MAPS Act

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4191 Introduced in House (IH)]

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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.
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