[Congressional Record Volume 166, Number 94 (Tuesday, May 19, 2020)]
[Senate]
[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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