II 

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. 

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 Act’’ or the ‘‘ADAPT 

6 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); 


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1 ‘‘(B) the drug is safe and clinically effec2 tive and has a satisfactory history of clinical 

3 trials and data; 

4 ‘‘(C) the manufacturer is capable of manu5 facturing the drug safely and consistently, and 

6 can assure the safety of the supply chain out7 side the United States; 

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

9 legal exclusivities are expired; 

10 ‘‘(E) absent reciprocal marketing approval, 

11 the drug is not approved for marketing in the 

12 United States; 

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

14 concern relating to safety or effectiveness, re15 scinded or withdrawn any such approval; and 

16 ‘‘(G) there is a public health or unmet 

17 medical need for the drug in the United States. 

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

19 this section may, as the Secretary determines appro20 priate, be subject to 1 or both of the following re21 quirements: 

22 ‘‘(A) The sponsor conduct appropriate 

23 postapproval studies to verify and describe the 

24 predicted effect on irreversible morbidity or 

25 mortality or other clinical benefit of the drug. 


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1 ‘‘(B) The sponsor submit copies of all pro2 motional materials related to the product dur3 ing the preapproval review period and, following 

4 approval and for such period thereafter as the 

5 Secretary determines to be appropriate, at least 

6 30 days prior to dissemination of the materials. 

7 ‘‘(c) TIMELINE.—The Secretary shall make a deter8 mination on an application described in subsection (a) not 

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

10 application.’’. 

Æ 


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