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[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 2669 Introduced in Senate (IS)]

<DOC>

115th CONGRESS
  2d Session
                                S. 2669

  To provide for accelerated approval of pain and addiction therapies.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             April 16, 2018

   Mr. Hatch (for himself, Mr. Bennet, Mr. Donnelly, and Mr. Young) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
  To provide for accelerated approval of pain and addiction therapies.

    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 ``Advancing Innovation in Alternative 
Pain and Addiction Therapies Act''.

SEC. 2. ACCELERATED APPROVAL OF PAIN AND ADDICTION THERAPIES.

    (a) Purpose.--It is the purpose of this section to clarify the 
appropriate processes for encouraging and expediting the review of non-
opioid or non-addictive medical products to treat chronic or acute pain 
or substance use disorders.
    (b) Draft Guidance.--
            (1) In general.--Not later than 1 year after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services (referred to in this section as the ``Secretary''), 
        acting through the Commissioner of Food and Drugs, shall issue 
        draft guidance, clarifying the methods and processes by which 
        the Food and Drug Administration may provide accelerated 
        approval for non-opioid or non-addictive drugs developed to 
        treat chronic or acute pain or substance use disorders.
            (2) Contents.--The guidance under paragraph (1) shall 
        address--
                    (A) eligibility requirements for such drugs to 
                receive accelerated approval;
                    (B) opportunities for engagement with the Food and 
                Drug Administration with respect to the accelerated 
                approval pathway;
                    (C) considerations for different types of pain and 
                product mechanism of action; and
                    (D) potential criteria for novel surrogate or 
                intermediate clinical endpoints or biomarkers to assess 
                pain.
    (c) Final Guidance.--Not later than 6 months after the close of the 
period for public comment on the draft guidance under subsection (b), 
the Secretary shall finalize such guidance.
    (d) Data in Performance Reports.--
            (1) In general.--As a component of the annual performance 
        report under section 736B(a) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 379h-2(a)), the Secretary shall include 
        information, as appropriate, on policies and processes of the 
        Division of Anesthesia, Analgesia, and Addiction Products of 
        the Food and Drug Administration (referred to in this section 
        as the ``DAAAP'') for the accelerated approval pathway with 
        respect to drugs developed to treat pain or substance use 
        disorders, during the previous fiscal year.
            (2) Contents.--Information submitted as a part of the 
        performance reports under section 736B(a) of the Federal Food, 
        Drug, and Cosmetic Act may address--
                    (A) the number of requests for accelerated approval 
                submitted to the DAAAP for non-opioid or non-addictive 
                medical products;
                    (B) the number of applications for accelerated 
                approval that the DAAAP granted, and a description of 
                the common reasons for granting applications for 
                accelerated approval;
                    (C) the number of applications for accelerated 
                approval that the DAAAP denied, and a description of 
                the common reasons for denying applications for 
                accelerated approval;
                    (D) the percentage of products in such review 
                division which met the review goals identified in the 
                letters described in section 101(b) of the Prescription 
                Drug User Fee Amendments of 2017 (Public Law 115-52);
                    (E) agency efforts to ensure consistency across 
                review divisions in the metrics and processes by which 
                new drug applications for non-addictive or non-opioid 
                products intended to treat pain are reviewed;
                    (F) a discussion and summary of the common reasons 
                for applications which did not meet the review goals 
                identified in the letters described in section 101(b) 
                of the Prescription Drug User Fee Amendments of 2017 
                (Public Law 115-52), as applicable and appropriate; and
                    (G) recommendations to better enable utilization of 
                the accelerated approval pathway.

SEC. 3. BREAKTHROUGH THERAPY STATUS FOR PAIN AND ADDICTION THERAPIES.

    (a) Draft Guidance.--
            (1) In general.--Not later than 1 year after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services (referred to in this section as the ``Secretary''), 
        acting through the Commissioner of Food and Drugs, shall issue 
        draft guidance, clarifying the methods and processes by which 
        the Food and Drug Administration may provide a breakthrough 
        therapy designation for non-opioid or non-addictive drugs or 
        devices developed to treat chronic or acute pain or substance 
        use disorders.
            (2) Contents.--The guidance under paragraph (1) shall 
        address--
                    (A) eligibility requirements for such drugs and 
                devices to receive breakthrough therapy designation;
                    (B) opportunities for engagement with the Food and 
                Drug Administration with respect to the breakthrough 
                therapy pathway;
                    (C) specific actions to ensure that the design of 
                the clinical trials is as efficient as practicable, 
                when applicable and scientifically appropriate, for 
                such drugs and devices; and
                    (D) the application of organizational commitment of 
                the Food and Drug Administration to facilitating 
                breakthrough designation for qualified drugs and 
                devices, including involvement of senior managers of 
                the Food and Drug Administration for such drugs and 
                devices.
    (b) Final Guidance.--Not later than 6 months after the close of the 
period for public comment on the draft guidance under subsection (a), 
the Secretary shall finalize such guidance.
    (c) Data in Performance Reports.--
            (1) In general.--As a component of the performance reports 
        under sections 736B(a) and 738A(a) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 379h-2, 379j-1), the Secretary 
        shall include information, as appropriate, on policies and 
        processes of the Division of Anesthesia, Analgesia, and 
        Addiction Products of the Food and Drug Administration 
        (referred to in this section as the ``DAAAP'') for the 
        breakthrough therapy pathway, with respect to drugs and devices 
        developed to treat chronic or acute pain or substance use 
        disorders, during the previous fiscal year.
            (2) Contents.--Information provided as a component of the 
        performance reports under sections 736B(a) and 738A(a) of the 
        Federal Food, Drug, and Cosmetic Act may address--
                    (A) the number of requests for breakthrough therapy 
                designation submitted to the DAAAP;
                    (B) the number of applications for breakthrough 
                therapy designation that the DAAAP granted, and a 
                description of the common reasons for granting 
                applications for breakthrough therapy designation;
                    (C) the number of applications for breakthrough 
                therapy designation that the DAAAP denied, and a 
                description of the common reasons for denying 
                applications for breakthrough therapy designation; and
                    (D) recommendations to better enable utilization of 
                the breakthrough therapy designation pathway for non-
                addictive or non-opioid products intended to treat 
                pain.
                                 <all>
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