[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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