I 
117TH CONGRESS 
2D SESSION 
H. R. 6963 
To amend the Federal Food, Drug, and Cosmetic Act to strengthen require-
ments 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 Representa-
tives 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’’. 
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SEC. 2. POSTAPPROVAL STUDIES REQUIRED FOR ACCELER-
ATED 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 ap-
proval shall— 
‘‘(I) conduct appropriate, ade-
quate, 
and 
well-controlled 
post-
approval studies to verify and describe 
the predicted effect on irreversible 
morbidity or mortality or other clin-
ical benefit; and 
‘‘(II) submit reports on such 
studies in accordance with section 
506B. 
‘‘(ii) 
AGREEMENT.—The 
Secretary 
and the sponsor shall enter into an agree-
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ment regarding the required conduct of 
such studies prior to the Secretary approv-
ing a product under accelerated approval. 
Such agreement may include requirements 
regarding enrollment targets, study pro-
tocol, and milestones, including the target 
date of study completion. 
‘‘(iii) STUDIES
BEGUN
BEFORE
AP-
PROVAL.—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 acceler-
ated approval shall’’; and 
(2) by striking paragraph (3) and inserting the 
following: 
‘‘(3) 
EXPEDITED
WITHDRAWAL
OF
AP-
PROVAL.— 
‘‘(A) IN
GENERAL.—The Secretary may 
withdraw approval of a product approved under 
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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, mile-
stones, or timely study completion; 
‘‘(iii) the sponsor fails to submit re-
ports 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 ef-
fective under the conditions of use; or 
‘‘(vi) the sponsor disseminates false or 
misleading promotional materials with re-
spect to the product. 
‘‘(B) 
EXPEDITED
PROCEDURES
DE-
SCRIBED.—Expedited procedures described in 
this subparagraph— 
‘‘(i) shall consist of— 
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‘‘(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 ad-
visory committee. 
‘‘(C) AUTOMATIC
EXPIRATION.—The ap-
proval of a product approved under accelerated 
approval after the date of enactment of the Ac-
celerated Approval Integrity Act of 2022 shall 
automatically expire 1 year after any target 
date of study completion included in an agree-
ment 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, un-
less— 
‘‘(i) a study required to verify and de-
scribe the predicted effect on irreversible 
morbidity or mortality or other clinical 
benefit of the product has verified that 
predicted effect; or 
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