[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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