[Congressional Record Volume 171, Number 126 (Wednesday, July 23, 2025)]
[Senate]
[Pages S4676-S4677]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 2987. Mr. PETERS (for himself, Mr. Lankford, Ms. Ernst, Mr.
Cotton, Mr. Kaine, Mr. King, and Mr. Scott of Florida) submitted an
amendment intended to be proposed by him to the bill S. 2296, to
authorize appropriations for fiscal year 2026 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 end of subtitle F of title X, insert the following:
SEC. 1067. 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) Essential Medicines List.--
(1) In general.--The Secretary, in coordination with the
heads of other relevant Federal departments and agencies and
in consultation with, as appropriate, stakeholders who have
relevant expertise, shall update and maintain a list of
essential medicines (referred to in this section as the
``Essential Medicines List''), initially developed in
response to Executive Order 13944 (85 Fed. Reg. 49929), to
include active pharmaceutical ingredients and drugs--
(A) that are directly related to responding to chemical,
biological, radiological, or nuclear threats and incidents
covered by the National Response Framework;
(B) of greatest priority for providing health care and
identified as being at high risk of shortage;
(C) the shortage of which would have an adverse health
outcome on patients with chronic conditions; or
(D) that the Secretary of Defense determines to be critical
for military preparedness.
(2) Updates to list.--The Secretary shall update the
Essential Medicines List regularly, on a timeframe that the
Secretary determines necessary and appropriate, and not less
frequently than every 2 years.
(3) Compilation of initial list.--The Secretary shall
complete the first updates to the Essential Medicines List
required pursuant to paragraph (1) not later than 180 days
after the date of enactment of this Act.
(4) Publication of list.--The Secretary shall publish the
Essential Medicines List promptly after each update pursuant
to paragraph (2) or (3).
(c) Essential Medicines Risk Assessment.--
(1) In general.--The Secretary, in coordination with the
Secretary of Defense and in consultation with the heads of
other relevant departments and agencies, shall conduct a
comprehensive risk assessment of the supply chains for active
pharmaceutical ingredients and drugs included on the
Essential Medicines List described in subsection (b).
(2) Contents of essential medicines risk assessment.--At a
minimum, the risk assessment under paragraph (1) shall
identify, to the extent available--
(A) key starting materials and excipients used in
manufacturing the active pharmaceutical ingredients and drugs
on the Essential Medicines List;
(B) the active pharmaceutical ingredients and drugs on the
Essential Medicines List that rely on a high-risk foreign
supplier or foreign entity of concern (as defined in section
9901(8) of the William M. (Mac) Thornberry National
Authorization Act for Fiscal Year 2021 (15 U.S.C. 4651(8)))
for more than 50 percent of production;
(C) the active pharmaceutical ingredients and drugs on the
Essential Medicines List that are sourced exclusively or
primarily from foreign establishments, including drugs
manufactured domestically from active pharmaceutical
ingredients sourced exclusively or primarily from foreign
establishments;
(D) current domestic manufacturing capabilities for active
pharmaceutical ingredients and drugs on the Essential
Medicines List, including the key starting materials and
excipients of such ingredients and drugs, and any cost-
effective manufacturing technologies, including advanced
manufacturing;
(E) public health and national security risks, including
cybersecurity threats and critical infrastructure
designations specific to the supply chains of active
pharmaceutical ingredients and drugs included on the
Essential Medicines List;
(F) any deficiencies, lack of authorities, or limitations
in policy or process that reduce the ability of the Federal
Government to address any identified public health or
national security risks related to supply chains for active
pharmaceutical ingredients and drugs included on the
Essential Medicines List; and
(G) how the Federal Government will mitigate such national
security risks, including through the use of authorities
under the Defense Production Act of 1950 (50 U.S.C. 4501 et
seq.).
(3) Report on assessment.--
(A) Submission of report.--Not later than 180 days after
the date of enactment of this Act, and annually thereafter,
the Secretary, in consultation with the heads of relevant
Federal departments and agencies consulted under paragraph
(1), shall submit a report with the findings under paragraph
(2) to--
(i) the Committee on Armed Services, the Committee on
Health, Education, Labor, and Pensions, and the Committee on
Homeland Security and Governmental Affairs of the Senate;
(ii) the Committee on Armed Services, the Committee on
Energy and Commerce, and the Committee on Homeland Security
of the House of Representatives; and
(iii) the Office of the Director of National Intelligence.
(B) Publication of report.--Not later than 1 year after the
date of enactment of this Act, the Secretary, in consultation
with the heads of relevant Federal departments and agencies
consulted under paragraph (1), shall release a public version
of the report submitted under subparagraph (A).
(d) 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, 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 (as
defined in section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321)) included on the Essential
Medicines List under subsection (b); 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 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 active pharmaceutical ingredients and finished
dosage forms of drugs described in paragraph (1)(A), and the
amount of such ingredients and finished dosage forms 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 the active pharmaceutical ingredients and
finished dosage forms, and the amount of such materials and
excipients produced at each such establishment; and
[[Page S4677]]
(iii) any regulatory actions with respect to such drugs or
the establishments manufacturing such drugs, including with
respect to inspections and related regulatory activities
conducted under section 704 of such Act (21 U.S.C. 374), the
seizure of such a drug pursuant to section 304 of such Act
(21 U.S.C. 334), any recalls of such a drug; inclusion of
such a drug on the drug shortage list under section 506E of
such Act (21 U.S.C. 356e), or prior drug shortages reports of
a discontinuance or interruption in the production of such a
drug 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 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; and
(E) the extent to which the Secretary has engaged relevant
industry in such mapping.
(e) 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 congressional committees described in clauses (i) and
(ii) of subsection (c)(3)(A) 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.
(f) 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) 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).
(3) 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)).
(4) Secretary.--The term ``Secretary'', except as otherwise
specified, means the Secretary of Health and Human Services.
(g) Additional Provisions.--
(1) Clarification.--The participation of the Secretary in
developing and updating the list of essential medicines under
subsection (b) shall be deemed to be full satisfaction of the
requirements applicable to such secretary under subsection
(c) of Executive Order 13944 (85 Fed. Reg. 49929).
(2) 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 subsections (c) and (d) 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 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.
(3) 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
subsections (c) and (d).
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