[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6992 Introduced in House (IH)]
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118th CONGRESS
2d Session
H. R. 6992
To require the Secretary of Health and Human Services to establish a
list of essential medicines, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
January 12, 2024
Ms. Matsui (for herself and Mr. Bucshon) introduced the following bill;
which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To require the Secretary of Health and Human Services to establish a
list of essential medicines, and for other purposes.
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. ESSENTIAL MEDICINES LIST UPDATE.
(a) In General.--The Secretary of Health and Human Services (in
this section referred to as the ``Secretary'') shall establish and
maintain a list of essential medicines.
(b) Criteria.-- The list under subsection (a) shall consist of
drugs and active pharmaceutical ingredients that--
(1) are reasonably likely to be required to respond to a
public health emergency or to a chemical, biological,
radiological, or nuclear threat; or
(2) the shortage of which would pose a significant threat
to the United States health care system or at-risk populations.
(c) Selection.--The Secretary shall select drugs and active
pharmaceutical ingredients for inclusion on the list under subsection
(a)--
(1) based on the criteria specified in subsection (b); and
(2) from the list of essential medicines, medical
countermeasures, and critical inputs developed by the Food and
Drug Administration in response to Executive Order 13944 (85
Fed. Reg. 49929) and other relevant assessments or lists.
(d) Process.--
(1) In general.--Before finalizing the list under
subsection (a) or any update to such list, the Secretary
shall--
(A) publish a proposed list or update, as
applicable; and
(B) provide an opportunity for public comment on
the proposed list or update.
(2) Initial list.--The Secretary shall--
(A) publish the proposed initial list under
subsection (a) not later than 6 months after the date
of enactment of this Act; and
(B) publish the final initial list under subsection
(a) not later than 1 year after such date of enactment.
(3) Regular review.--The Secretary shall regularly review
the list under subsection (a) to determine whether any updates
should be made pursuant to paragraph (1).
(e) Relation to Executive Order.--The participation of the
Secretary in establishing, maintaining, and updating the list under
subsection (a) shall be deemed to be full satisfaction of the
requirements applicable to the Secretary under section 3 of Executive
Order 13944 (85 Fed. Reg. 49929).
SEC. 3. FEDERAL UNITED STATES PHARMACEUTICAL SUPPLY CHAIN MAPPING.
(a) In General.--The Secretary of Health and Human Services, 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 other national security threats. Such activities
shall include, at a minimum--
(1) defining agency roles in monitoring the pharmaceutical
supply chain and communicating supply chain vulnerabilities;
and
(2) with respect to drugs and active pharmaceutical
ingredients on the list of essential medicines under section
2(a), establishing a database that shall include--
(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--
(i) the finished dosage forms of the drugs
on such list;
(ii) the active pharmaceutical ingredients
of such drugs; or
(iii) active pharmaceutical ingredients on
such list;
(B) the amount of such finished dosage forms and
active pharmaceutical ingredients produced at each such
establishment;
(C) to the extent available--
(i) the location of establishments involved
in the production of the key starting materials
and excipients used to produce the finished
dosage forms and active pharmaceutical
ingredients referred to in subparagraph (A);
and
(ii) the amount of such materials and
excipients produced at each such establishment;
and
(D) any regulatory actions with respect to the
establishments referred to in subparagraph (A) or (C),
including with respect to--
(i) labeling requirements;
(ii) registration and listing information
required to be submitted under section 510 of
the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360);
(iii) inspections and related regulatory
activities conducted under section 704 of such
Act (21 U.S.C. 374);
(iv) the seizure of such a drug or active
pharmaceutical ingredient pursuant to section
304 of such Act (21 U.S.C. 334);
(v) any recalls of a drug or active
pharmaceutical ingredient on the list of
essential medicines under section 2(a), or a
drug containing an active pharmaceutical
ingredient on such list;
(vi) inclusion of such a drug or active
pharmaceutical ingredient on the drug shortage
list under section 506E of such Act (21 U.S.C.
356e); or
(vii) prior reports of a discontinuance or
interruption in the production of such a drug
or active pharmaceutical ingredient under 506C
of such Act (21 U.S.C. 356c).
(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;
(2) gaps in data needed for full implementation of such
subsection;
(3) how the database established pursuant to subsection (a)
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.
(c) Confidential Commercial Information.--The exchange of
information among the Secretary of Health and Human Services 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.
(d) Clarification.--The information in the database established
pursuant to subsection (a) shall not be publicly disclosed. Nothing in
this subsection shall be construed to relieve the Secretary of Health
and Human Services from the Secretary's obligation to provide
information to Congress.
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