[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1066 Introduced in House (IH)]

114th CONGRESS
  1st Session
                                H. R. 1066

To amend the Federal Food, Drug, and Cosmetic Act to promote the use of 
    adaptive trial designs, Bayesian methods, and other innovative 
    statistical methods in clinical protocols for drugs, biological 
 products, and devices, and with respect to the requirement to conduct 
   postapproval studies and clinical trials, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 25, 2015

  Mr. Collins of New York (for himself and Mr. Pompeo) 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 to promote the use of 
    adaptive trial designs, Bayesian methods, and other innovative 
    statistical methods in clinical protocols for drugs, biological 
 products, and devices, and with respect to the requirement to conduct 
   postapproval studies and clinical trials, and for other purposes.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Clinical Trials Modernization Act of 
2015''.

SEC. 2. CLINICAL TRIAL MODERNIZATION.

    (a) Proposals for Use of Innovative Statistical Methods in Clinical 
Protocols for Drugs, Biological Products, and Devices.--Chapter V of 
the Federal Food, Drug, and Cosmetic Act is amended by inserting after 
section 506F (21 U.S.C. 356f) the following new section:

``SEC. 507. CLINICAL TRIAL MODERNIZATION.

    ``(a) In General.--To promote the efficiency of the development and 
regulatory review and approval, licensure, or clearance of drugs, 
biological products, and devices and the timely availability of 
innovative treatments, the Secretary shall, after providing notice and 
an opportunity for public comment, establish and implement a framework 
through which--
            ``(1) sponsors of drugs, biological products, or devices 
        may submit to the Secretary a proposal for the incorporation of 
        adaptive trial designs, Bayesian methods, or other alternative 
        statistical methods into proposed clinical protocols and 
        marketing applications for drugs, biological products, or 
        devices; and
            ``(2) the Secretary will commit to timelines for reviewing 
        and providing feedback on proposals so submitted.''.
    (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, licensure, or clearance of drugs, biological 
                products, and devices.
            (2) Contents.--The guidances under paragraph (1) shall--
                    (A) establish or clarify standards for using 
                adaptive trial designs and Bayesian methods in clinical 
                trials, including clinical trials that form the primary 
                basis for approval, clearance, or licensure of the 
                products involved (such as trials that provide 
                substantial evidence for the approval of drugs);
                    (B) establish a mechanism for sponsors to obtain 
                feedback from the Secretary under section 507, as added 
                by subsection (a), 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) specify the types of quantitative and 
                qualitative information required for review; and
                    (D) specify the recommended analysis methodology.
            (3) Public meeting.--Prior to updating or developing the 
        guidances required by paragraph (1), the Secretary shall 
        consult, through a public meeting to be held no later than 1 
        year after the date of enactment of this Act, with stakeholders 
        including representatives of regulated industry, academia, 
        patient advocacy organizations, and disease research 
        foundations.
            (4) Schedule.--The Secretary shall, after providing notice 
        and opportunity for public comment, publish--
                    (A) the final guidance required by paragraph (1)(A) 
                not later than 6 months after the date of the public 
                meeting required by paragraph (3); and
                    (B) the guidance required by paragraph (1)(B) not 
                later than 12 months after the date of the public 
                meeting required by paragraph (3).
            (5) Review and revision of guidance documents.--Not later 
        than 48 months after the date of enactment of this Act, the 
        Secretary shall review and, as appropriate, revise the guidance 
        documents required by subparagraphs (A) and (B) of paragraph 
        (1) to reflect developments in statistical methods that could 
        be appropriate for use in clinical trials, including clinical 
        trials that--
                    (A) form the primary basis for approval, clearance, 
                or licensure of drugs, biological products or devices; 
                or
                    (B) provide substantial evidence for the approval 
                of drugs.

SEC. 3. EVALUATIONS OF REQUIRED POSTAPPROVAL STUDIES AND CLINICAL 
              TRIALS.

    (a) In General.--Section 505(o)(3) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(o)(3)) is amended by adding at the end the 
following new subparagraph:
                    ``(G) Evaluations of required postapproval studies 
                and clinical trials.--
                            ``(i) In general.--The Secretary shall 
                        establish a process under which the Secretary, 
                        on the initiative of the Secretary or at the 
                        request of a responsible person, shall 
                        periodically evaluate a postapproval study or 
                        clinical trial required to be conducted under 
                        this paragraph to determine whether--
                                    ``(I) the trial or study is no 
                                longer scientifically warranted; or
                                    ``(II) the design, or the timelines 
                                applicable to the completion of, the 
                                study or trial should be renegotiated 
                                because of changes in medical practice 
                                or the standard of care.
                            ``(ii) Not scientifically warranted.--In 
                        the case of a determination under clause (i)(I) 
                        that a postapproval study or clinical trial 
                        required to be conducted under this paragraph 
                        is no longer scientifically warranted, the 
                        Secretary shall no longer require the 
                        responsible person to conduct the study or 
                        trial.
                            ``(iii) Renegotiation.--In the case of a 
                        determination under clause (i)(II) that the 
                        design, or the timelines applicable to the 
                        completion of, a postapproval study or clinical 
                        trial required to be conducted under this 
                        paragraph should be renegotiated, the Secretary 
                        shall enter into negotiations with the 
                        responsible person to make such changes as may 
                        be necessary to such design or timelines as the 
                        Secretary determines are necessary.''.
    (b) Guidance.--Not later than one year after the date of the 
enactment of this Act, the Secretary shall issue draft guidance on the 
implementation of subparagraph (G) of section 505(o)(3) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(3)), as added by 
subsection (a). Not later than two years after such date of enactment, 
the Secretary shall issue final guidance on such implementation.
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