This bill requires the Food and Drug Administration to issue guidance that addresses using alternative statistical methods, including adaptive trial design and Bayesian methods, in clinical trials and in the development and review of drugs and biological products.
[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(A) update and finalize the draft guidance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(B) issue draft guidance on the use of Bayesian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).
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Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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