Pharmaceutical Independence Long-Term Readiness Reform Act

I 116TH CONGRESS 1ST SESSION H. R. 4710 To direct the Secretary of Defense to include in each national defense strategy steps to strengthen the United States industrial base and to assure an uninterrupted supply of medicines, and for other purposes. IN THE HOUSE OF REPRESENTATIVES OCTOBER 17, 2019 Mr. GARAMENDI (for himself and Mrs. HARTZLER) introduced the following bill; which was referred to the Committee on Armed Services, and in ad- dition to the Committees on Veterans’ Affairs, and Financial Services, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the com- mittee concerned A BILL To direct the Secretary of Defense to include in each national defense strategy steps to strengthen the United States industrial base and to assure an uninterrupted supply of medicines, and for other purposes. 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 ‘‘Pharmaceutical Inde- 4 pendence Long-Term Readiness Reform Act’’. 5 VerDate Sep 11 2014 04:15 Oct 23, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H4710.IH H4710 kjohnson on DSK79L0C42 with BILLS 2 •HR 4710 IH SEC. 2. UNITED STATES MEDICINE SUPPLY CHAIN. 1 (a) NATIONAL DEFENSE STRATEGY.—The Secretary 2 of Defense shall include, in each national defense strategy 3 under section 113(g) of title 10, United States Code, steps 4 to be taken to assure the provision of medicines to enable 5 combat readiness and force health protection. 6 (b) REPORT TO CONGRESS.—Not later than one year 7 after the date of the enactment of this Act, the Secretary 8 of Defense, in consultation with the heads of other appro- 9 priate Federal departments and agencies, shall submit to 10 Congress a report on vulnerabilities to the United States 11 medicine supply chain. Such report shall include— 12 (1) an identification of any finished drugs and 13 their essential components including raw materials, 14 chemical components and active ingredients nec- 15 essary for the manufacture of medicines whose sup- 16 ply is at risk of disruption during a time of war or 17 national emergency; 18 (2) an identification of shortages of finished 19 drugs essential for combat readiness and force pro- 20 tection; 21 (3) an identification of the defense and geo- 22 political contingencies that are sufficiently likely to 23 arise that may disrupt, strain, compromise, or elimi- 24 nate supply chains of medicines and their essential 25 VerDate Sep 11 2014 04:15 Oct 23, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4710.IH H4710 kjohnson on DSK79L0C42 with BILLS 3 •HR 4710 IH components and recommendations for reasonable 1 preparation for the occurrence of such contingencies; 2 (4) an assessment of the resilience and capacity 3 of the current supply chain and industrial base to 4 support national defense upon the occurrence of the 5 contingencies identified in paragraph (3), including 6 with respect to— 7 (A) the manufacturing capacity of the 8 United States; 9 (B) gaps in domestic manufacturing capa- 10 bilities including non-existent, extinct, threat- 11 ened, and single-point-of-failure capabilities; 12 and 13 (C) supply chains with single points of fail- 14 ure and limited resiliency; 15 (5) legislative, regulatory, and policy changes 16 necessary to avoid, or prepare for, contingencies 17 identified in the report; and 18 (6) recommendations to diversify supply away 19 from complete dependency on sources of supply in 20 competitor countries and politically unstable coun- 21 tries that may cut off United States supply, and ad- 22 dress critical bottlenecks and mitigate single points 23 of failure and limited resilience. 24 (c) PREFERENCE FOR MEDICINES.— 25 VerDate Sep 11 2014 04:15 Oct 23, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4710.IH H4710 kjohnson on DSK79L0C42 with BILLS 4 •HR 4710 IH (1) IN GENERAL.—Except as provided in para- 1 graph (2) and under section 1107a(d) of title 10, 2 United States Code, the Secretary of Defense and 3 the Secretary of Veterans Affairs— 4 (A) may only acquire and purchase Amer- 5 ican-made and Federal Drug Administration 6 approved raw materials, medicines, and vaccines 7 for the Department of Defense; and 8 (B) shall use the authorities under the De- 9 fense Production Act to acquire and purchase 10 such raw materials, medicines, and vaccines, 11 recognizing the national security vulnerabilities 12 of a dependency on a foreign medical supply 13 chain. 14 (2) EXCEPTION.—Paragraph (1) does not apply 15 in any case where the Secretary of Defense deter- 16 mines that a shortage of any raw material, medicine, 17 or vaccine is such that it becomes unavoidable to ac- 18 quire such raw material, medicine, or vaccine from 19 a trusted foreign supplier. 20 (3) AMERICAN-MADE.—For purposes of this 21 subsection, the term ‘‘American-made’’ supplied 22 from, created, or supplied by the United States, in- 23 VerDate Sep 11 2014 04:15 Oct 23, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4710.IH H4710 kjohnson on DSK79L0C42 with BILLS 5 •HR 4710 IH cluding any territory or possession of the United 1 States. 2 Æ VerDate Sep 11 2014 04:15 Oct 23, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\H4710.IH H4710 kjohnson on DSK79L0C42 with BILLS