[Congressional Record Volume 170, Number 115 (Thursday, July 11, 2024)]
[Senate]
[Pages S4773-S4774]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 2459. Mr. PETERS (for himself, Mr. Lankford, and Mr. Braun) 
submitted an amendment intended to be proposed by him to the bill S. 
4638, to authorize appropriations for fiscal year 2025 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 H of title X, insert the following:

     SEC. 10___. FEDERAL U.S. PHARMACEUTICAL SUPPLY CHAIN MAPPING.

       (a) Short Title.--This section may be cited as the 
     ``Mapping America's Pharmaceutical Supply Act'' or the ``MAPS 
     Act''
       (b) Pharmaceutical Supply Chain Mapping.--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

[[Page S4774]]

     the production of such a drug under 506C of such Act (21 
     U.S.C. 355d).
       (c) 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 (b), shall submit a report to Congress on--
       (1) progress on implementing subsection (b), 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 (b)(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 (b)(2).
       (d) 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.
       (e) 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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