I 

118TH CONGRESS 

1ST SESSION H. R. 5575 

To direct the Secretaries of Health and Human Services, Defense, and Veterans Affairs to end American over-dependence on Chinese pharmaceuticals by encouraging the growth of a robust domestic medicine supply 

chain for generic drugs, to empower the Food and Drug Administration 

to issue boxed warnings in the case of critical contamination, and for 

other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 19, 2023 

Mr. POSEY introduced the following bill; which was referred to the Committee 

on Energy and Commerce, and in addition to the Committees on Armed 

Services, Veterans’ Affairs, and Ways and Means, 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 committee concerned 

A BILL 

To direct the Secretaries of Health and Human Services, 

Defense, and Veterans Affairs to end American overdependence on Chinese pharmaceuticals by encouraging 

the growth of a robust domestic medicine supply chain 

for generic drugs, to empower the Food and Drug Administration to issue boxed warnings in the case of critical contamination, 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, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Safe Medicine Act’’. 

3 SEC. 2. FINDINGS. 

4 Congress finds the following: 

5 (1) Following the enactment of the Drug Price 

6 Competition and Patent Term Restoration Act of 

7 1984 (Public Law 98–417), the People’s Republic of 

8 China was able to corner the market on generic 

9 drugs, pharmaceutical ingredients, and related mate10 rials through its steady supply of readily exploitable 

11 labor and threadbare safety regulations. Ninety per12 cent of the medications taken by individuals in the 

13 United States are generic, rendering them especially 

14 dependent on supplies originating in the People’s 

15 Republic of China. 

16 (2) The number of drugs produced outside of 

17 the United States doubled between 2001 and 2008. 

18 At present, 80 percent of the active pharmaceutical 

19 ingredients used in drugs taken by individuals in the 

20 United States come from overseas, mainly the Peo21 ple’s Republic of China and the Republic of India. 

22 The United States no longer produces penicillin, 

23 with the last fermentation plant phasing out of pro24 duction in 2004. 

25 (3) In 2008, the counterfeiting of Heparin pre26 cursor chemicals by a Chinese-based pharmaceutical 


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1 plant led to the deaths of 81 individuals in the 

2 United States, with 785 more being severely injured. 

3 The counterfeit product cost one-hundredth of the 

4 price of the real product, indicating a clear economic 

5 motive for distributing contaminated materials. 

6 (4) In 2018, the Secretary of Health and 

7 Human Services, acting through the Commissioner 

8 of Food and Drugs, issued recalls of Valsartan, 

9 Losartan, and Irbesartan, common blood pressure 

10 drugs. The Secretary of Health and Human Serv11 ices, acting through the Commissioner of Food and 

12 Drugs, determined that versions of such drugs have 

13 been contaminated as a result of Chinese and Indian 

14 manufacturing practices and that one Chinese com15 pany, Zhejaiang Huahai Pharmaceuticals, had ‘‘sys16 temic problems of supervision’’, with the potent car17 cinogens N-Nitroso-N-methyl-4-aminobutyric acid 

18 (NMBA), N-Nitrosodimethylamine (NDMA), and N19 Nitrosodiethylamine (NDEA), for a period of 4 

20 years before being detected. 

21 (5) During an October 30, 2020, hearing before 

22 the Health Subcommittee of the Energy and Com23 merce Committee of the House of Representatives, it 

24 was discovered that the Food and Drug Administra25 tion (FDA) has data on active pharmaceutical ingreVerDate Sep 11 2014 00:59 Sep 24, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5575.IH H5575

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1 dient facilities and locations because they regulate 

2 and inspect them. But the FDA does not know how 

3 much volume is produced at these facilities. A single 

4 plant could make 90 percent of global supply or 10 

5 percent, but the FDA does not know. 

6 (6) The FDA cannot determine the United 

7 States dependence because it does not thoroughly 

8 regulate or inspect the facilities where the key 

9 chemicals and raw materials to make active pharma10 ceutical ingredients are made. 

11 (7) Domestic pharmaceutical facilities undergo 

12 far more rigorous inspections than manufacturing 

13 facilities in the People’s Republic of China. Since 

14 early 2020, the FDA recalled its inspectors from 

15 China and elsewhere to protect them from the 

16 Coronavirus. As a result, FDA inspections have 

17 plummeted to near zero for the past year. 

18 (8) In 2010, the People’s Republic of China 

19 embargoed the shipment of rare earth metals to 

20 Japan as political leverage in its negotiations over a 

21 boating incident that took place between the 2 coun22 tries in the East China Sea. National security ex23 perts warn that if such an incident were to take 

24 place between the United States and China, and 

25 China were to embargo medicine and pharmaceutical 


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1 ingredients, the United States would be helpless. 

2 Sun Yu and Demetri Sevastopulo, ‘‘China Targets 

3 Rare Earth Export Curbs To Hobble US Defense 

4 Industry.’’ Ars Technica, February 16, 2021, 

5 arstechnica.com/tech-policy/2021/02/china-targets6 rare-earth-export-curbs-to-hobble-us-defense-indus7 try/. United States dependence on Chinese medicine 

8 and pharmaceutical ingredients poses a national se9 curity risk. 

10 (9) The United States is dependent on other 

11 nations, particularly China, for our generic medicine 

12 and key ingredients that are used to make these 

13 drugs. Inspections at Chinese facilities are inad14 equate compared to inspections at facilities located 

15 in the United States. 

16 (10) The United States cannot rely on ques17 tionable inspections at facilities located in China. 

18 (11) To protect Americans, we must encourage 

19 the development of essential generic drug manufac20 turing here in the United States and countries allied 

21 with the United States in a current defense effort 

22 for the 227 essential medicines and medical counter23 measures identified by the FDA in accordance with 

24 Executive Order 13944, issued on August 6, 2020. 


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1 SEC. 3. DOMESTIC MANUFACTURING TO END OVER-DE2 PENDENCE OF THE UNITED STATES ON CHI3 NESE DRUGS. 

4 (a) IN GENERAL.—The Secretaries of Health and 

5 Human Services, Defense, and Veterans Affairs, acting 

6 jointly and in consultation with the Commissioner of Food 

7 and Drugs, shall— 

8 (1) not later than 180 days after the date of 

9 enactment of this Act, develop a procurement strat10 egy, including for long-term contracts, to strengthen 

11 and mobilize the Public Health Industrial Base to 

12 increase the manufacture in the United States of es13 sential medicines, medical countermeasures, and 

14 critical inputs, including the 227 essential medicines, 

15 medical countermeasures, and critical inputs pub16 lished on October 30, 2020, by the Food and Drug 

17 Administration in accordance with Executive Order 

18 13944; and 

19 (2) beginning as soon as feasible after the de20 velopment of such strategy, and not later than 5 

21 years after the development of such strategy, imple22 ment such strategy. 

23 (b) CONTENTS.—The strategy under subsection (a) 

24 shall— 

25 (1) be consistent with all applicable Federal 

26 law; 


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1 (2) identify essential components, including key 

2 starting materials, active ingredients, and critical in3 puts, necessary for manufacturing the essential 

4 medicines and medical countermeasures published on 

5 October 30, 2020, by the Food and Drug Adminis6 tration in accordance with Executive Order 13944; 

7 and 

8 (3) address the capacity of the supply chain 

9 and industrial base to strengthen and mobilize the 

10 Public Health Industrial Base to increase the manu11 facture in the United States of essential medicines, 

12 medical countermeasures, and critical inputs. 

13 (c) DEFINITIONS.—In this section: 

14 (1) The term ‘‘critical inputs’’ means active 

15 pharmaceutical ingredients, active pharmaceutical 

16 ingredient starting material, and other ingredients of 

17 drugs and components of medical devices that the 

18 Commissioner of Food and Drugs determines to be 

19 critical in assessing the safety and effectiveness of 

20 essential medicines and medical countermeasures. 

21 (2) The term ‘‘essential medicine’’ means medi22 cine— 

23 (A) that is needed to protect the American 

24 public at all times, including from outbreaks of 

25 emerging infectious diseases, such as COVID– 


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1 19, as well as chemical, biological, radiological, 

2 and nuclear threats; and 

3 (B) of which sufficient and reliable, long4 term domestic production of these products, 

5 mostly generic drugs, their active pharma6 ceutical ingredients, and key starting materials, 

7 is needed to minimize potential shortages by re8 ducing the Nation’s dependence on foreign 

9 manufacturers of these products. 

10 (3) The term ‘‘medical countermeasure’’ 

11 means— 

12 (A) a qualified countermeasure (as defined 

13 in section 319F–1 of the Public Health Service 

14 Act (42 U.S.C. 247d–6a)); 

15 (B) a qualified pandemic or epidemic prod16 uct (as defined in section 319F–3 of such Act 

17 (42 U.S.C. 247d–6d)); 

18 (C) a security countermeasure (as defined 

19 in section 319F–2 of such Act (42 U.S.C. 

20 247d–6b)); or 

21 (D) personal protective equipment (such as 

22 gloves, respirators (face masks), and ventila23 tors). 

24 (4) The term ‘‘Public Health Industrial Base’’ 

25 means the facilities and associated workforces within 


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1 the United States, including research and develop2 ment facilities, that help produce essential medi3 cines, medical countermeasures, and critical inputs 

4 for the health care and public health sector. 

5 SEC. 4. REQUIRING BOXED WARNINGS ON POTENTIALLY 

6 CONTAMINATED DRUGS. 

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

8 Human Services, acting through the Commissioner of 

9 Food and Drugs, shall— 

10 (1) issue an order deeming a drug or active 

11 pharmaceutical ingredient (or a category thereof) to 

12 be misbranded within the meaning of section 502 of 

13 the Federal Food, Drug, and Cosmetic Act (21 

14 U.S.C. 352) if such drug or active pharmaceutical 

15 ingredient (or category thereof)— 

16 (A) is manufactured in a country that the 

17 Secretary determines may be producing con18 taminated drugs or active pharmaceutical ingre19 dients because of systemic problems of super20 vision in the manufacture of drugs or active 

21 pharmaceutical ingredients; and 

22 (B) the labeling of such drug or active 

23 pharmaceutical ingredient (or category thereof) 

24 does not bear a boxed warning of the potential 

25 for contamination; 


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1 (2) make each such order effective for a period 

2 of not more than 180 days; and 

3 (3) renew each such order each time the pre4 ceding order ends and the criteria listed in para5 graph (1) continue to apply. 

6 (b) WAIVERS.—The Secretary of Health and Human 

7 Services, acting through the Commissioner of Food and 

8 Drugs— 

9 (1) may waive the requirement to issue or 

10 renew an order under subsection (a) so long as the 

11 labeling of the drug or active pharmaceutical ingre12 dient (or category thereof) bears a boxed warning of 

13 the potential for contamination; 

14 (2) shall make any such waiver effective for a 

15 period not to exceed 180 days; and 

16 (3) may renew any such waiver one or more 

17 times. 

18 SEC. 5. LIMITATION ON WAIVER AUTHORITY UNDER THE 

19 TRADE AGREEMENTS ACT OF 1979. 

20 Section 301 of the Trade Agreements Act of 1979 

21 (19 U.S.C. 2511) is amended by adding at the end the 

22 following: 

23 ‘‘(g) LIMITATION ON WAIVER AUTHORITY RELATING

24 TO ESSENTIAL MEDICINES, MEDICAL COUNTER25 MEASURES, AND CRITICAL INPUTS.— 


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1 ‘‘(1) IN GENERAL.—The authority of the Presi2 dent under subsection (a) to waive the application of 

3 any law, regulation, procedure, or practice regarding 

4 Government procurement does not authorize the 

5 waiver of any preferences for goods that are essen6 tial medicines, medical countermeasures, or critical 

7 inputs. 

8 ‘‘(2) DEFINITIONS.—In this subsection, the 

9 terms ‘essential medicines’, ‘medical counter10 measures’, and ‘critical inputs’— 

11 ‘‘(A) have the meanings given such terms 

12 in section 3(c) of the Safe Medicine Act; and 

13 ‘‘(B) include the 227 essential medicines, 

14 medical countermeasures, and critical inputs 

15 published on October 30, 2020, by the Food 

16 and Drug Administration in accordance with 

17 Executive Order 13944.’’. 

Æ 


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