II 

117TH CONGRESS 

1ST SESSION S. 2983 

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 

OCTOBER 7, 2021 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Accelerated Drug Ap5 proval for Prescription Therapies for Coronavirus Act’’ or 

6 the ‘‘ADAPT for COVID Act’’. 


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1 SEC. 2. ACCELERATED APPROVAL OF CERTAIN DRUGS 

2 THAT ARE AUTHORIZED TO BE LAWFULLY 

3 MARKETED IN OTHER COUNTRIES. 

4 Chapter V of the Federal Food, Drug, and Cosmetic 

5 Act (21 U.S.C. 351 et seq.) is amended by inserting after 

6 section 506 the following: 

7 ‘‘SEC. 506–1. ACCELERATED APPROVAL OF CERTAIN DRUGS 

8 THAT ARE AUTHORIZED TO BE LAWFULLY 

9 MARKETED IN OTHER COUNTRIES. 

10 ‘‘(a) IN GENERAL.—The Secretary may approve an 

11 application for approval for a drug under subsection (c) 

12 or (j) of section 505 that is currently authorized to be 

13 marketed in one or more of the countries included in the 

14 list under section 802(b)(1), upon a determination by the 

15 Secretary that the sponsor has submitted evidence suffi16 cient to demonstrate all of the criteria under subsection 

17 (b)(1). 

18 ‘‘(b) CRITERIA.— 

19 ‘‘(1) IN GENERAL.—The Secretary may approve 

20 a drug under subsection (a) only if the Secretary de21 termines that there is evidence that— 

22 ‘‘(A) at the time of application, the drug is 

23 authorized to be marketed in a country included 

24 in the list under section 802(b)(1); 

25 ‘‘(B) the drug is safe and clinically effec26 tive; 


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1 ‘‘(C) the manufacturer is capable of manu2 facturing the drug safely and consistently, and 

3 can assure the safety of the supply chain out4 side the United States; 

5 ‘‘(D) all relevant United States patents or 

6 legal exclusivities are expired; 

7 ‘‘(E) absent reciprocal marketing approval, 

8 the drug is not approved for marketing in the 

9 United States; 

10 ‘‘(F) the Secretary has not, because of any 

11 concern relating to safety or effectiveness, re12 scinded or withdrawn any such approval; and 

13 ‘‘(G) the drug is intended for the treat14 ment or prevention of coronavirus or another 

15 disease of epidemic potential. 

16 ‘‘(2) LIMITATION.—Approval of a drug under 

17 this section may, as the Secretary determines appro18 priate, be subject to 1 or both of the following re19 quirements: 

20 ‘‘(A) The sponsor shall conduct appro21 priate postapproval studies to verify and de22 scribe the predicted effect on irreversible mor23 bidity or mortality or other clinical benefit of 

24 the drug. 


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1 ‘‘(B) The sponsor shall submit copies of all 

2 promotional materials related to the product 

3 during the preapproval review period and, fol4 lowing approval and for such period thereafter 

5 as the Secretary determines to be appropriate, 

6 at least 30 days prior to dissemination of the 

7 materials. 

8 ‘‘(c) TIMELINE.—The Secretary shall make a deter9 mination on an application described in subsection (a) not 

10 later than 180 days after the date of submission of such 

11 application. 

12 ‘‘(d) DEFINITION.—In this section, the term 

13 ‘coronavirus’ means SARS–CoV–2, COVID–19, or an14 other coronavirus.’’. 

Æ 


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