraph (2) the fol2 lowing: 

3 ‘‘(3) An applicant (as such term is used in sec4 tion 505(o)) who knowingly fails to comply with a 

5 requirement of an approved risk evaluation and miti6 gation strategy under such section 505(o) shall be 

7 subject to a civil money penalty of not less than 

8 $15,000 and not more than $250,000 per violation, 

9 and not to exceed $1,000,000 for all such violations 

10 adjudicated in a single proceeding.’’; 

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

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

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

14 striking ‘‘paragraph (1) or (2)’’ each place it ap15 pears and inserting ‘‘paragraph (1), (2), or (3)’’; 

16 and 

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

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

19 inserting ‘‘paragraph (5)’’. 

20 SEC. 103. CONFORMING AMENDMENTS. 

21 (a) REGULATION OF BIOLOGICAL PRODUCTS.—Sec22 tion 351 of the Public Health Service Act (42 U.S.C. 262) 

23 is amended— 

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

25 the following: 


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1 ‘‘(D) RISK EVALUATION AND MITIGATION STRAT2 EGY.—A person that submits an application for a license 

3 under this paragraph shall submit to the Secretary as part 

4 of the application a proposed risk evaluation and mitiga5 tion strategy as described under section 505(o) of the Fed6 eral Food, Drug, and Cosmetic Act.’’; and 

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

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

9 after ‘‘, and Cosmetic Act’’. 

10 (b) PRECLEARANCE OF ADVERTISEMENT.—Section 

11 502(n)(3)(A) of the Federal Food, Drug, and Cosmetic 

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

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

14 ‘‘except in extraordinary circumstances’’. 

15 (c) CONTENT OF A NEW DRUG APPLICATION.—Sec16 tion 505(b)(1) of the Federal Food, Drug, and Cosmetic 

17 Act (21 U.S.C. 355(b)) is amended— 

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

19 and 

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

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

22 risk evaluation and mitigation strategy as described 

23 under subsection (o).’’. 

24 (d) WITHDRAWAL OR SUSPENSION OF APPROVAL.— 

25 Section 505(e) of the Federal Food, Drug, and Cosmetic 


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

2 the following: ‘‘The Secretary may withdraw the approval 

3 of an application submitted under subsection (b) or (j), 

4 or suspend the approval of such an application, as pro5 vided under this subsection, without first ordering the ap6 plicant to submit an assessment of the approved risk eval7 uation and mitigation strategy for the drug under sub8 section (o)(6)(B)(i)(V).’’. 

9 (e) DRUGS SUBJECT TO AN ABBREVIATED NEW

10 DRUG APPLICATION.—Section 505(j)(2) of the Federal 

11 Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)) is 

12 amended by adding at the end the following: 

13 ‘‘(D) RISK EVALUATION AND MITIGATION STRATEGY

14 REQUIREMENT.—A drug that is the subject of an abbre15 viated new drug application under this subsection shall be 

16 subject to each element of the risk evaluation and mitiga17 tion strategy required under subsection (o) for the applica18 ble listed drug, except for any post-approval clinical trial 

19 requirement described under paragraph (4)(E) of such 

20 subsection.’’. 

21 SEC. 104. RESOURCES. 

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

23 735(6) of the Federal Food, Drug, and Cosmetic Act (21 

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


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1 ‘‘(F) Reviewing and implementing risk 

2 evaluation and mitigation strategies, and col3 lecting, developing, and reviewing safety infor4 mation on drugs, including adverse event re5 ports.’’. 

6 (b) PUBLIC ACCOUNTABILITY.—Section 505(a) of 

7 the Prescription Drug User Fee Amendments of 2002 

8 (Subtitle A of title V of the Public Health Security and 

9 Bioterrorism Preparedness and Response Act of 2002 

10 (Public Law 107-188)) is amended by adding at the end 

11 the following: 

12 ‘‘(3) DRUG SAFETY.—The recommendations 

13 under paragraph (1) shall include estimates of the 

14 amounts by which the fee revenue amounts for fiscal 

15 years 2008 through 2012 should be increased to re16 view and implement risk evaluation and mitigation 

17 strategies, and to collect, develop, and review safety 

18 information on drugs, including adverse event re19 ports.’’. 

20 (c) STRATEGIC PLAN FOR INFORMATION TECH21 NOLOGY.—Not later than 1 year after the date of enact22 ment of this title, the Secretary of Health and Human 

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

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

25 and Pensions and the Committee on Appropriations of the 


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1 Senate and the Committee on Energy and Commerce and 

2 the Committee on Appropriations of the House of Rep3 resentatives, a strategic plan on information technology 

4 that includes— 

5 (1) an assessment of the information technology 

6 infrastructure, including data collection and data 

7 mining systems, needed by the Food and Drug Ad8 ministration to comply with the requirements of this 

9 title (and the amendments made by this title), to es10 tablish standards to achieve interoperability, and to 

11 move toward electronic health records; 

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

13 current information technology assets of the Food 

14 and Drug Administration are sufficient to meet the 

15 needs assessment under paragraph (1); 

16 (3) a plan for enhancing the information tech17 nology assets of the Food and Drug Administration 

18 toward meeting the needs assessment under para19 graph (1); and 

20 (4) an assessment of additional resources need21 ed to so enhance the information technology assets 

22 of the Food and Drug Administration. 

23 SEC. 105. DRUG LABELING. 

24 (a) ACCESSIBLE REPOSITORY OF DRUG LABEL25 ING.—Not later than the effective date of this title, the 


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1 Secretary, through the Commissioner of Food and Drugs, 

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

3 establish a searchable repository of structured, electronic 

4 product information, including the approved professional 

5 labeling and any required patient labeling of each drug 

6 approved under section 505 of the Federal Food, Drug, 

7 and Cosmetic Act (21 U.S.C. 355) or licensed under sec8 tion 351 of the Public Health Service Act (42 U.S.C. 262) 

9 in order to improve patient safety through accessible prod10 uct information, support initiatives to improve patient care 

11 by better management of health care information, and 

12 provide standards for drug information. Such repository 

13 shall be made publicly accessible on the Internet website 

14 of the National Library of Medicine and through a link 

15 on the homepage of the Internet website of the Food and 

16 Drug Administration. 

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

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

19 professional labeling and any required patient labeling of 

20 a drug approved under such section 505 or licensed under 

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

22 the drug is approved, including in a supplemental applica23 tion with respect to a labeling change. 

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

25 the Committee on Energy and Commerce of the House 


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1 of Representatives and the Committee on Health, Edu2 cation, Labor and Pensions of the Senate on the status 

3 of the repository under subsection (a), and on progress 

4 in posting structured electronic product information, in5 cluding posting of information regarding drugs approved 

6 prior to the effective date of this title. 

7 (d) MEDICATION GUIDES.—Not later than the effec8 tive date of this title, the Secretary, through the Commis9 sioner of Food and Drugs, shall establish on the Internet 

10 website page for the repository under subsection (a) a link 

11 to a list of each drug, whether approved under such sec12 tion 505 or licensed under such section 351, for which a 

13 Medication Guide, as provided for under part 208 of title 

14 21, Code of Federal Regulations (or any successor regula15 tions), is required. 

16 SEC. 106. EFFECTIVE DATE AND APPLICABILITY. 

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

18 180 days after the date of enactment of this Act. 

19 (b) DRUGS DEEMED TO HAVE RISK EVALUATION

20 AND MITIGATION STRATEGIES.— 

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

22 before the effective date of this title and for which 

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

24 restrictions on distribution and use required under 

25 section 314.520 or section 600.42 of title 21, Code 


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1 of Federal Regulations, or otherwise agreed to by 

2 the applicant and the Secretary for such drug, shall 

3 be deemed to have an approved risk evaluation and 

4 mitigation strategy under such section 505(o) of the 

5 Federal Food, Drug, and Cosmetic Act (as added by 

6 this title). 

7 (2) RISK EVALUATION AND MITIGATION STRAT8 EGY.—The approved risk evaluation and mitigation 

9 strategy deemed in effect for a drug under para10 graph (1) shall consist of the elements described in 

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

12 section 505(o) and any other additional elements 

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

14 on the effective date of this title. 

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

16 after the effective date of this title, the Secretary 

17 shall notify the applicant for each drug described in 

18 paragraph (1)— 

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

20 approved risk evaluation and mitigation strat21 egy pursuant to such paragraph; and 

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

23 than 6 months after the applicant is so notified, 

24 by which the applicant shall submit to the SecVerDate Aug 31 2005 02:17 Aug 09, 2006 Jkt 049200 PO 00000 Frm 00038 Fmt 6652 Sfmt 6201 E:\BILLS\S3807.IS S3807

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1 retary an assessment of such approved strategy 

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

3 (4) ENFORCEMENT ONLY AFTER ASSESSMENT

4 AND REVIEW.—Neither the Secretary nor the Attor5 ney General may seek to enforce a requirement of a 

6 risk evaluation and mitigation strategy deemed in ef7 fect under paragraph (1) before the Secretary has 

8 completed review of, and acted on, the first assess9 ment of such strategy under such section 505(o). 

10 (c) OTHER DRUGS APPROVED BEFORE THE EFFEC11 TIVE DATE.—The Secretary, on a case-by-case basis, may 

12 require the applicant for a drug approved before the effec13 tive date of this title to which subsection (b) does not 

14 apply to submit a proposed risk evaluation and mitigation 

15 strategy in accordance with the timeframes provided for 

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

17 (6)(B)(i) of such section 505(o) if the Secretary deter18 mines that— 

19 (1) an element described under paragraph 

20 (3)(A) of such section 505(o) may require modifica21 tion; or 

22 (2) a standard for adding an element described 

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

24 is not in effect with respect to such drug may apply 

25 to such drug. 


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1 TITLE II—REAGAN-UDALL INSTI2 TUTE FOR APPLIED BIO3 MEDICAL RESEARCH 

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

5 BIOMEDICAL RESEARCH. 

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

7 Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amend8 ed by adding at the end the following: 

9 ‘‘Subchapter H—Establishment of Reagan10 Udall Institute for Applied Biomedical 

11 Research 

12 ‘‘SEC. 760. ESTABLISHMENT AND FUNCTIONS OF THE INSTI13 TUTE. 

14 ‘‘(a) IN GENERAL.—There is established within the 

15 Food and Drug Administration an Institute to be known 

16 as the Reagan-Udall Institute for Applied Biomedical Re17 search (referred to in this subchapter as the ‘Institute’). 

18 The Institute shall be headed by an Executive Director, 

19 appointed by the members of the Board of Directors under 

20 subsection (e). 

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

22 Institute is to advance the Critical Path Initiative of the 

23 Food and Drug Administration to modernize medical 

24 product development, accelerate innovation, and enhance 

25 product safety by— 


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1 ‘‘(1) initiating, sponsoring, and organizing col2 laborative and multidisciplinary research in the 

3 sciences of developing, manufacturing, and evalu4 ating the safety and effectiveness of diagnostics, de5 vices, biologics, and drugs; 

6 ‘‘(2) ensuring the broad participation of aca7 demic, government, and industrial researchers in the 

8 work of the Institute; and 

9 ‘‘(3) ensuring the maximum distribution and 

10 utilization of the outcomes of such research, includ11 ing through publication of research results and dis12 semination of intellectual property generated by the 

13 Institute. 

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

15 shall— 

16 ‘‘(1) establish goals and priorities relating to 

17 the sciences of developing, manufacturing, and eval18 uating the safety and effectiveness of diagnostics, 

19 devices, biologics, and drugs; 

20 ‘‘(2) identify unmet needs in the sciences of de21 veloping, manufacturing, and evaluating the safety 

22 and effectiveness of diagnostics, devices, biologics, 

23 and drugs; 

24 ‘‘(3) in consultation with the National Insti25 tutes of Health, assess existing and proposed FedVerDate Aug 31 2005 02:17 Aug 09, 2006 Jkt 049200 PO 00000 Frm 00041 Fmt 6652 Sfmt 6201 E:\BILLS\S3807.IS S3807

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1 eral intramural and extramural research and devel2 opment programs relating to such sciences, facilitate 

3 and encourage interagency coordination of such pro4 grams, and participate in such programs relating to 

5 such sciences, including— 

6 ‘‘(A) the identification and validation of 

7 biomarkers for use in diagnostic, device, bio8 logic, and drug development; 

9 ‘‘(B) the development and validation of 

10 animal models for human disease; 

11 ‘‘(C) pharmacogenomics and inter-indi12 vidual variability in drug and biologic response; 

13 ‘‘(D) the development of data analysis 

14 technology for use in device, biologic, and drug 

15 development; 

16 ‘‘(E) advancing improvements to the de17 sign and conduct of clinical trials; 

18 ‘‘(F) toxicological quality assessment tech19 nologies; 

20 ‘‘(G) device manufacturing, design and 

21 materials science; 

22 ‘‘(H) failure mode assessment for product 

23 development; 

24 ‘‘(I) improving adverse event reporting and 

25 analysis; 


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1 ‘‘(J) bridging engineering data and clinical 

2 performance for devices; and 

3 ‘‘(K) computer modeling; 

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

5 cooperative agreements with, scientists and entities 

6 to advance the purposes of the Institute pursuant to 

7 the processes established in the by-laws under sub8 section (d)(2)(A); 

9 ‘‘(5) release and publish information and data 

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

11 and release material, reagents, and techniques to 

12 maximize, promote, and coordinate the availability of 

13 such material, reagents, and techniques for use by 

14 the Food and Drug Administration, nonprofit orga15 nizations, and academic and industrial researchers; 

16 ‘‘(6) ensure that— 

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

18 patents for inventions developed by the Insti19 tute or with funds from the Institute; 

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

21 the licensing of inventions developed by the In22 stitute or with funds from the Institute; and 

23 ‘‘(C) executed licenses, memoranda of un24 derstanding, material transfer agreements, con25 tracts, and other such instruments promote, to 


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1 the maximum extent practicable, the broadest 

2 conversion to commercial and noncommercial 

3 applications of licensed and patented inventions 

4 of the Institute consistent with subsection 

5 (b)(3); 

6 ‘‘(7) recruit scientists and hold or sponsor (in 

7 whole or in part) meetings as appropriate to further 

8 the purposes of the Institute; 

9 ‘‘(8) provide objective clinical and scientific in10 formation to the Food and Drug Administration 

11 and, upon request, to other Federal agencies regard12 ing how to ensure that regulatory policy accommo13 dates scientific advances; 

14 ‘‘(9) conduct annual evaluations of research ac15 tivities that are supported by the Institute; and 

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

17 with the purposes of the Institute as the Board de18 termines appropriate. 

19 ‘‘(d) BOARD OF DIRECTORS.— 

20 ‘‘(1) ESTABLISHMENT.— 

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

22 have a Board of Directors (referred to in this 

23 subchapter as the ‘Board’), which shall be com24 posed of ex officio and appointed members in 


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1 accordance with this subsection. All appointed 

2 members of the Board shall be voting members. 

3 ‘‘(B) EX OFFICIO MEMBERS.—The ex offi4 cio members of the Board shall be— 

5 ‘‘(i) the immediate past Chair of 

6 Board of Directors of the Institute; 

7 ‘‘(ii) the Commissioner of Food and 

8 Drugs; and 

9 ‘‘(iii) the Director of the National In10 stitutes of Health. 

11 ‘‘(C) APPOINTED MEMBERS.— 

12 ‘‘(i) IN GENERAL.—The ex officio 

13 members of the Board under subparagraph 

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

15 Board 12 individuals. Of such appointed 

16 members— 

17 ‘‘(I) 4 shall be representatives of 

18 the general pharmaceutical, device, 

19 and biotechnology industries; 

20 ‘‘(II) 3 shall be representatives of 

21 academic research organizations; 

22 ‘‘(III) 2 shall be representatives 

23 of Government agencies, including the 

24 Food and Drug Administration and 

25 the National Institutes of Health; 


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1 ‘‘(IV) 2 shall be representatives 

2 of patient advocacy organizations; and 

3 ‘‘(V) 1 shall be a representative 

4 of health care providers. 

5 ‘‘(ii) REQUIREMENT.—The ex officio 

6 members shall ensure the Board member7 ship includes individuals with expertise in 

8 clinical pharmacology, biomedical 

9 informatics, information management, 

10 product safety, process improvement and 

11 pharmaceutical sciences, and medical de12 vice and biomedical engineering. 

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

14 ‘‘(A) establish by-laws for the Institute 

15 that— 

16 ‘‘(i) are published in the Federal Reg17 ister and available for public comment; 

18 ‘‘(ii) establish licensing, distribution, 

19 and publication policies that support the 

20 widest and least restrictive use by the pub21 lic of information and inventions developed 

22 by the Institute or with Institute funds to 

23 carry out the duties described in para24 graphs (5) and (6) of subsection (c); 


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1 ‘‘(iii) specify criteria and processes for 

2 the review of proposals and awarding of 

3 grants and contracts that include peer re4 view and that are substantially consistent 

5 with those established by other government 

6 organizations, such as the National Insti7 tutes of Health and the National Science 

8 Foundation; 

9 ‘‘(iv) specify a process for annual 

10 Board review of the operations of the Insti11 tute; and 

12 ‘‘(v) establish specific duties of the 

13 Executive Director; 

14 ‘‘(B) identify and prioritize the scientific 

15 needs that may be effectively and uniquely ad16 dressed by the Institute; 

17 ‘‘(C) prioritize and provide overall direction 

18 to the research activities of the Institute; 

19 ‘‘(D) evaluate the performance of the Ex20 ecutive Director; and 

21 ‘‘(E) carry out any other necessary activi22 ties regarding the functioning of the Institute. 

23 ‘‘(3) ADDITIONAL BOARD FUNCTIONS.— 

24 ‘‘(A) IN GENERAL.—The Board may estab25 lish 1 or more Critical Path Institutes to conVerDate Aug 31 2005 02:17 Aug 09, 2006 Jkt 049200 PO 00000 Frm 00047 Fmt 6652 Sfmt 6201 E:\BILLS\S3807.IS S3807

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1 duct multidisciplinary and collaborative re2 search, education, and outreach, and to mod3 ernize the sciences of developing, manufac4 turing, and evaluating the safety and effective5 ness of diagnostics, devices, biologics, and 

6 drugs. 

7 ‘‘(B) ELIGIBILITY.—To be eligible to host 

8 a Critical Path Institute described in subpara9 graph (A), an entity shall— 

10 ‘‘(i) be a State or local government, 

11 institution of higher education, or non12 profit entity with demonstrated ability, 

13 personnel, and clinical and other technical 

14 expertise to undertake the duties con15 sistent with the activities in subparagraph 

16 (A); and 

17 ‘‘(ii) submit to the Board an applica18 tion at such time, in such manner, and 

19 containing such information as the Board 

20 may require. 

21 ‘‘(4) CHAIR.—The ex officio members of the 

22 Board under paragraph (1)(B) shall designate an 

23 appointed member of the Board to serve as the 

24 Chair of the Board. 

25 ‘‘(5) TERMS AND VACANCIES.— 


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

2 member of the Board appointed under para3 graph (1)(C) shall be 4 years, except that the 

4 terms of offices for the initial appointed mem5 bers of the Board shall expire on a staggered 

6 basis as determined by the ex officio members. 

7 ‘‘(B) VACANCY.—Any vacancy in the mem8 bership of the Board— 

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

10 remaining members to execute the duties 

11 of the Board; and 

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

13 the ex officio members of the Board in the 

14 manner described under paragraph 

15 (1)(C)(i). 

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

17 Board does not serve the full term applicable 

18 under subparagraph (A), the individual ap19 pointed by the ex officio members of the Board 

20 in the manner described under paragraph 

21 (1)(C)(i) to fill the resulting vacancy shall be 

22 appointed for the remainder of the term of the 

23 predecessor of the individual. 

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

25 the Board may continue to serve after the expiVerDate Aug 31 2005 02:17 Aug 09, 2006 Jkt 049200 PO 00000 Frm 00049 Fmt 6652 Sfmt 6201 E:\BILLS\S3807.IS S3807

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1 ration of the term of the member until a suc2 cessor is appointed. 

3 ‘‘(6) COMPENSATION.—Members of the Board 

4 may not receive compensation for service on the 

5 Board. Such members may be reimbursed for travel, 

6 subsistence, and other necessary expenses incurred 

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

8 in the bylaws issued by the Board. 

9 ‘‘(e) EXECUTIVE DIRECTOR.— 

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

11 Executive Director who shall serve at the pleasure of 

12 the Board. The Executive Director shall be respon13 sible for the day-to-day operations of the Institute 

14 and shall have such specific duties and responsibil15 ities as the Board shall prescribe. 

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

17 the Executive Director shall be fixed by the Board 

18 but shall not be greater than the compensation of 

19 the Commissioner of Food and Drugs. 

20 ‘‘(f) ADMINISTRATIVE POWERS.—In carrying out this 

21 subchapter, the Board, acting through the Executive Di22 rector, may— 

23 ‘‘(1) hire, promote, compensate, and discharge 

24 1 or more officers, employees, and agents, as may be 

25 necessary, and define their duties; 


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1 ‘‘(2) prescribe the manner in which— 

2 ‘‘(A) real or personal property of the Insti3 tute is acquired, held, and transferred; 

4 ‘‘(B) general operations of the Institute 

5 are to be conducted; and 

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

7 by law are exercised and enjoyed; 

8 ‘‘(3) with the consent of the applicable executive 

9 department or independent agency, use the informa10 tion, services, and facilities of such department or 

11 agencies in carrying out this section; 

12 ‘‘(4) enter into contracts with public and pri13 vate organizations for the writing, editing, printing, 

14 and publishing of books and other material; 

15 ‘‘(5) hold, administer, invest, and spend any 

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

17 made to the Institute under subsection (g); 

18 ‘‘(6) enter into such other contracts, leases, co19 operative agreements, and other transactions as the 

20 Board considers appropriate to conduct the activities 

21 of the Institute; 

22 ‘‘(7) appoint other groups of advisors as may be 

23 determined necessary to carry out the functions of 

24 the Institute; and 


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1 ‘‘(8) exercise other powers as set forth in this 

2 section, and such other incidental powers as are nec3 essary to carry out its powers, duties, and functions 

4 in accordance with this subchapter. 

5 ‘‘(g) ACCEPTANCE OF FUNDS FROM OTHER

6 SOURCES.—The Executive Director may accept on behalf 

7 of the Institute, any funds, gifts, devises, or bequests of 

8 real or personal property made to the Institute from 

9 sources outside the Food and Drug Administration, in10 cluding private entities, for the purposes of carrying out 

11 the duties of the Institute. 

12 ‘‘(h) ANNUAL REPORTS.— 

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

14 a grant, contract, or cooperative agreement from the 

15 Institute under this section shall submit to the Insti16 tute a report on an annual basis for the duration of 

17 such grant, contract, or cooperative agreement, that 

18 describes the activities carried out under such grant, 

19 contract, or cooperative agreement. 

20 ‘‘(2) REPORT TO CONGRESS.—Beginning with 

21 fiscal year 2008, the Executive Director shall submit 

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

23 Pensions and the Committee on Appropriations of 

24 the Senate and the Committee on Energy and ComVerDate Aug 31 2005 02:17 Aug 09, 2006 Jkt 049200 PO 00000 Frm 00052 Fmt 6652 Sfmt 6201 E:\BILLS\S3807.IS S3807

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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, with emphasis on 

8 progress made by the Food and Drug Adminis9 tration in incorporating Critical Path priorities 

10 to modernize medical product development, ac11 celerate innovation, and enhance product safety; 

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

13 source of all funds used by the Institute to 

14 carry out such activities; and 

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

16 by the Institute. 

17 ‘‘(i) SEPARATION OF FUNDS.—The Executive Direc18 tor shall ensure that the funds received from the Treasury 

19 are held in separate accounts from funds received from 

20 private entities under subsection (g). 

21 ‘‘(j) AUTHORIZATION OF APPROPRIATIONS.— 

22 ‘‘(1) IN GENERAL.—There are authorized to be 

23 appropriated $20,000,000 for each of fiscal years 

24 2008 through 2013 to carry out this section, section 

25 761, and section 762. 


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1 ‘‘(2) LIMITATION.—From amounts appro2 priated for a fiscal year under subparagraph (A), 

3 the Secretary shall use not less than $1,200,000 to 

4 carry out subsections (a), (b), and (d) through (i).’’. 

5 (b) EMPLOYEES FROM OTHER FEDERAL AGEN6 CIES.—Chapter VII (21 U.S.C. 380 et seq.) (as amended 

7 by subsection (a)) is amended by adding at the end the 

8 following: 

9 ‘‘SEC. 761. ACCEPTING EMPLOYEES FROM OTHER FEDERAL 

10 AGENCIES. 

11 ‘‘(a) COLLABORATION WITH OTHER AGENCIES.—To 

12 carry out the purposes of the Institute, the Secretary, act13 ing through the Commissioner of Food and Drugs and in 

14 consultation with the Executive Director of the Institute, 

15 may collaborate with other Federal agencies and accept 

16 the services of employees from those agencies without re17 imbursement to those agencies. 

18 ‘‘(b) DETAIL OF GOVERNMENT EMPLOYEES.—Not 

19 more than 5 Federal Government employees may be de20 tailed to the Institute at any time for a period not to ex21 ceed 6 years for each such employee, and such detail shall 

22 be without civil service status or privilege. Such employees 

23 shall abide by the statutory, regulatory, ethical, and proce24 dural standards applicable to employees of the Food and 

25 Drug Administration. 


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1 ‘‘(c) PROCUREMENT OF TEMPORARY AND INTERMIT2 TENT SERVICES.—The Executive Director may procure 

3 temporary and intermittent services under section 3109(b) 

4 of title 5, United States Code, at rates for individuals 

5 which do not exceed the daily equivalent of the annual rate 

6 of basic pay prescribed for level V of the Executive Sched7 ule under section 5316 of such title. 

8 ‘‘(d) NO ADDITIONAL LIABILITY.—Nothing in this 

9 section adds to any liability that the United States may 

10 have under chapter 171 of title 28, United States Code 

11 (commonly known as the Federal Tort Claims Act).’’. 

12 (c) OTHER INSTITUTE PROVISIONS.—Chapter VII 

13 (21 U.S.C. 371 et seq.) (as amended by subsection (b)) 

14 is amended by adding at the end the following: 

15 ‘‘SEC. 762. LOCATION OF INSTITUTE. 

16 ‘‘(a) IN GENERAL.—The Institute shall, if prac17 ticable, be located not more than 20 miles from the Dis18 trict of Columbia. 

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

20 with the Administrator of General Services to ensure the 

21 most cost-efficient arrangement for the leasing or pur22 chase of real property for adequate facilities which, if 

23 practicable, shall be located at the Food and Drug Admin24 istration, to meet the needs of the Institute in carrying 

25 out this subchapter.’’. 


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1 (d) RECOVERY AND RETENTION OF FEES FOR FOIA 

2 REQUESTS.—Chapter VII of the Federal Food, Drug, and 

3 Cosmetic Act (21 U.S.C. 371 et seq.) (as amended by sub4 section (c)) is amended by adding at the end the following: 

5 ‘‘SEC. 763. RECOVERY AND RETENTION OF FEES FOR FREE6 DOM OF INFORMATION REQUESTS TO THE IN7 STITUTE. 

8 ‘‘(a) IN GENERAL.—The Secretary, acting through 

9 the Commissioner of Food and Drugs, may— 

10 ‘‘(1) set and charge fees, in accordance with 

11 section 552(a)(4)(A) of title 5, United States Code, 

12 to recover all reasonable costs incurred in processing 

13 requests made under section 552 of title 5, United 

14 States Code, for records obtained or created by the 

15 Institute under this Act or any other Federal law for 

16 which responsibility for administration has been del17 egated to the Institute by the Secretary; 

18 ‘‘(2) retain all fees charged for such requests; 

19 and 

20 ‘‘(3) establish an accounting system and proce21 dures to control receipts and expenditures of fees re22 ceived under this section. 

23 ‘‘(b) USE OF FEES.—The Secretary and the Commis24 sioner of Food and Drugs shall not use fees received under 

25 this section for any purpose other than funding the procVerDate Aug 31 2005 02:17 Aug 09, 2006 Jkt 049200 PO 00000 Frm 00056 Fmt 6652 Sfmt 6201 E:\BILLS\S3807.IS S3807

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1 essing of requests described in subsection (a)(1). Such fees 

2 shall not be used to reduce the amount of funds made 

3 available to carry out other provisions of this Act. 

4 ‘‘(c) WAIVER OF FEES.—Nothing in this section shall 

5 supersede the right of a requester to obtain a waiver of 

6 fees pursuant to section 552(a)(4)(A) of title 5, United 

7 States Code.’’. 

8 TITLE III—CLINICAL TRIALS 

9 SEC. 301. CLINICAL TRIAL REGISTRY DATABASE AND CLIN10 ICAL TRIAL RESULTS DATABASE. 

11 (a) IN GENERAL.—Section 402(j) of the Public 

12 Health Service Act (42 U.S.C. 282(j)) is amended to read 

13 as follows: 

14 ‘‘(j) CLINICAL TRIAL REGISTRY DATABASE; CLIN15 ICAL TRIAL RESULTS DATABASE.— 

16 ‘‘(1) DEFINITIONS; REQUIREMENT.— 

17 ‘‘(A) DEFINITIONS.—In this subsection: 

18 ‘‘(i) CLINICAL TRIAL INFORMATION.— 

19 The term ‘clinical trial information’ means 

20 those data elements that are necessary to 

21 complete an entry in the clinical trial reg22 istry database under paragraph (2) or the 

23 clinical trial results database under para24 graph (3), as applicable. 


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1 ‘‘(ii) COMPLETION DATE.—The term 

2 ‘completion date’ means, with respect to a 

3 clinical trial, the date on which the last pa4 tient enrolled in the clinical trial has com5 pleted his or her last medical visit of the 

6 clinical trial (known as last patient last 

7 visit), whether the clinical trial concluded 

8 according to the prespecified protocol plan 

9 or was terminated. 

10 ‘‘(iii) DRUG.—The term ‘drug’ means 

11 a drug as defined in section 201(g) of the 

12 Federal Food, Drug, and Cosmetic Act or 

13 a biological product as defined in section 

14 351 of this Act. 

15 ‘‘(iv) RESPONSIBLE PARTY.—The 

16 term ‘responsible party’, with respect to a 

17 clinical trial of a drug, means the sponsor 

18 of the clinical trial or the principal investi19 gator of such clinical trial if so designated 

20 by such sponsor. 

21 ‘‘(B) REQUIREMENT.—The Secretary shall 

22 develop a mechanism by which— 

23 ‘‘(i) the responsible party for each ap24 plicable clinical trial shall submit the iden25 tity and contact information of such reVerDate Aug 31 2005 02:17 Aug 09, 2006 Jkt 049200 PO 00000 Frm 00058 Fmt 6652 Sfmt 6201 E:\BILLS\S3807.IS S3807

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1 sponsible party to the Secretary at the 

2 time of submission of clinical trial informa3 tion under paragraph (2); and 

4 ‘‘(ii) other Federal agencies may iden5 tify the responsible party for an applicable 

6 clinical trial. 

7 ‘‘(2) CLINICAL TRIAL REGISTRY DATABASE.— 

8 ‘‘(A) APPLICABLE CLINICAL TRIAL.— 

9 ‘‘(i) IN GENERAL.—For purposes of 

10 this paragraph the term ‘applicable clinical 

11 trial’ means— 

12 ‘‘(I) an interventional clinical 

13 trial conducted before the drug is ap14 proved under section 505 of the Fed15 eral Food, Drug, and Cosmetic Act or 

16 licensed under section 351 of this Act 

17 that is— 

18 ‘‘(aa) a therapeutic or 

19 chemopreventive exploratory clin20 ical trial to verify the efficacy 

21 and establish appropriate doses 

22 for the drug; or 

23 ‘‘(bb) a therapeutic or 

24 chemopreventive confirmatory 

25 clinical trial; 


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1 ‘‘(II) a clinical trial conducted 

2 after the drug is approved under such 

3 section 505 or licensed under such 

4 section 351; or 

5 ‘‘(III) a pharmacokinetic study to 

6 support a pediatric indication for the 

7 drug. 

8 ‘‘(ii) EXCEPTION.—A clinical trial 

9 under clause (i)(I)(aa) does not include— 

10 ‘‘(I) an exploratory clinical trial 

11 that is intended solely to assess safety 

12 or solely to evaluate pharmacokinetics; 

13 or 

14 ‘‘(II) an observational study. 

15 ‘‘(B) ESTABLISHMENT.— 

16 ‘‘(i) IN GENERAL.—To enhance pa17 tient enrollment and provide a mechanism 

18 to track subsequent progress of clinical 

19 trials, the Secretary, acting through the 

20 Director of NIH, shall establish and ad21 minister a clinical trial registry database in 

22 accordance with this subsection (referred 

23 to in this subsection as the ‘registry data24 base’). The Director of NIH shall ensure 


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1 that the registry database is made publicly 

2 available through the Internet. 

3 ‘‘(ii) CONTENT.—The Secretary shall 

4 promulgate regulations for the submission 

5 to the registry database of clinical trial in6 formation that— 

7 ‘‘(I) conforms to the Inter8 national Clinical Trials Registry Plat9 form trial registration data set of the 

10 World Health Organization; 

11 ‘‘(II) if the drug is not approved 

12 under section 505 of the Federal 

13 Food, Drug, and Cosmetic Act or li14 censed under section 351 of this Act, 

15 specifies whether or not there is a 

16 mechanism to access the drug outside 

17 of the clinical trial for those who do 

18 not qualify for enrollment in the clin19 ical trial and how to obtain informa20 tion about such a mechanism; and 

21 ‘‘(III) requires the inclusion of 

22 such other data elements to the reg23 istry database as appropriate. 

24 ‘‘(C) FORMAT AND STRUCTURE.— 


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1 ‘‘(i) SEARCHABLE CATEGORIES.—The 

2 Director of NIH shall ensure that the pub3 lic may search the entries in the registry 

4 database by— 

5 ‘‘(I)(aa) the indication being 

6 studied in the clinical trial, using 

7 Medical Subject Headers (MeSH) 

8 descriptors; or 

9 ‘‘(bb) the safety issue being stud10 ied in the clinical trial; 

11 ‘‘(II) enrollment status of the 

12 clinical trial; and 

13 ‘‘(III) the sponsor of the clinical 

14 trial. 

15 ‘‘(ii) FORMAT.—The Director of the 

16 NIH shall ensure that the registry data17 base is easily used by patients, and that 

18 entries are easily compared. 

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

20 party for an applicable clinical trial shall submit 

21 to the Director of NIH for inclusion in the reg22 istry database the clinical trial information de23 scribed in subparagraph (B)(ii). 

24 ‘‘(E) TRUTHFUL CLINICAL TRIAL INFOR25 MATION.— 


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

2 information submitted by a responsible 

3 party under this paragraph shall not be 

4 false or misleading in any particular. 

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

6 have the effect of requiring clinical trial in7 formation with respect to an applicable 

8 clinical trial to include information from 

9 any source other than such clinical trial. 

10 ‘‘(F) CHANGES IN CLINICAL TRIAL STA11 TUS.— 

12 ‘‘(i) ENROLLMENT.—The responsible 

13 party for an applicable clinical trial shall 

14 update the enrollment status not later than 

15 30 days after the enrollment status of such 

16 clinical trial changes. 

17 ‘‘(ii) COMPLETION.—The responsible 

18 party for an applicable clinical trial shall 

19 report to the Director of NIH that such 

20 clinical trial is complete not later than 30 

21 days after the completion date of the clin22 ical trial. 

23 ‘‘(G) TIMING OF SUBMISSION.—The clin24 ical trial information for an applicable clinical 

25 trial required to be submitted under this paraVerDate Aug 31 2005 02:17 Aug 09, 2006 Jkt 049200 PO 00000 Frm 00063 Fmt 6652 Sfmt 6201 E:\BILLS\S3807.IS S3807

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1 graph shall be submitted not later than 14 days 

2 after the first patient is enrolled in such clinical 

3 trial. 

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

5 ‘‘(A) APPLICABLE CLINICAL TRIAL.— 

6 ‘‘(i) IN GENERAL.—For purposes of 

7 this paragraph, the term ‘applicable clin8 ical trial’ means— 

9 ‘‘(I) an interventional clinical 

10 trial conducted before the drug is ap11 proved under section 505 of the Fed12 eral Food, Drug, and Cosmetic Act or 

13 licensed under section 351 of this Act 

14 that is— 

15 ‘‘(aa) a therapeutic or 

16 chemopreventive confirmatory 

17 clinical trial; 

18 ‘‘(bb) a clinical trial for a 

19 drug approved as a fast-track 

20 product under section 506 of the 

21 Federal Food, Drug, and Cos22 metic Act, if such clinical trial is 

23 used to form the primary basis of 

24 an efficacy claim for such drug; 

25 or 


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1 ‘‘(cc) if required by the Sec2 retary under subparagraph 

3 (G)(i), a clinical trial described in 

4 paragraph (2)(A)(i)(I)(aa); 

5 ‘‘(II) a clinical trial completed 

6 after the drug is approved under such 

7 section 505 or licensed under such 

8 section 351; or 

9 ‘‘(III) a pharmacokinetic study to 

10 support a pediatric indication for the 

11 drug. 

12 ‘‘(ii) EXCEPTION.—A clinical trial 

13 under clause (i) does not include— 

14 ‘‘(I) an exploratory clinical trial 

15 that is intended solely to assess safety 

16 or solely to evaluate pharmacokinetics; 

17 or 

18 ‘‘(II) an observational study. 

19 ‘‘(B) ESTABLISHMENT.—To ensure that 

20 results of clinical trials are made public and 

21 that patients and providers have current infor22 mation regarding the results of clinical trials, 

23 the Secretary, acting through the Director of 

24 NIH, shall establish and administer a clinical 

25 trial results database in accordance with this 


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1 subsection (referred to in this subsection as the 

2 ‘results database’). 

3 ‘‘(C) SEARCHABLE CATEGORIES.—The Di4 rector of NIH shall ensure that the public may 

5 search the entries in the results database by— 

6 ‘‘(i)(I) the indication studied in the 

7 clinical trial, using Medical Subject Head8 ers (MeSH) descriptors; or 

9 ‘‘(II) the safety issue studied in the 

10 clinical trial; 

11 ‘‘(ii) whether an application for the 

12 tested indication is approved, pending ap13 proval, withdrawn, or not submitted; 

14 ‘‘(iii) the phase of the clinical trial; 

15 ‘‘(iv) the name of the drug that is the 

16 subject of the clinical trial; and 

17 ‘‘(v) within the documents described 

18 in subclauses (II) and (III) of subpara19 graph (D)(ii)— 

20 ‘‘(I) the sponsor of the clinical 

21 trial; and 

22 ‘‘(II) each financial sponsor of 

23 the clinical trial. 

24 ‘‘(D) CONTENTS.— 


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1 ‘‘(i) IN GENERAL.—The responsible 

2 party for an applicable clinical trial shall 

3 submit to the Director of NIH for inclu4 sion in the results database the clinical 

5 trial information described in clause (ii). 

6 ‘‘(ii) REQUIRED ELEMENTS.—In sub7 mitting clinical trial information for an ap8 plicable clinical trial to the Director of 

9 NIH for inclusion in the results database, 

10 the responsible party shall include, with re11 spect to such clinical trial, the following in12 formation: 

13 ‘‘(I) The information described in 

14 clauses (i) through (iv) of subpara15 graph (C). 

16 ‘‘(II) A non-promotional sum17 mary document that is written in non18 technical, understandable language for 

19 patients that includes the following: 

20 ‘‘(aa) The purpose of the 

21 clinical trial. 

22 ‘‘(bb) The sponsor of the 

23 clinical trial. 


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1 ‘‘(cc) A point of contact for 

2 information about the clinical 

3 trial. 

4 ‘‘(dd) A description of the 

5 patient population tested in the 

6 clinical trial. 

7 ‘‘(ee) A general description 

8 of the clinical trial and results, 

9 including a description of and the 

10 reasons for any changes in the 

11 clinical trial design that occurred 

12 since the date of submission of 

13 clinical trial information for in14 clusion in the registry database 

15 established under paragraph (2) 

16 and a description of any signifi17 cant safety information. 

18 ‘‘(III) A non-promotional sum19 mary document that is technical in 

20 nature that includes the following: 

21 ‘‘(aa) The purpose of the 

22 clinical trial. 

23 ‘‘(bb) The sponsor of the 

24 clinical trial. 


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1 ‘‘(cc) Each financial sponsor 

2 of the clinical trial. 

3 ‘‘(dd) A point of contact for 

4 scientific information about the 

5 clinical trial. 

6 ‘‘(ee) A description of the 

7 patient population tested in the 

8 clinical trial. 

9 ‘‘(ff) A general description 

10 of the clinical trial and results, 

11 including a description of and the 

12 reasons for any changes in the 

13 clinical trial design that occurred 

14 since the date of submission of 

15 clinical trial information for the 

16 clinical trial in the registry data17 base established under paragraph 

18 (2). 

19 ‘‘(gg) Summary data de20 scribing the results, including— 

21 ‘‘(AA) whether the pri22 mary endpoint was achieved, 

23 including relevant statistics; 

24 ‘‘(BB) an assessment of 

25 any secondary endpoints, if 


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1 applicable, including relevant 

2 statistics; and 

3 ‘‘(CC) any significant 

4 safety information, including 

5 a summary of the incidence 

6 of serious adverse events ob7 served in the clinical trial 

8 and a summary of the most 

9 common adverse events ob10 served in the clinical trial 

11 and the frequencies of such 

12 events. 

13 ‘‘(IV) A link to available peer-re14 viewed publications based on the re15 sults of the clinical trial, if any. 

16 ‘‘(V) The completion date of the 

17 clinical trial. 

18 ‘‘(VI) A link to the Internet web 

19 posting of any adverse regulatory ac20 tions taken by the Food and Drug 

21 Administration, such as a warning let22 ter, that was substantively based on 

23 the clinical trial design, outcome, or 

24 representation made by the applicant 


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1 about the design or outcome of the 

2 clinical trial. 

3 ‘‘(E) TIMING.—A responsible party shall 

4 submit to the Director of NIH for inclusion in 

5 the results database clinical trial information 

6 for an applicable clinical trial not later than 1 

7 year after the completion date of the clinical 

8 trial as reported under paragraph (2)(F)(ii). 

9 ‘‘(F) TRUTHFUL CLINICAL TRIAL INFOR10 MATION.— 

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

12 information submitted by a responsible 

13 party under this paragraph shall not be 

14 false or misleading in any particular. 

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

16 have the effect of requiring clinical trial in17 formation with respect to an applicable 

18 clinical trial to include information from 

19 any source other than such clinical trial. 

20 ‘‘(G) INCLUSION OF EARLIER CLINICAL

21 TRIALS.— 

22 ‘‘(i) IN GENERAL.—The Secretary 

23 may, subject to clause (ii), require through 

24 rulemaking the submission of clinical trial 

25 information for the clinical trials described 


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1 in paragraph (2)(A)(i)(I)(aa) to the Direc2 tor of NIH for inclusion in the results 

3 database. 

4 ‘‘(ii) CONDITIONS FOR REQUIRING IN5 CLUSION OF EARLIER TRIALS.—The Sec6 retary may promulgate regulations pursu7 ant to clause (i) if— 

8 ‘‘(I) the Comptroller General of 

9 the United States has submitted to 

10 the Secretary the report described 

11 under clause (iii); and 

12 ‘‘(II) such report recommends 

13 the inclusion in the results database 

14 of clinical trial information for the 

15 clinical trials described under para16 graph (2)(A)(i)(I)(aa). 

17 ‘‘(iii) STUDY BY GAO.—Not earlier 

18 than 2 years after the results database has 

19 been established, the Comptroller General 

20 of the United States shall initiate a report 

21 that— 

22 ‘‘(I) evaluates the operation of 

23 the database, including with respect to 

24 cost, burden on drug sponsors and 

25 agencies, and the value to patients 


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1 and health care providers of inclusion 

2 in the results database of clinical trial 

3 information with respect to clinical 

4 trials described in paragraph 

5 (2)(A)(i)(I)(aa); 

6 ‘‘(II) recommends whether or not 

7 clinical trial information for such clin8 ical trials should be included in the re9 sults database; 

10 ‘‘(III) if the recommendation 

11 under subclause (II) is to include the 

12 clinical trial information for such clin13 ical trials in the results database, rec14 ommends whether such information 

15 should be included in the same format 

16 as the clinical trial information of 

17 other applicable clinical trials, or if 

18 modifications are necessary; 

19 ‘‘(IV) provides recommendations 

20 for any modifications described under 

21 subclause (III); and 

22 ‘‘(V) is submitted to the Com23 mittee on Health, Education, Labor, 

24 and Pensions of the Senate, the Com25 mittee on Energy and Commerce of 


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1 the House of Representatives, and the 

2 Secretary. 

3 ‘‘(H) CHANGE IN REGULATORY STATUS.— 

4 The responsible party for an applicable clinical 

5 trial shall update the regulatory status sub6 mitted under subparagraph (C)(ii) of a drug 

7 that is the subject of an applicable clinical trial 

8 within 30 days of a change in such status. 

9 ‘‘(I) PUBLIC AVAILABILITY OF RESULTS.— 

10 ‘‘(i) PRE-APPROVAL STUDIES.—Ex11 cept as provided in clause (iv), with respect 

12 to an applicable clinical trial that is com13 pleted before the drug is initially approved 

14 under section 505 of the Federal Food, 

15 Drug, and Cosmetic Act or initially li16 censed under section 351 of this Act, the 

17 Director of NIH shall make publicly avail18 able on the results database the clinical 

19 trial information submitted for such clin20 ical trial not later than 30 days after— 

21 ‘‘(I) the drug is approved under 

22 such section 505 or licensed under 

23 such section 351; or 


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1 ‘‘(II) the Secretary issues a not 

2 approvable letter for the drug under 

3 such section 505 or such section 351. 

4 ‘‘(ii) POST-APPROVAL STUDIES.—Ex5 cept as provided in clauses (iii) and (iv), 

6 with respect to an applicable clinical trial 

7 that is completed after the drug is initially 

8 approved under such section 505 or ini9 tially licensed under such section 351, the 

10 Director of NIH shall make publicly avail11 able on the results database the clinical 

12 trial information submitted for such clin13 ical trial not later than 30 days after the 

14 date of such submission. 

15 ‘‘(iii) SEEKING APPROVAL OF A NEW

16 USE FOR THE DRUG.— 

17 ‘‘(I) IN GENERAL.—If the manu18 facturer of the drug is the sponsor or 

19 a financial sponsor of the applicable 

20 clinical trial, and such manufacturer 

21 certifies to the Director of NIH that 

22 such manufacturer has filed, or will 

23 file within 1 year, an application seek24 ing approval under such section 505 

25 or licensing under such section 351 


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1 for the use studied in such clinical 

2 trial (which use is not included in the 

3 labeling of the approved drug), then 

4 the Director of NIH shall make pub5 licly available on the results database 

6 the clinical trial information sub7 mitted for such clinical trial on the 

8 earlier of the date that is 30 days 

9 after the date— 

10 ‘‘(aa) the application is ap11 proved under such section 505 or 

12 licensed such section 351; 

13 ‘‘(bb) the Secretary issues a 

14 not approvable letter for the ap15 plication under such section 505 

16 or such section 351; or 

17 ‘‘(cc) the application under 

18 such section 505 or such section 

19 351 is withdrawn. 

20 ‘‘(II) LIMITATION ON CERTIFI21 CATION.—A manufacturer shall not 

22 make a certification under subclause 

23 (I) with respect to an applicable clin24 ical trial unless the manufacturer 

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1 spect to each applicable clinical trial 

2 that is required to be submitted in an 

3 application for approval of the use 

4 studied in the clinical trial involved. 

5 ‘‘(III) 2 YEAR LIMITATION.—The 

6 clinical trial information subject to 

7 subclause (I) shall be made publicly 

8 available on the results database on 

9 the date that is 2 years after the date 

10 that the clinical trial information was 

11 required to be submitted to the Direc12 tor of NIH if a regulatory action re13 ferred to in item (aa), (bb), or (cc) of 

14 subclause (I) has not occurred by 

15 such date. 

16 ‘‘(iv) SEEKING PUBLICATION.— 

17 ‘‘(I) IN GENERAL.—If the prin18 cipal investigator of the applicable 

19 clinical trial is seeking publication in 

20 a peer-reviewed biomedical journal of 

21 a manuscript based on the results of 

22 the clinical trial and the responsible 

23 party so certifies to the Director of 

24 NIH— 


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1 ‘‘(aa) the responsible party 

2 shall notify the Director of NIH 

3 of the publication date of such 

4 manuscript not later than 15 

5 days after such date; and 

6 ‘‘(bb) the Director of NIH 

7 shall make publicly available on 

8 the results database the clinical 

9 trial information submitted for 

10 such clinical trial on the date 

11 that is 30 days after the publica12 tion date of such manuscript. 

13 ‘‘(II) LIMITATION.—The clinical 

14 trial information subject to subclause 

15 (I) shall be made publicly available on 

16 the results database on the date that 

17 is 2 years after the date that the clin18 ical trial information was required to 

19 be submitted to the Director of NIH 

20 if the manuscript referred to in such 

21 subclause has not been published by 

22 such date. 

23 ‘‘(J) VERIFICATION OF SUBMISSION PRIOR

24 TO PUBLIC AVAILABILITY.—In the case of clin25 ical trial information that is submitted under 


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1 this paragraph, but is not made publicly avail2 able pending either regulatory action or publica3 tion under clause (iii) or (iv) of subparagraph 

4 (I), as applicable, the Director of NIH shall re5 spond to inquiries from other Federal agencies 

6 and peer-reviewed journals to confirm that such 

7 clinical trial information has been submitted 

8 but has not yet been made publicly available on 

9 the results database. 

10 ‘‘(4) COORDINATION AND COMPLIANCE.— 

11 ‘‘(A) CLINICAL TRIALS SUPPORTED BY

12 GRANTS FROM FEDERAL AGENCIES.— 

13 ‘‘(i) IN GENERAL.—No Federal agen14 cy may release funds under a research 

15 grant to a person who has not complied 

16 with paragraphs (2) and (3) for any appli17 cable clinical trial for which such person is 

18 the responsible party. 

19 ‘‘(ii) GRANTS FROM CERTAIN FED20 ERAL AGENCIES.—If an applicable clinical 

21 trial is funded in whole or in part by a 

22 grant from the National Institutes of 

23 Health, the Agency for Healthcare Re24 search and Quality, or the Department of 

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1 port forms required under such grant shall 

2 include a certification that the responsible 

3 party has made all required submissions to 

4 the Director of NIH under paragraphs (2) 

5 and (3). 

6 ‘‘(iii) VERIFICATION BY FEDERAL

7 AGENCIES.—The heads of the agencies re8 ferred to in clause (ii), as applicable, shall 

9 verify that the clinical trial information for 

10 each applicable clinical trial for which a 

11 grantee is the responsible party has been 

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

13 applicable, before releasing funding for a 

14 grant to such grantee. 

15 ‘‘(iv) NOTICE AND OPPORTUNITY TO

16 REMEDY.—If the head of an agency re17 ferred to in clause (ii), as applicable, 

18 verifies that a grantee has not submitted 

19 clinical trial information as described in 

20 clause (iii), such agency head shall provide 

21 notice to such grantee of such non-compli22 ance and allow such grantee 30 days to 

23 correct such non-compliance and submit 

24 the required clinical trial information. 


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1 ‘‘(v) CONSULTATION WITH OTHER

2 FEDERAL AGENCIES.—The Secretary 

3 shall— 

4 ‘‘(I) consult with other agencies 

5 that conduct human studies in accord6 ance with part 46 of title 45, Code of 

7 Federal Regulations (or any successor 

8 regulations), to determine if any such 

9 studies are applicable clinical trials 

10 under paragraph (2) or (3); and 

11 ‘‘(II) develop with such agencies 

12 procedures comparable to those de13 scribed in clauses (ii), (iii), and (iv) to 

14 ensure that clinical trial information 

15 for such applicable clinical trials is 

16 submitted under paragraphs (2) and 

17 (3). 

18 ‘‘(B) COORDINATION OF REGISTRY DATA19 BASE AND RESULTS DATABASE.— 

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

21 registry database under paragraph (2) 

22 shall include a link to the corresponding 

23 entry in the results database under para24 graph (3). 

25 ‘‘(ii) MISSING ENTRIES.— 


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1 ‘‘(I) IN GENERAL.—If, based on 

2 a review of the entries in the registry 

3 database under paragraph (2), the Di4 rector of NIH determines that a re5 sponsible party has failed to submit 

6 required clinical trial information to 

7 the results database under paragraph 

8 (3), the Director of NIH shall inform 

9 the responsible party involved of such 

10 failure and permit the responsible 

11 party to correct the failure within 30 

12 days. 

13 ‘‘(II) FAILURE TO CORRECT.—If 

14 the responsible party does not correct 

15 a failure to submit required clinical 

16 trial information within the 30-day 

17 period described under subclause (I), 

18 the Director of NIH shall report such 

19 non-compliance to the scientific peer 

20 review committees of the Federal re21 search agencies and to the Office of 

22 Human Research Protections. 

23 ‘‘(III) PUBLIC NOTICE OF FAIL24 URE TO CORRECT.—The Director of 

25 NIH shall include in the clinical trial 


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1 registry database entry and the clin2 ical trial results database entry for 

3 each such clinical trial a notice of any 

4 uncorrected failure to submit required 

5 clinical trial information and shall 

6 provide that the public may easily 

7 search for such entries. 

8 ‘‘(C) ACTION ON APPLICATIONS.— 

9 ‘‘(i) VERIFICATION PRIOR TO FIL10 ING.—The Secretary, acting through the 

11 Commissioner of Food and Drugs, shall 

12 verify that the clinical trial information re13 quired under paragraphs (2) and (3) for 

14 an applicable clinical trial is submitted 

15 pursuant to such applicable paragraph— 

16 ‘‘(I) when considering a drug for 

17 an exemption under section 505(i) of 

18 the Federal Food, Drug, and Cos19 metic Act, including as the drug pro20 gresses through the clinical trials de21 scribed under paragraph (2)(A)(i); 

22 and 

23 ‘‘(II) prior to filing an applica24 tion under section 505 of the Federal 

25 Food, Drug, and Cosmetic Act or 


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1 under section 351 of this Act that in2 cludes information from such clinical 

3 trial. 

4 ‘‘(ii) NOTIFICATION.—If the respon5 sible party has not submitted such clinical 

6 trial information, the Secretary shall notify 

7 the applicant and the responsible party of 

8 such non-compliance and require submis9 sion of such results within 30 days. 

10 ‘‘(iii) REFUSAL TO FILE.—If the re11 sponsible party does not remedy such non12 compliance within 30 days of receipt of no13 tification under clause (ii), the Secretary 

14 shall refuse to file such application. 

15 ‘‘(D) CONTENT REVIEW.— 

16 ‘‘(i) IN GENERAL.—To assure that the 

17 summary documents described in para18 graph (3)(D) are non-promotional, and are 

19 not false or misleading in any particular 

20 under paragraph (3)(F), the Secretary 

21 shall compare such documents to the re22 sults data of the clinical trial for a rep23 resentative sample of applicable clinical 

24 trials by— 


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1 ‘‘(I) acting through the Commis2 sioner of Food and Drugs to examine 

3 the results data for such clinical trials 

4 submitted to Secretary when such 

5 data are submitted— 

6 ‘‘(aa) for review as part of 

7 an application under section 505 

8 of the Federal Food, Drug, and 

9 Cosmetic Act or under section 

10 351 of this Act; or 

11 ‘‘(bb) in an annual status 

12 report on the drug under such 

13 application; 

14 ‘‘(II) acting through the Inspec15 tor General of the Department of 

16 Health and Human Services and with 

17 the Federal agency that funds such 

18 clinical trial in whole or in part by a 

19 grant to examine the results data for 

20 such clinical trials; and 

21 ‘‘(III) acting through inspections 

22 under section 704 of the Federal 

23 Food, Drug, and Cosmetic Act to ex24 amine results data for such clinical 


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1 trials not described in subclause (I) or 

2 (II). 

3 ‘‘(ii) NOTICE OF NON-COMPLIANCE.— 

4 If the Secretary or Inspector General of 

5 the Department of Health and Human 

6 Services determines that the clinical trial 

7 information submitted in such a summary 

8 document is promotional, or false or mis9 leading in any particular, the Secretary 

10 shall notify the responsible party and give 

11 such party an opportunity to remedy such 

12 non-compliance by submitting the required 

13 revised clinical trial information within 30 

14 days of such notification. 

15 ‘‘(E) PENALTY FOR NON-COMPLIANCE.—In 

16 determining whether to apply a penalty under 

17 section 301(ii) of the Federal Food, Drug, and 

18 Cosmetic Act, the Secretary, acting through the 

19 Commissioner of Food and Drugs, shall con20 sider— 

21 ‘‘(i) whether the responsible party 

22 promptly corrects the non-compliance when 

23 provided notice; 


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1 ‘‘(ii) whether the responsible party 

2 has engaged in a pattern or practice of 

3 non-compliance; and 

4 ‘‘(iii) the extent to which the non5 compliance involved may have significantly 

6 misled healthcare providers or patients 

7 concerning the safety or effectiveness of 

8 the drug involved. 

9 ‘‘(5) LIMITATION ON DISCLOSURE OF CLINICAL

10 TRIAL INFORMATION.—Disclosure to the public of 

11 clinical trial information submitted to the Director 

12 of NIH under this subsection and requested under 

13 section 552 of title 5, United States Code (com14 monly known as the Freedom of Information Act) 

15 shall be made only as provided for under paragraphs 

16 (2) and (3). 

17 ‘‘(6) AUTHORIZATION OF APPROPRIATIONS.— 

18 There are authorized to be appropriated to carry out 

19 this subsection such sums as may be necessary.’’. 

20 (b) CONFORMING AMENDMENTS.— 

21 (1) PROHIBITED ACTS.—Section 301 of the 

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

23 331) is amended by adding at the end the following: 


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1 ‘‘(ii)(1) The failure to submit clinical trial informa2 tion as required by section 402(j) of the Public Health 

3 Service Act. 

4 ‘‘(2) The submission of clinical trial information 

5 under section 402(j) of the Public Health Service Act that 

6 is promotional or false or misleading in any particular 

7 under paragraph (2)(E) or (3)(F) of such section 402(j).’’. 

8 (2) NEW DRUGS.— 

9 (A) INVESTIGATIONAL NEW DRUGS.—Sec10 tion 505(i) of the Federal Food, Drug, and 

11 Cosmetic Act (21 U.S.C. 355(i)) is amended— 

12 (i) in paragraph (1)— 

13 (I) in subparagraph (C), by strik14 ing ‘‘and’’ after the semicolon; 

15 (II) in subparagraph (D), by 

16 striking the period at the end and in17 serting ‘‘; and’’; and 

18 (III) by adding at the end the 

19 following: 

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

21 clinical trial information for the clinical investigation 

22 at issue required under section 402(j) of the Public 

23 Health Service Act for inclusion in the registry data24 base and the results database described in such sec25 tion.’’; 


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1 (ii) in paragraph (3)(B)— 

2 (I) in clause (i), by striking ‘‘or’’ 

3 after the semicolon; 

4 (II) in clause (ii), by striking the 

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

6 and 

7 (III) by adding at the end the 

8 following: 

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

10 investigation at issue was not submitted in compli11 ance with section 402(j) of the Public Health Service 

12 Act.’’; and 

13 (iii) in paragraph (4), by adding at 

14 the end the following: ‘‘The Secretary shall 

15 update such regulations to require inclu16 sion in the informed consent form a state17 ment that clinical trial information for 

18 such clinical investigation will be submitted 

19 for inclusion in the registry database and 

20 results database, as applicable, described 

21 in section 402(j) of the Public Health 

22 Service Act.’’. 

23 (B) REFUSAL TO APPROVE APPLICA24 TION.—Section 505(d) of the Federal Food, 


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1 Drug, and Cosmetic Act (21 U.S.C. 355(d)) is 

2 amended— 

3 (i) in the first sentence, by inserting 

4 after ‘‘or any particular;’’ the following: 

5 ‘‘or (8) the applicant failed to submit the 

6 clinical trial information for any applicable 

7 clinical trial submitted as part of the appli8 cation to the Director of the National In9 stitutes of Health in compliance with sec10 tion 402(j) of the Public Health Service 

11 Act;’’; and 

12 (ii) in the second sentence, by striking 

13 ‘‘clauses (1) through (6)’’ and inserting 

14 ‘‘(1) through (8)’’. 

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

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

17 and Drugs, in consultation with the Director of the Na18 tional Institutes of Health, shall issue guidance to clarify 

19 which clinical trials are applicable clinical trials (as de20 fined in section 402(j)(2) of the Public Health Service Act, 

21 as amended by this section) (42 U.S.C. 282(j)(2)) and are 

22 required to be submitted for inclusion in the clinical trial 

23 registry database described in such section 402(j)(2). 

24 (d) PREEMPTION.— 


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1 (1) IN GENERAL.—No State or political subdivi2 sion of a State may establish or continue in effect 

3 any requirement for the registration of clinical trials 

4 or for the inclusion of information relating to the re5 sults of clinical trials in a database. 

6 (2) RULE OF CONSTRUCTION.—The fact of sub7 mission of clinical trial information, if submitted in 

8 compliance with section 402(j) of the Public Health 

9 Service Act (as amended by this section) (42 U.S.C. 

10 282(j)), that relates to a use of a drug not included 

11 in the labeling of the approved drug shall not be 

12 construed by the Secretary or in any administrative 

13 or judicial proceeding, as evidence of a new intended 

14 use of the drug that is different from the intended 

15 use of the drug set forth in the official labeling of 

16 the drug. The availability of clinical trial information 

17 through the databases under paragraphs (2) and (3) 

18 of such section 402(j), if submitted in compliance 

19 with such section 402(j), shall not be considered as 

20 labeling, adulteration, or misbranding of the drug 

21 under the Federal Food, Drug, and Cosmetic Act 

22 (21 U.S.C. 301 et seq.). 

23 (e) EFFECTIVE DATES.— 

24 (1) ESTABLISHMENT OF REGISTRY DATABASE

25 AND RESULTS DATABASE.—Not later than 1 year 


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

2 of NIH shall establish the registry database and the 

3 results database of clinical trials of drugs in accord4 ance with section 402(j) of the Public Health Service 

5 Act (42 U.S.C. 282(j)) (as amended by subsection 

6 (a)). 

7 (2) CLINICAL TRIALS INITIATED PRIOR TO OP8 ERATION OF REGISTRY DATABASE.—The responsible 

9 party (as defined in such section 402(j)) for an ap10 plicable clinical trial under paragraph (2) of such 

11 section 402(j) that is initiated after the date of en12 actment of this Act and before the date such reg13 istry database is established under paragraph (1) of 

14 this subsection, shall submit required clinical trial 

15 information not later than 120 days after the date 

16 such registry database is established. 

17 (3) CLINICAL TRIALS INITIATED AFTER OPER18 ATION OF REGISTRY DATABASE.—The responsible 

19 party (as defined in such section 402(j)) for an ap20 plicable clinical trial under paragraph (2) of such 

21 section 402(j) that is initiated after the date such 

22 registry database is established under paragraph (1) 

23 of this subsection shall submit required clinical trial 

24 information in accordance with such paragraph (2). 


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1 (4) TRIALS COMPLETED BEFORE OPERATION

2 OF RESULTS DATABASE.— 

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

4 section 402(j) shall take effect 90 days after 

5 the date the results database is established 

6 under paragraph (1) of this subsection with re7 spect to any applicable clinical trial (as defined 

8 in such section 402(j)(3)) that— 

9 (i) involves a drug to treat a serious 

10 and life-threatening condition; and 

11 (ii) is completed between the date of 

12 enactment of this section and such date of 

13 establishment under paragraph (1) of this 

14 subsection. 

15 (B) OTHER TRIALS.—Except as provided 

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

17 section 402(j) shall take effect 180 days after 

18 the date that the results database is established 

19 under paragraph (1) of this subsection with re20 spect to any applicable clinical trial (as defined 

21 in such section 402(j)(3)) that is completed be22 tween the date of enactment of this Act and 

23 such date of establishment under paragraph 

24 (1). 


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1 (C) TRIALS SUBMITTED IN AN APPLICA2 TION.—Except as provided in subparagraph 

3 (A), paragraph (3) of such section 402(j) shall 

4 take effect for any clinical trial if— 

5 (i) such clinical trial would otherwise 

6 be an applicable clinical trial under para7 graph (3) except for its date of completion; 

8 and 

9 (ii) data from such clinical trial is 

10 submitted in an application or supplement 

11 to an application under section 505 of the 

12 Food, Drug, and Cosmetic Act or under 

13 section 351 of the Public Health Service 

14 Act that— 

15 (I) is submitted 180 days or 

16 more after the date that the results 

17 database is established under para18 graph (1) of this subsection; and 

19 (II) contains data from an appli20 cable clinical trial. 

21 (5) TRIALS COMPLETED AFTER ESTABLISH22 MENT OF RESULTS DATABASE.—Paragraph (3) of 

23 such section 402(j) shall apply to any applicable 

24 clinical trial that is completed after the date that the 


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1 results database is established under paragraph (1) 

2 of this subsection. 

3 (6) FUNDING RESTRICTIONS.—Subparagraph 

4 (A) of paragraph (4) of such section 402(j) shall 

5 take effect 210 days after the date that the clinical 

6 trial registry database and the clinical trial results 

7 database are established under paragraph (1) of this 

8 subsection. 

9 (7) STATUS OF CLINICALTRIALS.GOV

10 WEBSITE.— 

11 (A) IN GENERAL.—After receiving public 

12 comment and not later than 90 days after the 

13 date of enactment of this Act, the Secretary 

14 shall publish in the Federal Register a notice 

15 determining the more efficient approach to es16 tablishing the registry database described in 

17 paragraph (2) of such section 402(j) and 

18 whether such approach is— 

19 (i) that such registry database should 

20 expand and build upon the database de21 scribed in section 402(j) of the Public 

22 Health Service Act (as in effect on the day 

23 before the date of enactment of this Act); 

24 or 


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1 (ii) that such registry database should 

2 supplant the database described in such 

3 section 402(j) (as in effect on the day be4 fore the date of enactment of this Act). 

5 (B) CLINICALTRIALS.GOV SUPPLANTED.— 

6 If the Secretary determines to apply the ap7 proach described under subparagraph (A)(ii), 

8 the Secretary shall maintain an archive of the 

9 database described in such section 402(j) (as in 

10 effect on the day before the date of enactment 

11 of this Act) on the Internet website of the Na12 tional Library of Medicine. 

13 TITLE IV—CONFLICTS OF 

14 INTEREST 

15 SEC. 401. CONFLICTS OF INTEREST. 

16 (a) IN GENERAL.—Subchapter A of chapter VII of 

17 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 

18 et seq.) is amended by inserting at the end the following: 

19 ‘‘SEC. 712. CONFLICTS OF INTEREST. 

20 ‘‘(a) DEFINITIONS.—For purposes of this section: 

21 ‘‘(1) INVOLVEMENT.—The term ‘involvement’ 

22 means any financial interest in— 

23 ‘‘(A) a product that is under consideration 

24 by a panel; 


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1 ‘‘(B) a competing product of such a prod2 uct; 

3 ‘‘(C) the sponsor of such product; or 

4 ‘‘(D) the sponsor of such a competing 

5 product. 

6 ‘‘(2) PANEL.—The term ‘panel’ means any 

7 committee, board, commission, council, conference, 

8 panel, task force, or other similar group, or any sub9 committee or other subgroup thereof, that is estab10 lished by statute or by the Secretary to provide ad11 vice or recommendations to the Secretary regarding 

12 activities of the Food and Drug Administration. 

13 ‘‘(3) PRODUCT.—The term ‘product’ means a 

14 food, drug, biological product, device, or electronic 

15 product that is regulated by the Food and Drug Ad16 ministration. 

17 ‘‘(b) APPOINTMENTS TO PANELS.— 

18 ‘‘(1) DISCLOSURE.—Prior to appointment to a 

19 panel, each candidate member of a panel shall dis20 close to the Secretary all involvements that such 

21 candidate may have with the work likely to be un22 dertaken by the panel during the term of the ap23 pointment for which the candidate is under consider24 ation. 


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1 ‘‘(2) EVALUATION AND CRITERIA.—When con2 sidering an appointment to a panel, the Secretary— 

3 ‘‘(A) shall review the expertise and poten4 tial involvements of the candidate for appoint5 ment relative to the scope of work likely to be 

6 undertaken by the panel during the term of the 

7 appointment for which the candidate is under 

8 consideration, so as to— 

9 ‘‘(i) maximize to the extent prac10 ticable the appointment of qualified indi11 viduals with no involvements, or only po12 tential involvements of low magnitude, with 

13 such work; and 

14 ‘‘(ii) minimize to the extent prac15 ticable the appointment of individuals with 

16 potential involvements of high magnitude 

17 with such work; and 

18 ‘‘(B) may appoint 2 or more qualified indi19 viduals with similar expertise and non-overlap20 ping or minimally overlapping potential involve21 ments, so as to minimize the likelihood that a 

22 panel will need the expertise of an appointed in23 dividual who requires a waiver for service on 

24 the panel at a meeting of such panel. 

25 ‘‘(c) DISCLOSURE BY PANEL MEMBER.— 


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1 ‘‘(1) IN GENERAL.—Prior to a meeting of a 

2 panel, each member of such panel shall disclose to 

3 the Secretary all involvements that such member 

4 may have with the work to be undertaken by such 

5 panel at such meeting. 

6 ‘‘(2) DETERMINATION BY SECRETARY WITH RE7 SPECT TO PANEL MEETINGS.— 

8 ‘‘(A) IN GENERAL.—The Secretary shall 

9 make a determination with respect to each 

10 panel member based on the expertise of such 

11 panel member and the disclosure under para12 graph (1). Such a determination shall be in one 

13 of the following categories: 

14 ‘‘(i) APPROVAL FOR SERVICE.—The 

15 Secretary shall make the determination of 

16 approval for service for a panel member if 

17 there are no involvements or if the involve18 ments of the panel member are of low 

19 magnitude. 

20 ‘‘(ii) APPROVAL FOR SERVICE WITH A

21 WAIVER OR LIMITED WAIVER.—The Sec22 retary shall make the determination of ap23 proval for service with a waiver or limited 

24 waiver for a panel member if the involve25 ments of the panel member are of medium 


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1 or high magnitude and the Secretary cer2 tifies in writing that— 

3 ‘‘(I) such waiver is necessary to 

4 provide the panel with essential exper5 tise; or 

6 ‘‘(II) the need for the individual’s 

7 service outweighs the potential for a 

8 conflict of interest created by the dis9 closed involvements. 

10 ‘‘(iii) RECUSAL.—The Secretary shall 

11 make the determination of recusal for a 

12 panel member if the involvements of the 

13 panel member are of medium or high mag14 nitude but a waiver or limited waiver could 

15 not be granted under clause (ii) because 

16 the criteria for certification by the Sec17 retary under such clause were not met. 

18 ‘‘(B) NOTICE OF DETERMINATION.— 

19 ‘‘(i) MORE THAN 15 DAYS IN AD20 VANCE.—A soon as practicable, but in no 

21 case later than 15 days prior to a meeting 

22 of a panel to which a determination for a 

23 panel member under clause (ii) or (iii) of 

24 subparagraph (A) applies, the Secretary 

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1 empted from disclosure under section 552 

2 of title 5, United States Code (popularly 

3 known as the Freedom of Information 

4 Act)) on the Internet website of the Food 

5 and Drug Administration— 

6 ‘‘(I) the type of the involvements; 

7 ‘‘(II) the nature of the involve8 ments; 

9 ‘‘(III) the magnitude of the in10 volvements; and 

11 ‘‘(IV) the reasons for any deter12 mination of the Secretary under such 

13 clause (ii). 

14 ‘‘(ii) LESS THAN 15 DAYS IN AD15 VANCE.—In the case of a conflict of inter16 est that becomes known to the Secretary 

17 less than 15 days prior to a meeting to 

18 which the determination under clause (ii) 

19 or (iii) of subparagraph (A) applies, the 

20 Secretary shall disclose (other than infor21 mation exempted from disclosure under 

22 section 552 of title 5, United States Code 

23 (popularly known as the Freedom of Infor24 mation Act)) on the Internet website of the 

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1 mation described in subclauses (I) through 

2 (IV) of clause (i) of this subparagraph as 

3 soon as practicable, but in no event later 

4 than the date of such meeting. 

5 ‘‘(d) LIMITATIONS.—In no case— 

6 ‘‘(1) may the Secretary grant a waiver under 

7 subsection (c)(2) for a panel member if the scientific 

8 work of such member is under consideration by the 

9 panel; or 

10 ‘‘(2) may a panel member vote with respect to 

11 any matter considered by the panel if such panel 

12 member or an immediate family member of such 

13 panel member could gain financially from the advice 

14 given to the Secretary with respect to such matter. 

15 ‘‘(e) PUBLIC RECORD.—The Secretary shall ensure 

16 that the public record of each meeting of a panel includes 

17 a description of any determination of the Secretary made 

18 under subsection (c)(2), including the category of such de19 termination and the involvements of each panel member 

20 (other than information exempted from disclosure under 

21 section 552 of title 5, United States Code (popularly 

22 known as the Freedom of Information Act)).’’. 

23 (b) GUIDANCE.— 

24 (1) NOMINATIONS.—Not later than 270 days 

25 after the date of enactment of this Act the Secretary 


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1 shall publish in the Federal Register for public com2 ment a proposed mechanism for encouraging the 

3 nomination of individuals who are classified by the 

4 Food and Drug Administration as academicians or 

5 practitioners for service on a panel (as defined in 

6 section 712 of the Federal Food, Drug, and Cos7 metic Act (as added by this section)). 

8 (2) CONFLICT OF INTEREST DETERMINA9 TIONS.—Not later than 270 days after the date of 

10 enactment of this Act the Secretary shall issue or re11 vise guidance— 

12 (A) that defines the circumstances that, 

13 taking into consideration the categories of de14 termination under subsection (c) of section 712 

15 of the Federal Food, Drug, and Cosmetic Act 

16 (as added by this section)— 

17 (i) favor the inclusion of an individual 

18 on a panel; 

19 (ii) favor a waiver of a conflict of in20 terest requirement for an individual on a 

21 panel; 

22 (iii) favor a limited waiver of a con23 flict of interest requirement for an indi24 vidual on a panel; and 


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1 (iv) disfavor the inclusion of an indi2 vidual on a panel; 

3 (B) that gives greater priority to consider4 ation of an individual’s net worth over consider5 ation of absolute dollar value of an involvement 

6 in evaluating the magnitude of an involvement 

7 for purposes of making a determination under 

8 such subsection (c); 

9 (C) that defines how financial interests im10 puted to an individual bear upon his or her eli11 gibility for service on a panel or for service at 

12 a meeting of a panel; 

13 (D) that clarifies and improves the proc14 esses to ensure disclosure of, and to verify the 

15 accuracy of, financial interests imputed to an 

16 individual; and 

17 (E) to ensure consistency within and 

18 among the centers of the Food and Drug Ad19 ministration in the issuance of determinations 

20 under such subsection (c). 

21 (3) PERIODIC REVIEW.—At least once every 5 

22 years, the Secretary shall review the guidance de23 scribed under paragraph (2) and update such guid24 ance as necessary. 

25 (c) REVIEW BY INSPECTOR GENERAL.— 


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1 (1) IN GENERAL.—The Inspector General of 

2 the Department of Health and Human Services 

3 shall, on a periodic basis, conduct a review of the 

4 current financial interests, which shall be disclosed 

5 to the Inspector General in the same format and 

6 manner as under subsection (c) of section 712 of the 

7 Federal Food, Drug, and Cosmetic Act (as added by 

8 this section), of a representative sample of individ9 uals who have completed service on such a panel (as 

10 defined in such section 712). 

11 (2) SUBMISSION OF REPORT.—As part of the 

12 semiannual report required under section 5 of the 

13 Inspector General Act of 1978 (5 U.S.C. App.), the 

14 Inspector General of the Department of Health and 

15 Human Services shall include any findings with re16 spect to an individual being rewarded or otherwise 

17 compensated by a sponsor of a product or a sponsor 

18 of a competing product in exchange for the individ19 ual’s vote as a member of a panel of the Food and 

20 Drug Administration which considered the product 

21 or a competing product (as such terms are used in 

22 such section 712), or the absence of any such find23 ings. 


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1 (d) CONFORMING AMENDMENT.—Section 505(n) of 

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

3 355(n)) is amended by— 

4 (1) striking paragraph (4); and 

5 (2) redesignating paragraphs (5), (6), (7), and 

6 (8) as paragraphs (4), (5), (6), and (7), respectively. 

7 (e) EFFECTIVE DATE.—The amendments made by 

8 this section shall take effect on October 1, 2007. 

Æ 


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