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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4191 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 4191
To improve coordination of Federal efforts to identify and mitigate
health and national security risks through maintaining a list of
essential medicines, conducting a risk assessment of essential medicine
supply chains, and creating a monitoring system to map essential
medicine supply chains using data analytics.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 26, 2025
Ms. Matsui (for herself and Mr. Crenshaw) introduced the following
bill; which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To improve coordination of Federal efforts to identify and mitigate
health and national security risks through maintaining a list of
essential medicines, conducting a risk assessment of essential medicine
supply chains, and creating a monitoring system to map essential
medicine supply chains using data analytics.
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 ``Mapping America's Pharmaceutical
Supply Act'' or the ``MAPS Act''.
SEC. 2. ESSENTIAL MEDICINES LIST.
(a) 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
Act as the ``Essential Medicines List''), initially developed in
response to Executive Order 13944 (85 Fed. Reg. 49929), to include
active pharmaceutical ingredients and drugs--
(1) that are directly related to responding to chemical,
biological, radiological, or nuclear threats and incidents
covered by the National Response Framework;
(2) of greatest priority for providing health care and
identified as being at high risk of shortage; or
(3) the shortage of which would have an adverse health
outcome on patients with chronic conditions.
(b) Updates to List.--The Secretary shall review the Essential
Medicines List regularly, on a timeframe that the Secretary determines
necessary and appropriate, and not less frequently than every 2 years;
and shall update the Essential Medicines List as necessary based on the
findings of such review.
(c) Compilation of Initial List.--The Secretary shall complete the
first updates to the Essential Medicines List required pursuant to
subsection (a) not later than 180 days after the date of enactment of
this Act.
(d) Publication of List.--The Secretary shall publish the Essential
Medicines List promptly after each update pursuant to subsection (b) or
(c).
SEC. 3. ESSENTIAL MEDICINES RISK ASSESSMENT.
(a) In General.--The Secretary, 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 section 2.
(b) Contents of Essential Medicines Risk Assessment.--At a minimum,
the risk assessment under subsection (a) shall identify, to the extent
available--
(1) key starting materials and excipients used in
manufacturing the active pharmaceutical ingredients and drugs
on the Essential Medicines List;
(2) the active pharmaceutical ingredients and drugs on the
Essential Medicines List that rely on a foreign supplier for
more than 50 percent of production;
(3) the active pharmaceutical ingredients and drugs on the
Essential Medicines List that are sourced exclusively or
primarily from a single supplier, including drugs manufactured
domestically from active pharmaceutical ingredients sourced
exclusively or primarily from a single supplier;
(4) 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;
(5) 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;
(6) 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
(7) 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.).
(c) Report on Assessment.--
(1) 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 subsection (a), shall
submit a report with the findings under subsection (b) to the
relevant Committees of Congress.
SEC. 4. U.S. PHARMACEUTICAL SUPPLY CHAINS MAPPING.
(a) Pharmaceutical Supply Chain Mapping.--The Secretary of Health
and Human Services (referred to in this section as 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--
(1) 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
section 2; and
(2) use data analytics to identify supply chain
vulnerabilities that pose a threat to public health or national
security, as determined by the Secretary or the heads of other
relevant Federal departments and agencies.
(b) Requirements.--In carrying out subsection (a), the Secretary
shall--
(1) 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; and
(2) 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 paragraph (1) related
to drugs described in subsection (a)(1). Such information
should include, at a minimum--
(A) 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 subsection (a)(1), and the amount of such
ingredients and finished dosage forms produced at each
such establishment;
(B) 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
(C) 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 reports of a discontinuance
or interruption in the production of such a drug under
section 506C of such Act (21 U.S.C. 356c).
(c) 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
subsection (a), shall submit a report to the relevant committees of
Congress on--
(1) the current status of efforts to map and analyze
pharmaceutical supply chains, as described in subsection (a);
(2) activities of the Secretary carried out under this
section to coordinate efforts as described in subsection (a),
including information sharing between relevant Federal
departments, agencies, and offices;
(3) the roles and responsibilities described in subsection
(b)(1), including the identification of any gaps, data
limitations, or areas of unnecessary duplication between such
roles and responsibilities;
(4) 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
(5) the extent to which the Secretary has engaged relevant
industry in such mapping.
SEC. 5. DEFINITIONS.
In this Act:
(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.
SEC. 6. ADDITIONAL PROVISIONS.
(a) Clarification.--The participation of the Secretary in
developing and updating the list of essential medicines under section 2
shall be deemed to be full satisfaction of the requirements applicable
to such Secretary under section 3 of Executive Order 13944 (85 Fed.
Reg. 49929).
(b) 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 sections 3 and 4
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.
(c) 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 sections 3 and 4.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
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