[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2364 Introduced in Senate (IS)]

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118th CONGRESS
  1st Session
                                S. 2364

   To map the United States pharmaceutical supply chain and use data 
 analytics to identify supply chain vulnerabilities and other national 
                           security threats.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 18, 2023

 Mr. Peters (for himself, Mr. Lankford, and Mr. Braun) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To map the United States pharmaceutical supply chain and use data 
 analytics to identify supply chain vulnerabilities and other national 
                           security threats.

    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. FEDERAL U.S. PHARMACEUTICAL SUPPLY CHAIN MAPPING.

    (a) In General.--The Secretary of Health and Human Services, in 
coordination with the heads of other relevant agencies, including the 
Secretary of Defense and the Secretary of Homeland Security, shall 
support efforts, including through public-private partnerships, to map 
the entire United States pharmaceutical supply chain, from inception to 
distribution, and use data analytics to identify supply chain 
vulnerabilities and other national security threats. Such activities 
shall include, at minimum--
            (1) defining agency roles in monitoring the pharmaceutical 
        supply chain and communicating supply chain vulnerabilities;
            (2) establishing a database of drugs selected from the 
        essential medicines list developed by the Food and Drug 
        Administration in response to Executive Order 13944 (85 Fed. 
        Reg. 49929) and any other relevant assessments or lists, as 
        appropriate, to identify, in coordination with the private 
        sector, a list of essential medicines, to be updated regularly 
        and published on a timeframe that the Secretary of Health and 
        Human Services, in coordination with the Secretary of Defense 
        and the Secretary of Homeland Security, determines appropriate, 
        which shall include the drugs and the active pharmaceutical 
        ingredients of such drugs that--
                    (A) are reasonably likely to be required to respond 
                to a public health emergency or to a chemical, 
                biological, radiological, or nuclear threat; or
                    (B) the shortage of which would pose a significant 
                threat to the United States health care system or at-
                risk populations; and
            (3) with respect to drugs selected for inclusion in the 
        database pursuant to paragraph (2), identifying--
                    (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, and the amount 
                of such ingredients and finished dosage forms produced 
                at each such establishment;
                    (B) to the extent available, 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 the 
                establishments manufacturing such drugs, including with 
                respect to labeling requirements, registration and 
                listing information required to be submitted under 
                section 510 of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 360), 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).
    (b) Report.--Not later than 18 months after the date of enactment 
of this Act, and annually thereafter, the Secretary of Health and Human 
Services, in consultation with the heads of agencies with which such 
Secretary coordinates under subsection (a), shall submit a report to 
Congress on--
            (1) progress on implementing subsection (a), including any 
        timelines for full implementation, if any;
            (2) gaps in data needed for full implementation of such 
        subsection;
            (3) how the database established under subsection (a)(2) 
        increases Federal visibility into the pharmaceutical supply 
        chain;
            (4) how Federal agencies are able to use data analytics to 
        conduct predictive modeling of anticipated drug shortages or 
        national security threats; and
            (5) the extent to which industry has cooperated in mapping 
        the pharmaceutical supply chain and building the database 
        described in subsection (a)(2).
    (c) Confidential Commercial Information.--The exchange of 
information among the Secretary of Health and Human Services and the 
heads of other relevant agencies, including the Secretary of Defense 
and the Secretary of Homeland Security, for purposes of carrying out 
this section shall not be a violation of section 1905 of title 18, 
United States Code.
    (d) Clarification.--The database established under this section 
shall not be publicly disclosed. Nothing this subsection shall be 
construed to relieve the Secretary of Health and Human Services from 
its obligation to provide information to Congress.
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