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[Page S2508]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
TEXT OF AMENDMENTS
SA 1588. Mr. BRAUN submitted an amendment intended to be proposed by
him to the bill S. 658, to provide for an accelerated approval pathway
for certain drugs that are authorized to be lawfully marketed in other
countries; which was referred to the Committee on Health, Education,
Labor, and Pensions; as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Accelerated Drug Approval
for Prescription Therapies Act'' or the ``ADAPT Act''.
SEC. 2. ACCELERATED APPROVAL OF CERTAIN DRUGS THAT ARE
AUTHORIZED TO BE LAWFULLY MARKETED IN OTHER
COUNTRIES.
Chapter V of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 351 et seq.) is amended by inserting after section 506
the following:
``SEC. 506-1. ACCELERATED APPROVAL OF CERTAIN DRUGS THAT ARE
AUTHORIZED TO BE LAWFULLY MARKETED IN OTHER
COUNTRIES.
``(a) In General.--The Secretary may approve an application
for approval for a drug or vaccine under subsection (c) or
(j) of section 505 of this Act or under subsection (a) or (k)
of section 351 of the Public Health Service Act that is
currently authorized to be marketed in one or more of the
countries included in the list under section 802(b)(1) or the
United Kingdom, upon a determination by the Secretary that
the sponsor has submitted evidence sufficient to demonstrate
all of the criteria under subsection (b)(1).
``(b) Criteria.--
``(1) In general.--The Secretary may approve a drug or
vaccine under subsection (a) only if the Secretary determines
that there is evidence that--
``(A) at the time of application, the drug or vaccine is
authorized to be marketed in a country included in the list
under section 802(b)(1) or the United Kingdom;
``(B) the drug or vaccine is safe and clinically effective;
``(C) the manufacturer is capable of manufacturing the drug
or vaccine safely and consistently, and can assure the safety
of the supply chain outside the United States;
``(D) all relevant United States patents or legal
exclusivities are expired;
``(E) absent reciprocal marketing approval, the drug or
vaccine is not approved for marketing in the United States;
``(F) the Secretary has not, because of any concern
relating to safety or effectiveness, rescinded or withdrawn
any such approval; and
``(G) the drug or vaccine is intended for the treatment or
prevention of a disease or condition that poses a threat of
epidemic or pandemic, including with respect to the
coronavirus, or the drug is intended to treat the
coronavirus, including reduced risk of death, severe disease,
and progression of symptoms in individuals exposed to the
virus.
``(2) Limitation.--Approval of a drug or vaccine under this
section may, as the Secretary determines appropriate, be
subject to 1 or both of the following requirements:
``(A) The sponsor conduct appropriate postapproval studies
to verify and describe the predicted effect on irreversible
morbidity or mortality or other clinical benefit of the drug
or vaccine.
``(B) 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.
``(c) Timeline.--
``(1) In general.--The Secretary shall make a determination
on an application described in subsection (a) not later than
30 days after the date of submission of such application.
``(2) Review of applications during epidemics and
pandemics.--In the case of an epidemic or pandemic, including
with respect to the coronavirus, the Secretary shall accept
and review various portions of an application submitted under
this section on a rolling basis, and the review of any part
of an application so submitted shall be completed not later
than 3 weeks after submission.
``(d) Coronavirus Defined.--The term `coronavirus' means
SARS-CoV-2, COVID-19, or another coronavirus with epidemic
potential.
``(e) Real-time Epidemic and Pandemic Vaccine Approval.--
``(1) In general.--In the case of a vaccine approved under
the authority of this section that is intended to treat or
prevent diseases or conditions that pose a threat of an
epidemic or pandemic, including the coronavirus, the
Secretary shall share data information regarding the approval
of the vaccine with the Advisory Committee on Immunization
Practices of the Centers for Disease Control and Prevention
as the review nears completion.
``(2) Evaluation.--Any vaccine that has been approved under
the authority of this section for an epidemic or pandemic-
related disease or condition, including the coronavirus,
shall be evaluated by the Advisory Committee on Immunization
Practices of the Centers for Disease Control and Prevention
not later than 1 week after the date of submission to the
Advisory Committee by the Secretary of the vaccine.''.
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