ADAPT Act

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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Accelerated Drug Ap- 4 proval for Prescription Therapies Act’’ or the ‘‘ADAPT 5 Act’’. 6 VerDate Sep 11 2014 21:52 Mar 13, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S658.IS S658 pamtmann on DSKBFK8HB2PROD with BILLS 2 •S 658 IS SEC. 2. ACCELERATED APPROVAL OF CERTAIN DRUGS 1 THAT ARE AUTHORIZED TO BE LAWFULLY 2 MARKETED IN OTHER COUNTRIES. 3 Chapter V of the Federal Food, Drug, and Cosmetic 4 Act (21 U.S.C. 351 et seq.) is amended by inserting after 5 section 506 the following: 6 ‘‘SEC. 506–1. ACCELERATED APPROVAL OF CERTAIN DRUGS 7 THAT ARE AUTHORIZED TO BE LAWFULLY 8 MARKETED IN OTHER COUNTRIES. 9 ‘‘(a) IN GENERAL.—The Secretary may approve an 10 application for approval for a drug under subsection (c) 11 or (j) of section 505 that is currently authorized to be 12 marketed in one or more of the countries included in the 13 list under section 802(b)(1), upon a determination by the 14 Secretary that the sponsor has submitted evidence suffi- 15 cient to demonstrate all of the criteria under subsection 16 (b)(1). 17 ‘‘(b) CRITERIA.— 18 ‘‘(1) IN GENERAL.—The Secretary may approve 19 a drug under subsection (a) only if the Secretary de- 20 termines that there is evidence that— 21 ‘‘(A) at the time of application, the drug is 22 authorized to be marketed in a country included 23 in the list under section 802(b)(1); 24 VerDate Sep 11 2014 21:52 Mar 13, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S658.IS S658 pamtmann on DSKBFK8HB2PROD with BILLS 3 •S 658 IS ‘‘(B) the drug is safe and clinically effec- 1 tive and has a satisfactory history of clinical 2 trials and data; 3 ‘‘(C) the manufacturer is capable of manu- 4 facturing the drug safely and consistently, and 5 can assure the safety of the supply chain out- 6 side the United States; 7 ‘‘(D) all relevant United States patents or 8 legal exclusivities are expired; 9 ‘‘(E) absent reciprocal marketing approval, 10 the drug is not approved for marketing in the 11 United States; 12 ‘‘(F) the Secretary has not, because of any 13 concern relating to safety or effectiveness, re- 14 scinded or withdrawn any such approval; and 15 ‘‘(G) there is a public health or unmet 16 medical need for the drug in the United States. 17 ‘‘(2) LIMITATION.—Approval of a drug under 18 this section may, as the Secretary determines appro- 19 priate, be subject to 1 or both of the following re- 20 quirements: 21 ‘‘(A) The sponsor conduct appropriate 22 postapproval studies to verify and describe the 23 predicted effect on irreversible morbidity or 24 mortality or other clinical benefit of the drug. 25 VerDate Sep 11 2014 21:52 Mar 13, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S658.IS S658 pamtmann on DSKBFK8HB2PROD with BILLS 4 •S 658 IS ‘‘(B) The sponsor submit copies of all pro- 1 motional materials related to the product dur- 2 ing the preapproval review period and, following 3 approval and for such period thereafter as the 4 Secretary determines to be appropriate, at least 5 30 days prior to dissemination of the materials. 6 ‘‘(c) TIMELINE.—The Secretary shall make a deter- 7 mination on an application described in subsection (a) not 8 later than 180 days after the date of submission of such 9 application.’’. 10 Æ VerDate Sep 11 2014 21:52 Mar 13, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\S658.IS S658 pamtmann on DSKBFK8HB2PROD with BILLS