Title: Accelerated Approval Integrity Act of 2022
Policy area: Health

Summary:
Accelerated Approval Integrity Act of 2022
This bill establishes requirements relating to postapproval studies for drugs that receive accelerated approval for serious or life-threatening diseases or conditions, such as requiring product sponsors to agree in advance to conduct such studies and terminating product approval if certain benchmarks are not met.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6963 Introduced in House (IH)]

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117th CONGRESS
  2d Session
                                H. R. 6963

    To amend the Federal Food, Drug, and Cosmetic Act to strengthen 
    requirements for postapproval studies for drugs approved using 
             accelerated approval, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 7, 2022

 Mr. Pallone 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 strengthen 
    requirements for postapproval studies for drugs approved using 
             accelerated approval, 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 ``Accelerated Approval Integrity Act 
of 2022''.

SEC. 2. POSTAPPROVAL STUDIES REQUIRED FOR ACCELERATED APPROVAL DRUGS.

    (a) In General.--Section 506(c) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356(c)) is amended--
            (1) in paragraph (2)--
                    (A) in the matter preceding subparagraph (A), by 
                striking ``may be subject to 1 or both of'' and 
                inserting ``shall be subject to'';
                    (B) by amending subparagraph (A) to read as 
                follows:
                    ``(A) Postapproval studies.--
                            ``(i) In general.--The sponsor of a product 
                        approved under accelerated approval shall--
                                    ``(I) conduct appropriate, 
                                adequate, and well-controlled 
                                postapproval studies to verify and 
                                describe the predicted effect on 
                                irreversible morbidity or mortality or 
                                other clinical benefit; and
                                    ``(II) submit reports on such 
                                studies in accordance with section 
                                506B.
                            ``(ii) Agreement.--The Secretary and the 
                        sponsor shall enter into an agreement regarding 
                        the required conduct of such studies prior to 
                        the Secretary approving a product under 
                        accelerated approval. Such agreement may 
                        include requirements regarding enrollment 
                        targets, study protocol, and milestones, 
                        including the target date of study completion.
                            ``(iii) Studies begun before approval.--The 
                        Secretary may--
                                    ``(I) require such studies to be 
                                underway prior to approval; and
                                    ``(II) refuse to approve a product 
                                under accelerated approval until such 
                                studies are underway.''; and
                    (C) in subparagraph (B), by striking ``(B) That the 
                sponsor'' and inserting the following:
                    ``(B) Promotional materials.--The sponsor of a 
                product approved under accelerated approval shall''; 
                and
            (2) by striking paragraph (3) and inserting the following:
            ``(3) Expedited withdrawal of approval.--
                    ``(A) In general.--The Secretary may withdraw 
                approval of a product approved under accelerated 
                approval using expedited procedures described in 
                subparagraph (B), if--
                            ``(i) the sponsor fails to conduct any 
                        required postapproval study of the product with 
                        due diligence;
                            ``(ii) the sponsor fails to achieve agreed 
                        upon enrollment targets, milestones, or timely 
                        study completion;
                            ``(iii) the sponsor fails to submit reports 
                        in accordance with section 506B;
                            ``(iv) 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;
                            ``(v) other evidence demonstrates that the 
                        product is not shown to be safe or effective 
                        under the conditions of use; or
                            ``(vi) the sponsor disseminates false or 
                        misleading promotional materials with respect 
                        to the product.
                    ``(B) Expedited procedures described.--Expedited 
                procedures described in this subparagraph--
                            ``(i) shall consist of--
                                    ``(I) providing the sponsor due 
                                notice and an opportunity for written 
                                appeal to the Commissioner of Food and 
                                Drugs; and
                                    ``(II) an opportunity for public 
                                comment on the notice proposing to 
                                withdraw approval; and
                            ``(ii) may include, at the Secretary's 
                        discretion, convening and consulting an 
                        advisory committee.
                    ``(C) Automatic expiration.--The approval of a 
                product approved under accelerated approval after the 
                date of enactment of the Accelerated Approval Integrity 
                Act of 2022 shall automatically expire 1 year after any 
                target date of study completion included in an 
                agreement described in clause (ii) of paragraph (2)(A), 
                and in no case later than 5 years after the date on 
                which the product is approved, unless--
                            ``(i) a study required to verify and 
                        describe the predicted effect on irreversible 
                        morbidity or mortality or other clinical 
                        benefit of the product has verified that 
                        predicted effect; or
                            ``(ii) the Secretary has determined that 
                        adequate progress has been made on completion 
                        of postapproval studies required under 
                        paragraph (2)(A).
            ``(4) Labeling.--
                    ``(A) In general.--Subject to subparagraph (B), the 
                label for a product approved under accelerated approval 
                shall include--
                            ``(i) a statement indicating that the 
                        product was approved under accelerated 
                        approval;
                            ``(ii) a statement indicating that 
                        continued approval of the product is subject to 
                        postmarketing studies to verify clinical 
                        benefit;
                            ``(iii) identification of the clinical 
                        endpoint that is under study and any known 
                        limitations of that surrogate or intermediate 
                        endpoint in determining clinical benefit;
                            ``(iv) a succinct description of the 
                        product and any uncertainty about anticipated 
                        clinical benefit and a discussion of available 
                        evidence with respect to such clinical benefit; 
                        and
                            ``(v) any other information required by the 
                        Secretary in the order approving the product.
                    ``(B) Applicability.--The labeling requirements of 
                subparagraph (A) shall apply only to products approved 
                under accelerated approval for which the predicted 
                effect on irreversible morbidity or mortality or other 
                clinical benefit has not been verified.''.
    (b) Reports of Postmarketing Studies.--Section 506B(a) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356b(a)) is amended--
            (1) by redesignating paragraph (2) as paragraph (3); and
            (2) by inserting after paragraph (1) the following:
            ``(2) Accelerated approval.--Notwithstanding paragraph (1), 
        a sponsor of a drug approved under accelerated approval shall 
        submit to the Secretary a report of the progress of any study 
        required under section 506(c), including progress toward any 
        agreed upon enrollment targets, milestones, and other 
        information as required by the Secretary, not later than 90 
        days after the approval of such drug and not less frequently 
        than every 90 days thereafter, until the study is completed or 
        terminated.''.
    (c) Enforcement.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by inserting after paragraph 
(eee) the following:
    ``(fff) The failure of a sponsor of a product approved under 
accelerated approval pursuant to section 506(c)--
            ``(1) to conduct with due diligence any postapproval study 
        required under section 506(c) with respect to such product; or
            ``(2) to submit timely reports with respect to such product 
        in accordance with section 506B(a)(2).''.
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