What This Bill Does
This bill allows companies seeking approval to sell new drugs in the United States to use research studies conducted in certain foreign countries instead of conducting all new research in the U.S. The bill also creates a special committee to review these foreign-based drug applications and speeds up the approval process for drugs already approved and sold in other countries.
Who It Affects
Drug companies applying for approval to sell new medications in the United States. The Food and Drug Administration (the federal agency that approves drugs). Doctors and patients who may gain access to medications already approved elsewhere. Members appointed to the Foreign Drug Review Advisory Committee.
Key Provisions
Drug companies can rely on clinical and nonclinical investigations (studies testing whether a drug works and is safe) and postmarket surveillance studies (ongoing safety monitoring after approval) conducted in certain foreign countries, as long as the drug is already approved for sale in that country. (Sec. 2(a)(1))
The Secretary of Health and Human Services must approve a drug application within 90 days if the drug is already approved in a qualifying foreign country and meets safety, effectiveness and manufacturing standards. (Sec. 2(a)(2)(A))
The Secretary must establish a standing Foreign Drug Review Advisory Committee made up of Food and Drug Administration employees and appointed experts to provide scientific advice on these foreign-based drug applications. (Sec. 2(a)(2)(D))
The Secretary must make all final decisions on foreign drug applications publicly available on the Food and Drug Administration website, including the reasoning and the advisory committee's recommendations. (Sec. 2(a)(2)(E))
What Changes
Currently, drug companies must conduct their own investigations in the United States to prove a drug is safe and effective. This bill allows companies to use investigations already completed in certain foreign countries instead. Decisions on these applications must be made within 90 days, and if no decision is made in that time, the application is automatically considered approved. A new advisory committee will review these applications and provide expert recommendations that the public can see.
Important Definitions
Postmarket surveillance studies: Ongoing safety monitoring that happens after a drug is approved and being sold. Irreversible morbidity or mortality: Permanent sickness or death that cannot be reversed. Premarket clinical and nonclinical investigations: Studies done before a drug is approved testing how it works in animals and people.
Effective Date
Not specified in bill text
II
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 coun-
tries, and for other purposes.
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Accelerated Drug Ap-
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proval for Prescription Therapies 2.0 Act’’ or the
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‘‘ADAPT 2.0 Act’’.
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•S 1132 IS
SEC. 2. DRUGS APPROVED IN CERTAIN FOREIGN COUN-
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TRIES.
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(a) IN GENERAL.—Section 505 of the Federal Food,
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Drug, and Cosmetic Act (21 U.S.C. 355) is amended—
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(1) in subsection (b), by adding at the end the
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following:
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‘‘(7) An application described in paragraph (2) may
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rely upon investigations conducted in a country listed
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under section 802(b)(1)(A) or designated under section
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802(b)(1)(B), including premarket clinical and nonclinical
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investigations and postmarket surveillance studies, if the
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drug that is the subject of such application has been ap-
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proved in such country.’’; and
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(2) in subsection (c)—
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(A) in paragraph (1), by striking ‘‘Within’’
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and inserting ‘‘Except as provided in paragraph
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(6), within’’; and
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(B) by adding at the end the following:
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‘‘(6)(A) In the case of an application that relies on
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investigations conducted in a foreign country, as described
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in subsection (b)(7), within 90 days after the filing of such
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application under subsection (b), the Secretary shall ap-
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prove the application if the Secretary determines evidence
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that—
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‘‘(i) at the time of application, the drug is au-
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thorized to be marketed in a country listed under
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•S 1132 IS
section 802(b)(1)(A) or designated under section
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802(b)(1)(B);
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‘‘(ii) the drug is safe and clinically effective;
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‘‘(iii) the manufacturer is capable of manufac-
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turing the drug safely and consistently, and can en-
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sure the safety of the supply chain outside the
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United States;
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‘‘(iv) all relevant United States patents or legal
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periods of exclusivity are expired;
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‘‘(v) absent reciprocal marketing approval, the
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drug is not approved for marketing in the United
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States;
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‘‘(vi) the Secretary has not, because of any con-
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cern relating to safety or effectiveness, rescinded or
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withdrawn any such approval; and
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‘‘(vii) the Secretary finds that none of the
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grounds for denying approval specified in subsection
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(d) applies.
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‘‘(B) LIMITATIONS.—Approval of a drug under this
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section may, as the Secretary determines appropriate, be
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subject to 1 or both of the following requirements:
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‘‘(i) The sponsor conduct appropriate post-
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approval studies to verify and describe the predicted
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effect of the drug on irreversible morbidity or mor-
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tality or another clinical benefit of the drug.
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•S 1132 IS
‘‘(ii) The sponsor submit copies of all pro-
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motional materials related to the drug during the
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preapproval review period and, following approval
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and for such period thereafter as the Secretary de-
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termines to be appropriate, at least 30 days prior to
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the dissemination of the materials.
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‘‘(C) TIMELINE.—If the Secretary does not approve
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the application or take such other action within such 90-
8
day period, the application shall be considered approved
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under this subsection.
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‘‘(D) ADVISORY COMMITTEE.—
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‘‘(i) ESTABLISHMENT.—For the purpose of pro-
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viding expert scientific advice and recommendations
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to the Secretary regarding the approval of applica-
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tions described in subsection (b)(7), the Secretary
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shall establish a standing Foreign Drug Review Ad-
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visory Committee.
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‘‘(ii) MEMBERSHIP.—The standing Foreign
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Drug Review Advisory Committee established under
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clause (i) shall consist of employees of the Food and
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Drug Administration and individuals appointed by
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the Secretary, reflecting a balanced composition of
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sufficient scientific expertise. The Secretary shall ap-
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point members who have diverse interests, education,
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training, experience, and expertise in biopharma-
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•S 1132 IS
cology, statistics, chemistry, legal issues, ethics, and
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other appropriate expertise pertaining to the drugs
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under review, such as expertise in foreign regulatory
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and manufacturing practices and drug development,
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and other individuals, as the Secretary determines
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appropriate.
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‘‘(iii) REVIEW OF APPLICATIONS.—Upon the fil-
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ing of an application described in subsection
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(b)(7)—
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‘‘(I) the Secretary shall immediately refer
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the application to the Foreign Drug Review Ad-
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visory Committee for review; and
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‘‘(II) within 60 days after the receipt by
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such advisory committee of such application,
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the advisory committee shall provide the Sec-
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retary with recommendations with respect to
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such application.
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‘‘(E) PUBLICATION OF FINAL DECISION.—The Sec-
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retary shall make publically available, on the website of
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the Food and Drug Administration, each final decision on
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whether to approve an application described in subsection
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(b)(7), including the rationale for the decision and the rec-
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ommendations and conclusions of the Foreign Drug Re-
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view Advisory Committee under subparagraph (D)(iii).’’.
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(b)
TECHNICAL
AMENDMENT.—Section
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802(b)(1)(A)(i) of the Federal Food, Drug, and Cosmetic
2
Act (21 U.S.C. 382(b)(1)(A)(i)) is amended by striking
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‘‘or South Africa’’ and inserting ‘‘South Africa, or the
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United Kingdom’’.
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Æ
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