Commission on America’s Medical Security Act

II 116TH CONGRESS 2D SESSION S. 3478 To require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States. IN THE SENATE OF THE UNITED STATES MARCH 12, 2020 Mr. DURBIN (for himself, Mr. ALEXANDER, Mrs. MURRAY, Mr. ROMNEY, Mr. JONES, Mr. BLUNT, Ms. SMITH, Ms. BALDWIN, Mr. REED, Ms. KLO- BUCHAR, and Mr. BLUMENTHAL) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States. 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 ‘‘Commission on Amer- 4 ica’s Medical Security Act’’. 5 VerDate Sep 11 2014 03:01 Mar 21, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S3478.IS S3478 kjohnson on DSK79L0C42PROD with BILLS 2 •S 3478 IS SEC. 2. NATIONAL ACADEMIES REPORT ON AMERICA’S 1 MEDICAL PRODUCT SUPPLY CHAIN SECU- 2 RITY. 3 (a) IN GENERAL.—Not later than 60 days after the 4 date of enactment of this Act, the Secretary of Health and 5 Human Services shall enter into an agreement with the 6 National Academies of Sciences, Engineering, and Medi- 7 cine (referred to in this section as the ‘‘National Acad- 8 emies’’) to examine, and, in a manner that does not com- 9 promise national security, report on, the security of the 10 United States medical product supply chain. 11 (b) PURPOSES.—The report developed under this sec- 12 tion shall— 13 (1) assess and evaluate the dependence of the 14 United States, including the private commercial sec- 15 tor, States, and the Federal Government, on critical 16 drugs and devices that are sourced or manufactured 17 outside of the United States, which may include an 18 analysis of— 19 (A) the supply chain of critical drugs and 20 devices of greatest priority to providing health 21 care; 22 (B) any potential public health security or 23 national security risks associated with reliance 24 on critical drugs and devices sourced or manu- 25 factured outside of the United States, which 26 VerDate Sep 11 2014 03:01 Mar 21, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S3478.IS S3478 kjohnson on DSK79L0C42PROD with BILLS 3 •S 3478 IS may include responses to previous or existing 1 shortages or public health emergencies, such as 2 infectious disease outbreaks, bioterror attacks, 3 and other public health threats; 4 (C) any existing supply chain information 5 gaps, as applicable; and 6 (D) potential economic impact of increased 7 domestic manufacturing; and 8 (2) provide recommendations, which may in- 9 clude a plan to improve the resiliency of the supply 10 chain for critical drugs and devices as described in 11 paragraph (1), and to address any supply vulnerabil- 12 ities or potential disruptions of such products that 13 would significantly affect or pose a threat to public 14 health security or national security, as appropriate, 15 which may include strategies to— 16 (A) promote supply chain redundancy and 17 contingency planning; 18 (B) encourage domestic manufacturing, in- 19 cluding consideration of economic impacts, if 20 any; 21 (C) improve supply chain information 22 gaps; 23 VerDate Sep 11 2014 03:01 Mar 21, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S3478.IS S3478 kjohnson on DSK79L0C42PROD with BILLS 4 •S 3478 IS (D) improve planning considerations for 1 medical product supply chain capacity during 2 public health emergencies; and 3 (E) promote the accessibility of such drugs 4 and devices. 5 (c) INPUT.—In conducting the study and developing 6 the report under subsection (b), the National Academies 7 shall— 8 (1) consider input from the Department of 9 Health and Human Services, the Department of 10 Homeland Security, the Department of Defense, the 11 Department of Commerce, the Department of State, 12 the Department of Veterans Affairs, the Department 13 of Justice, and any other Federal agencies as appro- 14 priate; and 15 (2) consult with relevant stakeholders, which 16 may include conducting public meetings and other 17 forms of engagement, as appropriate, with health 18 care providers, medical professional societies, State- 19 based societies, public health experts, State and local 20 public health departments, State medical boards, pa- 21 tient groups, medical product manufacturers, health 22 care distributors, wholesalers and group purchasing 23 organizations, pharmacists, and other entities with 24 VerDate Sep 11 2014 03:01 Mar 21, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S3478.IS S3478 kjohnson on DSK79L0C42PROD with BILLS 5 •S 3478 IS experience in health care and public health, as ap- 1 propriate. 2 (d) DEFINITIONS.—In this section, the terms ‘‘de- 3 vice’’ and ‘‘drug’’ have the meanings given such terms in 4 section 201 of the Federal Food, Drug, and Cosmetic Act 5 (21 U.S.C. 321). 6 Æ VerDate Sep 11 2014 03:01 Mar 21, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\S3478.IS S3478 kjohnson on DSK79L0C42PROD with BILLS