Pharmaceutical Supply Chain Risk Assessment Act of 2023

II 118TH CONGRESS 1ST SESSION S. 1961 To require an interagency risk assessment of the pharmaceutical supply chain to identify and mitigate health and national security risks, and for other purposes. IN THE SENATE OF THE UNITED STATES JUNE 13, 2023 Mr. PETERS (for himself and Ms. ERNST) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To require an interagency risk assessment of the pharma- ceutical supply chain to identify and mitigate health and national security risks, 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 Supply 4 Chain Risk Assessment Act of 2023’’. 5 SEC. 2. RISK ASSESSMENT. 6 (a) IN GENERAL.—The Secretary of Health and 7 Human Services shall lead, in coordination with the Sec- 8 retary of Defense, the Secretary of Homeland Security, 9 VerDate Sep 11 2014 23:30 Jul 06, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1961.IS S1961 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •S 1961 IS and the Director of the Office of Pandemic Preparedness 1 and Response Policy, a comprehensive risk assessment of 2 the United States pharmaceutical supply chain and report 3 to the relevant committees of Congress on the findings of 4 each such assessment. The assessment shall be completed 5 not later than 18 months after the date of enactment of 6 this Act, and shall be updated annually thereafter. 7 (b) CONTENTS.—At a minimum, the risk assessment 8 under subsection (a) shall— 9 (1) use, as applicable, any drugs from the es- 10 sential medicines list developed by the Food and 11 Drug Administration in response to Executive Order 12 13944 (85 Fed. Reg. 49929) and any other relevant 13 assessments or lists, as appropriate, to identify, in 14 coordination with the private sector, a list of essen- 15 tial medicines, to be updated regularly on a time- 16 frame that the Secretary of Health and Human 17 Services, in coordination with the Secretary of De- 18 fense and the Secretary of Homeland Security, de- 19 termines appropriate, which shall include the active 20 pharmaceutical ingredients and drugs that— 21 (A) are reasonably likely to be required to 22 respond to a public health emergency or to a 23 chemical, biological, radiological, or nuclear 24 threat; or 25 VerDate Sep 11 2014 23:30 Jul 06, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1961.IS S1961 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •S 1961 IS (B) the shortage of which would pose a 1 significant threat to the United States health 2 care system or at-risk populations; 3 (2) identify, for each of the active pharma- 4 ceutical ingredients and drugs that are identified 5 under paragraph (1)— 6 (A) the active pharmaceutical ingredients 7 and drugs with vulnerable supply chains; 8 (B) the amount manufactured by each es- 9 tablishment registered under section 510(b) of 10 the Federal Food, Drug, and Cosmetic Act (21 11 U.S.C. 360(b)), as reported under section 12 510(j)(3) of such Act (21 U.S.C. 360(j)(3)), or, 13 with respect to any active pharmaceutical ingre- 14 dient or drug for which such information is un- 15 available, an explanation for why the informa- 16 tion is unavailable; 17 (C) the drugs that are sourced either ex- 18 clusively or primarily from foreign establish- 19 ments, including drugs manufactured domesti- 20 cally from active pharmaceutical ingredients 21 sourced exclusively or primarily from foreign es- 22 tablishments; and 23 VerDate Sep 11 2014 23:30 Jul 06, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1961.IS S1961 pbinns on DSKJLVW7X2PROD with $$_JOB 4 •S 1961 IS (D) the active pharmaceutical ingredients 1 that are sourced either exclusively or primarily 2 from foreign establishments; 3 (3) assess key starting materials and excipients 4 used in manufacturing the active pharmaceutical in- 5 gredients and drugs identified under paragraph (1); 6 (4) assess current domestic manufacturing ca- 7 pabilities with respect to drugs (including key start- 8 ing materials, excipients, and active pharmaceutical 9 ingredients) identified under paragraph (1), includ- 10 ing advanced manufacturing capabilities; 11 (5) identify critical vulnerabilities, including cy- 12 bersecurity threats; 13 (6) identify the existing statutory authorities 14 the Department of Defense, the Department of 15 Health and Human Services, and the Department of 16 Homeland Security have to address public health or 17 national security risks that may arise as a result of 18 vulnerabilities in the pharmaceutical supply chain; 19 and 20 (7) identify any deficiencies, lack of authorities, 21 or limitations in policy or process that limit the abil- 22 ity of any of the departments described in paragraph 23 (6) to address vulnerabilities in the pharmaceutical 24 supply chain identified in the risk assessment, and 25 VerDate Sep 11 2014 23:30 Jul 06, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1961.IS S1961 pbinns on DSKJLVW7X2PROD with $$_JOB 5 •S 1961 IS describe the plans of the departments described in 1 paragraph (6) to mitigate such vulnerabilities. 2 (c) PUBLICATION OF ASSESSMENT.—The risk assess- 3 ment under subsection (a) (including any updates) shall 4 be publicly available in an unclassified form but may in- 5 clude a classified annex containing any information that 6 the Secretary of Health and Human Services determines 7 to be sensitive. 8 (d) DEFINITIONS.—In this section: 9 (1) ADVANCED MANUFACTURING.—The term 10 ‘‘advanced manufacturing’’ has the meaning given 11 the term ‘‘advanced and continuous pharmaceutical 12 manufacturing’’ in section 3016(h) of the 21st Cen- 13 tury Cures Act (21 U.S.C. 399h(h)). 14 (2) CYBERSECURITY THREAT.—The term ‘‘cy- 15 bersecurity threat’’ has the meaning given such term 16 in section 2200 of the Homeland Security Act of 17 2002 (6 U.S.C. 650). 18 (3) DRUG.—The term ‘‘drug’’ has the meaning 19 given such term in section 201(g) of the Federal 20 Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)). 21 (4) RELEVANT COMMITTEES OF CONGRESS.— 22 The term ‘‘relevant committees of Congress’’ means 23 the Committee on Homeland Security and Govern- 24 mental Affairs, the Committee on Health, Edu- 25 VerDate Sep 11 2014 23:30 Jul 06, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1961.IS S1961 pbinns on DSKJLVW7X2PROD with $$_JOB 6 •S 1961 IS cation, Labor, and Pensions, and the Committee on 1 Armed Services of the Senate and the Committee on 2 Homeland Security, the Committee on Energy and 3 Commerce, and the Committee on Armed Services of 4 the House of Representatives. 5 (e) CLARIFICATION.—The participation of the Sec- 6 retary of Health and Human Services in developing and 7 updating the list of essential medicines under subsection 8 (b)(1) shall be deemed to be full satisfaction of the re- 9 quirements applicable to such secretary under section 3 10 of Executive Order 13944 (85 Fed. Reg. 49929). 11 Æ VerDate Sep 11 2014 23:30 Jul 06, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\S1961.IS S1961 pbinns on DSKJLVW7X2PROD with $$_JOB