ADAPT 2.0 Act
Bill: S.3576 | Sponsor: Sen. Braun, Mike (R-IN)
Policy area: Health

Summary:
Accelerated Drug Approval for Prescription Therapies 2.0 Act or the ADAPT 2.0 Act
This bill allows applicants seeking Food and Drug Administration (FDA) approval to market a new drug to rely on investigations conducted in certain other countries and addresses related issues.
If an applicant seeks market approval for a new drug with an application that relies on at least one investigation that the applicant did not conduct and did not obtain approval to use, the applicant may rely on an investigation that was conducted in certain foreign countries if the drug in question has already been approved in that country. The investigation must have been conducted in Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, the United Kingdom, the European Union, a country in the European Economic Area, or another country that the FDA has found to meet certain requirements.
The FDA must make a decision on such an application within 90 days of the application's filing. If the FDA does not take certain actions within that period, the application shall be considered approved. The FDA may require the applicant to conduct postapproval studies of the drug and to submit copies of all promotional materials.
The bill also establishes an advisory committee to provide the FDA with recommendations as to each application that relies on a foreign investigation. The FDA must make available on its public website each decision on such an application, including the rationale for the decision and the advisory committee's recommendations.

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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