II 

118TH CONGRESS 

1ST SESSION S. 3143 

To establish postmarket reporting requirements for pharmaceuticals, and for 

other purposes. 

IN THE SENATE OF THE UNITED STATES 

OCTOBER 26, 2023 

Mr. RUBIO (for himself, Mr. ROUNDS, and Mr. CRAMER) introduced the following bill; which was read twice and referred to the Committee on 

Health, Education, Labor, and Pensions 

A BILL 

To establish postmarket reporting requirements for 

pharmaceuticals, 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 ‘‘Further Strengthening 

5 America’s Supply Chain and National Security Act’’. 

6 SEC. 2. MODIFICATION OF RULES OF ORIGIN FOR PHARMA7 CEUTICAL PRODUCTS. 

8 (a) TRADE AGREEMENTS.—Section 308(4)(B) of the 

9 Trade Agreements Act of 1979 (19 U.S.C. 2518(4)(B)) 

10 is amended— 

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1 (1) in clause (i), by striking ‘‘instrumentality, 

2 or’’ and inserting ‘‘instrumentality,’’; 

3 (2) in clause (ii), by inserting ‘‘, other than an 

4 active pharmaceutical ingredient,’’ after ‘‘part of 

5 materials’’; and 

6 (3) by striking the period at the end and insert7 ing ‘‘, or (iii) in the case of an article which consists 

8 of an active pharmaceutical ingredient, the pharma9 ceutical ingredient is wholly the growth, product, or 

10 manufacture of that country or instrumentality.’’. 

11 (b) FEDERAL ACQUISITION REGULATION.—Not later 

12 than 180 days after the date of the enactment of this Act, 

13 the President shall prescribe regulations to update sec14 tions 52.225–5 and 25.003 of title 48, Code of Federal 

15 Regulations (or successor regulations) to be consistent 

16 with rules of origin determinations for active pharma17 ceutical ingredients made under section 308(4)(B) of the 

18 Trade Agreements Act of 1979 (19 U.S.C. 2518(4)(B)), 

19 as amended by subsection (a). 

20 SEC. 3. POSTMARKET REPORTING REQUIREMENTS FOR 

21 PHARMACEUTICALS. 

22 (a) IN GENERAL.—The Secretary of Health and 

23 Human Services, acting through the Commissioner of 

24 Food and Drugs, shall ensure that each holder of an ap25 proved application under section 505 of the Federal Food, 

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1 Drug, and Cosmetic Act (21 U.S.C. 355) or under section 

2 351 of the Public Health Service Act (42 U.S.C. 262) an3 nually submit, as part of the postmarket annual report 

4 required by the Secretary under section 314.81(b)(2) of 

5 title 21, Code of Federal Regulations (or any successor 

6 regulation), the following information: 

7 (1) The names and addresses of the sources of 

8 active and inactive ingredients of the drug. 

9 (2) For each active and inactive ingredient of 

10 the drug, the percentage of the aggregate amount of 

11 such ingredient used in the manufacture of the drug 

12 during the reporting period that is from each of the 

13 sources identified under paragraph (1). 

14 (b) DISCLOSURE OF INFORMATION.—The Secretary 

15 of Health and Human Services shall— 

16 (1) annually provide the information reported in 

17 paragraphs (1) and (2) of subsection (a) to the Sec18 retary of Defense for purposes of understanding the 

19 dependency on foreign manufacturers of drugs used 

20 by members of the Armed Forces; and 

21 (2) publish the information reported under such 

22 paragraphs on a publicly available internet website 

23 of the Federal Government in a single, aggregate 

24 form, without disclosing proprietary information. 

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1 SEC. 4. ADDITIONAL RISK FACTORS FOR CONSIDERATION 

2 DURING INSPECTIONS OF DRUG AND DEVICE 

3 ESTABLISHMENTS. 

4 Section 510(h)(4) of the Federal Food, Drug, and 

5 Cosmetic Act (21 U.S.C. 360(h)(4)) is amended— 

6 (1) by redesignating subparagraph (G) as sub7 paragraph (J); and 

8 (2) by inserting after subparagraph (F) the fol9 lowing: 

10 ‘‘(G) Whether the establishment has been 

11 inspected by an entity that carries out inspec12 tions on behalf of a foreign government deter13 mined to be a foreign adversary under section 

14 7.4 of title 15, Code of Federal Regulations (or 

15 successor regulations). 

16 ‘‘(H) The particular drugs or devices (with 

17 a focus on drugs and devices included on the 

18 list of essential medicines pursuant to section 

19 3(c) of Executive Order 13944 (85 Fed. Reg. 

20 49929)) manufactured, prepared, propagated, 

21 compounded, or processed in the establishment, 

22 with particular attention to the number of other 

23 establishments globally that also manufacture, 

24 prepare, propagate, compound, or process the 

25 same drug or device from which the United 

26 States sources such drug or device. 

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1 ‘‘(I) Whether the establishment is located 

2 in a country with a history or 1 or more pre3 vious instances of exporting illicit drugs or pre4 cursor chemicals to the United States, as deter5 mined by the Secretary by reference to the most 

6 recent report submitted to Congress pursuant 

7 to section 489 of the Foreign Assistance Act of 

8 1961.’’. 

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