[Congressional Record Volume 172, Number 106 (Wednesday, June 24, 2026)]
[Senate]
[Pages S3272-S3273]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 6067. Mr. PETERS (for himself, Mr. Lankford, Mr. Kaine, Mr.
Cotton, Mr. King, and Ms. Slotkin) submitted an amendment intended to
be proposed by him to the bill S. 4784, to authorize appropriations for
fiscal year 2027 for military activities of the Department of Defense,
for military construction, and for defense activities of the Department
of Energy, to prescribe military personnel strengths for such fiscal
year, and for other purposes; which was ordered to lie on the table; as
follows:
At the appropriate place in title X, insert the following:
SEC. 10___. MAPPING AMERICA'S PHARMACEUTICAL SUPPLY.
(a) Short Title.--This section may be cited as the
``Mapping America's Pharmaceutical Supply Act'' or the ``MAPS
Act''.
(b) U.S. Pharmaceutical Supply Chains Mapping.--
(1) Pharmaceutical supply chain mapping.--The Secretary, in
coordination with the heads of other relevant Federal
departments and agencies, shall ensure coordination of
efforts of the Department of Health and Human Services,
including through public-private partnerships, as
appropriate, to--
(A) map, or otherwise visualize, the supply chains, from
manufacturing of key starting materials through manufacturing
of finished dosage forms and distribution, of drugs and
biological products, including the active ingredients of
those drugs and biological products, that are--
(i) directly related to responding to chemical, biological,
radiological, or nuclear threats and incidents covered by the
National Response Framework; or
(ii) of greatest priority for providing health care and
identified as being at high risk of shortage; and
(B) use data analytics to identify supply chain
vulnerabilities that pose a threat to national security, as
determined by the Secretary or the heads of other relevant
Federal departments and agencies.
(2) Requirements.--In carrying out paragraph (1), the
Secretary shall--
(A) describe the roles and responsibilities of agencies and
offices within the Department of Health and Human Services
related to monitoring such supply chains and assessing any
related vulnerabilities;
(B) facilitate the exchange of information between Federal
departments, agencies, and offices, as appropriate and
necessary to enable such agencies and offices to carry out
roles and responsibilities described in subparagraph (A)
related to drugs and biological products described in
paragraph (1)(A), which may include--
(i) the location of establishments registered under
subsection (b), (c), or (i) of section 510 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360) involved in the
production of drugs and biological products, including the
active ingredients of those drugs and biological products,
described in paragraph (1)(A), and to the extent available,
the amount of each such drug and biological product,
including the active ingredients of those drugs and
biological products, produced at each such establishment;
(ii) to the extent available and as appropriate, the
location of establishments so registered involved in the
production of the key starting materials and excipients
needed to produce each drug and biological product, including
the active ingredients of those drugs and biological
products, and the amount of such materials and excipients
produced at each such establishment; and
(iii) any applicable regulatory actions with respect to
each such drug and biological product, or the establishments
manufacturing such drugs and biological products, including
with respect to--
(I) inspections and related regulatory activities conducted
under section 704 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 374);
(II) seizures pursuant to section 304 of such Act (21
U.S.C. 334);
(III) any recalls issued;
(IV) drugs or biological products that are, at the time of
the determination, or that were at a previous time, included
on the drug shortage list consistent with section 506E of
such Act (21 U.S.C. 356e); and
(V) discontinuances or interruptions in the production of
such drugs or biological products under 506C of such Act (21
U.S.C. 355d).
(3) Report.--Not later than 18 months after the date of
enactment of this Act, and annually thereafter, the
Secretary, in consultation with the heads of departments and
agencies with which the Secretary coordinates under paragraph
(1), shall submit a report to the relevant committees of
Congress on--
(A) the current status of efforts to map and analyze
pharmaceutical supply chains, as described in paragraph (1);
(B) activities of the Secretary carried out under this
subsection to coordinate efforts as described in paragraph
(1), including information sharing between relevant Federal
departments, agencies, and offices;
(C) the roles and responsibilities described in paragraph
(2)(A), including the identification of any gaps, data
limitations, or areas of unnecessary duplication between such
roles and responsibilities;
(D) the extent to which Federal agencies use data analytics
to conduct predictive modeling of anticipated drug shortages
or risks associated with supply chain vulnerabilities that
pose a threat to national security;
(E) the extent to which the Secretary has engaged relevant
industry in such mapping;
(F) the drugs and biological products, including the active
ingredients of those drugs and biological products, described
in paragraph (1)(A) that rely on, for more than 50 percent of
production, a high-risk foreign supplier or foreign entity of
concern (as defined in section 9901(8) of the William M.
(Mac) Thornberry National Defense Authorization Act for
Fiscal Year 2021 (15 U.S.C. 4651(8)));
(G) the drugs and biological products, including the active
ingredients of those drugs and biological products, described
in paragraph (1)(A) that are sourced from foreign
establishments for more than 50 percent of production,
including drugs manufactured domestically from active
pharmaceutical ingredients sourced from foreign
establishments for more than 50 percent of production;
(H) the current domestic manufacturing capabilities for
drugs and biological products, including the active
ingredients of those drugs and biological products, described
in paragraph (1)(A), including the key starting materials and
excipients of such drugs, biological products, and
ingredients, and whether such capabilities utilize advanced
manufacturing technologies; and
(I) any public health or national security risks, including
cybersecurity threats and critical infrastructure
designations, with respect to the supply chains of drugs and
biological products, including the active ingredients of
those drugs and biological products, described in paragraph
(1)(A).
(c) Department of Defense Biannual Reports.--Not later than
180 days after the date of enactment of this Act, and every
180 days thereafter, the Secretary of Defense shall submit to
the relevant committees of Congress a report that lists all
drugs purchased by the Department of Defense during the 180-
day period preceding the date of the report--
(1) that contain key starting materials, excipients, or
active pharmaceutical ingredients sourced from the People's
Republic of China; or
(2) for which the finished drug product was manufactured in
the People's Republic of China.
(d) Definitions.--In this section:
(1) Advanced manufacturing.--The term ``advanced
manufacturing'' has the meaning given the term ``advanced and
continuous pharmaceutical manufacturing'' in section 3016(h)
of the 21st Century Cures Act (21 U.S.C. 399h(h)).
(2) Biological product.--The term ``biological product''
has the meaning given such term in section 351(i) of the
Public Health Service Act (42 U.S.C. 262(i)).
(3) Cybersecurity threat.--The term ``cybersecurity
threat'' has the meaning given such term in section 2200 of
the Homeland Security Act of 2002 (6 U.S.C. 650).
(4) Drug.--The term ``drug'' has the meaning given such
term in section 201(g) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(g)).
(5) Relevant committees of congress.--The term ``relevant
committees of Congress'' means--
(A) the Committee on Armed Services and the Committee on
Health, Education, Labor, and Pensions of the Senate; and
(B) the Committee on Armed Services and the Committee on
Energy and Commerce of the House of Representatives.
(6) Secretary.--The term ``Secretary'', except as otherwise
specified, means the Secretary of Health and Human Services.
(e) Additional Provisions.--
(1) Confidential commercial information.--The exchange of
information among the Secretary and the heads of other
relevant Federal departments and agencies for purposes of
carrying out subsection (b) shall not be a violation of
section 1905 of title 18, United States Code. This section
shall not be construed to affect the status, if any, of such
information as trade secret or confidential commercial
information for purposes of section 301(j) of the Federal
Food, Drug, and
[[Page S3273]]
Cosmetic Act (21 U.S.C. 331(j)), section 552 of title 5,
United States Code, or section 1905 of title 18, United
States Code.
(2) Cybersecurity measures.--The Secretary shall ensure
that robust cybersecurity measures are in place to prevent
inappropriate access to, or unauthorized disclosure of, the
information identified, exchanged, or disclosed under
subsection (b).
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