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[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2438 Introduced in House (IH)]

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.

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

SECTION 1. BROADER APPLICATION OF BAYESIAN STATISTICS AND ADAPTIVE 
              TRIAL DESIGNS.

    (a) Proposals for Use of Innovative Statistical Methods in Clinical 
Protocols for Drugs and Biological Products.--For purposes of assisting 
sponsors in incorporating adaptive trial design and Bayesian methods 
into proposed clinical protocols and applications for new drugs under 
section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
and biological products under section 351 of the Public Health Service 
Act (42 U.S.C. 262), the Secretary shall conduct a public meeting and 
issue guidance in accordance with subsection (b).
    (b) Guidance Addressing Use of Adaptive Trial Designs and Bayesian 
Methods.--
            (1) In general.--The Secretary of Health and Human 
        Services, acting through the Commissioner of Food and Drugs (in 
        this subsection referred to as the ``Secretary''), shall--
                    (A) update and finalize the draft guidance 
                addressing the use of adaptive trial design for drugs 
                and biological products; and
                    (B) issue draft guidance on the use of Bayesian 
                methods in the development and regulatory review and 
                approval or licensure of drugs and biological products.
            (2) Contents.--The guidances under paragraph (1) shall 
        address--
                    (A) the use of adaptive trial designs and Bayesian 
                methods in clinical trials, including clinical trials 
                proposed or submitted to help satisfy the substantial 
                evidence standard under section 505(d) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 355(d));
                    (B) how sponsors may obtain feedback from the 
                Secretary on technical issues related to modeling and 
                simulations prior to--
                            (i) completion of such modeling or 
                        simulations; or
                            (ii) the submission of resulting 
                        information to the Secretary;
                    (C) the types of quantitative and qualitative 
                information that should be submitted for review; and
                    (D) recommended analysis methodologies.
            (3) Public meeting.--Prior to updating or developing the 
        guidances required by paragraph (1), the Secretary shall 
        consult with stakeholders, including representatives of 
        regulated industry, academia, patient advocacy organizations, 
        and disease research foundations, through a public meeting to 
        be held not later than 1 year after the date of enactment of 
        this Act.
            (4) Schedule.--The Secretary shall publish--
                    (A) the final guidance required by paragraph (1)(A) 
                not later than 18 months after the date of the public 
                meeting required by paragraph (3); and
                    (B) the guidance required by paragraph (1)(B) not 
                later than 48 months after the date of the public 
                meeting required by paragraph (3).
                                 <all>
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