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[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 658 Introduced in Senate (IS)]

<DOC>

116th CONGRESS
  1st Session
                                 S. 658

 To provide for an accelerated approval pathway for certain drugs that 
       are authorized to be lawfully marketed in other countries.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             March 5, 2019

   Mr. Braun introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
 To provide for an accelerated approval pathway for certain drugs that 
       are authorized to be lawfully marketed in other countries.

    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 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 under subsection (c) or (j) of section 505 that is 
currently authorized to be marketed in one or more of the countries 
included in the list under section 802(b)(1), 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 under 
        subsection (a) only if the Secretary determines that there is 
        evidence that--
                    ``(A) at the time of application, the drug is 
                authorized to be marketed in a country included in the 
                list under section 802(b)(1);
                    ``(B) the drug is safe and clinically effective and 
                has a satisfactory history of clinical trials and data;
                    ``(C) the manufacturer is capable of manufacturing 
                the drug 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 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) there is a public health or unmet medical 
                need for the drug in the United States.
            ``(2) Limitation.--Approval of a drug 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.
                    ``(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.--The Secretary shall make a determination on an 
application described in subsection (a) not later than 180 days after 
the date of submission of such application.''.
                                 <all>
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