II 

118TH CONGRESS 

2D SESSION S. 5419 

To require the Secretary of Health and Human Services to maintain a 

list of the country of origin of certain critical drugs marketed in the 

United States, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 4, 2024 

Mr. COTTON (for himself and Mr. KAINE) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL 

To require the Secretary of Health and Human Services 

to maintain a list of the country of origin of certain 

critical drugs marketed in the United States, and for 

other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Protecting Our Essen5 tial Medicines Act’’. 


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1 SEC. 2. LIST OF CRITICAL DRUGS PRODUCED OUTSIDE THE 

2 UNITED STATES. 

3 Subchapter A of chapter V of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend5 ed by adding at the end the following: 

6 ‘‘SEC. 524C. LIST OF CRITICAL DRUGS PRODUCED OUTSIDE 

7 THE UNITED STATES. 

8 ‘‘(a) LIST OF CRITICAL DRUGS.— 

9 ‘‘(1) IN GENERAL.—For purposes of strength10 ening the public health supply chain and industrial 

11 base, and increasing the manufacture of essential 

12 drugs, including biological products, and critical in13 puts of such drugs in the United States, the Sec14 retary shall compile and maintain a list of each drug 

15 that is— 

16 ‘‘(A) approved under subsection (c) or (j) 

17 of section 505 of this Act or licensed under sub18 section (a) or (k) of section 351 of the Public 

19 Health Service Act; 

20 ‘‘(B) imported into the United States; and 

21 ‘‘(C)(i) determined by the interagency task 

22 force established under subsection (e) to be crit23 ical to the health and safety of consumers in 

24 the United States; 

25 ‘‘(ii) determined by such task force to be 

26 a drug the shortage of which would have an adVerDate Sep 11 2014 22:50 Dec 10, 2024 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S5419.IS S5419

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1 verse health outcome on patients with chronic 

2 conditions; or 

3 ‘‘(iii) a qualified countermeasure, as de4 fined in section 319F–1(a)(2) of the Public 

5 Health Service Act, a qualified pandemic or epi6 demic product, as defined in section 319F–3(i) 

7 of such Act, or a security countermeasure, as 

8 defined in section 319F–2(c) of such Act. 

9 ‘‘(2) SUPPLY CHAIN INFORMATION.—The list 

10 required by paragraph (1) shall, with respect to each 

11 drug included on the list, provide information about 

12 each facility registered under section 510 that is in13 volved in the manufacture, preparation, propagation, 

14 compounding, or processing of the drug or an ingre15 dient of the drug. 

16 ‘‘(3) NO PUBLIC DISCLOSURE.—The list re17 quired by paragraph (1), and any portion thereof, 

18 shall not be publicly disclosed, and nothing in para19 graph (1) or (2) shall be construed as authorizing 

20 the Secretary to disclose any information that is a 

21 trade secret or confidential information subject to 

22 section 552(b)(4) of title 5, United States Code, or 

23 section 1905 of title 18, United States Code. 

24 ‘‘(4) PERMISSIBLE DISCLOSURE TO NATIONAL

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1 MENT.—The list required by paragraph (1) (and any 

2 portion thereof) may be disclosed by the Secretary 

3 only— 

4 ‘‘(A) within the Department of Health and 

5 Human Services and pursuant to reporting 

6 under subsection (e); and 

7 ‘‘(B) for purposes of evaluating supply 

8 chain vulnerabilities and other national security 

9 issues, with national security agencies of the 

10 Federal Government, including all elements of 

11 the Department of Defense and national intel12 ligence agencies. 

13 ‘‘(5) DEFINITION.—In this subsection, the term 

14 ‘critical inputs’ means active pharmaceutical ingredi15 ents, starting material for active pharmaceutical in16 gredients, and other ingredients of drugs that the 

17 Commissioner of Food and Drugs determines to be 

18 critical in assessing the safety and effectiveness of 

19 drugs described in paragraph (1). 

20 ‘‘(b) ADDITIONAL LISTS.— 

21 ‘‘(1) IN GENERAL.—In conjunction with the list 

22 under subsection (a), the Secretary shall, in con23 sultation with the interagency task force established 

24 under subsection (e), compile and maintain— 


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1 ‘‘(A) a list of drugs included on the list 

2 under subsection (a) that are exclusively pro3 duced in, or use active pharmaceutical ingredi4 ents produced in, a foreign entity of concern (as 

5 defined in section 9901(8) of the William M. 

6 (Mac) Thornberry National Defense Authoriza7 tion Act for Fiscal Year 2021); and 

8 ‘‘(B) a list identifying the top 3 countries 

9 from which the United States imports drugs de10 scribed in subsection (a)(1). 

11 ‘‘(2) DISCLOSURE.— 

12 ‘‘(A) LIST OF DRUGS.— 

13 ‘‘(i) NO PUBLIC DISCLOSURE.—The 

14 list required by paragraph (1)(A) (and any 

15 portion thereof) shall not be publicly dis16 closed. 

17 ‘‘(ii) PERMISSIBLE DISCLOSURE TO

18 NATIONAL SECURITY AGENCIES OF THE

19 FEDERAL GOVERNMENT.—The list re20 quired by paragraph (1)(A), and any por21 tion thereof, may be disclosed by the Sec22 retary only— 

23 ‘‘(I) within the Department of 

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1 suant to reporting under subsection 

2 (f); and 

3 ‘‘(II) for purposes of evaluating 

4 supply chain vulnerabilities and other 

5 national security issues, with national 

6 security agencies of the Federal Gov7 ernment. 

8 ‘‘(B) LIST OF TOP 3 COUNTRIES.—The 

9 Secretary shall publicly disclose the list required 

10 by paragraph (1)(B), but may not include in 

11 any such disclosure— 

12 ‘‘(i) information about an identifiable 

13 drug or active pharmaceutical ingredient; 

14 or 

15 ‘‘(ii) proprietary information regard16 ing a drug or active pharmaceutical ingre17 dient, including information that is a trade 

18 secret or confidential information subject 

19 to section 552(b)(4) of title 5, United 

20 States Code, or section 1905 of title 18, 

21 United States Code. 

22 ‘‘(c) TIMELINES.— 

23 ‘‘(1) INITIAL LIST.—The Secretary shall com24 pile the initial lists of drugs under subsections (a) 

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1 actment of the Protecting Our Essential Medicines 

2 Act. 

3 ‘‘(2) UPDATES.—The Secretary shall update 

4 the lists of drugs under subsections (a) and (b), as 

5 the Secretary determines necessary and appropriate, 

6 and not less frequently than every 2 years. 

7 ‘‘(d) CYBERSECURITY MEASURES.— Prior to sharing 

8 of any lists required by subsection (a) or (b), within the 

9 Department of Health and Human Services or to national 

10 security agencies, the Secretary shall ensure that robust 

11 cybersecurity measures are in place to prevent inappro12 priate access to, or unauthorized disclosure of, the list or 

13 any information related to the list. 

14 ‘‘(e) INTERAGENCY TASK FORCE.— 

15 ‘‘(1) ESTABLISHMENT.—Not later than 30 days 

16 after the date of enactment of the Protecting Our 

17 Essential Medicines Act, the Secretary shall estab18 lish an interagency task force for purposes of identi19 fying drugs to include in the list of critical drugs, as 

20 described in subsection (a)(1)(C) and consulting 

21 with the Secretary with respect to compiling, main22 taining, and updating the list under subsection (b). 

23 The task force shall be comprised of representatives 

24 of the Federal Government as the Secretary, in con25 sultation with the Commissioner of Food and Drugs, 


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1 the Director of the Centers for Disease Control and 

2 Prevention, the Secretary of Defense, the Assistant 

3 Secretary for Preparedness and Response, the Sec4 retary of Homeland Security, the Commissioner of 

5 U.S. Customs and Border Protection, and the Direc6 tor of National Intelligence, determines appropriate. 

7 ‘‘(2) PROCEDURES.—Not later than 60 days 

8 after the date of enactment of the Protecting Our 

9 Essential Medicines Act, the task force established 

10 under paragraph (1) shall submit a report on the 

11 procedures such task force will follow in making de12 terminations with respect to drugs as described in 

13 clauses (i) and (ii) of subsection (a)(1)(C) to— 

14 ‘‘(A) the Committee on Health, Education, 

15 Labor, and Pensions, the Committee on Fi16 nance, and the Committee on Armed Services of 

17 the Senate; and 

18 ‘‘(B) the Committee on Energy and Com19 merce, the Committee on Ways and Means, and 

20 the Committee on Armed Services of the House 

21 of Representatives. 

22 ‘‘(f) REPORTING.—Upon compiling the initial list of 

23 drugs as required under subsections (a) and (b), and upon 

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1 section (c)(2), the Secretary shall submit the list of drugs 

2 to— 

3 ‘‘(1) the Secretary of Defense; 

4 ‘‘(2) the Attorney General; and 

5 ‘‘(3) the Director of National Intelligence.’’. 

Æ 


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