II 

117TH CONGRESS 

2D SESSION S. 3576 

To allow sponsors of certain new drug applications to rely upon investigations 

conducted in certain foreign countries, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 3, 2022 

Mr. BRAUN (for himself and Mr. PAUL) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To allow sponsors of certain new drug applications to rely 

upon investigations conducted in certain foreign countries, and for other purposes. 

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 2.0 Act’’ or the 

6 ‘‘ADAPT 2.0 Act’’. 


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•S 3576 IS

1 SEC. 2. DRUGS APPROVED IN CERTAIN FOREIGN COUN2 TRIES. 

3 (a) IN GENERAL.—Section 505 of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 355) is amended— 

5 (1) in subsection (b), by adding at the end the 

6 following: 

7 ‘‘(7) An application described in paragraph (2) may 

8 rely upon investigations conducted in a country listed 

9 under section 802(b)(1)(A) or designated under section 

10 802(b)(1)(B), including premarket clinical and nonclinical 

11 investigations and postmarket surveillance studies, if the 

12 drug that is the subject of such application has been ap13 proved in such country.’’; and 

14 (2) in subsection (c)— 

15 (A) in paragraph (1), by striking ‘‘Within’’ 

16 and inserting ‘‘Except as provided in paragraph 

17 (6), within’’; and 

18 (B) by adding at the end the following: 

19 ‘‘(6)(A) In the case of an application that relies on 

20 investigations conducted in a foreign country, as described 

21 in subsection (b)(7), within 90 days after the filing of such 

22 application under subsection (b), the Secretary shall ap23 prove the application if the Secretary determines evidence 

24 that— 

25 ‘‘(i) at the time of application, the drug is au26 thorized to be marketed in a country listed under 


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1 section 802(b)(1)(A) or designated under section 

2 802(b)(1)(B); 

3 ‘‘(ii) the drug is safe and clinically effective; 

4 ‘‘(iii) the manufacturer is capable of manufac5 turing the drug safely and consistently, and can en6 sure the safety of the supply chain outside the 

7 United States; 

8 ‘‘(iv) all relevant United States patents or legal 

9 periods of exclusivity are expired; 

10 ‘‘(v) absent reciprocal marketing approval, the 

11 drug is not approved for marketing in the United 

12 States; 

13 ‘‘(vi) the Secretary has not, because of any con14 cern relating to safety or effectiveness, rescinded or 

15 withdrawn any such approval; and 

16 ‘‘(vii) the Secretary finds that none of the 

17 grounds for denying approval specified in subsection 

18 (d) applies. 

19 ‘‘(B) LIMITATIONS.—Approval of a drug under this 

20 section may, as the Secretary determines appropriate, be 

21 subject to 1 or both of the following requirements: 

22 ‘‘(i) The sponsor conduct appropriate post23 approval studies to verify and describe the predicted 

24 effect of the drug on irreversible morbidity or mor25 tality or another clinical benefit of the drug. 


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1 ‘‘(ii) The sponsor submit copies of all pro2 motional materials related to the drug during the 

3 preapproval review period and, following approval 

4 and for such period thereafter as the Secretary de5 termines to be appropriate, at least 30 days prior to 

6 the dissemination of the materials. 

7 ‘‘(C) TIMELINE.—If the Secretary does not approve 

8 the application or take such other action within such 90- 

9 day period, the application shall be considered approved 

10 under this subsection. 

11 ‘‘(D) ADVISORY COMMITTEE.— 

12 ‘‘(i) ESTABLISHMENT.—For the purpose of pro13 viding expert scientific advice and recommendations 

14 to the Secretary regarding the approval of applica15 tions described in subsection (b)(7), the Secretary 

16 shall establish a standing Foreign Drug Review Ad17 visory Committee. 

18 ‘‘(ii) MEMBERSHIP.—The standing Foreign 

19 Drug Review Advisory Committee established under 

20 clause (i) shall consist of employees of the Food and 

21 Drug Administration and individuals appointed by 

22 the Secretary, reflecting a balanced composition of 

23 sufficient scientific expertise. The Secretary shall ap24 point members who have diverse interests, education, 

25 training, experience, and expertise in biopharmaVerDate Sep 11 2014 04:56 Feb 05, 2022 Jkt 029200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3576.IS S3576

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1 cology, statistics, chemistry, legal issues, ethics, and 

2 other appropriate expertise pertaining to the drugs 

3 under review, such as expertise in foreign regulatory 

4 and manufacturing practices and drug development, 

5 and other individuals, as the Secretary determines 

6 appropriate. 

7 ‘‘(iii) REVIEW OF APPLICATIONS.—Upon the fil8 ing of an application described in subsection 

9 (b)(7)— 

10 ‘‘(I) the Secretary shall immediately refer 

11 the application to the Foreign Drug Review Ad12 visory Committee for review; and 

13 ‘‘(II) within 60 days after the receipt by 

14 such advisory committee of such application, 

15 the advisory committee shall provide the Sec16 retary with recommendations with respect to 

17 such application. 

18 ‘‘(E) PUBLICATION OF FINAL DECISION.—The Sec19 retary shall make publically available, on the website of 

20 the Food and Drug Administration, each final decision on 

21 whether to approve an application described in subsection 

22 (b)(7), including the rationale for the decision and the rec23 ommendations and conclusions of the Foreign Drug Re24 view Advisory Committee under subparagraph (D)(iii).’’. 


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1 (b) TECHNICAL AMENDMENT.—Section 

2 802(b)(1)(A)(i) of the Federal Food, Drug, and Cosmetic 

3 Act (21 U.S.C. 382(b)(1)(A)(i)) is amended by striking 

4 ‘‘or South Africa’’ and inserting ‘‘South Africa, or the 

5 United Kingdom’’. 

Æ 


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