I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Accelerated Approval 

5 Integrity Act of 2022’’. 


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1 SEC. 2. POSTAPPROVAL STUDIES REQUIRED FOR ACCELER2 ATED APPROVAL DRUGS. 

3 (a) IN GENERAL.—Section 506(c) of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)) is 

5 amended— 

6 (1) in paragraph (2)— 

7 (A) in the matter preceding subparagraph 

8 (A), by striking ‘‘may be subject to 1 or both 

9 of’’ and inserting ‘‘shall be subject to’’; 

10 (B) by amending subparagraph (A) to read 

11 as follows: 

12 ‘‘(A) POSTAPPROVAL STUDIES.— 

13 ‘‘(i) IN GENERAL.—The sponsor of a 

14 product approved under accelerated ap15 proval shall— 

16 ‘‘(I) conduct appropriate, ade17 quate, and well-controlled post18 approval studies to verify and describe 

19 the predicted effect on irreversible 

20 morbidity or mortality or other clin21 ical benefit; and 

22 ‘‘(II) submit reports on such 

23 studies in accordance with section 

24 506B. 

25 ‘‘(ii) AGREEMENT.—The Secretary 

26 and the sponsor shall enter into an agreeVerDate Sep 11 2014 22:42 Mar 09, 2022 Jkt 029200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H6963.IH H6963

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1 ment regarding the required conduct of 

2 such studies prior to the Secretary approv3 ing a product under accelerated approval. 

4 Such agreement may include requirements 

5 regarding enrollment targets, study pro6 tocol, and milestones, including the target 

7 date of study completion. 

8 ‘‘(iii) STUDIES BEGUN BEFORE AP9 PROVAL.—The Secretary may— 

10 ‘‘(I) require such studies to be 

11 underway prior to approval; and 

12 ‘‘(II) refuse to approve a product 

13 under accelerated approval until such 

14 studies are underway.’’; and 

15 (C) in subparagraph (B), by striking ‘‘(B) 

16 That the sponsor’’ and inserting the following: 

17 ‘‘(B) PROMOTIONAL MATERIALS.—The 

18 sponsor of a product approved under acceler19 ated approval shall’’; and 

20 (2) by striking paragraph (3) and inserting the 

21 following: 

22 ‘‘(3) EXPEDITED WITHDRAWAL OF AP23 PROVAL.— 

24 ‘‘(A) IN GENERAL.—The Secretary may 

25 withdraw approval of a product approved under 


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1 accelerated approval using expedited procedures 

2 described in subparagraph (B), if— 

3 ‘‘(i) the sponsor fails to conduct any 

4 required postapproval study of the product 

5 with due diligence; 

6 ‘‘(ii) the sponsor fails to achieve 

7 agreed upon enrollment targets, mile8 stones, or timely study completion; 

9 ‘‘(iii) the sponsor fails to submit re10 ports in accordance with section 506B; 

11 ‘‘(iv) a study required to verify and 

12 describe the predicted effect on irreversible 

13 morbidity or mortality or other clinical 

14 benefit of the product fails to verify and 

15 describe such effect or benefit; 

16 ‘‘(v) other evidence demonstrates that 

17 the product is not shown to be safe or ef18 fective under the conditions of use; or 

19 ‘‘(vi) the sponsor disseminates false or 

20 misleading promotional materials with re21 spect to the product. 

22 ‘‘(B) EXPEDITED PROCEDURES DE23 SCRIBED.—Expedited procedures described in 

24 this subparagraph— 

25 ‘‘(i) shall consist of— 


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1 ‘‘(I) providing the sponsor due 

2 notice and an opportunity for written 

3 appeal to the Commissioner of Food 

4 and Drugs; and 

5 ‘‘(II) an opportunity for public 

6 comment on the notice proposing to 

7 withdraw approval; and 

8 ‘‘(ii) may include, at the Secretary’s 

9 discretion, convening and consulting an ad10 visory committee. 

11 ‘‘(C) AUTOMATIC EXPIRATION.—The ap12 proval of a product approved under accelerated 

13 approval after the date of enactment of the Ac14 celerated Approval Integrity Act of 2022 shall 

15 automatically expire 1 year after any target 

16 date of study completion included in an agree17 ment described in clause (ii) of paragraph 

18 (2)(A), and in no case later than 5 years after 

19 the date on which the product is approved, un20 less— 

21 ‘‘(i) a study required to verify and de22 scribe the predicted effect on irreversible 

23 morbidity or mortality or other clinical 

24 benefit of the product has verified that 

25 predicted effect; or 


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1 ‘‘(ii) the Secretary has determined 

2 that adequate progress has been made on 

3 completion of postapproval studies required 

4 under paragraph (2)(A). 

5 ‘‘(4) LABELING.— 

6 ‘‘(A) IN GENERAL.—Subject to subpara7 graph (B), the label for a product approved 

8 under accelerated approval shall include— 

9 ‘‘(i) a statement indicating that the 

10 product was approved under accelerated 

11 approval; 

12 ‘‘(ii) a statement indicating that con13 tinued approval of the product is subject to 

14 postmarketing studies to verify clinical 

15 benefit; 

16 ‘‘(iii) identification of the clinical end17 point that is under study and any known 

18 limitations of that surrogate or inter19 mediate endpoint in determining clinical 

20 benefit; 

21 ‘‘(iv) a succinct description of the 

22 product and any uncertainty about antici23 pated clinical benefit and a discussion of 

24 available evidence with respect to such clin25 ical benefit; and 


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1 ‘‘(v) any other information required 

2 by the Secretary in the order approving the 

3 product. 

4 ‘‘(B) APPLICABILITY.—The labeling re5 quirements of subparagraph (A) shall apply 

6 only to products approved under accelerated ap7 proval for which the predicted effect on irre8 versible morbidity or mortality or other clinical 

9 benefit has not been verified.’’. 

10 (b) REPORTS OF POSTMARKETING STUDIES.—Sec11 tion 506B(a) of the Federal Food, Drug, and Cosmetic 

12 Act (21 U.S.C. 356b(a)) is amended— 

13 (1) by redesignating paragraph (2) as para14 graph (3); and 

15 (2) by inserting after paragraph (1) the fol16 lowing: 

17 ‘‘(2) ACCELERATED APPROVAL.—Notwith18 standing paragraph (1), a sponsor of a drug ap19 proved under accelerated approval shall submit to 

20 the Secretary a report of the progress of any study 

21 required under section 506(c), including progress to22 ward any agreed upon enrollment targets, mile23 stones, and other information as required by the 

24 Secretary, not later than 90 days after the approval 

25 of such drug and not less frequently than every 90 


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1 days thereafter, until the study is completed or ter2 minated.’’. 

3 (c) ENFORCEMENT.—Section 301 of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend5 ed by inserting after paragraph (eee) the following: 

6 ‘‘(fff) The failure of a sponsor of a product approved 

7 under accelerated approval pursuant to section 506(c)— 

8 ‘‘(1) to conduct with due diligence any post9 approval study required under section 506(c) with 

10 respect to such product; or 

11 ‘‘(2) to submit timely reports with respect to 

12 such product in accordance with section 

13 506B(a)(2).’’. 

Æ 


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