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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-
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tives of the United States of America in Congress assembled,
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SECTION 1. SHORT TITLE.
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This Act may be cited as the ‘‘Strengthening Amer-
2
ica’s Supply Chain and National Security Act’’.
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SEC. 2. REPORT ON RELIANCE BY DEPARTMENT OF DE-
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FENSE
ON
PHARMACEUTICAL
PRODUCTS
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FROM CERTAIN COUNTRIES.
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(a) IN GENERAL.—Not later than one year after the
7
date of the enactment of this Act, the Secretary of De-
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fense, in coordination with the Secretary of Health and
9
Human Services, shall submit to the appropriate congres-
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sional committees a classified report on the reliance by the
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Department of Defense on imports of certain pharma-
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ceutical products made in part or in whole in a covered
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country.
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(b) ELEMENTS.—The report required by subsection
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(a) shall—
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(1) analyze the percent of pharmaceutical prod-
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ucts used by the Department of Defense that are
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made in part or in whole in a covered country, in-
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cluding—
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(A) drugs;
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(B) active ingredients;
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(C) raw pharmaceutical components;
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(D) nonprescription drugs intended for
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human use; and
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•HR 6393 IH
(E) any other pharmaceutical product, or
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its components, as the Secretary considers ap-
2
propriate;
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(2) assess the products identified under para-
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graph (1) to determine—
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(A) whether the Department of Defense
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can procure the product from other sources;
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(B) whether reliance by the Department of
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Defense on the product is likely, or has signifi-
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cant potential, to be used for a military, geo-
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political, or economic advantage against the
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United States;
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(C) whether reliance on the product cre-
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ates a risk for the United States; and
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(D) what impact there would be if access
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to the product was terminated;
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(3) set forth recommendations to ensure that by
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2025 no pharmaceutical products purchased for
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beneficiaries of health care from the Department of
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Defense or any associated program are made in part
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or in whole in a covered country;
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(4) assess the resilience and capacity of the cur-
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rent supply chain and industrial base to support na-
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tional defense if no pharmaceutical products pur-
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chased for beneficiaries of health care from the De-
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•HR 6393 IH
partment of Defense or any associated program are
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made in part or in whole in a covered country, in-
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cluding with respect to—
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(A) the manufacturing capacity of the
4
United States;
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(B) gaps in domestic manufacturing capa-
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bilities, including non-existent, extinct, threat-
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ened, and single-point-of-failure capabilities;
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and
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(C) supply chains with single points of fail-
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ure and limited resiliency;
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(5) set forth recommendations—
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(A) to diversify supply of pharmaceutical
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products away from complete dependency on
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sources of supply in countries that are competi-
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tors of the United States or politically unstable
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that may cut off supply in the United States;
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(B) to address critical bottlenecks in the
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supply of pharmaceutical products in the
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United States; and
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(C) to mitigate single points of failure and
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limited resilience of supply chains for pharma-
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ceutical products in the United States; and
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(6) set forth recommendations for legislative
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and administrative action necessary to avoid, or pre-
2
pare for, contingencies identified in the report.
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(c) PUBLICATION
OF UNCLASSIFIED SUMMARY.—
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Concurrent with the submittal of the report required by
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subsection (a), the Secretary of Defense shall publish on
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a publicly available internet website of the Department of
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Defense an unclassified summary of the report.
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(d) DEFINITIONS.—In this section:
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(1) APPROPRIATE
CONGRESSIONAL
COMMIT-
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TEES.—The term ‘‘appropriate congressional com-
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mittees’’ means—
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(A) the Committee on Armed Services, the
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Select Committee on Intelligence, the Com-
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mittee on Finance, the Committee on Banking,
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Housing, and Urban Affairs, and the Com-
16
mittee on Health, Education, Labor, and Pen-
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sions of the Senate; and
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(B) the Committee on Armed Services, the
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Permanent Select Committee on Intelligence,
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the Committee on Ways and Means, the Com-
21
mittee on Financial Services, and the Com-
22
mittee on Energy and Commerce of the House
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of Representatives.
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•HR 6393 IH
(2) COVERED
COUNTRY.—The term ‘‘covered
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country’’ means—
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(A) China; and
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(B) any other country as determined by
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the Secretary of Defense for national security
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purposes.
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(3) DRUG.—The term ‘‘drug’’ means a product
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subject to regulation under section 505 or section
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802 of the Federal Food, Drug, and Cosmetic Act
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(21 U.S.C. 355 or 382) or under section 351 of the
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Public Health Service Act (42 U.S.C. 262).
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(4) NONPRESCRIPTION DRUG.—The term ‘‘non-
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prescription drug’’ has the meaning given that term
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in section 760(a)(2) of the Federal Food, Drug, and
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Cosmetic Act (21 U.S.C. 379aa(a)(2)).
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SEC. 3. MODIFICATION OF RULES OF ORIGIN FOR PHARMA-
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CEUTICAL PRODUCTS.
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(a) TRADE AGREEMENTS.—Section 308(4)(B) of the
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Trade Agreements Act of 1979 (19 U.S.C. 2518(4)(B))
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is amended—
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(1) in clause (i), by striking ‘‘instrumentality,
21
or’’ and inserting ‘‘instrumentality,’’;
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(2) in clause (ii)—
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•HR 6393 IH
(A) by inserting ‘‘, other than an active
1
pharmaceutical ingredient,’’ after ‘‘part of ma-
2
terials’’; and
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(B) by striking the period at the end and
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inserting ‘‘, or’’; and
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(3) by inserting before the period at the end the
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following: ‘‘(iii) in the case of an article which con-
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sists of an active pharmaceutical ingredient, the
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pharmaceutical ingredient is wholly the growth,
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product, or manufacture of that country or instru-
10
mentality’’.
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(b) FEDERAL ACQUISITION REGULATION.—Not later
12
than 180 days after the date of the enactment of this Act,
13
the President shall prescribe regulations to update sec-
14
tions 52.225–5 and 25.003 of title 48, Code of Federal
15
Regulations (or successor regulations) to be consistent
16
with rules of origin determinations for active pharma-
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ceutical ingredients made under section 308(4)(B) of the
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Trade Agreements Act of 1979 (19 U.S.C. 2518(4)(B)),
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as amended by subsection (a).
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SEC. 4. POSTMARKET REPORTING REQUIREMENTS FOR
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PHARMACEUTICALS.
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(a) IN GENERAL.—The Secretary of Health and
23
Human Services, acting through the Commissioner of
24
Food and Drugs, shall ensure that each holder of an ap-
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•HR 6393 IH
proved application under section 505 of the Federal Food,
1
Drug, and Cosmetic Act (21 U.S.C. 355) or under section
2
351 of the Public Health Service Act (42 U.S.C. 262) an-
3
nually submit, as part of the postmarket annual report
4
required by the Secretary under section 314.81(b)(2) of
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title 21, Code of Federal Regulations (or any successor
6
regulation), the following information:
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(1) The names and addresses of the sources of
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active and inactive ingredients of the drug.
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(2) For each active and inactive ingredient of
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the drug, the percentage of the aggregate amount of
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such ingredient used in the manufacture of the drug
12
during the reporting period that is from each of the
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sources identified under paragraph (1).
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(b) DISCLOSURE OF INFORMATION.—The Secretary
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of Health and Human Services shall—
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(1) annually provide the information reported in
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paragraphs (1) and (2) of subsection (a) to the Sec-
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retary of Defense for purposes of understanding the
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dependency on foreign manufacturers of drugs used
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by members of the Armed Forces; and
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(2) publish the information reported under such
22
paragraphs on a publicly available internet website
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•HR 6393 IH
of the Federal Government in a single, aggregate
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form, without disclosing proprietary information.
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Æ
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