II 

110TH CONGRESS 

1ST SESSION S. 484 

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 

FEBRUARY 1, 2007 

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 2007’’. 


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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 to 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. 

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

16 ‘‘(A) ADVERSE DRUG EXPERIENCE.—The 

17 term ‘adverse drug experience’ means any ad18 verse event associated with the use of a drug in 

19 humans, whether or not considered drug re20 lated, including— 

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

22 course of the use of the drug in profes23 sional practice; 


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1 ‘‘(ii) an adverse event occurring from 

2 an overdose of the drug, whether acci3 dental or intentional; 

4 ‘‘(iii) an adverse event occurring from 

5 abuse of the drug; 

6 ‘‘(iv) an adverse event occurring from 

7 withdrawal of the drug; and 

8 ‘‘(v) any failure of expected pharma9 cological action of the drug. 

10 ‘‘(B) SERIOUS ADVERSE DRUG EXPERI11 ENCE.—The term ‘serious adverse drug experi12 ence’ is an adverse event that— 

13 ‘‘(i) results in— 

14 ‘‘(I) death; 

15 ‘‘(II) a adverse drug experience 

16 that places the patient at immediate 

17 risk of death from the adverse drug 

18 experience as it occurred (not includ19 ing an adverse drug experience that 

20 might have caused death had it oc21 curred in a more severe form); 

22 ‘‘(III) inpatient hospitalization or 

23 prolongation of existing hospitaliza24 tion; 


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1 ‘‘(IV) a persistent or significant 

2 incapacity or substantial disruption of 

3 the ability to conduct normal life 

4 functions; or 

5 ‘‘(V) a congenital anomaly or 

6 birth defect; or 

7 ‘‘(ii) based on appropriate medical 

8 judgment, may jeopardize the patient and 

9 may require a medical or surgical interven10 tion to prevent an outcome described under 

11 clause (i). 

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

13 risk’ means a risk of a serious adverse drug ex14 perience. 

15 ‘‘(D) UNEXPECTED SERIOUS RISK.—The 

16 term ‘unexpected serious risk’ means a serious 

17 adverse drug experience that is not listed in the 

18 labeling of a drug, or that may be sympto19 matically and pathophysiologically related to an 

20 adverse drug experience identified in the label21 ing, but differs from such adverse drug experi22 ence because of greater severity, specificity, or 

23 prevalence. 

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

25 term ‘signal of a serious risk’ means informaVerDate Aug 31 2005 03:36 Feb 03, 2007 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S484.IS S484

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1 tion related to a serious adverse drug experi2 ence associated with use of a drug and derived 

3 from— 

4 ‘‘(i) a clinical trial; 

5 ‘‘(ii) adverse event reports; 

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

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

8 ‘‘(iv) peer-reviewed biomedical lit9 erature. 

10 ‘‘(F) NEW SAFETY INFORMATION.—The 

11 term ‘new safety information’ with respect to a 

12 drug means information about— 

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

14 serious risk associated with use of the drug 

15 that the Secretary has become aware of 

16 since the last assessment of the approved 

17 risk evaluation and mitigation strategy for 

18 the drug; or 

19 ‘‘(ii) the effectiveness of the approved 

20 risk evaluation and mitigation strategy for 

21 the drug obtained since the last assessment 

22 of such strategy. 

23 ‘‘(3) REQUIRED ELEMENTS OF ARISK EVALUA24 TION AND MITIGATION STRATEGY.—The risk evaluaVerDate Aug 31 2005 03:36 Feb 03, 2007 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S484.IS S484

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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 of reports to the Vaccine 

10 Adverse Event Reporting Systems 

11 (VAERS); or 

12 ‘‘(II) surveillance using the Vaccine 

13 Safety Datalink (VSD) or successor data14 bases; 

15 ‘‘(C) a pharmacovigilance statement— 

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

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

18 analysis and surveillance under subpara19 graph (B)(ii), and the periodic assessment 

20 under subparagraph (E), are sufficient to 

21 assess the serious risks and to identify un22 expected serious risks of the drug; and 

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

24 surveillance, and such periodic assessment 

25 are not sufficient to assess the serious 


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1 risks and to identify unexpected serious 

2 risks of the drug, that describes what 

3 study or studies of the drug are required 

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

5 trial or trials of the drug are required 

6 under paragraph (4)(E); 

7 ‘‘(D) a justification for the 

8 pharmacovigilance statement in subparagraph 

9 (C) that takes into consideration— 

10 ‘‘(i) the estimated size of the treat11 ment population for the drug; 

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

13 condition that the drug is used to treat or 

14 prevent; 

15 ‘‘(iii) the expected or actual duration 

16 of treatment with the drug; 

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

18 drug or other treatment, if any, for such 

19 disease or condition to which the safety of 

20 the drug may be compared; and 

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

22 issue and its background incidence in the 

23 population; and 

24 ‘‘(E) a timetable for submission of assess25 ments of the strategy, that— 


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

2 once annually for the first 3 years after 

3 the drug is initially approved under sub4 section (c) or licensed under section 351 of 

5 the Public Health Service Act, and at a 

6 frequency specified in the strategy for sub7 sequent years; 

8 ‘‘(ii) may be increased or reduced in 

9 frequency as necessary as provided for in 

10 paragraph (6)(B)(iv)(VI) ; and 

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

12 3 years if the Secretary determines that 

13 serious risks of the drug have been ade14 quately identified and assessed and are 

15 being adequately managed. 

16 ‘‘(4) ADDITIONAL POTENTIAL ELEMENTS OF A

17 RISK EVALUATION AND MITIGATION STRATEGY.— 

18 ‘‘(A) IN GENERAL.—The Secretary may re19 quire that the risk evaluation and mitigation 

20 strategy for a drug include 1 or more of the ad21 ditional elements described in this paragraph, 

22 so long as the Secretary makes the determina23 tion required with respect to each additional in24 cluded element. 


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1 ‘‘(B) MEDGUIDE; PATIENT PACKAGE IN2 SERT.—The risk evaluation and mitigation 

3 strategy for a drug may require that the appli4 cant develop for distribution to each patient 

5 when the drug is dispensed— 

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

7 for under part 208 of title 21, Code of 

8 Federal Regulations (or any successor reg9 ulations); or 

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

11 Secretary determines that such insert may 

12 help mitigate a serious risk of the drug. 

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

14 evaluation and mitigation strategy for a drug 

15 may require that the applicant conduct a com16 munication plan to health care providers, if, 

17 with respect to such drug, the Secretary deter18 mines that such plan may support implementa19 tion of an element of the strategy. Such plan 

20 may include— 

21 ‘‘(i) sending letters to health care pro22 viders; 

23 ‘‘(ii) disseminating information about 

24 the elements of the risk evaluation and 

25 mitigation strategy to encourage implemenVerDate Aug 31 2005 03:36 Feb 03, 2007 Jkt 059200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S484.IS S484

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1 tation by health care providers of compo2 nents that apply to such health care pro3 viders, or to explain certain safety proto4 cols (such as medical monitoring by peri5 odic laboratory tests); or 

6 ‘‘(iii) disseminating information to 

7 health care providers through professional 

8 societies about any serious risks of the 

9 drug and any protocol to assure safe use. 

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

11 evaluation and mitigation strategy for a drug 

12 may require that the applicant conduct, or pro13 vide that the Secretary will conduct, an appro14 priate post-approval study, such as a prospec15 tive or retrospective observational study (includ16 ing through the systematic use of established 

17 health care networks and databases), of the 

18 drug (with a target schedule for completing the 

19 study and reporting the results to the Sec20 retary), if the Secretary determines the reports, 

21 analysis and surveillance, and periodic assess22 ments referred to in paragraph (3)(C) are not 

23 sufficient to— 

24 ‘‘(i) assess a signal of a serious risk 

25 with use of the drug; or 


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1 ‘‘(ii) identify unexpected serious risks 

2 in domestic populations who use the drug, 

3 including populations not included in stud4 ies used to approve the drug (such as older 

5 people, people with comorbidities, pregnant 

6 women, or children). 

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

8 The risk evaluation and mitigation strategy for 

9 a drug may require that the applicant for a 

10 drug for which there is no effective approved 

11 application under subsection (j) of this section 

12 as of the date that the requirement is first im13 posed conduct an appropriate post-approval 

14 clinical trial of the drug (with a target schedule 

15 for completing the clinical trial and reporting 

16 the results to the Secretary) to be included in 

17 the clinical trial registry database and clinical 

18 trial results database provided for under section 

19 402(i) of the Public Health Service Act, if the 

20 Secretary determines that a study or studies 

21 under subparagraph (D) will likely be inad22 equate to assess a signal of a serious risk with 

23 use of the drug. 

24 ‘‘(F) PRECLEARANCE.— 


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1 ‘‘(i) IN GENERAL.—The risk evalua2 tion and mitigation strategy for a drug 

3 may require that the applicant submit to 

4 the Secretary advertisements of the drug 

5 for preclearance, if the Secretary deter6 mines that such preclearance is necessary 

7 to ensure compliance with section 502(n) 

8 with respect to the disclosure of informa9 tion about a serious risk listed in the label10 ing of the drug. The advertisements re11 quired to be submitted under the preceding 

12 sentence shall be reviewed and cleared by 

13 the Secretary within 45 days of submis14 sion. 

15 ‘‘(ii) SPECIFICATION OF ADVERTISE16 MENTS.—The Secretary may specify the 

17 advertisements required to be submitted 

18 under clause (i). 

19 ‘‘(G) SPECIFIC DISCLOSURES.— 

20 ‘‘(i) IN GENERAL.—The risk evalua21 tion and mitigation strategy for a drug 

22 may require that the applicant include in 

23 advertisements of the drug a specific dis24 closure— 


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1 ‘‘(I) of the date the drug was ap2 proved and that the existing informa3 tion may not have identified or al4 lowed for full assessment of all serious 

5 risks of using the drug, if the Sec6 retary determines that such disclosure 

7 is necessary to protect public health 

8 and safety; or 

9 ‘‘(II) about a serious adverse 

10 event listed in the labeling of the drug 

11 or a protocol to ensure safe use de12 scribed in the labeling of the drug, if 

13 the Secretary determines that such 

14 advertisements lacking such disclosure 

15 would be false or misleading. 

16 ‘‘(ii) SPECIFICATION OF ADVERTISE17 MENTS.—The Secretary may specify the 

18 advertisements required to include a spe19 cific disclosure under clause (i). 

20 ‘‘(H) TEMPORARY MORATORIUM.—The 

21 risk evaluation and mitigation strategy for a 

22 drug may require that for a fixed period after 

23 initial approval, not to exceed 2 years, the ap24 plicant not issue or cause to be issued direct25 to-consumer advertisements of the drug, if the 


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1 Secretary determines that disclosure under sub2 paragraph (G) is inadequate to protect public 

3 health and safety, and that such prohibition is 

4 necessary to protect public health and safety 

5 while additional information about serious risks 

6 of the drug is collected, considering— 

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

8 be treated with the drug; 

9 ‘‘(ii) the seriousness of the condition 

10 for which the drug will be used; 

11 ‘‘(iii) the serious adverse events listed 

12 in the labeling of the drug; 

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

14 access to other approved drugs in the 

15 pharmacological class of the drug and with 

16 the same intended use as the drug; and 

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

18 used to approve the drug may not have 

19 identified serious risks that might occur 

20 among patients expected to be treated with 

21 the drug. 

22 ‘‘(5) RESTRICTIONS ON DISTRIBUTION OR

23 USE.— 

24 ‘‘(A) IN GENERAL.—If the Secretary deter25 mines that a drug shown to be effective can be 


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1 safely used only if distribution or use of such 

2 drug is restricted, the Secretary may require as 

3 elements of the risk evaluation and mitigation 

4 strategy such restrictions on distribution or use 

5 as are needed to assure safe use of the drug. 

6 ‘‘(B) LIMITS ON RESTRICTIONS.—Such re7 strictions under subparagraph (A) shall— 

8 ‘‘(i) be commensurate with the spe9 cific risk presented by the drug; 

10 ‘‘(ii) not be unduly burdensome on pa11 tient access to the drug, particularly for 

12 patients with serious or life-threatening 

13 diseases or conditions; and 

14 ‘‘(iii) to the extent practicable, con15 form with restrictions on distribution or 

16 use for other drugs with similar risks, so 

17 as to minimize the burden on the health 

18 care delivery system. 

19 ‘‘(C) ELEMENTS.—The restrictions on dis20 tribution or use described under subparagraph 

21 (A) shall include 1 or more goals to evaluate or 

22 mitigate a serious risk listed in the labeling of 

23 the drug and may require that— 


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1 ‘‘(i) health care providers that pre2 scribe the drug have special training or ex3 perience, or are specially certified; 

4 ‘‘(ii) pharmacies, practitioners, or 

5 health care settings that dispense the drug 

6 are specially certified; 

7 ‘‘(iii) the drug be dispensed to pa8 tients only in certain health care settings, 

9 such as hospitals; 

10 ‘‘(iv) the drug be dispensed to pa11 tients with evidence or other documenta12 tion of safe-use conditions, such as labora13 tory test results; 

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

15 subject to certain monitoring; or 

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

17 enrolled in a registry. 

18 ‘‘(D) IMPLEMENTATION SYSTEM.—The re19 strictions on distribution or use described under 

20 subparagraph (A) may require a system 

21 through which the applicant is able to— 

22 ‘‘(i) monitor and evaluate implementa23 tion of the restrictions by health care pro24 viders, pharmacists, patients, and other 

25 parties in the health care system who are 


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1 responsible for implementing the restric2 tions; 

3 ‘‘(ii) work to improve implementation 

4 of the restrictions by health care providers, 

5 pharmacists, patients, and other parties in 

6 the health care system who are responsible 

7 for implementing the restrictions; and 

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

9 those health care providers, pharmacists, 

10 and other parties in the health care sys11 tem— 

12 ‘‘(I) who are responsible for im13 plementing the restrictions; and 

14 ‘‘(II) whom the applicant knows 

15 have failed to meet their responsibil16 ities for implementing the restrictions, 

17 after the applicant has informed such 

18 party of such failure and such party 

19 has not remedied such failure. 

20 ‘‘(6) SUBMISSION AND REVIEW OF RISK EVAL21 UATION AND MITIGATION STRATEGY.— 

22 ‘‘(A) PROPOSED RISK EVALUATION AND

23 MITIGATION STRATEGY.— 

24 ‘‘(i) INITIAL APPROVAL.—An appli25 cant shall include a proposed risk evaluaVerDate Aug 31 2005 03:36 Feb 03, 2007 Jkt 059200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\S484.IS S484

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1 tion and mitigation strategy in an applica2 tion under subsection (b) or section 351 of 

3 the Public Health Service Act for initial 

4 approval of the drug. 

5 ‘‘(ii) APPROVAL OF NEW INDICA6 TION.—If no risk evaluation and mitiga7 tion strategy for the drug is in effect under 

8 this subsection and the drug may not be 

9 dispensed without a prescription, the appli10 cant shall include a proposed risk evalua11 tion and mitigation strategy in an applica12 tion, including in a supplemental applica13 tion, seeking a new indication for such 

14 drug. 

15 ‘‘(iii) CONTENTS.—A proposed risk 

16 evaluation and mitigation strategy— 

17 ‘‘(I) shall include the minimal 

18 elements required under paragraph 

19 (3); and 

20 ‘‘(II) may also include additional 

21 elements as provided for under para22 graphs (4) and (5). 

23 ‘‘(B) ASSESSMENT AND MODIFICATION OF

24 A RISK EVALUATION AND MITIGATION STRAT25 EGY.— 


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1 ‘‘(i) VOLUNTARY ASSESSMENTS.—The 

2 applicant may submit to the Secretary an 

3 assessment of, and propose a modification 

4 to, the approved risk evaluation and miti5 gation strategy for a drug at any time. 

6 ‘‘(ii) REQUIRED ASSESSMENTS.—The 

7 applicant shall submit an assessment of, 

8 and may propose a modification to, the ap9 proved risk evaluation and mitigation 

10 strategy for a drug— 

11 ‘‘(I) when submitting a supple12 mental application for a new indica13 tion under subsection (b) or section 

14 351 of the Public Health Service Act, 

15 unless the drug may be dispensed 

16 without a prescription and the risk 

17 evaluation and mitigation strategy for 

18 the drug includes only the elements 

19 under paragraph (3); 

20 ‘‘(II) when required by the strat21 egy, as provided for in the timetable 

22 under paragraph (3)(E); 

23 ‘‘(III) within a time specified by 

24 the Secretary, not to be less than 45 

25 days, when ordered by the Secretary, 


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1 if the Secretary determines that new 

2 safety information indicates that an 

3 element under paragraph (3) or (4) 

4 should be modified or included in the 

5 strategy; 

6 ‘‘(IV) within 90 days when or7 dered by the Secretary, if the Sec8 retary determines that new safety in9 formation indicates that an element 

10 under paragraph (5) should be modi11 fied or included in the strategy; or 

12 ‘‘(V) within 15 days when or13 dered by the Secretary, if the Sec14 retary determines that there may be a 

15 cause for action by the Secretary 

16 under subsection (e). 

17 ‘‘(iii) ASSESSMENT.—An assessment 

18 of the approved risk evaluation and mitiga19 tion strategy for a drug shall include— 

20 ‘‘(I) with respect to any goal 

21 under paragraph (5), an assessment 

22 of how well the restrictions on dis23 tribution or use are meeting the goal 

24 or whether the goal or such restric25 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, including whether any difficul5 ties completing the study have been 

6 encountered; and 

7 ‘‘(III) with respect to any post8 approval clinical trial required under 

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

10 clinical trial, including whether enroll11 ment has begun, the number of par12 ticipants enrolled, the expected com13 pletion date, whether any difficulties 

14 completing the clinical trial have been 

15 encountered, and registration informa16 tion with respect to requirements 

17 under section 402(i) of the Public 

18 Health Service Act. 

19 ‘‘(iv) MODIFICATION.—A modification 

20 (whether an enhancement or a reduction) 

21 to the approved risk evaluation and mitiga22 tion strategy for a drug may include the 

23 addition or modification of any element 

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

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1 tion, or removal of any element under 

2 paragraph (4) or (5), such as— 

3 ‘‘(I) a labeling change, including 

4 the addition of a boxed warning; 

5 ‘‘(II) adding a post-approval 

6 study or clinical trial requirement; 

7 ‘‘(III) modifying a post-approval 

8 study or clinical trial requirement 

9 (such as a change in trial design due 

10 to legitimate difficulties recruiting 

11 participants); 

12 ‘‘(IV) adding, modifying, or re13 moving a restriction on advertising 

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

15 of paragraph (4); 

16 ‘‘(V) adding, modifying, or re17 moving a restriction on distribution or 

18 use under paragraph (5); or 

19 ‘‘(VI) modifying the timetable for 

20 assessments of the strategy under 

21 paragraph (3)(E), including to elimi22 nate assessments. 

23 ‘‘(C) REVIEW.—The Secretary shall 

24 promptly review the proposed risk evaluation 

25 and mitigation strategy for a drug submitted 


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1 under subparagraph (A), or an assessment of 

2 the approved risk evaluation and mitigation 

3 strategy for a drug submitted under subpara4 graph (B). 

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

6 initiate discussions of the proposed risk evalua7 tion and mitigation strategy for a drug sub8 mitted under subparagraph (A), or of an as9 sessment of the approved risk evaluation and 

10 mitigation strategy for a drug submitted under 

11 subparagraph (B), with the applicant to deter12 mine a strategy— 

13 ‘‘(i) if the proposed strategy or assess14 ment is submitted as part of an application 

15 or supplemental application under subpara16 graph (A) or (B)(ii)(I), not less than 60 

17 days before the action deadline for the ap18 plication that has been agreed to by the 

19 Secretary and that has been set forth in 

20 goals identified in letters of the Secretary 

21 (relating to the use of fees collected under 

22 section 736 to expedite the drug develop23 ment process and the review of human 

24 drug applications); 


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1 ‘‘(ii) if the assessment is submitted 

2 under subclause (II) or (III) of subpara3 graph (B)(ii), not later than 20 days after 

4 such submission; 

5 ‘‘(iii) if the assessment is submitted 

6 under subparagraph (B)(i) or under sub7 paragraph (B)(ii)(IV), not later than 30 

8 days after such submission; or 

9 ‘‘(iv) if the assessment is submitted 

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

11 than 10 days after such submission. 

12 ‘‘(E) ACTION.— 

13 ‘‘(i) IN GENERAL.—Unless the appli14 cant requests the dispute resolution proc15 ess described under subparagraph (F), the 

16 Secretary shall approve and describe the 

17 risk evaluation and mitigation strategy for 

18 a drug, or any modification to the strat19 egy— 

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

21 on the application, when a proposed 

22 strategy is submitted under subpara23 graph (A) or an assessment of the 

24 strategy is submitted under subpara25 graph (B)(ii)(I); or 


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1 ‘‘(II) in an order, which shall be 

2 made public, issued not later than 50 

3 days after the date discussions of such 

4 modification begin under subpara5 graph (C), when an assessment of the 

6 strategy is under subparagraph (B)(i) 

7 or under subclause (II), (III), (IV), or 

8 (V) of subparagraph (B)(ii). 

9 ‘‘(ii) 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 under 

13 clause (i). 

14 ‘‘(F) DISPUTE RESOLUTION.— 

15 ‘‘(i) REQUEST FOR REVIEW.—Not 

16 earlier than 15 days, and not later than 35 

17 days, after discussions under subparagraph 

18 (D) have begun, the applicant may request 

19 in writing that a dispute about the strat20 egy be reviewed by the Drug Safety Over21 sight Board. 

22 ‘‘(ii) SCHEDULING REVIEW.—If the 

23 applicant requests review under clause (i), 

24 the Secretary— 


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1 ‘‘(I) shall schedule the dispute 

2 for review at 1 of the next 2 regular 

3 meetings of the Drug Safety Over4 sight Board, whichever meeting date 

5 is more practicable; or 

6 ‘‘(II) may convene a special 

7 meeting of the Drug Safety Oversight 

8 Board to review the matter more 

9 promptly, including to meet an action 

10 deadline on an application (including 

11 a supplemental application). 

12 ‘‘(iii) AGREEMENT AFTER DISCUSSION

13 OR ADMINISTRATIVE APPEALS.— 

14 ‘‘(I) FURTHER DISCUSSION OR

15 ADMINISTRATIVE APPEALS.—A re16 quest for review under clause (i) shall 

17 not preclude further discussions to 

18 reach agreement on the risk evalua19 tion and mitigation strategy, and such 

20 a request shall not preclude the use of 

21 administrative appeals within the 

22 Food and Drug Administration to 

23 reach agreement on the strategy, in24 cluding appeals as described in letters 

25 of the Secretary (relating to the use of 


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1 fees collected under section 736 to ex2 pedite the drug development process 

3 and the review of human drug appli4 cations) for procedural or scientific 

5 matters involving the review of human 

6 drug applications and supplemental 

7 applications that cannot be resolved at 

8 the divisional level. 

9 ‘‘(II) AGREEMENT TERMINATES

10 DISPUTE RESOLUTION.—At any time 

11 before a decision and order is issued 

12 under clause (vi), the Secretary and 

13 the applicant may reach an agreement 

14 on the risk evaluation and mitigation 

15 strategy through further discussion or 

16 administrative appeals, terminating 

17 the dispute resolution process, and the 

18 Secretary shall issue an action letter 

19 or order, as appropriate, that de20 scribes the strategy. 

21 ‘‘(iv) MEETING OF THE BOARD.—At 

22 the meeting of the Drug Safety Oversight 

23 Board described in clause (ii), the Board 

24 shall— 

25 ‘‘(I) hear from both parties; and 


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1 ‘‘(II) review the dispute. 

2 ‘‘(v) RECOMMENDATION OF THE

3 BOARD.—Not later than 5 days after such 

4 meeting of the Drug Safety Oversight 

5 Board, the Board shall provide a written 

6 recommendation on resolving the dispute 

7 to the Secretary. 

8 ‘‘(vi) ACTION BY THE SECRETARY.— 

9 ‘‘(I) ACTION LETTER.—With re10 spect to a proposed risk evaluation 

11 and mitigation strategy submitted 

12 under subparagraph (A) or to an as13 sessment of the strategy submitted 

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

15 Secretary shall issue an action letter 

16 that resolves the dispute not later 

17 than the later of— 

18 ‘‘(aa) the action deadline re19 ferred to in subparagraph (D)(i); 

20 or 

21 ‘‘(bb) 7 days after receiving 

22 the recommendation of the Drug 

23 Safety Oversight Board. 

24 ‘‘(II) ORDER.—With respect to 

25 an assessment of the risk evaluation 


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1 and mitigation strategy under sub2 paragraph (B)(i) or under subclause 

3 (II), (III), (IV), or (V) of subpara4 graph (B)(ii), the Secretary shall 

5 issue an order, which shall be made 

6 public, that resolves the dispute not 

7 later than 7 days after receiving the 

8 recommendation of the Drug Safety 

9 Oversight Board. 

10 ‘‘(vii) INACTION.—An approved risk 

11 evaluation and mitigation strategy shall re12 main in effect until the Secretary acts, if 

13 the Secretary fails to act as provided for 

14 under clause (vi). 

15 ‘‘(viii) EFFECT ON ACTION DEAD16 LINE.—With respect to the application or 

17 supplemental application in which a pro18 posed risk evaluation and mitigation strat19 egy is submitted under subparagraph (A) 

20 or in which an assessment of the strategy 

21 is submitted under subparagraph 

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

23 to have met the action deadline referred to 

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

25 such application if the applicant requests 


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1 the dispute resolution process described in 

2 this subparagraph and if the Secretary— 

3 ‘‘(I) has initiated the discussions 

4 described under subparagraph (D) not 

5 less than 60 days before such action 

6 deadline; and 

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

9 by the Drug Safety Oversight Board, 

10 providing a written recommendation, 

11 and issuing an action letter under 

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

13 ‘‘(ix) DISQUALIFICATION.—No indi14 vidual who is an employee of the Food and 

15 Drug Administration and who reviews a 

16 drug or who participated in an administra17 tive appeal under clause (iii)(I) with re18 spect to such drug may serve on the Drug 

19 Safety Oversight Board at a meeting under 

20 clause (iv) to review a dispute about the 

21 risk evaluation and mitigation strategy for 

22 such drug. 

23 ‘‘(x) ADDITIONAL EXPERTISE.—The 

24 Drug Safety Oversight Board may add 

25 members with relevant expertise from the 


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1 Food and Drug Administration, including 

2 the Office of Pediatrics, the Office of 

3 Women’s Health, or the Office of Rare 

4 Diseases, or from other Federal public 

5 health or health care agencies, for a meet6 ing under clause (iv) of the Drug Safety 

7 Oversight Board. 

8 ‘‘(G) USE OF ADVISORY COMMITTEES.— 

9 The Secretary may convene a meeting of 1 or 

10 more advisory committees of the Food and 

11 Drug Administration to— 

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

13 of a drug or class of drugs, including be14 fore an assessment of the risk evaluation 

15 and mitigation strategy or strategies of 

16 such drug or drugs is required to be sub17 mitted under subclause (II), (III), (IV), or 

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

19 ‘‘(ii) review the risk evaluation and 

20 mitigation strategy or strategies of a drug 

21 or group of drugs; or 

22 ‘‘(iii) with the consent of the appli23 cant, review a dispute under subparagraph 

24 (F). 


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1 ‘‘(H) PROCESS FOR ADDRESSING DRUG

2 CLASS EFFECTS.— 

3 ‘‘(i) IN GENERAL.—When a concern 

4 about a serious risk of a drug may be re5 lated to the pharmacological class of the 

6 drug, the Secretary may defer assessments 

7 of the approved risk evaluation and mitiga8 tion strategies for such drugs until the 

9 Secretary has convened, after appropriate 

10 public notice, 1 or more public meetings to 

11 consider possible responses to such con12 cern. 

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

14 meetings may include— 

15 ‘‘(I) 1 or more meetings of the 

16 applicants for such drugs; 

17 ‘‘(II) 1 or more meetings of 1 or 

18 more advisory committees of the Food 

19 and Drug Administration, as provided 

20 for under subparagraph (G); or 

21 ‘‘(III) 1 or more workshops of 

22 scientific experts and other stake23 holders. 


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

2 discussions from any meetings under 

3 clause (ii), the Secretary may— 

4 ‘‘(I) announce in the Federal 

5 Register a planned regulatory action, 

6 including a modification to each risk 

7 evaluation and mitigation strategy, for 

8 drugs in the pharmacological class; 

9 ‘‘(II) seek public comment about 

10 such action; and 

11 ‘‘(III) after seeking such com12 ment, issue an order addressing such 

13 regulatory action. 

14 ‘‘(I) INTERNATIONAL COORDINATION.— 

15 The Secretary may coordinate the timetable for 

16 submission of assessments under paragraph 

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

18 clinical trial under paragraph (4)(E), with ef19 forts to identify and assess the serious risks of 

20 such drug by the marketing authorities of other 

21 countries whose drug approval and risk man22 agement processes the Secretary deems com23 parable to the drug approval and risk manage24 ment processes of the United States. 


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1 ‘‘(J) EFFECT.—Use of the processes de2 scribed in subparagraphs (H) and (I) shall not 

3 delay action on an application or a supplement 

4 to an application for a drug. 

5 ‘‘(K) NO EFFECT ON LABELING CHANGES

6 THAT DO NOT REQUIRE PREAPPROVAL.—In the 

7 case of a labeling change to which section 

8 314.70 of title 21, Code of Federal Regulations 

9 (or any successor regulation), applies for which 

10 the submission of a supplemental application is 

11 not required or for which distribution of the 

12 drug involved may commence upon the receipt 

13 by the Secretary of a supplemental application 

14 for the change, the submission of an assessment 

15 of the approved risk evaluation and mitigation 

16 strategy for the drug under this subsection is 

17 not required. 

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

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

20 Drug Safety Oversight Board. 

21 ‘‘(B) COMPOSITION; MEETINGS.—The 

22 Drug Safety Oversight Board shall— 

23 ‘‘(i) be composed of scientists and 

24 health care practitioners who are appointed 

25 by the Secretary; 


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1 ‘‘(ii) include representatives from of2 fices throughout the Food and Drug Ad3 ministration; 

4 ‘‘(iii) include at least 1 representative 

5 from each of the National Institutes of 

6 Health, the Department of Health and 

7 Human Services (other than the Food and 

8 Drug Administration), and the Veterans 

9 Health Administration; and 

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

11 oversight and advice to the Secretary on 

12 the management of important drug safety 

13 issues.’’. 

14 SEC. 102. ENFORCEMENT. 

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

16 Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend17 ed by adding at the end the following: 

18 ‘‘(x) If it is a drug subject to an approved risk evalua19 tion and mitigation strategy under section 505(o) and the 

20 applicant for such drug fails to— 

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

22 strategy after the Secretary has completed review of, 

23 and acted on, an assessment of such strategy under 

24 paragraph (6) of such section; or 


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1 ‘‘(2) comply with a requirement of such strat2 egy with respect to advertising as provided for under 

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

4 such section.’’. 

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

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

7 amended— 

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

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

10 (2) by inserting after paragraph (2) the fol11 lowing: 

12 ‘‘(3) An applicant (as such term is used in sec13 tion 505(o)) who knowingly fails to comply with a 

14 requirement of an approved risk evaluation and miti15 gation strategy under such section 505(o) shall be 

16 subject to a civil money penalty of not less than 

17 $15,000 and not more than $250,000 per violation, 

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

19 adjudicated in a single proceeding.’’; 

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

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

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

23 striking ‘‘paragraph (1) or (2)’’ each place it ap24 pears and inserting ‘‘paragraph (1), (2), or (3)’’; 

25 and 


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

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

3 inserting ‘‘paragraph (5)’’. 

4 SEC. 103. REGULATION OF BIOLOGICAL PRODUCTS. 

5 Section 351 of the Public Health Service Act (42 

6 U.S.C. 262) is amended— 

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

8 the following: 

9 ‘‘(D) RISK EVALUATION AND MITIGATION STRAT10 EGY.—A person that submits an application for a license 

11 under this paragraph shall submit to the Secretary as part 

12 of the application a proposed risk evaluation and mitiga13 tion strategy as described under section 505(o) of the Fed14 eral Food, Drug, and Cosmetic Act.’’; and 

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

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

17 after ‘‘, and Cosmetic Act’’. 

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

19 APPROVAL. 

20 Section 505(e) of the Federal Food, Drug, and Cos21 metic Act (21 U.S.C. 355(e)) is amended by adding at 

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

23 approval of an application submitted under this section, 

24 or suspend the approval of such an application, as pro25 vided under this subsection, without first ordering the apVerDate Aug 31 2005 03:36 Feb 03, 2007 Jkt 059200 PO 00000 Frm 00037 Fmt 6652 Sfmt 6201 E:\BILLS\S484.IS S484

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1 plicant to submit an assessment of the approved risk eval2 uation and mitigation strategy for the drug under sub3 section (o)(6)(B)(ii)(V).’’. 

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

5 APPLICATION. 

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

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

8 at the end the following: 

9 ‘‘(D) RISK EVALUATION AND MITIGATION STRATEGY

10 REQUIREMENT.— 

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

12 of an abbreviated new drug application under this 

13 subsection shall be subject to only the following ele14 ments of the risk evaluation and mitigation strategy 

15 required under subsection (o) for the applicable list16 ed drug: 

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

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

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

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

21 listed drug. 

22 ‘‘(III) A Medication Guide or patient pack23 age insert, if required under subsection 

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


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1 ‘‘(IV) Preclearance of advertising, if re2 quired under subsection (o)(4)(F) for the appli3 cable listed drug. 

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

5 required under subsection (o)(4)(G) for the ap6 plicable listed drug. 

7 ‘‘(VI) A temporary moratorium on direct8 to-consumer advertising, if required under sub9 section (o)(4)(H) for the applicable listed drug. 

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

11 if required under subsection (o)(5) for the ap12 plicable listed drug, except that such drug may 

13 use a different, comparable aspect of such re14 strictions on distribution or use as are needed 

15 to assure safe use of such drug if — 

16 ‘‘(aa) the corresponding aspect of the 

17 restrictions on distribution or use for the 

18 applicable listed drug is claimed by a pat19 ent that has not expired or is a method or 

20 process that as a trade secret is entitled to 

21 protection; and 

22 ‘‘(bb) the applicant certifies that it 

23 has sought a license for use of such aspect 

24 of the restrictions on distribution or use 

25 for the applicable listed drug. 


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1 ‘‘(ii) ACTION BY SECRETARY.—For an applica2 ble listed drug for which a drug is approved under 

3 this subsection, the Secretary— 

4 ‘‘(I) shall undertake any communication 

5 plan to health care providers required under 

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

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

8 required under subsection (o)(4)(D) for the ap9 plicable listed drug; 

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

11 approved under this subsection if the risk eval12 uation and mitigation strategy for the applica13 ble listed drug is modified; and 

14 ‘‘(IV) in order to minimize the burden on 

15 the health care delivery system of different re16 strictions on distribution or use for the drug 

17 approved under this subsection and the applica18 ble listed drug, may seek to negotiate a license 

19 under which the applicant for such drug may 

20 use an aspect of the restrictions on distribution 

21 or use, if required under subsection (o)(5) for 

22 the applicable listed drug, that is claimed by a 

23 patent that has not expired or is a method or 

24 process that as a trade secret is entitled to pro25 tection.’’. 


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1 SEC. 106. CONFORMING AMENDMENTS. 

2 (a) PRECLEARANCE OF ADVERTISEMENTS.—Section 

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

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

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

6 ‘‘except in extraordinary circumstances’’. 

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

8 505(b)(1) of the Federal Food, Drug, and Cosmetic Act 

9 (21 U.S.C. 355(b)) is amended— 

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

11 and 

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

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

14 risk evaluation and mitigation strategy as described 

15 under subsection (o).’’. 

16 SEC. 107. RESOURCES. 

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

18 735(6) of the Federal Food, Drug, and Cosmetic Act (21 

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

20 ‘‘(F) Reviewing and implementing risk 

21 evaluation and mitigation strategies, and col22 lecting, developing, and reviewing safety infor23 mation on drugs, including adverse event re24 ports.’’. 

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

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1 metic Act (21 U.S.C. 379h(c)(2)) is amended to read as 

2 follows: 

3 ‘‘(A) The adjustment shall be determined 

4 by the Secretary based on a weighted average 

5 of the change in the total number of human 

6 drug applications, commercial investigational 

7 new drug applications, efficacy supplements, 

8 manufacturing supplements, assessments of risk 

9 evaluation and mitigation strategies, and uses 

10 of dispute resolution under the process for re11 viewing and assessing risk evaluation and miti12 gation strategies. The Secretary shall publish in 

13 the Federal Register the fee revenues and fees 

14 resulting from the adjustment and supporting 

15 methodologies.’’. 

16 (c) STRATEGIC PLAN FOR INFORMATION TECH17 NOLOGY.—Not later than 1 year after the date of enact18 ment of this title, the Secretary of Health and Human 

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

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

21 and Pensions and the Committee on Appropriations of the 

22 Senate and the Committee on Energy and Commerce and 

23 the Committee on Appropriations of the House of Rep24 resentatives, a strategic plan on information technology 

25 that includes— 


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1 (1) an assessment of the information technology 

2 infrastructure, including systems for data collection, 

3 access to data in external health care databases, 

4 data mining capabilities, personnel, and personnel 

5 training programs, needed by the Food and Drug 

6 Administration to— 

7 (A) comply with the requirements of this 

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

9 (B) achieve interoperability within and 

10 among the Centers of the Food and Drug Ad11 ministration and between the Food and Drug 

12 Administration and product application spon13 sors; and 

14 (C) utilize electronic health records; 

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

16 current information technology assets of the Food 

17 and Drug Administration are sufficient to meet the 

18 needs assessments under paragraph (1); 

19 (3) a plan for enhancing the information tech20 nology assets of the Food and Drug Administration 

21 toward meeting the needs assessments under para22 graph (1); and 

23 (4) an assessment of additional resources need24 ed to so enhance the information technology assets 

25 of the Food and Drug Administration. 


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1 SEC. 108. DRUG LABELING. 

2 (a) ACCESSIBLE REPOSITORY OF DRUG LABEL3 ING.—Not later than the effective date of this title, the 

4 Secretary, through the Commissioner of Food and Drugs, 

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

6 establish a searchable repository of structured, electronic 

7 product information, including the approved professional 

8 labeling and any required patient labeling of each drug 

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

10 and Cosmetic Act (21 U.S.C. 355) or licensed under sec11 tion 351 of the Public Health Service Act (42 U.S.C. 262) 

12 in order to improve patient safety through accessible prod13 uct information, support initiatives to improve patient care 

14 by better management of health care information, and 

15 provide standards for drug information. Such repository 

16 shall be made publicly accessible on the Internet website 

17 of the National Library of Medicine and through a link 

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

19 Drug Administration. 

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

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

22 professional labeling and any required patient labeling of 

23 a drug approved under such section 505 or licensed under 

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

25 the drug is approved, including in a supplemental applica26 tion with respect to a labeling change. 


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

2 the Committee on Health, Education, Labor and Pensions 

3 of the Senate and the Committee on Energy and Com4 merce of the House of Representatives on the status of 

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

6 posting structured electronic product information, includ7 ing posting of information regarding drugs approved prior 

8 to the effective date of this title. 

9 (d) MEDICATION GUIDES.—Not later than the effec10 tive date of this title, the Secretary, through the Commis11 sioner of Food and Drugs, shall establish on the Internet 

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

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

14 505 or licensed under such section 351, for which a Medi15 cation Guide, as provided for under part 208 of title 21, 

16 Code of Federal Regulations (or any successor regula17 tions), is required. 

18 SEC. 109. EFFECTIVE DATE AND APPLICABILITY. 

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

20 180 days after the date of enactment of this Act. 

21 (b) DRUGS DEEMED TO HAVE RISK EVALUATION

22 AND MITIGATION STRATEGIES.— 

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

24 before the effective date of this title shall be deemed 

25 to have an approved risk evaluation and mitigation 


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

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

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

4 restrictions on distribution or use— 

5 (A) required under section 314.520 or sec6 tion 601.42 of title 21, Code of Federal Regula7 tions; or 

8 (B) otherwise agreed to by the applicant 

9 and the Secretary for such drug. 

10 (2) RISK EVALUATION AND MITIGATION STRAT11 EGY.—The approved risk evaluation and mitigation 

12 strategy deemed in effect for a drug under para13 graph (1) shall consist of the elements described in 

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

15 section 505(o) and any other additional elements 

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

17 on the effective date of this title. 

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

19 after the effective date of this title, the Secretary 

20 shall notify the applicant for each drug described in 

21 paragraph (1)— 

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

23 approved risk evaluation and mitigation strat24 egy pursuant to such paragraph; and 


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

2 than 6 months after the applicant is so notified, 

3 by which the applicant shall submit to the Sec4 retary an assessment of such approved strategy 

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

6 (4) ENFORCEMENT ONLY AFTER ASSESSMENT

7 AND REVIEW.—Neither the Secretary nor the Attor8 ney General may seek to enforce a requirement of a 

9 risk evaluation and mitigation strategy deemed in ef10 fect under paragraph (1) before the Secretary has 

11 completed review of, and acted on, the first assess12 ment of such strategy under such section 505(o). 

13 (c) OTHER DRUGS APPROVED BEFORE THE EFFEC14 TIVE DATE.—The Secretary, on a case-by-case basis, may 

15 require the applicant for a drug approved before the effec16 tive date of this title to which subsection (b) does not 

17 apply to submit a proposed risk evaluation and mitigation 

18 strategy in accordance with the timeframes provided for 

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

20 (6)(B)(ii) of such section 505(o) if the Secretary deter21 mines that— 

22 (1) an element described under paragraph 

23 (3)(A) of such section 505(o) may require modifica24 tion; or 


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1 (2) a standard for adding an element described 

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

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

4 to such drug. 

5 TITLE II—REAGAN-UDALL INSTI6 TUTE FOR APPLIED BIO7 MEDICAL RESEARCH 

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

9 BIOMEDICAL RESEARCH. 

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

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

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

13 at the end the following: 

14 ‘‘Subchapter I—Reagan-Udall Institute for 

15 Applied Biomedical Research 

16 ‘‘SEC. 770. ESTABLISHMENT AND FUNCTIONS OF THE INSTI17 TUTE. 

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

19 nonprofit corporation to be known as the Reagan-Udall 

20 Institute for Applied Biomedical Research (referred to in 

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

22 headed by an Executive Director, appointed by the mem23 bers of the Board of Directors under subsection (e). The 

24 Institute shall not be an agency or instrumentality of the 

25 United States Government. 


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

2 Institute is to advance the Critical Path Initiative of the 

3 Food and Drug Administration to modernize medical 

4 product development, accelerate innovation, and enhance 

5 product safety. 

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

7 shall— 

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

9 published by the Food and Drug Administration en10 titled ‘Innovation or Stagnation? Challenge and Op11 portunity on the Critical Path to New Medical Prod12 ucts’, identify unmet needs in the sciences of devel13 oping, manufacturing, and evaluating the safety and 

14 effectiveness of diagnostics, devices, biologics, and 

15 drugs, including— 

16 ‘‘(A) the identification and validation of 

17 biomarkers for use in diagnostic, device, bio18 logic, and drug development; 

19 ‘‘(B) the development and validation of 

20 animal models for human disease and medical 

21 product safety; 

22 ‘‘(C) pharmacogenomics and inter-indi23 vidual variability in drug, biologic, and device 

24 response; 


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1 ‘‘(D) the development of data analysis 

2 technology and methodology for use in device, 

3 biologic, drug, and diagnostic development; 

4 ‘‘(E) advancing improvements to the de5 sign and conduct of clinical trials; 

6 ‘‘(F) toxicological quality assessment tech7 nologies; 

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

9 manufacturing, design, and materials science; 

10 ‘‘(H) failure mode assessment for medical 

11 product development; 

12 ‘‘(I) improving adverse event reporting and 

13 analysis; 

14 ‘‘(J) bridging engineering data and clinical 

15 performance for devices; and 

16 ‘‘(K) computer modeling; 

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

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

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

20 existing and proposed Federal intramural and extra21 mural research and development programs relating 

22 to the goals and priorities established under para23 graph (2) and facilitate and encourage interagency 

24 coordination of such programs; 


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

2 cooperative agreements with, scientists and entities 

3 to advance the goals and priorities established under 

4 paragraph (2); 

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

6 sponsor (in whole or in part) meetings as appro7 priate to further the goals and priorities established 

8 under paragraph (2); 

9 ‘‘(6) 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 to further the goals and priorities established under 

17 paragraph (2); 

18 ‘‘(7) ensure that— 

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

20 patents for inventions developed by the Insti21 tute or with funds from the Institute; 

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

23 the licensing of inventions developed by the In24 stitute or with funds from the Institute; and 


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1 ‘‘(C) executed licenses, memoranda of un2 derstanding, material transfer agreements, con3 tracts, and other such instruments promote, to 

4 the maximum extent practicable, the broadest 

5 conversion to commercial and noncommercial 

6 applications of licensed and patented inventions 

7 of the Institute to further the goals and prior8 ities established under paragraph (2); 

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

11 and, upon request, to other Federal agencies to as12 sist in agency determinations of how to ensure that 

13 regulatory policy accommodates scientific advances; 

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

15 needs identified in paragraph (1); 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; 

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

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

12 Disease Control and Prevention; and 

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

14 Healthcare Research and Quality. 

15 ‘‘(C) APPOINTED MEMBERS.— 

16 ‘‘(i) IN GENERAL.—The ex officio 

17 members of the Board under subparagraph 

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

19 Board 12 individuals. Of such appointed 

20 members— 

21 ‘‘(I) 4 shall be representatives of 

22 the general pharmaceutical, device, 

23 and biotechnology industries; 

24 ‘‘(II) 3 shall be representatives of 

25 academic research organizations; 


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1 ‘‘(III) 2 shall be representatives 

2 of Government agencies, including the 

3 Food and Drug Administration and 

4 the National Institutes of Health; 

5 ‘‘(IV) 2 shall be representatives 

6 of patient advocacy organizations; and 

7 ‘‘(V) 1 shall be a representative 

8 of health care providers. 

9 ‘‘(ii) REQUIREMENT.—The ex officio 

10 members shall ensure the Board member11 ship includes individuals with expertise in 

12 areas including clinical pharmacology, bio13 medical informatics, product safety, proc14 ess improvement and pharmaceutical 

15 sciences, and medical device and bio16 medical engineering. 

17 ‘‘(D) INITIAL MEETING.— 

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

19 days after the date of the enactment of the 

20 Enhancing Drug Safety and Innovation 

21 Act of 2007, the Secretary shall convene a 

22 meeting of the ex officio members of the 

23 Board to— 

24 ‘‘(I) incorporate the Institute; 

25 and 


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1 ‘‘(II) appoint the members of the 

2 Board in accordance with subpara3 graph (C). 

4 ‘‘(ii) SERVICE OF EX OFFICIO MEM5 BERS.—Upon the appointment of the 

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

7 the terms of service of the ex officio mem8 bers of the Board as members of the 

9 Board shall terminate. 

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

11 of the Board under subparagraph (B) shall 

12 designate an appointed member of the 

13 Board to serve as the Chair of the Board. 

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

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

16 that— 

17 ‘‘(i) are published in the Federal Reg18 ister and available for public comment; 

19 ‘‘(ii) establish policies for the selection 

20 of the officers, employees, agents, and con21 tractors of the Institute; 

22 ‘‘(iii) establish policies, including eth23 ical standards, for the acceptance, solicita24 tion, and disposition of donations and 


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1 grants to the Institution and for the dis2 position of the assets of the Institute; 

3 ‘‘(iv) establish policies whereby any 

4 individual who is an officer, employee, or 

5 member of the Board of the Institute may 

6 not personally or substantially participate 

7 in the consideration or determination by 

8 the Institute of any matter that would di9 rectly or predictably affect any financial 

10 interest of the individual or a relative (as 

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

12 the Ethics in Government Act of 1978) of 

13 the individual, of any business organization 

14 or other entity, or of which the individual 

15 is an officer or employee or is negotiating 

16 for employment, or in which the individual 

17 has any other financial interest; 

18 ‘‘(v) 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 (6) and (7) of subsection (c); 


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1 ‘‘(vi) specify principles for the review 

2 of proposals and awarding of grants and 

3 contracts that include peer review and that 

4 are substantially consistent with those of 

5 the Foundation for the National Institutes 

6 of Health; 

7 ‘‘(vii) specify a process for annual 

8 Board review of the operations of the Insti9 tute; and 

10 ‘‘(viii) establish specific duties of the 

11 Executive Director; 

12 ‘‘(B) prioritize and provide overall direc13 tion to the activities of the Institute; 

14 ‘‘(C) evaluate the performance of the Exec15 utive Director; and 

16 ‘‘(D) carry out any other necessary activi17 ties regarding the functioning of the Institute. 

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

19 Board may coordinate and collaborate with other en20 tities to conduct research, education, and outreach, 

21 and to modernize the sciences of developing, manu22 facturing, and evaluating the safety and effective23 ness of diagnostics, devices, biologics, and drugs. 

24 ‘‘(4) 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 individuals described in clauses (i) 

14 through (v) of paragraph (1)(B) by major15 ity vote. 

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 under subparagraph (B) to fill the re20 sulting vacancy shall be appointed for the re21 mainder of the term of the predecessor of the 

22 individual. 

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

24 the Board may continue to serve after the expiVerDate Aug 31 2005 03:36 Feb 03, 2007 Jkt 059200 PO 00000 Frm 00058 Fmt 6652 Sfmt 6201 E:\BILLS\S484.IS S484

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

3 ‘‘(5) 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) INCORPORATION.—The ex officio members of the 

10 Board shall serve as incorporators and shall take whatever 

11 actions necessary to incorporate the Institute. 

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

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

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

15 the provisions of such section. 

16 ‘‘(g) EXECUTIVE DIRECTOR.— 

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

18 Executive Director who shall serve at the pleasure of 

19 the Board. The Executive Director shall be respon20 sible for the day-to-day operations of the Institute 

21 and shall have such specific duties and responsibil22 ities as the Board shall prescribe. 

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

24 the Executive Director shall be fixed by the Board 


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1 but shall not be greater than the compensation of 

2 the Commissioner of Food and Drugs. 

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

4 this subchapter, the Board, acting through the Executive 

5 Director, may— 

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

7 which shall be judicially noticed; 

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

9 1 or more officers, employees, and agents, as may be 

10 necessary, and define their duties; 

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

12 ‘‘(A) real or personal property of the Insti13 tute is acquired, held, and transferred; 

14 ‘‘(B) general operations of the Institute 

15 are to be conducted; and 

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

17 by law are exercised and enjoyed; 

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

19 department or independent agency, use the informa20 tion, services, and facilities of such department or 

21 agencies in carrying out this section; 

22 ‘‘(5) enter into contracts with public and pri23 vate organizations for the writing, editing, printing, 

24 and publishing of books and other material; 


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

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

3 made to the Institute under subsection (i); 

4 ‘‘(7) enter into such other contracts, leases, co5 operative agreements, and other transactions as the 

6 Board considers appropriate to conduct the activities 

7 of the Institute; 

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

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

10 in which it has an interest under this subchapter; 

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

12 obtain patents and licenses for devices and proce13 dures developed by the Institute and its employees; 

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

15 and complain and defend in courts of competent ju16 risdiction; 

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

18 be determined necessary to carry out the functions 

19 of the Institute; and 

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

21 section, and such other incidental powers as are nec22 essary to carry out its powers, duties, and functions 

23 in accordance with this subchapter. 

24 ‘‘(i) ACCEPTANCE OF FUNDS FROM OTHER

25 SOURCES.—The Executive Director may solicit and accept 


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

2 or bequests of real or personal property made to the Insti3 tute, including from private entities, for the purposes of 

4 carrying out the duties of the Institute. 

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

6 Government employees may serve on committees advisory 

7 to the Institute and otherwise cooperate with and assist 

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

9 employees do not direct or control Institute activities. 

10 ‘‘(k) DETAIL OF GOVERNMENT EMPLOYEES.—Fed11 eral Government employees may be detailed from Federal 

12 agencies with or without reimbursement to those agencies 

13 to the Institute at any time, and such detail shall be with14 out interruption or loss of civil service status or privilege. 

15 Each such employee shall abide by the statutory, regu16 latory, ethical, and procedural standards applicable to the 

17 employees of the agency from which such employee is de18 tailed and those of the Institute. 

19 ‘‘(l) ANNUAL REPORTS.— 

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

21 a grant, contract, or cooperative agreement from the 

22 Institute under this section shall submit to the Insti23 tute a report on an annual basis for the duration of 

24 such grant, contract, or cooperative agreement, that 


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1 describes the activities carried out under such grant, 

2 contract, or cooperative agreement. 

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

4 year 2009, the Executive Director shall submit to 

5 the Commissioner an annual report that— 

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

7 furthering the goals and priorities established 

8 under subsection (c)(2); and 

9 ‘‘(B) provides recommendations for incor10 porating such progress into regulatory and 

11 product review activities of the Food and Drug 

12 Administration. 

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

14 fiscal year 2009, the Executive Director shall submit 

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

16 Pensions and the Committee on Appropriations of 

17 the Senate and the Committee on Energy and Com18 merce and the Committee on Appropriations of the 

19 House of Representatives an annual report that— 

20 ‘‘(A) describes the activities of the Insti21 tute and of the recipients of a grant, contract, 

22 or cooperative agreement under this section, in23 cluding the practical impact of the Institute on 

24 medical product development; 


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

2 source of all funds used by the Institute to 

3 carry out such activities; and 

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

5 by the Institute. 

6 ‘‘(m) SEPARATION OF FUNDS.—The Executive Di7 rector shall ensure that the funds received from the Treas8 ury are held in separate accounts from funds received 

9 from entities under subsection (i). 

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

11 are authorized to be appropriated such sums as may be 

12 necessary for each of fiscal years 2008 through 2013 to 

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

14 (b) OTHER INSTITUTE PROVISIONS.—Chapter VII 

15 (21 U.S.C. 371 et seq.) (as amended by subsection (a)) 

16 is amended by adding at the end the following: 

17 ‘‘SEC. 771. LOCATION OF INSTITUTE. 

18 ‘‘(a) IN GENERAL.—The Institute shall, if prac19 ticable, be located not more than 20 miles from the Dis20 trict of Columbia. 

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

22 with the Administrator of General Services to ensure the 

23 most cost-efficient arrangement for the leasing or pur24 chase of real property for adequate facilities which, if 

25 practicable, shall be located at the Food and Drug AdminVerDate Aug 31 2005 03:36 Feb 03, 2007 Jkt 059200 PO 00000 Frm 00064 Fmt 6652 Sfmt 6201 E:\BILLS\S484.IS S484

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1 istration, to meet the needs of the Institute in carrying 

2 out this subchapter. 

3 ‘‘SEC. 772. ACTIVITIES OF THE FOOD AND DRUG ADMINIS4 TRATION. 

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

6 and assess the report submitted to the Commissioner by 

7 the Executive Director of the Institute under section 

8 770(l)(2). 

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

10 shall submit to the Committee on Health, Education, 

11 Labor, and Pensions and the Committee on Appropria12 tions of the Senate and the Committee on Energy and 

13 Commerce and the Committee on Appropriations of the 

14 House of Representatives an annual report that describes 

15 the implementation of any recommendations included in 

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

17 TITLE III—CLINICAL TRIALS 

18 SEC. 301. CLINICAL TRIAL REGISTRY DATABASE AND CLIN19 ICAL TRIAL RESULTS DATABASE. 

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

21 the Public Health Service Act (42 U.S.C. 282), as amend22 ed by Public Law 109–482, is amended to read as follows: 

23 ‘‘(i) CLINICAL TRIAL REGISTRY DATABASE; CLIN24 ICAL TRIAL RESULTS DATABASE.— 

25 ‘‘(1) DEFINITIONS; REQUIREMENT.— 


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

2 ‘‘(i) CLINICAL TRIAL INFORMATION.— 

3 The term ‘clinical trial information’ means 

4 those data elements that are necessary to 

5 complete an entry in the clinical trial reg6 istry database under paragraph (2) or the 

7 clinical trial results database under para8 graph (3), as applicable. 

9 ‘‘(ii) COMPLETION DATE.—The term 

10 ‘completion date’ means, with respect to a 

11 clinical trial, the date on which the last pa12 tient enrolled in the clinical trial has com13 pleted his or her last medical visit of the 

14 clinical trial, whether the clinical trial con15 cluded according to the prespecified pro16 tocol plan or was terminated. 

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

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

19 Federal Food, Drug, and Cosmetic Act or 

20 a biological product as defined in section 

21 351 of this Act. 

22 ‘‘(iv) RESPONSIBLE PARTY.—The 

23 term ‘responsible party’, with respect to a 

24 clinical trial of a drug, means the sponsor 

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1 gator of such clinical trial if so designated 

2 by such sponsor. 

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

4 develop a mechanism by which— 

5 ‘‘(i) the responsible party for each ap6 plicable clinical trial shall submit the iden7 tity and contact information of such re8 sponsible party to the Secretary at the 

9 time of submission of clinical trial informa10 tion under paragraph (2); and 

11 ‘‘(ii) other Federal agencies may iden12 tify the responsible party for an applicable 

13 clinical trial. 

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

15 ‘‘(A) APPLICABLE CLINICAL TRIAL.— 

16 ‘‘(i) IN GENERAL.—For purposes of 

17 this paragraph the term ‘applicable clinical 

18 trial’ means— 

19 ‘‘(I) a therapeutic or chemo20 preventive clinical trial to verify the 

21 efficacy and establish appropriate 

22 doses for the drug conducted before 

23 the drug is approved under section 

24 505 of the Federal Food, Drug, and 


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1 Cosmetic Act or licensed under section 

2 351 of this Act; 

3 ‘‘(II) a therapeutic or chemo4 preventive confirmatory clinical trial; 

5 ‘‘(III) a clinical trial conducted 

6 after the drug is approved under such 

7 section 505 or licensed under such 

8 section 351; or 

9 ‘‘(IV) a pharmacokinetic study to 

10 support a pediatric indication for the 

11 drug. 

12 ‘‘(ii) EXCEPTIONS.— 

13 ‘‘(I) CERTAIN EXPLORATORY

14 TRIALS.—A clinical trial under clause 

15 (i)(I) does not include an exploratory 

16 clinical trial that is intended solely to 

17 assess safety, solely to evaluate phar18 macokinetics, or solely to verify effi19 cacy. 

20 ‘‘(II) OBSERVATIONAL STUD21 IES.—A clinical trial under clause (i) 

22 does not include an observational 

23 study. 

24 ‘‘(B) ESTABLISHMENT.— 


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1 ‘‘(i) IN GENERAL.—To enhance pa2 tient enrollment and provide a mechanism 

3 to track subsequent progress of clinical 

4 trials, the Secretary, acting through the 

5 Director of NIH, shall establish and ad6 minister a clinical trial registry database in 

7 accordance with this subsection (referred 

8 to in this subsection as the ‘registry data9 base’). The Director of NIH shall ensure 

10 that the registry database is made publicly 

11 available through the Internet. 

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

13 promulgate regulations for the submission 

14 to the registry database of clinical trial in15 formation that— 

16 ‘‘(I) conforms to the Inter17 national Clinical Trials Registry Plat18 form trial registration data set of the 

19 World Health Organization; 

20 ‘‘(II) includes the city, State, and 

21 zip code for each clinical trial location; 

22 ‘‘(III) if the drug is not approved 

23 under section 505 of the Federal 

24 Food, Drug, and Cosmetic Act or li25 censed under section 351 of this Act, 


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1 specifies whether or not there is ex2 panded access to the drug under sec3 tion 561 of the Federal Food, Drug, 

4 and Cosmetic Act for those who do 

5 not qualify for enrollment in the clin6 ical trial and how to obtain informa7 tion about such access; and 

8 ‘‘(IV) requires the inclusion of 

9 such other data elements to the reg10 istry database as appropriate. 

11 ‘‘(C) FORMAT AND STRUCTURE.— 

12 ‘‘(i) SEARCHABLE CATEGORIES.—The 

13 Director of NIH shall ensure that the pub14 lic may search the entries in the registry 

15 database by 1 or more of the following cri16 teria: 

17 ‘‘(I) The indication being studied 

18 in the clinical trial, using Medical 

19 Subject Headers (MeSH) descriptors. 

20 ‘‘(II) The safety issue being stud21 ied in the clinical trial. 

22 ‘‘(III) The enrollment status of 

23 the clinical trial. 

24 ‘‘(IV) The sponsor of the clinical 

25 trial. 


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1 ‘‘(ii) FORMAT.—The Director of the 

2 NIH shall ensure that the registry data3 base is easily used by patients, and that 

4 entries are easily compared. 

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

6 party for an applicable clinical trial shall submit 

7 to the Director of NIH for inclusion in the reg8 istry database the clinical trial information de9 scribed in subparagraph (B)(ii). 

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

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

13 information submitted by a responsible 

14 party under this paragraph shall not be 

15 false or misleading in any particular. 

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

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

19 clinical trial to include information from 

20 any source other than such clinical trial. 

21 ‘‘(F) CHANGES IN CLINICAL TRIAL STA22 TUS.— 

23 ‘‘(i) ENROLLMENT.—The responsible 

24 party for an applicable clinical trial shall 

25 update the enrollment status not later than 


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1 30 days after the enrollment status of such 

2 clinical trial changes. 

3 ‘‘(ii) COMPLETION.—The responsible 

4 party for an applicable clinical trial shall 

5 report to the Director of NIH that such 

6 clinical trial is complete not later than 30 

7 days after the completion date of the clin8 ical trial. 

9 ‘‘(G) TIMING OF SUBMISSION.—The clin10 ical trial information for an applicable clinical 

11 trial required to be submitted under this para12 graph shall be submitted not later than 14 days 

13 after the first patient is enrolled in such clinical 

14 trial. 

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

16 ‘‘(A) APPLICABLE CLINICAL TRIAL.— 

17 ‘‘(i) IN GENERAL.—For purposes of 

18 this paragraph, the term ‘applicable clin19 ical trial’ means— 

20 ‘‘(I) a clinical trial conducted be21 fore the drug is approved under sec22 tion 505 of the Federal Food, Drug, 

23 and Cosmetic Act or licensed under 

24 section 351 of this Act that is— 


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1 ‘‘(aa) a therapeutic or 

2 chemopreventive confirmatory 

3 clinical trial; 

4 ‘‘(bb) a clinical trial for a 

5 drug approved as a fast-track 

6 product under section 506 of the 

7 Federal Food, Drug, and Cos8 metic Act, if such clinical trial is 

9 used to form the primary basis of 

10 an efficacy claim for such drug; 

11 or 

12 ‘‘(cc) if required by the Sec13 retary under subparagraph 

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

15 paragraph (2)(A)(i)(I); 

16 ‘‘(II) a clinical trial completed 

17 after the drug is approved under such 

18 section 505 or licensed under such 

19 section 351; or 

20 ‘‘(III) a pharmacokinetic study to 

21 support a pediatric indication for the 

22 drug. 

23 ‘‘(ii) EXCEPTIONS.— 

24 ‘‘(I) CERTAIN EXPLORATORY

25 TRIALS.—A clinical trial under clause 


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1 (i)(I) does not include an exploratory 

2 clinical trial that is intended solely to 

3 assess safety, solely to evaluate phar4 macokinetics, or solely to verify effi5 cacy. 

6 ‘‘(II) OBSERVATION STUDIES.—A 

7 clinical trial under clause (i) does not 

8 include an observational study. 

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

10 results of clinical trials are made public and 

11 that patients and providers have current infor12 mation regarding the results of clinical trials, 

13 the Secretary, acting through the Director of 

14 NIH, shall establish and administer a clinical 

15 trial results database in accordance with this 

16 subsection (referred to in this subsection as the 

17 ‘results database’). 

18 ‘‘(C) SEARCHABLE CATEGORIES.—The Di19 rector of NIH shall ensure that the public may 

20 search the entries in the results database by 1 

21 or more of the following: 

22 ‘‘(i) The indication studied in the clin23 ical trial, using Medical Subject Headers 

24 (MeSH) descriptors. 


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

2 clinical trial. 

3 ‘‘(iii) Whether an application for the 

4 tested indication is approved, pending ap5 proval, withdrawn, or not submitted. 

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

7 ‘‘(v) The name of the drug that is the 

8 subject of the clinical trial. 

9 ‘‘(vi) Within the documents described 

10 in subclauses (II) and (III) of subpara11 graph (D)(ii), the following information, as 

12 applicable: 

13 ‘‘(I) The sponsor of the clinical 

14 trial. 

15 ‘‘(II) Each financial sponsor of 

16 the clinical trial. 

17 ‘‘(D) CONTENTS.— 

18 ‘‘(i) IN GENERAL.—The responsible 

19 party for an applicable clinical trial shall 

20 submit to the Director of NIH for inclu21 sion in the results database the clinical 

22 trial information described in clause (ii). 

23 ‘‘(ii) REQUIRED ELEMENTS.—In sub24 mitting clinical trial information for an ap25 plicable clinical trial to the Director of 


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1 NIH for inclusion in the results database, 

2 the responsible party shall include, with re3 spect to such clinical trial, the following in4 formation: 

5 ‘‘(I) The information described in 

6 clauses (i) through (v) of subpara7 graph (C). 

8 ‘‘(II) A non-promotional sum9 mary document that is written in non10 technical, understandable language for 

11 patients that includes the following: 

12 ‘‘(aa) The purpose of the 

13 clinical trial. 

14 ‘‘(bb) The sponsor of the 

15 clinical trial. 

16 ‘‘(cc) A point of contact for 

17 information about the clinical 

18 trial. 

19 ‘‘(dd) A description of the 

20 patient population tested in the 

21 clinical trial. 

22 ‘‘(ee) A general description 

23 of the clinical trial and results, 

24 including a description of and the 

25 reasons for any changes in the 


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1 clinical trial design that occurred 

2 since the date of submission of 

3 clinical trial information for in4 clusion in the registry database 

5 established under paragraph (2) 

6 and a description of any signifi7 cant safety information. 

8 ‘‘(III) A non-promotional sum9 mary document that is technical in 

10 nature that includes the following: 

11 ‘‘(aa) The purpose of the 

12 clinical trial. 

13 ‘‘(bb) The sponsor of the 

14 clinical trial. 

15 ‘‘(cc) Each financial sponsor 

16 of the clinical trial. 

17 ‘‘(dd) A point of contact for 

18 scientific information about the 

19 clinical trial. 

20 ‘‘(ee) A description of the 

21 patient population tested in the 

22 clinical trial. 

23 ‘‘(ff) A general description 

24 of the clinical trial and results, 

25 including a description of and the 


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1 reasons for any changes in the 

2 clinical trial design that occurred 

3 since the date of submission of 

4 clinical trial information for the 

5 clinical trial in the registry data6 base established under paragraph 

7 (2). 

8 ‘‘(gg) Summary data de9 scribing the results, including— 

10 ‘‘(AA) whether the pri11 mary endpoint was achieved, 

12 including relevant statistics; 

13 ‘‘(BB) an assessment of 

14 any secondary endpoints, if 

15 applicable, including relevant 

16 statistics; and 

17 ‘‘(CC) any significant 

18 safety information, including 

19 a summary of the incidence 

20 of serious adverse events ob21 served in the clinical trial 

22 and a summary of the most 

23 common adverse events ob24 served in the clinical trial 


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1 and the frequencies of such 

2 events. 

3 ‘‘(IV) A link to available peer-re4 viewed publications based on the re5 sults of the clinical trial. 

6 ‘‘(V) The completion date of the 

7 clinical trial. 

8 ‘‘(VI) A link to the Internet web 

9 posting of any adverse regulatory ac10 tions taken by the Food and Drug 

11 Administration, such as a warning let12 ter, that was substantively based on 

13 the clinical trial design, outcome, or 

14 representation made by the applicant 

15 about the design or outcome of the 

16 clinical trial. 

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

18 submit to the Director of NIH for inclusion in 

19 the results database clinical trial information 

20 for an applicable clinical trial not later than 1 

21 year after the completion date of the clinical 

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

23 ‘‘(F) TRUTHFUL CLINICAL TRIAL INFOR24 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 ‘‘(G) INCLUSION OF EARLIER-STAGE CLIN11 ICAL TRIALS.— 

12 ‘‘(i) IN GENERAL.—The Secretary 

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

14 rulemaking the submission of clinical trial 

15 information for the clinical trials described 

16 in paragraph (2)(A)(i)(I) to the Director of 

17 NIH for inclusion in the results database. 

18 ‘‘(ii) CONDITIONS FOR REQUIRING IN19 CLUSION OF EARLIER-STAGE TRIALS.—The 

20 Secretary may promulgate regulations pur21 suant to clause (i) if— 

22 ‘‘(I) the Comptroller General of 

23 the United States has submitted to 

24 the Secretary the report described 

25 under clause (iii); and 


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1 ‘‘(II) such report recommends 

2 the inclusion in the results database 

3 of clinical trial information for the 

4 clinical trials described under para5 graph (2)(A)(i)(I). 

6 ‘‘(iii) STUDY BY GAO.—Not earlier 

7 than 2 years after the results database has 

8 been established, the Comptroller General 

9 of the United States shall initiate a report 

10 that— 

11 ‘‘(I) evaluates the operation of 

12 the database, including with respect to 

13 cost, burden on drug sponsors and 

14 agencies, and the value to patients 

15 and health care providers of inclusion 

16 in the results database of clinical trial 

17 information with respect to clinical 

18 trials described in paragraph 

19 (2)(A)(i)(I); 

20 ‘‘(II) recommends whether or not 

21 clinical trial information for such clin22 ical trials should be included in the re23 sults database; 

24 ‘‘(III) if the recommendation 

25 under subclause (II) is to include the 


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1 clinical trial information for such clin2 ical trials in the results database, rec3 ommends whether such information 

4 should be included in the same format 

5 as the clinical trial information of 

6 other applicable clinical trials, or if 

7 modifications are necessary; 

8 ‘‘(IV) provides recommendations 

9 for any modifications described under 

10 subclause (III); and 

11 ‘‘(V) is submitted to the Com12 mittee on Health, Education, Labor, 

13 and Pensions of the Senate, the Com14 mittee on Energy and Commerce of 

15 the House of Representatives, and the 

16 Secretary. 

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

18 The responsible party for an applicable clinical 

19 trial shall inform the Director of NIH of a 

20 change in the regulatory status submitted 

21 under subparagraph (C)(ii) of a drug that is 

22 the subject of an applicable clinical trial within 

23 30 days of such change, so that the Director 

24 can update the results database accordingly. 

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


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1 ‘‘(i) PRE-APPROVAL STUDIES.—Ex2 cept as provided in clause (iv), with respect 

3 to an applicable clinical trial that is com4 pleted before the drug is initially approved 

5 under section 505 of the Federal Food, 

6 Drug, and Cosmetic Act or initially li7 censed under section 351 of this Act, the 

8 Director of NIH shall make publicly avail9 able on the results database the clinical 

10 trial information submitted for such clin11 ical trial not later than 30 days after— 

12 ‘‘(I) the drug is approved under 

13 such section 505 or licensed under 

14 such section 351; or 

15 ‘‘(II) the Secretary issues a not 

16 approvable letter for the drug under 

17 such section 505 or such section 351. 

18 ‘‘(ii) POST-APPROVAL STUDIES.—Ex19 cept as provided in clauses (iii) and (iv), 

20 with respect to an applicable clinical trial 

21 that is completed after the drug is initially 

22 approved under such section 505 or ini23 tially licensed under such section 351, the 

24 Director of NIH shall make publicly avail25 able on the results database the clinical 


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1 trial information submitted for such clin2 ical trial not later than 30 days after the 

3 date of such submission. 

4 ‘‘(iii) SEEKING APPROVAL OF A NEW

5 USE FOR THE DRUG.— 

6 ‘‘(I) IN GENERAL.—If the manu7 facturer of the drug is the sponsor or 

8 a financial sponsor of the applicable 

9 clinical trial, and such manufacturer 

10 certifies to the Director of NIH that 

11 such manufacturer has filed, or will 

12 file within 1 year, an application seek13 ing approval under such section 505 

14 or licensing under such section 351 

15 for the use studied in such clinical 

16 trial (which use is not included in the 

17 labeling of the approved drug), then 

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

20 the clinical trial information sub21 mitted for such clinical trial on the 

22 earlier of the date that is 30 days 

23 after the date— 


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1 ‘‘(aa) the application is ap2 proved under such section 505 or 

3 licensed such section 351; 

4 ‘‘(bb) the Secretary issues a 

5 not approvable letter for the ap6 plication under such section 505 

7 or such section 351; or 

8 ‘‘(cc) the application under 

9 such section 505 or such section 

10 351 is withdrawn. 

11 ‘‘(II) LIMITATION ON CERTIFI12 CATION.—A manufacturer shall not 

13 make a certification under subclause 

14 (I) with respect to an applicable clin15 ical trial unless the manufacturer 

16 makes such a certification with re17 spect to each applicable clinical trial 

18 that is required to be submitted in an 

19 application for approval of the use 

20 studied in the clinical trial involved. 

21 ‘‘(III) 2-YEAR LIMITATION.—The 

22 clinical trial information subject to 

23 subclause (I) shall be made publicly 

24 available on the results database on 

25 the date that is 2 years after the date 


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1 the certification referred to in sub2 clause (I) was made to the Director of 

3 NIH, if a regulatory action referred to 

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

5 (I) has not occurred by such date. 

6 ‘‘(iv) SEEKING PUBLICATION.— 

7 ‘‘(I) IN GENERAL.—If the prin8 cipal investigator of the applicable 

9 clinical trial is seeking publication in 

10 a peer-reviewed biomedical journal of 

11 a manuscript based on the results of 

12 the clinical trial and the responsible 

13 party so certifies to the Director of 

14 NIH— 

15 ‘‘(aa) the responsible party 

16 shall notify the Director of NIH 

17 of the publication date of such 

18 manuscript not later than 15 

19 days after such date; and 

20 ‘‘(bb) the Director of NIH 

21 shall make publicly available on 

22 the results database the clinical 

23 trial information submitted for 

24 such clinical trial on the date 


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1 that is 30 days after the publica2 tion date of such manuscript. 

3 ‘‘(II) LIMITATION.—The clinical 

4 trial information subject to subclause 

5 (I) shall be made publicly available on 

6 the results database on the date that 

7 is 2 years after the date that the clin8 ical trial information was required to 

9 be submitted to the Director of NIH 

10 if the manuscript referred to in such 

11 subclause has not been published by 

12 such date. 

13 ‘‘(J) VERIFICATION OF SUBMISSION PRIOR

14 TO PUBLIC AVAILABILITY.—In the case of clin15 ical trial information that is submitted under 

16 this paragraph, but is not made publicly avail17 able pending either regulatory action or publica18 tion under clause (iii) or (iv) of subparagraph 

19 (I), as applicable, the Director of NIH shall re20 spond to inquiries from other Federal agencies 

21 and peer-reviewed journals to confirm that such 

22 clinical trial information has been submitted 

23 but has not yet been made publicly available on 

24 the results database. 

25 ‘‘(4) COORDINATION AND COMPLIANCE.— 


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1 ‘‘(A) CLINICAL TRIALS SUPPORTED BY

2 GRANTS FROM FEDERAL AGENCIES.— 

3 ‘‘(i) IN GENERAL.—No Federal agen4 cy may release funds under a research 

5 grant to a person who has not complied 

6 with paragraphs (2) and (3) for any appli7 cable clinical trial for which such person is 

8 the responsible party. 

9 ‘‘(ii) GRANTS FROM CERTAIN FED10 ERAL AGENCIES.—If an applicable clinical 

11 trial is funded in whole or in part by a 

12 grant from the National Institutes of 

13 Health, the Agency for Healthcare Re14 search and Quality, or the Department of 

15 Veterans Affairs, any grant or progress re16 port forms required under such grant shall 

17 include a certification that the responsible 

18 party has made all required submissions to 

19 the Director of NIH under paragraphs (2) 

20 and (3). 

21 ‘‘(iii) VERIFICATION BY FEDERAL

22 AGENCIES.—The heads of the agencies re23 ferred to in clause (ii), as applicable, shall 

24 verify that the clinical trial information for 

25 each applicable clinical trial for which a 


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1 grantee is the responsible party has been 

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

3 applicable, before releasing funding for a 

4 grant to such grantee. 

5 ‘‘(iv) NOTICE AND OPPORTUNITY TO

6 REMEDY.—If the head of an agency re7 ferred to in clause (ii), as applicable, 

8 verifies that a grantee has not submitted 

9 clinical trial information as described in 

10 clause (iii), such agency head shall provide 

11 notice to such grantee of such non-compli12 ance and allow such grantee 30 days to 

13 correct such non-compliance and submit 

14 the required clinical trial information. 

15 ‘‘(v) CONSULTATION WITH OTHER

16 FEDERAL AGENCIES.—The Secretary 

17 shall— 

18 ‘‘(I) consult with other agencies 

19 that conduct human studies in accord20 ance with part 46 of title 45, Code of 

21 Federal Regulations (or any successor 

22 regulations), to determine if any such 

23 studies are applicable clinical trials 

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


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1 ‘‘(II) develop with such agencies 

2 procedures comparable to those de3 scribed in clauses (ii), (iii), and (iv) to 

4 ensure that clinical trial information 

5 for such applicable clinical trials is 

6 submitted under paragraphs (2) and 

7 (3). 

8 ‘‘(B) COORDINATION OF REGISTRY DATA9 BASE AND RESULTS DATABASE.— 

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

11 registry database under paragraph (2) 

12 shall include a link to the corresponding 

13 entry in the results database under para14 graph (3). 

15 ‘‘(ii) MISSING ENTRIES.— 

16 ‘‘(I) IN GENERAL.—If, based on 

17 a review of the entries in the registry 

18 database under paragraph (2), the Di19 rector of NIH determines that a re20 sponsible party has failed to submit 

21 required clinical trial information to 

22 the results database under paragraph 

23 (3), the Director of NIH shall inform 

24 the responsible party involved of such 

25 failure and permit the responsible 


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1 party to correct the failure within 30 

2 days. 

3 ‘‘(II) FAILURE TO CORRECT.—If 

4 the responsible party does not correct 

5 a failure to submit required clinical 

6 trial information within the 30-day 

7 period described under subclause (I), 

8 the Director of NIH shall report such 

9 non-compliance to the scientific peer 

10 review committees of the Federal re11 search agencies and to the Office of 

12 Human Research Protections. 

13 ‘‘(III) PUBLIC NOTICE OF FAIL14 URE TO CORRECT.—The Director of 

15 NIH shall include in the clinical trial 

16 registry database entry and the clin17 ical trial results database entry for 

18 each such clinical trial a notice of any 

19 uncorrected failure to submit required 

20 clinical trial information and shall 

21 provide that the public may easily 

22 search for such entries. 

23 ‘‘(C) ACTION ON APPLICATIONS.— 

24 ‘‘(i) VERIFICATION PRIOR TO FIL25 ING.—The Secretary, acting through the 


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1 Commissioner of Food and Drugs, shall 

2 verify that the clinical trial information re3 quired under paragraphs (2) and (3) for 

4 an applicable clinical trial is submitted 

5 pursuant to such applicable paragraph— 

6 ‘‘(I) when considering a drug for 

7 an exemption under section 505(i) of 

8 the Federal Food, Drug, and Cos9 metic Act, including as the drug pro10 gresses through the clinical trials de11 scribed under paragraph (2)(A)(i); 

12 and 

13 ‘‘(II) prior to filing an applica14 tion under section 505 of the Federal 

15 Food, Drug, and Cosmetic Act or 

16 under section 351 of this Act that in17 cludes information from such clinical 

18 trial. 

19 ‘‘(ii) NOTIFICATION.—If the respon20 sible party has not submitted such clinical 

21 trial information, the Secretary shall notify 

22 the applicant and the responsible party of 

23 such non-compliance and require submis24 sion of such results within 30 days. 


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1 ‘‘(iii) REFUSAL TO FILE.—If the re2 sponsible party does not remedy such non3 compliance within 30 days of receipt of no4 tification under clause (ii), the Secretary 

5 shall refuse to file such application. 

6 ‘‘(D) CONTENT REVIEW.— 

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

8 summary documents described in para9 graph (3)(D) are non-promotional, and are 

10 not false or misleading in any particular 

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

12 shall compare such documents to the re13 sults data of the clinical trial for a rep14 resentative sample of applicable clinical 

15 trials by— 

16 ‘‘(I) acting through the Commis17 sioner of Food and Drugs to examine 

18 the results data for such clinical trials 

19 submitted to Secretary when such 

20 data are submitted— 

21 ‘‘(aa) for review as part of 

22 an application under section 505 

23 of the Federal Food, Drug, and 

24 Cosmetic Act or under section 

25 351 of this Act; or 


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1 ‘‘(bb) in an annual status 

2 report on the drug under such 

3 application; 

4 ‘‘(II) acting with the Federal 

5 agency that funds such clinical trial in 

6 whole or in part by a grant to exam7 ine the results data for such clinical 

8 trials; and 

9 ‘‘(III) acting through inspections 

10 under section 704 of the Federal 

11 Food, Drug, and Cosmetic Act to ex12 amine results data for such clinical 

13 trials not described in subclause (I) or 

14 (II). 

15 ‘‘(ii) NOTICE OF NON-COMPLIANCE.— 

16 If the Secretary determines that the clin17 ical trial information submitted in such a 

18 summary document is promotional, or false 

19 or misleading in any particular, the Sec20 retary shall notify the responsible party 

21 and give such party an opportunity to rem22 edy such non-compliance by submitting the 

23 required revised clinical trial information 

24 within 30 days of such notification. 


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

2 determining whether to apply a penalty under 

3 section 301(jj) of the Federal Food, Drug, and 

4 Cosmetic Act, the Secretary, acting through the 

5 Commissioner of Food and Drugs, shall con6 sider— 

7 ‘‘(i) whether the responsible party 

8 promptly corrects the non-compliance when 

9 provided notice; 

10 ‘‘(ii) whether the responsible party 

11 has engaged in a pattern or practice of 

12 non-compliance; and 

13 ‘‘(iii) the extent to which the non14 compliance involved may have significantly 

15 misled healthcare providers or patients 

16 concerning the safety or effectiveness of 

17 the drug involved. 

18 ‘‘(5) LIMITATION ON DISCLOSURE OF CLINICAL

19 TRIAL INFORMATION.—Disclosure to the public of 

20 clinical trial information submitted to the Director 

21 of NIH under this subsection and requested under 

22 section 552 of title 5, United States Code (com23 monly known as the Freedom of Information Act) 

24 shall be made only as provided for under paragraphs 

25 (2) and (3). 


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1 ‘‘(6) AUTHORIZATION OF APPROPRIATIONS.— 

2 There are authorized to be appropriated to carry out 

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

4 (b) CONFORMING AMENDMENTS.— 

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

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

7 331), as amended by Public Law 109–462, is 

8 amended by adding at the end the following: 

9 ‘‘(jj)(1) The failure to submit clinical trial informa10 tion as required by section 402(i) of the Public Health 

11 Service Act. 

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

13 under section 402(i) of the Public Health Service Act that 

14 is promotional or false or misleading in any particular 

15 under paragraph (2)(E) or (3)(F) of such section 402(i).’’. 

16 (2) NEW DRUGS.— 

17 (A) INVESTIGATIONAL NEW DRUGS.—Sec18 tion 505(i) of the Federal Food, Drug, and 

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

20 (i) in paragraph (1)— 

21 (I) in subparagraph (C), by strik22 ing ‘‘and’’ after the semicolon; 

23 (II) in subparagraph (D), by 

24 striking the period at the end and in25 serting ‘‘; and’’; and 


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1 (III) by adding at the end the 

2 following: 

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

4 clinical trial information for the clinical investigation 

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

6 Health Service Act for inclusion in the registry data7 base and the results database described in such sec8 tion.’’; 

9 (ii) in paragraph (3)(B)— 

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

11 after the semicolon; 

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

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

14 and 

15 (III) by adding at the end the 

16 following: 

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

18 investigation at issue was not submitted in compli19 ance with section 402(i) of the Public Health Service 

20 Act.’’; and 

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

22 the end the following: ‘‘The Secretary shall 

23 update such regulations to require inclu24 sion in the informed consent form a state25 ment that clinical trial information for 


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1 such clinical investigation will be submitted 

2 for inclusion in the registry database and 

3 results database, as applicable, described 

4 in section 402(i) of the Public Health 

5 Service Act.’’. 

6 (B) REFUSAL TO APPROVE APPLICA7 TION.—Section 505(d) of the Federal Food, 

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

9 amended— 

10 (i) in the first sentence, by inserting 

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

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

13 clinical trial information for any applicable 

14 clinical trial submitted as part of the appli15 cation to the Director of the National In16 stitutes of Health in compliance with sec17 tion 402(i) of the Public Health Service 

18 Act;’’; and 

19 (ii) in the second sentence, by striking 

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

21 ‘‘paragraphs (1) through (8)’’. 

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

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

24 and Drugs, in consultation with the Director of the Na25 tional Institutes of Health, shall issue guidance to clarify 


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1 which clinical trials are applicable clinical trials (as de2 fined in section 402(i)(2) of the Public Health Service Act, 

3 as amended by this section) and are required to be sub4 mitted for inclusion in the clinical trial registry database 

5 described in such section 402(i)(2). 

6 (d) PREEMPTION.— 

7 (1) IN GENERAL.—No State or political subdivi8 sion of a State may establish or continue in effect 

9 any requirement for the registration of clinical trials 

10 or for the inclusion of information relating to the re11 sults of clinical trials in a database. 

12 (2) RULE OF CONSTRUCTION.—The fact of sub13 mission of clinical trial information, if submitted in 

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

15 Service Act (as amended by this section), that re16 lates to a use of a drug not included in the official 

17 labeling of the approved drug shall not be construed 

18 by the Secretary or in any administrative or judicial 

19 proceeding, as evidence of a new intended use of the 

20 drug that is different from the intended use of the 

21 drug set forth in the official labeling of the drug. 

22 The availability of clinical trial information through 

23 the databases under paragraphs (2) and (3) of such 

24 section 402(i), if submitted in compliance with such 

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


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1 adulteration, or misbranding of the drug under the 

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

3 301 et seq.). 

4 (e) EFFECTIVE DATES.— 

5 (1) ESTABLISHMENT OF REGISTRY DATABASE

6 AND RESULTS DATABASE.—Not later than 1 year 

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

8 of NIH shall establish the registry database and the 

9 results database of clinical trials of drugs in accord10 ance with section 402(i) of the Public Health Service 

11 Act (as amended by subsection (a)). 

12 (2) CLINICAL TRIALS INITIATED PRIOR TO OP13 ERATION OF REGISTRY DATABASE.—The responsible 

14 party (as defined in such section 402(i)) for an ap15 plicable clinical trial under paragraph (2) of such 

16 section 402(i) that is initiated after the date of en17 actment of this Act and before the date such reg18 istry database is established under paragraph (1) of 

19 this subsection, shall submit required clinical trial 

20 information not later than 120 days after the date 

21 such registry database is established. 

22 (3) CLINICAL TRIALS INITIATED AFTER OPER23 ATION OF REGISTRY DATABASE.—The responsible 

24 party (as defined in such section 402(i)) for an ap25 plicable clinical trial under paragraph (2) of such 


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1 section 402(i) that is initiated after the date such 

2 registry database is established under paragraph (1) 

3 of this subsection shall submit required clinical trial 

4 information in accordance with such paragraph (2). 

5 (4) TRIALS COMPLETED BEFORE OPERATION

6 OF RESULTS DATABASE.— 

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

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

9 the date the results database is established 

10 under paragraph (1) of this subsection with re11 spect to any applicable clinical trial (as defined 

12 in such section 402(i)(3)) that— 

13 (i) involves a drug to treat a serious 

14 or life-threatening condition; and 

15 (ii) is completed between the date of 

16 enactment of this section and such date of 

17 establishment under paragraph (1) of this 

18 subsection. 

19 (B) OTHER TRIALS.—Except as provided 

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

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

22 the date that the results database is established 

23 under paragraph (1) of this subsection with re24 spect to any applicable clinical trial (as defined 

25 in such section 402(i)(3)) that is completed beVerDate Aug 31 2005 03:36 Feb 03, 2007 Jkt 059200 PO 00000 Frm 00101 Fmt 6652 Sfmt 6201 E:\BILLS\S484.IS S484

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1 tween the date of enactment of this Act and 

2 such date of establishment under paragraph 

3 (1). 

4 (C) TRIALS SUBMITTED IN AN APPLICA5 TION.—Except as provided in subparagraph 

6 (A), paragraph (3) of such section 402(i) shall 

7 take effect for any clinical trial if— 

8 (i) data from such clinical trial is sub9 mitted in an application or supplement to 

10 an application under section 505 of the 

11 Food, Drug, and Cosmetic Act or under 

12 section 351 of the Public Health Service 

13 Act that— 

14 (I) is submitted 180 days or 

15 more after the date that the results 

16 database is established under para17 graph (1) of this subsection; and 

18 (II) contains data from an appli19 cable clinical trial; and 

20 (ii) such clinical trial would otherwise 

21 be an applicable clinical trial under such 

22 paragraph (3) except for its date of com23 pletion. 

24 (5) TRIALS COMPLETED AFTER ESTABLISH25 MENT OF RESULTS DATABASE.—Paragraph (3) of 


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1 such section 402(i) shall apply to any applicable 

2 clinical trial that is completed after the date that the 

3 results database is established under paragraph (1) 

4 of this subsection. 

5 (6) FUNDING RESTRICTIONS.—Subparagraph 

6 (A) of paragraph (4) of such section 402(i) shall 

7 take effect 210 days after the date that the clinical 

8 trial registry database and the clinical trial results 

9 database are established under paragraph (1) of this 

10 subsection. 

11 (7) STATUS OF CLINICALTRIALS.GOV

12 WEBSITE.— 

13 (A) IN GENERAL.—After receiving public 

14 comment and not later than 90 days after the 

15 date of enactment of this Act, the Secretary 

16 shall publish in the Federal Register a notice 

17 determining the more efficient approach to es18 tablishing the registry database described in 

19 paragraph (2) of such section 402(i) and 

20 whether such approach is— 

21 (i) that such registry database should 

22 expand and build upon the database de23 scribed in section 402(i) of the Public 

24 Health Service Act (as in effect on the day 


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•S 484 IS

1 before the date of enactment of this Act); 

2 or 

3 (ii) that such registry database should 

4 supplant the database described in such 

5 section 402(i) (as in effect on the day be6 fore the date of enactment of this Act). 

7 (B) CLINICALTRIALS.GOV SUPPLANTED.— 

8 If the Secretary determines to apply the ap9 proach described under subparagraph (A)(ii), 

10 the Secretary shall maintain an archive of the 

11 database described in such section 402(i) (as in 

12 effect on the day before the date of enactment 

13 of this Act) on the Internet website of the Na14 tional Library of Medicine. 

15 TITLE IV—CONFLICTS OF 

16 INTEREST 

17 SEC. 401. CONFLICTS OF INTEREST. 

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

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

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

21 ‘‘SEC. 712. CONFLICTS OF INTEREST. 

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

23 ‘‘(1) ADVISORY COMMITTEE.—The term ‘advi24 sory committee’ means an advisory committee under 

25 the Federal Advisory Committee Act that provides 


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1 advice or recommendations to the Secretary regard2 ing activities of the Food and Drug Administration. 

3 ‘‘(2) FINANCIAL INTEREST.—The term ‘finan4 cial interest’ means a financial interest under section 

5 208(a) of title 18, United States Code. 

6 ‘‘(3) INDUSTRY FINANCIAL INTEREST.—The 

7 term ‘industry financial interest’, with respect to ap8 pointment for a term to an advisory committee, 

9 means an interest in a company that is a member 

10 of the relevant industry that would be a financial in11 terest were an advisory committee to consider a par12 ticular matter involving such company. 

13 ‘‘(4) RELEVANT INDUSTRY.—The term ‘rel14 evant industry’ means— 

15 ‘‘(A) with respect to an advisory committee 

16 that advises the Secretary on human drugs, bio17 logics, or devices, the pharmaceutical, bio18 technology, and device industries; 

19 ‘‘(B) with respect to an advisory committee 

20 that advises the Secretary on animal drugs or 

21 devices, the animal drug and the animal device 

22 industries; and 

23 ‘‘(C) with respect to an advisory committee 

24 that advises the Secretary on foods, the food in25 dustry. 


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1 ‘‘(b) APPOINTMENTS TO ADVISORY COMMITTEES.— 

2 ‘‘(1) DISCLOSURE OF INDUSTRY FINANCIAL IN3 TERESTS.—Each individual under consideration for 

4 a term appointment to an advisory committee shall 

5 disclose to the Secretary all industry financial inter6 ests. 

7 ‘‘(2) DISCLOSURES NOT PUBLICLY AVAIL8 ABLE.—No disclosure required under paragraph (1) 

9 shall be made available to the public. 

10 ‘‘(3) EVALUATION AND CRITERIA.—When con11 sidering a term appointment to an advisory com12 mittee, the Secretary— 

13 ‘‘(A) shall review the expertise and the in14 dustry financial interests, as disclosed under 

15 paragraph (1), of each individual under consid16 eration for the appointment, so as to appoint 

17 the individuals, from among those individuals 

18 under consideration for appointment, who are 

19 the most qualified relative to their industry fi20 nancial interests that could require a written 

21 determination as referred to in section 

22 208(b)(1) of title 18, United States Code, a 

23 written certification as referred to in section 

24 208(b)(3) of title 18, United States Code, or a 

25 waiver as referred to in subsection (c)(3) for 


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1 service on the committee at a meeting of the 

2 committee; and 

3 ‘‘(B) may appoint 2 or more qualified indi4 viduals with similar expertise and whose indus5 try financial interests are nonoverlapping or 

6 minimally overlapping, so as to minimize the 

7 likelihood that an advisory committee will need 

8 the expertise of an appointed individual who re9 quires a written determination as referred to in 

10 section 208(b)(1) of title 18, United States 

11 Code, a written certification as referred to in 

12 section 208(b)(3) of title 18, United States 

13 Code, or a waiver as referred to in subsection 

14 (c)(3) for service on the committee at a meeting 

15 of the committee. 

16 ‘‘(c) GRANTING AND DISCLOSURE OF WAIVERS.— 

17 ‘‘(1) IN GENERAL.—Not later then 45 days be18 fore a meeting of an advisory committee, each mem19 ber of the committee shall disclose to the Secretary 

20 all financial interests in accordance with section 

21 208(b) of title 18, United States Code. 

22 ‘‘(2) FINANCIAL GAIN OF ADVISORY COMMITTEE

23 MEMBER OR FAMILY MEMBER.—No member of an 

24 advisory committee may vote with respect to any 

25 matter considered by the advisory committee if such 


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1 member or an immediate family member of such 

2 member could gain financially from the advice given 

3 to the Secretary with respect to such matter. 

4 ‘‘(3) WAIVER.—In addition to considerations 

5 under section 208(b) of title 18, United States Code, 

6 the Secretary may grant a waiver of a conflict of in7 terest requirement if such waiver is necessary to af8 ford the advisory committee essential expertise. 

9 ‘‘(4) LIMITATION.—In no case may the Sec10 retary grant a waiver under paragraph (3) for a 

11 member of an advisory committee if the scientific 

12 work of such member is under consideration by the 

13 committee. 

14 ‘‘(5) DISCLOSURE OF WAIVER.— 

15 ‘‘(A) MORE THAN 15 DAYS IN ADVANCE.— 

16 As soon as practicable, but in no case later 

17 than 15 days prior to a meeting of an advisory 

18 committee to which a written determination as 

19 referred to in section 208(b)(1) of title 18, 

20 United States Code, a written certification as 

21 referred to in section 208(b)(3) of title 18, 

22 United States Code, or a waiver as referred to 

23 in paragraph (3) applies, the Secretary shall 

24 disclose (other than information exempted from 

25 disclosure under section 552 of title 5, United 


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1 States Code, and section 552a of title 5, United 

2 States Code (popularly known as the Freedom 

3 of Information Act and the Privacy Act of 

4 1974, respectively)) on the Internet website of 

5 the Food and Drug Administration— 

6 ‘‘(i) the financial interests of the advi7 sory committee member to which such de8 termination, certification, or waiver ap9 plies; and 

10 ‘‘(ii) the reasons of the Secretary for 

11 such determination, certification, or waiv12 er. 

13 ‘‘(B) LESS THAN 15 DAYS IN ADVANCE.— 

14 In the case of a financial interest that becomes 

15 known to the Secretary less than 30 days prior 

16 to a meeting of an advisory committee to which 

17 a written determination as referred to in section 

18 208(b)(1) of title 18, United States Code, a 

19 written certification as referred to in section 

20 208(b)(3) of title 18, United States Code, or a 

21 waiver as referred to in paragraph (3) applies, 

22 the Secretary shall disclose (other than infor23 mation exempted from disclosure under section 

24 552 of title 5, United States Code, and section 

25 552a of title 5, United States Code) on the 


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1 Internet website of the Food and Drug Admin2 istration, the information described in clauses 

3 (i) and (ii) of subparagraph (A) as soon as the 

4 Secretary makes such determination, certifi5 cation, or waiver, but in no event later than the 

6 date of such meeting. 

7 ‘‘(d) PUBLIC RECORD.—The Secretary shall ensure 

8 that the public record and transcript of each meeting of 

9 an advisory committee includes the disclosure required 

10 under subsection (c)(5) (other than information exempted 

11 from disclosure under section 552 of title 5, United States 

12 Code, and section 552a of title 5, United States Code). 

13 ‘‘(e) ANNUAL REPORT.—Not later than January 15 

14 of each year, the Secretary shall submit a report to the 

15 Inspector General of the Department of Health and 

16 Human Services, the Committee on Appropriations and 

17 the Committee on Health, Education, Labor, and Pen18 sions of the Senate, and the Committee on Appropriations 

19 and the Committee on Energy and Commerce of the 

20 House of Representatives— 

21 ‘‘(1) with respect to the fiscal year that ended 

22 on September 30 of the previous year, the number 

23 of vacancies on each advisory committee, the number 

24 of nominees received for each committee, and the 

25 number of such nominees willing to serve; 


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1 ‘‘(2) with respect to such year, the aggregate 

2 number of disclosures required under subsection 

3 (c)(5) for each meeting of each advisory committee 

4 and the percentage of individuals to whom such dis5 closures did not apply who served on such committee 

6 for each such meeting; 

7 ‘‘(3) with respect to such year, the number of 

8 times the disclosures required under subsection 

9 (c)(5) occurred under subparagraph (B) of such sub10 section; and 

11 ‘‘(4) how the Secretary plans to reduce the 

12 number of vacancies reported under paragraph (1) 

13 during the fiscal year following such year.’’. 

14 (b) GUIDANCE.— 

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

16 after the date of enactment of this Act, and after 

17 seeking input from professional medical and sci18 entific societies, the Secretary shall publish in the 

19 Federal Register for public comment a proposed 

20 mechanism for encouraging the nomination of indi21 viduals who are classified by the Food and Drug Ad22 ministration as academicians or practitioners for 

23 service on an advisory committee. 


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1 (2) WAIVER DETERMINATIONS.—Not later than 

2 270 days after the date of enactment of this Act the 

3 Secretary shall issue or revise guidance— 

4 (A) that clarifies the circumstances in 

5 which the Secretary may make a written deter6 mination as referred to in section 208(b)(1) of 

7 title 18, United States Code, make a written 

8 certification as referred to in section 208(b)(3) 

9 of title 18, United States Code, or grant a waiv10 er as referred to section 712(c)(3) of the Fed11 eral Food, Drug, and Cosmetic Act (as added 

12 by this section), including those circumstances 

13 that— 

14 (i) favor the inclusion of an individual 

15 on an advisory committee; 

16 (ii) favor making such a determina17 tion, certification, or waiver for an indi18 vidual on an advisory committee; 

19 (iii) favor limitations on an individ20 ual’s ability to act when making such a de21 termination, certification, or waiver for the 

22 individual on an advisory committee; and 

23 (iv) disfavor the inclusion of an indi24 vidual on an advisory committee; 


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1 (B) that defines how financial interests im2 puted to an individual bear upon his or her eli3 gibility for service on an advisory committee or 

4 for service at a meeting of an advisory com5 mittee; and 

6 (C) to ensure consistency within and 

7 among the centers of the Food and Drug Ad8 ministration in applying section 208(b) of title 

9 18, United States Code, and such section 

10 712(c)(3). 

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

12 years, the Secretary shall review the guidance de13 scribed under paragraph (2) and update such guid14 ance as necessary. 

15 (c) REVIEW BY INSPECTOR GENERAL.— 

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

17 the Department of Health and Human Services shall 

18 conduct a review, which may include surveys of past 

19 or current members of advisory committees, of the 

20 processes of the Food and Drug Administration 

21 for— 

22 (A) evaluating the financial interests of a 

23 member of such an advisory committee while 

24 the member serves on such a committee and 


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1 after the member has served on such a com2 mittee; and 

3 (B) assuring the completeness and accu4 racy of information contained in the disclosures 

5 described in subsections (b)(1) and (c)(1) of 

6 such section 712 of the Federal Food, Drug, 

7 and Cosmetic Act (as added by this section). 

8 (2) SUBMISSION OF REPORT.—Not later than 

9 18 months after the effective date of this section, 

10 the Inspector General of the Department of Health 

11 and Human Services shall submit to Congress a re12 port based on the review required under paragraph 

13 (1), and include any recommendations for the im14 provement of such processes. 

15 (d) DEFINITIONS.—For purposes of this section, the 

16 terms ‘‘advisory committee’’ and ‘‘financial interest’’ have 

17 the meaning given such terms in section 712 of the Fed18 eral Food, Drug, and Cosmetic Act (as added by this sec19 tion). 

20 (e) CONFORMING AMENDMENT.—Section 505(n) of 

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

22 355(n)) is amended by— 

23 (1) striking paragraph (4); and 

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

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


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1 (f) EFFECTIVE DATE.—The amendments made by 

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

Æ 


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