Medical Supply Chain Security Act

II 116TH CONGRESS 2D SESSION S. 3343 To amend the Federal Food, Drug, and Cosmetic Act to provide enhanced security for the medical supply chain. IN THE SENATE OF THE UNITED STATES FEBRUARY 27, 2020 Mr. HAWLEY introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Federal Food, Drug, and Cosmetic Act to provide enhanced security for the medical supply chain. 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 ‘‘Medical Supply Chain 4 Security Act’’. 5 SEC. 2. MEDICAL SUPPLY CHAIN SECURITY. 6 (a) ADDITIONAL MANUFACTURER REPORTING FOR 7 ESSENTIAL MEDICAL DEVICES.—Section 506C of the 8 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c) 9 is amended— 10 VerDate Sep 11 2014 04:13 Feb 28, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S3343.IS S3343 kjohnson on DSK79L0C42PROD with BILLS 2 •S 3343 IS (1) in subsection (a)— 1 (A) in the matter preceding paragraph (1), 2 by inserting ‘‘or device’’ after ‘‘a drug’’; and 3 (B) in the flush matter by inserting ‘‘or 4 device’’ after ‘‘drug’’ each place such term ap- 5 pears; 6 (2) in subsection (c), by inserting ‘‘and devices’’ 7 after ‘‘drugs’’; 8 (3) in subsection (g)— 9 (A) in the matter preceding paragraph (1), 10 by striking ‘‘drug shortage of a drug’’ and in- 11 serting ‘‘shortage of a drug or device’’; 12 (B) in paragraph (1), by striking ‘‘; or’’ 13 and inserting a semicolon; 14 (C) by redesignating paragraph (2) as 15 paragraph (3); 16 (D) by inserting after paragraph (1) the 17 following: 18 ‘‘(2) expedite the review of a device subject to 19 premarket approval under section 515 that could 20 help mitigate or prevent such shortage; or’’; and 21 (E) in paragraph (3), as so redesignated, 22 by striking ‘‘drug shortage’’ and inserting 23 ‘‘shortage’’; 24 (4) in subsection (h)— 25 VerDate Sep 11 2014 04:13 Feb 28, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S3343.IS S3343 kjohnson on DSK79L0C42PROD with BILLS 3 •S 3343 IS (A) by amending paragraph (2) to read as 1 follows: 2 ‘‘(2) the term ‘shortage’, with respect to a drug 3 or device, means a period of time when the demand 4 or projected demand for the drug or device within 5 the United States exceeds the supply of the drug or 6 device; and’’; and 7 (B) in paragraph (3)(A), by inserting ‘‘or 8 device’’ after ‘‘drug’’; and 9 (5) by adding at the end the following: 10 ‘‘(j) ADDITIONAL MANUFACTURER REPORTING FOR 11 ESSENTIAL DRUGS AND DEVICES.—Each manufacturer 12 of a drug or device described in subsection (a) shall pro- 13 vide to the Food and Drug Administration, on an annual 14 basis, or more frequently at the request of the Secretary, 15 information related to the manufacturing capacity of such 16 drug or device. Such information shall include— 17 ‘‘(1) details about— 18 ‘‘(A) all locations of production; 19 ‘‘(B) the sourcing of all component parts; 20 ‘‘(C) the sourcing of any active pharma- 21 ceutical ingredients; and 22 ‘‘(D) the use of any scarce raw materials; 23 and 24 VerDate Sep 11 2014 04:13 Feb 28, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S3343.IS S3343 kjohnson on DSK79L0C42PROD with BILLS 4 •S 3343 IS ‘‘(2) any other information determined by the 1 Secretary to be relevant to the security of the supply 2 chain of the drug or device.’’. 3 (b) PROVISION OF ADDITIONAL INFORMATION.—Sec- 4 tion 506C–1 of the Federal Food, Drug, and Cosmetic Act 5 (21 U.S.C. 356c–1) is amended— 6 (1) in the heading, by striking ‘‘DRUG SHORT- 7 AGES’’ and inserting ‘‘DRUG OR DEVICE SHORT- 8 AGES’’; 9 (2) by striking ‘‘drug shortages’’ each place it 10 appears and inserting ‘‘drug or device shortages’’; 11 (3) in subsection (a)— 12 (A) in paragraph (3)(B)— 13 (i) in clause (i), by striking ‘‘section 14 506C(g)(1)’’ and inserting ‘‘paragraph (1) 15 or (2) of section 506C(g)’’; and 16 (ii) in clause (ii), by striking ‘‘section 17 506C(g)(2)’’ and inserting ‘‘section 18 506C(g)(3)’’; and 19 (B) in paragraph (5), by striking ‘‘drug 20 shortage’’ and inserting ‘‘drug or device short- 21 age’’; and 22 (4) in subsection (c), by striking ‘‘ ‘drug short- 23 age’ or’’. 24 Æ VerDate Sep 11 2014 04:13 Feb 28, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\S3343.IS S3343 kjohnson on DSK79L0C42PROD with BILLS