119-hr4191

[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.
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