I 

114TH CONGRESS 

1ST SESSION H. R. 2438 

To amend the Federal Food, Drug, and Cosmetic Act with respect to broader 

application of Bayesian statistics and adaptive trial designs. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 19, 2015 

Mr. COLLINS of New York introduced the following bill; which was referred 

to the Committee on Energy and Commerce 

A BILL 

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

respect to broader application of Bayesian statistics and 

adaptive trial designs. 

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

3 SECTION 1. BROADER APPLICATION OF BAYESIAN STATIS4 TICS AND ADAPTIVE TRIAL DESIGNS. 

5 (a) PROPOSALS FOR USE OF INNOVATIVE STATIS6 TICAL METHODS IN CLINICAL PROTOCOLS FOR DRUGS

7 AND BIOLOGICAL PRODUCTS.—For purposes of assisting 

8 sponsors in incorporating adaptive trial design and 

9 Bayesian methods into proposed clinical protocols and ap10 plications for new drugs under section 505 of the Federal 


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1 Food, Drug, and Cosmetic Act (21 U.S.C. 355) and bio2 logical products under section 351 of the Public Health 

3 Service Act (42 U.S.C. 262), the Secretary shall conduct 

4 a public meeting and issue guidance in accordance with 

5 subsection (b). 

6 (b) GUIDANCE ADDRESSING USE OF ADAPTIVE

7 TRIAL DESIGNS AND BAYESIAN METHODS.— 

8 (1) IN GENERAL.—The Secretary of Health and 

9 Human Services, acting through the Commissioner 

10 of Food and Drugs (in this subsection referred to as 

11 the ‘‘Secretary’’), shall— 

12 (A) update and finalize the draft guidance 

13 addressing the use of adaptive trial design for 

14 drugs and biological products; and 

15 (B) issue draft guidance on the use of 

16 Bayesian methods in the development and regu17 latory review and approval or licensure of drugs 

18 and biological products. 

19 (2) CONTENTS.—The guidances under para20 graph (1) shall address— 

21 (A) the use of adaptive trial designs and 

22 Bayesian methods in clinical trials, including 

23 clinical trials proposed or submitted to help sat24 isfy the substantial evidence standard under 


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1 section 505(d) of the Federal Food, Drug, and 

2 Cosmetic Act (21 U.S.C. 355(d)); 

3 (B) how sponsors may obtain feedback 

4 from the Secretary on technical issues related 

5 to modeling and simulations prior to— 

6 (i) completion of such modeling or 

7 simulations; or 

8 (ii) the submission of resulting infor9 mation to the Secretary; 

10 (C) the types of quantitative and quali11 tative information that should be submitted for 

12 review; and 

13 (D) recommended analysis methodologies. 

14 (3) PUBLIC MEETING.—Prior to updating or 

15 developing the guidances required by paragraph (1), 

16 the Secretary shall consult with stakeholders, includ17 ing representatives of regulated industry, academia, 

18 patient advocacy organizations, and disease research 

19 foundations, through a public meeting to be held not 

20 later than 1 year after the date of enactment of this 

21 Act. 

22 (4) SCHEDULE.—The Secretary shall publish— 

23 (A) the final guidance required by para24 graph (1)(A) not later than 18 months after the 


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1 date of the public meeting required by para2 graph (3); and 

3 (B) the guidance required by paragraph 

4 (1)(B) not later than 48 months after the date 

5 of the public meeting required by paragraph 

6 (3). 

Æ 


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