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[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6996 Introduced in House (IH)]

<DOC>

117th CONGRESS
  2d Session
                                H. R. 6996

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
  accelerated approval of a product for a serious or life-threatening 
             disease or condition, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             March 8, 2022

  Mrs. Rodgers of Washington 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 the 
  accelerated approval of a product for a serious or life-threatening 
             disease or condition, 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 ``Accelerating Access for Patients Act 
of 2022''.

SEC. 2. ACCELERATED APPROVAL.

    (a) In General.--Subsection (c) of section 506 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356) is amended to read as follows:
    ``(c) Accelerated Approval of a Drug for a Serious or Life-
Threatening Disease or Condition, Including a Fast Track Product.--
            ``(1) In general.--
                    ``(A) Accelerated approval.--The Secretary may 
                approve an application for approval of a product for a 
                serious or life-threatening disease or condition, 
                including a fast track product, under section 505(c) of 
                this Act or section 351(a) of the Public Health Service 
                Act upon a determination--
                            ``(i) that the product has an effect on a 
                        surrogate endpoint that is reasonably likely to 
                        predict clinical benefit, or on a clinical 
                        endpoint that can be measured earlier than 
                        irreversible morbidity or mortality, that is 
                        reasonably likely to predict an effect on 
                        irreversible morbidity or mortality or other 
                        clinical benefit, taking into account the 
                        severity, rarity, or prevalence of the disease 
                        or condition and the availability or lack of 
                        alternative treatments; or
                            ``(ii) of the safety and effectiveness of 
                        the product based on the known benefit-risk 
                        profile of such product in the intended 
                        population, taking into account the severity, 
                        rarity, or prevalence of the disease or 
                        condition and the availability or lack of 
                        alternative treatments.
                    ``(B) Comprehensive clinical development plan.--The 
                Secretary shall establish procedures by which a sponsor 
                of a product seeking approval described in subparagraph 
                (A) may meet with appropriate officials of the Food and 
                Drug Administration to develop a plan to provide 
                clarity and certainty for the sponsor regarding the 
                applicability of the requirements of this subsection. 
                Such a plan shall include--
                            ``(i) a determination as to whether the 
                        product subject to such approval is intended to 
                        treat an unmet medical need;
                            ``(ii) an agreement on the surrogate or 
                        intermediate clinical endpoint to be assessed, 
                        if applicable;
                            ``(iii) an agreement on the design of the 
                        studies to be conducted to support the 
                        approval;
                            ``(iv) a plan for a postapproval study to 
                        satisfy paragraph (2)(A), if required, 
                        including a plan for reaching agreement on the 
                        design of any such study;
                            ``(v) a plan for reaching agreement on the 
                        types of developmental milestones to be met; 
                        and
                            ``(vi) a strategy for the inclusion of 
                        diverse populations.
                    ``(C) Evidence.--The evidence to support that an 
                endpoint is reasonably likely to predict clinical 
                benefit under subparagraph (A)(i) may include 
                epidemiological, pathophysiological, therapeutic, 
                pharmacologic, or other evidence developed using 
                biomarkers, for example, or other scientific methods or 
                tools.
                    ``(D) References.--In this section, approval 
                described in subparagraph (A) is referred to as 
                `accelerated approval'.
            ``(2) Limitation.--Approval of a product under this 
        subsection may be subject to 1 or both of the following 
        requirements:
                    ``(A) That the sponsor conduct appropriate 
                postapproval studies (which may include clinical 
                evidence, patient registries, or other sources of real 
                world evidence) to verify and describe the predicted 
                effect on irreversible morbidity or mortality or other 
                clinical benefit.
                    ``(B) That the sponsor submit copies of all 
                promotional materials related to the product during the 
                preapproval review period and, following approval and 
                for such period thereafter as the Secretary determines 
                to be appropriate, at least 30 days prior to 
                dissemination of the materials.
            ``(3) Guidance.--The Secretary shall issue--
                    ``(A) guidance describing criteria, processes, and 
                other general considerations for demonstrating the 
                safety and effectiveness of drugs submitted for 
                approval described in paragraph (1)(A)(ii); and
                    ``(B) guidance on the use of novel clinical trial 
                designs that may be used to conduct appropriate 
                postapproval studies as may be required under paragraph 
                (2)(A).
            ``(4) Approval of study protocol.--Not later than 60 
        calendar days after the submission by the sponsor of a product 
        of a proposed protocol for a postapproval study required under 
        paragraph (2)(A), the Secretary shall--
                    ``(A) approve the protocol; or
                    ``(B) specify changes to the protocol that would 
                enable such approval.
            ``(5) Expedited withdrawal of approval.--The Secretary may 
        withdraw approval of a product approved under accelerated 
        approval using expedited procedures (as prescribed by the 
        Secretary in regulations which shall include an opportunity for 
        an informal hearing) if--
                    ``(A) the sponsor fails to conduct any required 
                postapproval study of the product with due diligence;
                    ``(B) a study required to verify and describe the 
                predicted effect on irreversible morbidity or mortality 
                or other clinical benefit of the product fails to 
                verify and describe such effect or benefit;
                    ``(C) other evidence demonstrates that the product 
                is not safe or effective under the conditions of use; 
                or
                    ``(D) the sponsor disseminates false or misleading 
                promotional materials with respect to the product.
            ``(6) Reporting.--Not later than 180 days after the date of 
        enactment of the Accelerating Access for Patients Act of 2022, 
        and annually thereafter, the Secretary shall submit to the 
        Committee on Energy and Commerce of the House of 
        Representatives and the Committee on Health, Education, Labor, 
        and Pensions of the Senate a report describing--
                    ``(A) the circumstances and number of applications 
                submitted for approval described in paragraph (1)(A) 
                for which real world evidence was deemed appropriate to 
                support or fulfill postapproval studies required under 
                this subsection; and
                    ``(B) the circumstances and number of applications 
                submitted for approval described in paragraph (1)(A) 
                for which real world evidence was submitted for such 
                postapproval studies.''.
    (b) Initial Guidance.--The Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs--
            (1) shall issue draft guidance pursuant to section 
        506(c)(3) of the Federal Food, Drug, and Cosmetic Act, as 
        amended by subsection (a), not later than 18 months after the 
        date of enactment of this Act;
            (2) shall promulgate final guidance pursuant to such 
        section 506(c)(3) not later than 18 months after the close of 
        the public comment period on such draft guidance; and
            (3) may approve products as described in section 
        506(c)(1)(A) of the Federal Food, Drug, and Cosmetic Act, as 
        amended by subsection (a), prior to issuing initial draft or 
        final guidance under this subsection.
                                 <all>
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