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