II 116th CONGRESS 2d Session S. 3343 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.

1. Short title This Act may be cited as the Medical Supply Chain Security Act . 2. Medical supply chain security (a) Additional manufacturer reporting for essential medical devices Section 506C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c ) is amended— (1) in subsection (a)— (A) in the matter preceding paragraph (1), by inserting or device after a drug ; and (B) in the flush matter by inserting or device after drug each place such term appears; (2) in subsection (c), by inserting and devices after drugs ; (3) in subsection (g)— (A) in the matter preceding paragraph (1), by striking drug shortage of a drug and inserting shortage of a drug or device ; (B) in paragraph (1), by striking ; or and inserting a semicolon; (C) by redesignating paragraph (2) as paragraph (3); (D) by inserting after paragraph (1) the following: (2) expedite the review of a device subject to premarket approval under section 515 that could help mitigate or prevent such shortage; or ; and (E) in paragraph (3), as so redesignated, by striking drug shortage and inserting shortage ; (4) in subsection (h)— (A) by amending paragraph (2) to read as follows: (2) the term shortage , with respect to a drug or device, means a period of time when the demand or projected demand for the drug or device within the United States exceeds the supply of the drug or device; and ; and (B) in paragraph (3)(A), by inserting or device after drug ; and (5) by adding at the end the following: (j) Additional manufacturer reporting for essential drugs and devices Each manufacturer of a drug or device described in subsection (a) shall provide to the Food and Drug Administration, on an annual basis, or more frequently at the request of the Secretary, information related to the manufacturing capacity of such drug or device. Such information shall include— (1) details about— (A) all locations of production; (B) the sourcing of all component parts; (C) the sourcing of any active pharmaceutical ingredients; and (D) the use of any scarce raw materials; and (2) any other information determined by the Secretary to be relevant to the security of the supply chain of the drug or device. . (b) Provision of additional information Section 506C–1 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356c–1 ) is amended— (1) in the heading, by striking drug shortages and inserting drug or device shortages ; (2) by striking drug shortages each place it appears and inserting drug or device shortages ; (3) in subsection (a)— (A) in paragraph (3)(B)— (i) in clause (i), by striking section 506C(g)(1) and inserting paragraph (1) or (2) of section 506C(g) ; and (ii) in clause (ii), by striking section 506C(g)(2) and inserting section 506C(g)(3) ; and (B) in paragraph (5), by striking drug shortage and inserting drug or device shortage ; and (4) in subsection (c), by striking drug shortage or .