[Congressional Record Volume 170, Number 119 (Tuesday, July 23, 2024)]
[Senate]
[Page S5259]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 3001. 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 (referred to in this section as the 
     ``Secretary''), in coordination with the heads of other 
     relevant agencies, 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 related 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, as determined by the 
     Secretary with consideration given to 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, in coordination with the 
     heads of other relevant agencies, 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, 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 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).
       (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 (b), shall 
     submit a report to the relevant congressional committees 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 and the heads of other 
     relevant agencies, 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 in this 
     subsection shall be construed to relieve the Secretary from 
     its reporting obligation under subsection (c).
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