[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1132 Introduced in Senate (IS)]
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118th CONGRESS
1st Session
S. 1132
To allow sponsors of certain new drug applications to rely upon
investigations conducted in certain foreign countries, and for other
purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 30, 2023
Mr. Braun (for himself and Mr. Paul) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To allow sponsors of certain new drug applications to rely upon
investigations conducted in certain foreign countries, 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 Drug Approval for
Prescription Therapies 2.0 Act'' or the ``ADAPT 2.0 Act''.
SEC. 2. DRUGS APPROVED IN CERTAIN FOREIGN COUNTRIES.
(a) In General.--Section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) is amended--
(1) in subsection (b), by adding at the end the following:
``(7) An application described in paragraph (2) may rely upon
investigations conducted in a country listed under section 802(b)(1)(A)
or designated under section 802(b)(1)(B), including premarket clinical
and nonclinical investigations and postmarket surveillance studies, if
the drug that is the subject of such application has been approved in
such country.''; and
(2) in subsection (c)--
(A) in paragraph (1), by striking ``Within'' and
inserting ``Except as provided in paragraph (6),
within''; and
(B) by adding at the end the following:
``(6)(A) In the case of an application that relies on
investigations conducted in a foreign country, as described in
subsection (b)(7), within 90 days after the filing of such application
under subsection (b), the Secretary shall approve the application if
the Secretary determines evidence that--
``(i) at the time of application, the drug is authorized to
be marketed in a country listed under section 802(b)(1)(A) or
designated under section 802(b)(1)(B);
``(ii) the drug is safe and clinically effective;
``(iii) the manufacturer is capable of manufacturing the
drug safely and consistently, and can ensure the safety of the
supply chain outside the United States;
``(iv) all relevant United States patents or legal periods
of exclusivity are expired;
``(v) absent reciprocal marketing approval, the drug is not
approved for marketing in the United States;
``(vi) the Secretary has not, because of any concern
relating to safety or effectiveness, rescinded or withdrawn any
such approval; and
``(vii) the Secretary finds that none of the grounds for
denying approval specified in subsection (d) applies.
``(B) Limitations.--Approval of a drug under this section may, as
the Secretary determines appropriate, be subject to 1 or both of the
following requirements:
``(i) The sponsor conduct appropriate postapproval studies
to verify and describe the predicted effect of the drug on
irreversible morbidity or mortality or another clinical benefit
of the drug.
``(ii) The sponsor submit copies of all promotional
materials related to the drug 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 the dissemination of the materials.
``(C) Timeline.--If the Secretary does not approve the application
or take such other action within such 90-day period, the application
shall be considered approved under this subsection.
``(D) Advisory Committee.--
``(i) Establishment.--For the purpose of providing expert
scientific advice and recommendations to the Secretary
regarding the approval of applications described in subsection
(b)(7), the Secretary shall establish a standing Foreign Drug
Review Advisory Committee.
``(ii) Membership.--The standing Foreign Drug Review
Advisory Committee established under clause (i) shall consist
of employees of the Food and Drug Administration and
individuals appointed by the Secretary, reflecting a balanced
composition of sufficient scientific expertise. The Secretary
shall appoint members who have diverse interests, education,
training, experience, and expertise in biopharmacology,
statistics, chemistry, legal issues, ethics, and other
appropriate expertise pertaining to the drugs under review,
such as expertise in foreign regulatory and manufacturing
practices and drug development, and other individuals, as the
Secretary determines appropriate.
``(iii) Review of applications.--Upon the filing of an
application described in subsection (b)(7)--
``(I) the Secretary shall immediately refer the
application to the Foreign Drug Review Advisory
Committee for review; and
``(II) within 60 days after the receipt by such
advisory committee of such application, the advisory
committee shall provide the Secretary with
recommendations with respect to such application.
``(E) Publication of Final Decision.--The Secretary shall make
publically available, on the website of the Food and Drug
Administration, each final decision on whether to approve an
application described in subsection (b)(7), including the rationale for
the decision and the recommendations and conclusions of the Foreign
Drug Review Advisory Committee under subparagraph (D)(iii).''.
(b) Technical Amendment.--Section 802(b)(1)(A)(i) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 382(b)(1)(A)(i)) is amended by
striking ``or South Africa'' and inserting ``South Africa, or the
United Kingdom''.
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