I 
116TH CONGRESS 
2D SESSION 
H. R. 5982 
To direct the Secretary of Health and Human Services to study American 
dependence on Chinese pharmaceuticals and to empower the Food and 
Drug Administration to issue boxed warnings in the case of critical 
contamination. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 26, 2020 
Mr. POSEY (for himself and Mr. RYAN) introduced the following bill; which 
was referred to the Committee on Energy and Commerce 
A BILL 
To direct the Secretary of Health and Human Services to 
study American dependence on Chinese pharmaceuticals 
and to empower the Food and Drug Administration to 
issue boxed warnings in the case of critical contamina-
tion. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Safe Medicine Act’’. 
SEC. 2. FINDINGS. 
(a) FINDINGS.—Congress finds the following: 
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(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 
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 
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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 In-
dian manufacturing practices and that one Chinese 
company, Zhejaiang Huahai Pharmaceuticals had 
‘‘systemic problems of supervision’’, with the potent 
carcinogens 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) Domestic pharmaceutical facilities are in-
spected every 2 years, whereas foreign pharma-
ceutical facilities are inspected only every 9 years. 
Further, inspections of foreign facilities by the Food 
and Drug Administration have declined in the past 
2 years. In the People’s Republic of China, these in-
spections have fallen by more than 10 percent. 
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(6) 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 two 
countries in the East China Sea. National security 
experts warn that if such an incident were to take 
place between the United States and China, and 
China were to embargo medicine and pharmaceutical 
ingredients, the United States would be helpless. 
United States dependence on Chinese medicine and 
pharmaceutical ingredients poses a national security 
risk. 
(b) PURPOSES.—The purposes of this Act are— 
(1) to direct the Secretary of Health and 
Human Services to study the dependence of the 
United States on Chinese drugs; and 
(2) to authorize the Food and Drug Adminis-
tration to order a temporary boxed warning on po-
tentially contaminated drugs. 
SEC. 3. STUDY OF DEPENDENCE OF UNITED STATES ON 
CHINESE DRUGS. 
Not later than one year after the date of the enact-
ment of this Act, the Secretary of Health and Human 
Services, in consultation with the heads of other appro-
priate Federal departments and agencies, shall submit to 
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Congress a report on vulnerabilities to the United States 
medicine supply chain. Such report shall include— 
(1) an identification of any finished drugs and 
their essential components including raw materials, 
chemical components, and active ingredients nec-
essary for the manufacture of medicines whose sup-
ply is at risk of disruption due to dependence on a 
single or limited number of providing countries; 
(2) an identification of the defense and geo-
political contingencies that are sufficiently likely to 
arise that may disrupt, strain, compromise, or elimi-
nate supply chains of medicines and their essential 
components and recommendations for reasonable 
preparation for the occurrence of such contingencies; 
(3) an assessment of the resilience and capacity 
of the current supply chain and industrial base to 
support the population of the United States upon 
the occurrence of the contingencies identified pursu-
ant to paragraph (2), including with respect to— 
(A) the manufacturing capacity of the 
United States; 
(B) gaps in domestic manufacturing capa-
bilities including non-existent, extinct, threat-
ened, and single-point-of-failure capabilities; 
and 
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(C) supply chains with single points of fail-
ure and limited resiliency; 
(4) legislative, regulatory, and policy changes 
necessary to avoid, or prepare for, contingencies 
identified pursuant to paragraph (2); 
(5) recommendations to diversify supply away 
from predominant dependency on sources of supply 
in competitor countries and politically unstable coun-
tries that may cut off United States supply, and ad-
dress critical bottlenecks and mitigate single points 
of failure and limited resilience; and 
(6) an assessment of the potential impact on 
domestic drug prices if the People’s Republic of 
China were to embargo the export of drugs and 
pharmaceutical ingredients to the United States. 
SEC. 4. AUTHORIZING TEMPORARY BOXED WARNINGS ON 
POTENTIALLY CONTAMINATED DRUGS. 
The Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, may issue 
a temporary order deeming certain drugs to be mis-
branded within the meaning of section 502 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352), if— 
(1) such drugs, or the active pharmaceutical in-
gredients thereof, are manufactured in a country 
that the Secretary determines may be producing 
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contaminated drugs (or active pharmaceutical ingre-
dients) because of systemic problems of supervision 
in the manufacture of such drugs or active pharma-
ceutical ingredients; and 
(2) the labeling of such drugs does not bear a 
boxed warning of the potential for contamination. 
Æ 
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