[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4449 Introduced in House (IH)]
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118th CONGRESS
1st Session
H. R. 4449
To establish the Commission on Strengthening the Domestic
Pharmaceutical Supply Chain, and for other purposes.
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IN THE HOUSE OF REPRESENTATIVES
June 30, 2023
Mr. Torres of New York introduced the following bill; which was
referred to the Committee on Energy and Commerce
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A BILL
To establish the Commission on Strengthening the Domestic
Pharmaceutical Supply Chain, 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 ``Pharmaceutical Security Production
Act''.
SEC. 2. COMMISSION ON STRENGTHENING THE DOMESTIC PHARMACEUTICAL SUPPLY
CHAIN.
(a) Establishment.--There is established a commission to be known
as the ``Commission on Strengthening the Domestic Pharmaceutical Supply
Chain'' (in this section referred to as the ``Commission'') to assess
the current security and vulnerabilities of the United States
pharmaceutical supply chain.
(b) Duties.--The duties of the Commission are the following:
(1) Determine concrete timelines and metrics for success
for the Pharmaceutical Manufacturing in America program of the
Biomedical Advanced Research and Development Authority to
produce advanced pharmaceutical ingredients for medicines
included in the essential medicines list.
(2) Evaluate and identify vulnerabilities in the existing
United States pharmaceutical supply chain that could be
exploited by foreign adversaries and nonstate actors.
(3) Review and propose solutions to strengthen the domestic
pharmaceutical manufacturing workforce to support increased
production of advanced pharmaceutical ingredients and finished
drugs.
(4) Assess how Federal health care programs (as defined in
section 1128B(f) of the Social Security Act (42 U.S.C. 1320a-
7b(f))), the program established under chapter 89 of title 5,
United States Code, and provider facilities can be used to
create a viable financial market for domestically made advanced
pharmaceutical ingredients and finished drug products.
(5) Review the successes and failures of Operation Warp
Speed and determine if any best practices for public-private
partnerships can be used to bolster domestic manufacturing of
advanced pharmaceutical ingredients and finished drug products.
(6) Estimate the Federal funding necessary to catalyze and
strengthen domestic pharmaceutical manufacturing.
(7) Identify facilities throughout the United States that
can be repurposed to produce advanced pharmaceutical
ingredients, especially advanced pharmaceutical ingredients
listed on the essential medicines list.
(8) Identify partner countries where advanced
pharmaceutical ingredients and finished drug products could be
manufactured to reduce dependence on China and other countries.
(9) Provide recommendations on legislative and regulatory
actions that can be taken to address vulnerabilities in the
United States pharmaceutical supply chain and increase the
number of manufacturers of advanced pharmaceutical ingredients
and finished drug products in the United States.
(10) Identify and propose steps that can be taken to
increase coordination among different Federal and State
programs to increase manufacturing of domestic advanced
pharmaceutical ingredients and finished drug products.
(c) Membership.--
(1) In general.--The Commission shall be composed of at
least 6 but not more than 11 members as follows:
(A) The National Security Advisor, who shall serve
as co-chair.
(B) The White House Domestic Policy Council, who
shall serve as co-chair.
(C) The Secretary of Health and Human Services.
(D) The Secretary of Defense.
(E) The Secretary of State.
(F) The Secretary of Commerce.
(G) Not more than 5 members as may be appointed by
joint action of the co-chairs of the Commission, from
among the employees and officers of appropriate Federal
departments and agencies.
(2) Terms.--Each member shall be appointed for the life of
the Commission.
(3) Quorum.--A majority of the Commission shall constitute
a quorum but a lesser number may hold hearings.
(d) Powers of Commission.--The Commission may, for the purpose of
carrying out this Act, hold hearings, sit and act at times and places,
take testimony, and receive evidence as the Commission considers
appropriate.
(e) Reports.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, and annually thereafter until the date
of the termination of the Commission under subsection (f), the
Commission shall submit to Congress a report detailing the
findings, conclusions, and recommendations of the Commission in
fulfilling its duties under subsection (b).
(2) Form of reports.--The reports described in paragraph
(1) shall be submitted in unclassified form but may include a
classified annex.
(f) Termination.--The Commission shall terminate on the date that
is 4 years after the date of enactment of this Act.
(g) Essential Medicines List Defined.--In this section, the term
``essential medicines list'' means the list of the Food and Drug
Administration described in section 3(c) of Executive Order 13944.
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