[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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