I 
118TH CONGRESS 
1ST SESSION H. R. 5575 
To direct the Secretaries of Health and Human Services, Defense, and Vet-
erans Affairs to end American over-dependence on Chinese pharma-
ceuticals 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 sub-
sequently 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 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 Ad-
ministration to issue boxed warnings in the case of crit-
ical contamination, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Safe Medicine Act’’. 
SEC. 2. FINDINGS. 
Congress finds the following: 
(1) Following the enactment of the Drug Price 
Competition and Patent Term Restoration Act of 
1984 (Public Law 98–417), the People’s Republic of 
China was able to corner the market on generic 
drugs, pharmaceutical ingredients, and related mate-
rials through its steady supply of readily exploitable 
labor and threadbare safety regulations. Ninety per-
cent of the medications taken by individuals in the 
United States are generic, rendering them especially 
dependent on supplies originating in the People’s 
Republic of China. 
(2) The number of drugs produced outside of 
the United States doubled between 2001 and 2008. 
At present, 80 percent of the active pharmaceutical 
ingredients used in drugs taken by individuals in the 
United States come from overseas, mainly the Peo-
ple’s Republic of China and the Republic of India. 
The United States no longer produces penicillin, 
with the last fermentation plant phasing out of pro-
duction in 2004. 
(3) In 2008, the counterfeiting of Heparin pre-
cursor chemicals by a Chinese-based pharmaceutical 
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plant led to the deaths of 81 individuals in the 
United States, with 785 more being severely injured. 
The counterfeit product cost one-hundredth of the 
price of the real product, indicating a clear economic 
motive for distributing contaminated materials. 
(4) In 2018, the Secretary of Health and 
Human Services, acting through the Commissioner 
of Food and Drugs, issued recalls of Valsartan, 
Losartan, and Irbesartan, common blood pressure 
drugs. The Secretary of Health and Human Serv-
ices, acting through the Commissioner of Food and 
Drugs, determined that versions of such drugs have 
been contaminated as a result of Chinese and Indian 
manufacturing practices and that one Chinese com-
pany, Zhejaiang Huahai Pharmaceuticals, had ‘‘sys-
temic problems of supervision’’, with the potent car-
cinogens N-Nitroso-N-methyl-4-aminobutyric acid 
(NMBA), N-Nitrosodimethylamine (NDMA), and N- 
Nitrosodiethylamine (NDEA), for a period of 4 
years before being detected. 
(5) During an October 30, 2020, hearing before 
the Health Subcommittee of the Energy and Com-
merce Committee of the House of Representatives, it 
was discovered that the Food and Drug Administra-
tion (FDA) has data on active pharmaceutical ingre-
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dient facilities and locations because they regulate 
and inspect them. But the FDA does not know how 
much volume is produced at these facilities. A single 
plant could make 90 percent of global supply or 10 
percent, but the FDA does not know. 
(6) The FDA cannot determine the United 
States dependence because it does not thoroughly 
regulate or inspect the facilities where the key 
chemicals and raw materials to make active pharma-
ceutical ingredients are made. 
(7) Domestic pharmaceutical facilities undergo 
far more rigorous inspections than manufacturing 
facilities in the People’s Republic of China. Since 
early 2020, the FDA recalled its inspectors from 
China and elsewhere to protect them from the 
Coronavirus. As a result, FDA inspections have 
plummeted to near zero for the past year. 
(8) In 2010, the People’s Republic of China 
embargoed the shipment of rare earth metals to 
Japan as political leverage in its negotiations over a 
boating incident that took place between the 2 coun-
tries in the East China Sea. National security ex-
perts warn that if such an incident were to take 
place between the United States and China, and 
China were to embargo medicine and pharmaceutical 
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ingredients, the United States would be helpless. 
Sun Yu and Demetri Sevastopulo, ‘‘China Targets 
Rare Earth Export Curbs To Hobble US Defense 
Industry.’’ Ars Technica, February 16, 2021, 
arstechnica.com/tech-policy/2021/02/china-targets- 
rare-earth-export-curbs-to-hobble-us-defense-indus-
try/. United States dependence on Chinese medicine 
and pharmaceutical ingredients poses a national se-
curity risk. 
(9) The United States is dependent on other 
nations, particularly China, for our generic medicine 
and key ingredients that are used to make these 
drugs. Inspections at Chinese facilities are inad-
equate compared to inspections at facilities located 
in the United States. 
(10) The United States cannot rely on ques-
tionable inspections at facilities located in China. 
(11) To protect Americans, we must encourage 
the development of essential generic drug manufac-
turing here in the United States and countries allied 
with the United States in a current defense effort 
for the 227 essential medicines and medical counter-
measures identified by the FDA in accordance with 
Executive Order 13944, issued on August 6, 2020. 
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SEC. 3. DOMESTIC MANUFACTURING TO END OVER-DE-
PENDENCE OF THE UNITED STATES ON CHI-
NESE DRUGS. 
(a) IN GENERAL.—The Secretaries of Health and 
Human Services, Defense, and Veterans Affairs, acting 
jointly and in consultation with the Commissioner of Food 
and Drugs, shall— 
(1) not later than 180 days after the date of 
enactment of this Act, develop a procurement strat-
egy, including for long-term contracts, to strengthen 
and mobilize the Public Health Industrial Base to 
increase the manufacture in the United States of es-
sential medicines, medical countermeasures, and 
critical inputs, including the 227 essential medicines, 
medical countermeasures, and critical inputs pub-
lished on October 30, 2020, by the Food and Drug 
Administration in accordance with Executive Order 
13944; and 
(2) beginning as soon as feasible after the de-
velopment of such strategy, and not later than 5 
years after the development of such strategy, imple-
ment such strategy. 
(b) CONTENTS.—The strategy under subsection (a) 
shall— 
(1) be consistent with all applicable Federal 
law; 
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(2) identify essential components, including key 
starting materials, active ingredients, and critical in-
puts, necessary for manufacturing the essential 
medicines and medical countermeasures published on 
October 30, 2020, by the Food and Drug Adminis-
tration in accordance with Executive Order 13944; 
and 
(3) address the capacity of the supply chain 
and industrial base to strengthen and mobilize the 
Public Health Industrial Base to increase the manu-
facture in the United States of essential medicines, 
medical countermeasures, and critical inputs. 
(c) DEFINITIONS.—In this section: 
(1) The term ‘‘critical inputs’’ means active 
pharmaceutical ingredients, active pharmaceutical 
ingredient starting material, and other ingredients of 
drugs and components of medical devices that the 
Commissioner of Food and Drugs determines to be 
critical in assessing the safety and effectiveness of 
essential medicines and medical countermeasures. 
(2) The term ‘‘essential medicine’’ means medi-
cine— 
(A) that is needed to protect the American 
public at all times, including from outbreaks of 
emerging infectious diseases, such as COVID– 
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