Strengthening America's Supply Chain and National Security Act
This bill requires the Department of Defense (DOD) and the Department of Health and Human Services (HHS) to take specified actions concerning the importation of pharmaceutical products from China and any other countries selected by DOD.
DOD must submit to Congress a classified report that addresses, among other issues, the percentage of pharmaceutical products used by DOD that are made by such countries and recommendations related to the domestic manufacturing capacity and the resiliency of the supply chain for such products. An unclassified summary of this report must be published on a DOD website.
A manufacturer of a pharmaceutical product that has received market approval must annually submit to HHS specified information about the product's active and inactive pharmaceutical ingredients, including the sources of such ingredients and the percentage of the aggregate amount of such ingredients from China and other countries selected by DOD. HHS shall provide such information to DOD.
In addition, the bill revises certain statutory tests used to determine the country of origin of a pharmaceutical product. Specifically, a pharmaceutical product shall be deemed to have the same country of origin as the product's active pharmaceutical ingredient (API). (A recent court case held that a drug manufactured in the United States using an API from India is considered a U.S.-made product for procurement purposes.)
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6393 Introduced in House (IH)]
<DOC>
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
pharmaceutical 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 addition
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 Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Strengthening America's Supply Chain
and National Security Act''.
SEC. 2. REPORT ON RELIANCE BY DEPARTMENT OF DEFENSE 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 Defense, in coordination with
the Secretary of Health and Human Services, shall submit to the
appropriate congressional committees a classified report on the
reliance by the Department of Defense on imports of certain
pharmaceutical 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 products used by
the Department of Defense that are made in part or in whole in
a covered country, including--
(A) drugs;
(B) active ingredients;
(C) raw pharmaceutical components;
(D) nonprescription drugs intended for human use;
and
(E) any other pharmaceutical product, or its
components, as the Secretary considers appropriate;
(2) assess the products identified under paragraph (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 significant potential,
to be used for a military, geopolitical, or economic
advantage against the United States;
(C) whether reliance on the product creates 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 current
supply chain and industrial base to support national defense if
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,
including with respect to--
(A) the manufacturing capacity of the United
States;
(B) gaps in domestic manufacturing capabilities,
including non-existent, extinct, threatened, and
single-point-of-failure capabilities; and
(C) supply chains with single points of failure 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 competitors 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 pharmaceutical
products in the United States; and
(6) set forth recommendations for legislative and
administrative action necessary to avoid, or prepare 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 committees.--The term
``appropriate congressional committees'' means--
(A) the Committee on Armed Services, the Select
Committee on Intelligence, the Committee on Finance,
the Committee on Banking, Housing, and Urban Affairs,
and the Committee on Health, Education, Labor, and
Pensions of the Senate; and
(B) the Committee on Armed Services, the Permanent
Select Committee on Intelligence, the Committee on Ways
and Means, the Committee on Financial Services, and the
Committee on Energy and Commerce of the House of
Representatives.
(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 ``nonprescription
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 PHARMACEUTICAL 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)--
(A) by inserting ``, other than an active
pharmaceutical ingredient,'' after ``part of
materials''; 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 consists of
an active pharmaceutical ingredient, the pharmaceutical
ingredient is wholly the growth, product, or manufacture of
that country or instrumentality''.
(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 sections 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 pharmaceutical 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 approved 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) annually 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 Secretary 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 of the Federal
Government in a single, aggregate form, without disclosing
proprietary information.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Ways and Means, and in addition 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.
Referred to the Committee on Ways and Means, and in addition 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.
Referred to the Committee on Ways and Means, and in addition 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.
Referred to the Committee on Ways and Means, and in addition 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.
Referred to the Subcommittee on Trade.
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