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-
VerDate Sep 11 2014 
03:45 Aug 13, 2021
Jkt 019200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H5003.IH
H5003
kjohnson on DSK79L0C42PROD with BILLS
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 
VerDate Sep 11 2014 
03:45 Aug 13, 2021
Jkt 019200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H5003.IH
H5003
kjohnson on DSK79L0C42PROD with BILLS
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. 
VerDate Sep 11 2014 
03:45 Aug 13, 2021
Jkt 019200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H5003.IH
H5003
kjohnson on DSK79L0C42PROD with BILLS
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; 
VerDate Sep 11 2014 
02:40 Aug 20, 2021
Jkt 019200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H5003.IH
H5003
kjohnson on DSK79L0C42PROD with BILLS
(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– 
VerDate Sep 11 2014 
03:45 Aug 13, 2021
Jkt 019200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H5003.IH
H5003
kjohnson on DSK79L0C42PROD with BILLS
19, as well as chemical, biological, radiological, 
and nuclear threats; and 
(B) of which sufficient and reliable, long- 
term domestic production of these products, 
mostly generic drugs, their active pharma-
ceutical ingredients, and key starting materials, 
is needed to minimize potential shortages by re-
ducing the Nation’s dependence on foreign 
manufacturers of these products. 
(3) 
The 
term 
‘‘medical 
countermeasure’’ 
means— 
(A) a qualified countermeasure (as defined 
in section 319F–1 of the Public Health Service 
Act (42 U.S.C. 247d–6a)); 
(B) a qualified pandemic or epidemic prod-
uct (as defined in section 319F–3 of such Act 
(42 U.S.C. 247d–6d)); 
(C) a security countermeasure (as defined 
in section 319F–2 of such Act (42 U.S.C. 
247d–6b)); or 
(D) personal protective equipment (such as 
gloves, respirators (face masks), and ventila-
tors). 
(4) The term ‘‘Public Health Industrial Base’’ 
means the facilities and associated workforces within 
VerDate Sep 11 2014 
03:45 Aug 13, 2021
Jkt 019200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H5003.IH
H5003
kjohnson on DSK79L0C42PROD with BILLS
the United States, including research and develop-
ment facilities, that help produce essential medi-
cines, medical countermeasures, and critical inputs 
for the health care and public health sector. 
SEC. 4. REQUIRING BOXED WARNINGS ON POTENTIALLY 
CONTAMINATED DRUGS. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services, acting through the Commissioner of 
Food and Drugs, shall— 
(1) issue an order deeming a drug or active 
pharmaceutical ingredient (or a category thereof) to 
be misbranded within the meaning of section 502 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 352) if such drug or active pharmaceutical 
ingredient (or category thereof)— 
(A) is manufactured in a country that the 
Secretary determines may be producing con-
taminated drugs or active pharmaceutical ingre-
dients because of systemic problems of super-
vision in the manufacture of drugs or active 
pharmaceutical ingredients; and 
(B) the labeling of such drug or active 
pharmaceutical ingredient (or category thereof) 
does not bear a boxed warning of the potential 
for contamination; 
VerDate Sep 11 2014 
03:45 Aug 13, 2021
Jkt 019200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H5003.IH
H5003
kjohnson on DSK79L0C42PROD with BILLS
(2) make each such order effective for a period 
of not more than 180 days; and 
(3) renew each such order each time the pre-
ceding order ends and the criteria listed in para-
graph (1) continue to apply. 
(b) WAIVERS.—The Secretary of Health and Human 
Services, acting through the Commissioner of Food and 
Drugs— 
(1) may waive the requirement to issue or 
renew an order under subsection (a) so long as the 
labeling of the drug or active pharmaceutical ingre-
dient (or category thereof) bears a boxed warning of 
the potential for contamination; 
(2) shall make any such waiver effective for a 
period not to exceed 180 days; and 
(3) may renew any such waiver one or more 
times. 
SEC. 5. LIMITATION ON WAIVER AUTHORITY UNDER THE 
TRADE AGREEMENTS ACT OF 1979. 
Section 301 of the Trade Agreements Act of 1979 
(19 U.S.C. 2511) is amended by adding at the end the 
following: 
‘‘(g) LIMITATION ON WAIVER AUTHORITY RELATING 
TO
ESSENTIAL
MEDICINES, 
MEDICAL
COUNTER-
MEASURES, AND CRITICAL INPUTS.— 
VerDate Sep 11 2014 
03:45 Aug 13, 2021
Jkt 019200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H5003.IH
H5003
kjohnson on DSK79L0C42PROD with BILLS
‘‘(1) IN GENERAL.—The authority of the Presi-
dent under subsection (a) to waive the application of 
any law, regulation, procedure, or practice regarding 
Government procurement does not authorize the 
waiver of any preferences for goods that are essen-
tial medicines, medical countermeasures, or critical 
inputs. 
‘‘(2) DEFINITIONS.—In this subsection, the 
terms 
‘essential 
medicines’, 
‘medical 
counter-
measures’, and ‘critical inputs’— 
‘‘(A) have the meanings given such terms 
in section 3(c) of the Safe Medicine Act; and 
‘‘(B) include the 227 essential medicines, 
medical countermeasures, and critical inputs 
published on October 30, 2020, by the Food 
and Drug Administration in accordance with 
Executive Order 13944.’’. 
Æ 
VerDate Sep 11 2014 
03:45 Aug 13, 2021
Jkt 019200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6301
E:\BILLS\H5003.IH
H5003
kjohnson on DSK79L0C42PROD with BILLS