I 
116TH CONGRESS 
2D SESSION 
H. R. 6393 
To require the Secretary of Defense to submit to Congress a report on 
the reliance by the Department of Defense on imports of certain pharma-
ceutical products made in part or in whole in certain countries, to 
establish postmarket reporting requirements for pharmaceuticals, and 
for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 25, 2020 
Mr. WALTZ (for himself and Mr. MCGOVERN) introduced the following bill; 
which was referred to the Committee on Ways and Means, and in addi-
tion to the Committees on Armed Services, Oversight and Reform, and 
Energy and Commerce, 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 require the Secretary of Defense to submit to Congress 
a report on the reliance by the Department of Defense 
on imports of certain pharmaceutical products made in 
part or in whole in certain countries, to establish 
postmarket reporting requirements for pharmaceuticals, 
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 ‘‘Strengthening Amer-
ica’s Supply Chain and National Security Act’’. 
SEC. 2. REPORT ON RELIANCE BY DEPARTMENT OF DE-
FENSE 
ON 
PHARMACEUTICAL 
PRODUCTS 
FROM CERTAIN COUNTRIES. 
(a) IN GENERAL.—Not later than one year after the 
date of the enactment of this Act, the Secretary of De-
fense, in coordination with the Secretary of Health and 
Human Services, shall submit to the appropriate congres-
sional committees a classified report on the reliance by the 
Department of Defense on imports of certain pharma-
ceutical products made in part or in whole in a covered 
country. 
(b) ELEMENTS.—The report required by subsection 
(a) shall— 
(1) analyze the percent of pharmaceutical prod-
ucts used by the Department of Defense that are 
made in part or in whole in a covered country, in-
cluding— 
(A) drugs; 
(B) active ingredients; 
(C) raw pharmaceutical components; 
(D) nonprescription drugs intended for 
human use; and 
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(E) any other pharmaceutical product, or 
its components, as the Secretary considers ap-
propriate; 
(2) assess the products identified under para-
graph (1) to determine— 
(A) whether the Department of Defense 
can procure the product from other sources; 
(B) whether reliance by the Department of 
Defense on the product is likely, or has signifi-
cant potential, to be used for a military, geo-
political, or economic advantage against the 
United States; 
(C) whether reliance on the product cre-
ates a risk for the United States; and 
(D) what impact there would be if access 
to the product was terminated; 
(3) set forth recommendations to ensure that by 
2025 no pharmaceutical products purchased for 
beneficiaries of health care from the Department of 
Defense or any associated program are made in part 
or in whole in a covered country; 
(4) assess the resilience and capacity of the cur-
rent supply chain and industrial base to support na-
tional defense if no pharmaceutical products pur-
chased for beneficiaries of health care from the De-
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partment of Defense or any associated program are 
made in part or in whole in a covered country, in-
cluding 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 
(C) supply chains with single points of fail-
ure and limited resiliency; 
(5) set forth recommendations— 
(A) to diversify supply of pharmaceutical 
products away from complete dependency on 
sources of supply in countries that are competi-
tors of the United States or politically unstable 
that may cut off supply in the United States; 
(B) to address critical bottlenecks in the 
supply of pharmaceutical products in the 
United States; and 
(C) to mitigate single points of failure and 
limited resilience of supply chains for pharma-
ceutical products in the United States; and 
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(6) set forth recommendations for legislative 
and administrative action necessary to avoid, or pre-
pare for, contingencies identified in the report. 
(c) PUBLICATION
OF UNCLASSIFIED SUMMARY.— 
Concurrent with the submittal of the report required by 
subsection (a), the Secretary of Defense shall publish on 
a publicly available internet website of the Department of 
Defense an unclassified summary of the report. 
(d) DEFINITIONS.—In this section: 
(1) APPROPRIATE
CONGRESSIONAL
COMMIT-
TEES.—The term ‘‘appropriate congressional com-
mittees’’ means— 
(A) the Committee on Armed Services, the 
Select Committee on Intelligence, the Com-
mittee on Finance, the Committee on Banking, 
Housing, and Urban Affairs, and the Com-
mittee on Health, Education, Labor, and Pen-
sions of the Senate; and 
(B) the Committee on Armed Services, the 
Permanent Select Committee on Intelligence, 
the Committee on Ways and Means, the Com-
mittee on Financial Services, and the Com-
mittee on Energy and Commerce of the House 
of Representatives. 
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(2) COVERED
COUNTRY.—The term ‘‘covered 
country’’ means— 
(A) China; and 
(B) any other country as determined by 
the Secretary of Defense for national security 
purposes. 
(3) DRUG.—The term ‘‘drug’’ means a product 
subject to regulation under section 505 or section 
802 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355 or 382) or under section 351 of the 
Public Health Service Act (42 U.S.C. 262). 
(4) NONPRESCRIPTION DRUG.—The term ‘‘non-
prescription drug’’ has the meaning given that term 
in section 760(a)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379aa(a)(2)). 
SEC. 3. MODIFICATION OF RULES OF ORIGIN FOR PHARMA-
CEUTICAL PRODUCTS. 
(a) TRADE AGREEMENTS.—Section 308(4)(B) of the 
Trade Agreements Act of 1979 (19 U.S.C. 2518(4)(B)) 
is amended— 
(1) in clause (i), by striking ‘‘instrumentality, 
or’’ and inserting ‘‘instrumentality,’’; 
(2) in clause (ii)— 
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(A) by inserting ‘‘, other than an active 
pharmaceutical ingredient,’’ after ‘‘part of ma-
terials’’; and 
(B) by striking the period at the end and 
inserting ‘‘, or’’; and 
(3) by inserting before the period at the end the 
following: ‘‘(iii) in the case of an article which con-
sists of an active pharmaceutical ingredient, the 
pharmaceutical ingredient is wholly the growth, 
product, or manufacture of that country or instru-
mentality’’. 
(b) FEDERAL ACQUISITION REGULATION.—Not later 
than 180 days after the date of the enactment of this Act, 
the President shall prescribe regulations to update sec-
tions 52.225–5 and 25.003 of title 48, Code of Federal 
Regulations (or successor regulations) to be consistent 
with rules of origin determinations for active pharma-
ceutical ingredients made under section 308(4)(B) of the 
Trade Agreements Act of 1979 (19 U.S.C. 2518(4)(B)), 
as amended by subsection (a). 
SEC. 4. POSTMARKET REPORTING REQUIREMENTS FOR 
PHARMACEUTICALS. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services, acting through the Commissioner of 
Food and Drugs, shall ensure that each holder of an ap-
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proved application under section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) or under section 
351 of the Public Health Service Act (42 U.S.C. 262) an-
nually submit, as part of the postmarket annual report 
required by the Secretary under section 314.81(b)(2) of 
title 21, Code of Federal Regulations (or any successor 
regulation), the following information: 
(1) The names and addresses of the sources of 
active and inactive ingredients of the drug. 
(2) For each active and inactive ingredient of 
the drug, the percentage of the aggregate amount of 
such ingredient used in the manufacture of the drug 
during the reporting period that is from each of the 
sources identified under paragraph (1). 
(b) DISCLOSURE OF INFORMATION.—The Secretary 
of Health and Human Services shall— 
(1) annually provide the information reported in 
paragraphs (1) and (2) of subsection (a) to the Sec-
retary of Defense for purposes of understanding the 
dependency on foreign manufacturers of drugs used 
by members of the Armed Forces; and 
(2) publish the information reported under such 
paragraphs on a publicly available internet website 
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of the Federal Government in a single, aggregate 
form, without disclosing proprietary information. 
Æ 
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