[Congressional Record Volume 168, Number 162 (Tuesday, October 11, 2022)]
[Senate]
[Pages S6611-S6612]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 6468. Mr. REED (for Mr. Cassidy) submitted an amendment intended
to be proposed to amendment SA 5499 proposed by Mr. Reed (for himself
and Mr. Inhofe) to the bill H.R. 7900, to authorize appropriations for
fiscal year 2023 for military activities of the Department of Defense
and 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 B of title VII, add the following:
SEC. 730. PILOT PROGRAM ON ENSURING PHARMACEUTICAL SUPPLY
STABILITY.
(a) In General.--Not later than January 1, 2024, the
Secretary of Defense, acting through the Director of the
Defense Logistics Agency, shall establish a pilot program to
acquire, manage, and replenish a 180-day supply of not fewer
than 30 commonly used generic drugs and their active
pharmaceutical ingredients determined by the Secretary to be
at risk of shortage under the military health system as a
result of a pharmaceutical supply chain disruption to ensure
the stability of such supply, with a preference given to
manufacturers in the United States and manufacturers
leveraging innovative technological approaches, including
biotechnology.
(b) Military Medical Treatment Facilities.--The Secretary
of Defense shall select for participation in the pilot
program under subsection (a) not fewer than five military
medical treatment facilities that are--
(1) located in the continental United States; and
(2) at the greatest risk of pharmaceutical supply chain
disruption, as determined by the Secretary.
(c) Elements.--In carrying out the pilot program under
subsection (a), the Secretary of Defense shall--
(1) use the systems and processes of the direct vendor
delivery system established under section 352 of the National
Defense Authorization Act for Fiscal Year 1996 (Public Law
104-106; 10 U.S.C. 2458 note);
(2) establish a vendor managed inventory approach to
pharmaceutical distribution to acquire, manage, and replenish
the vendor-held supply, with preference given to supplies of
pharmaceuticals manufactured and sourced in the United
States, leveraging innovative technological approaches
described in subsection (a) to prevent product expiration and
shortages; and
(3) ensure guaranteed access by the Department of Defense
to the vendor managed inventory approach specified in
paragraph (2).
(d) Termination.--The pilot program under subsection (a)
shall terminate on the date that is three years after the
date of the enactment of this Act.
(e) Initial Report.--
(1) In general.--Not later than 30 days after the date of
the establishment of the pilot program under subsection (a),
the Secretary of Defense shall submit to the Committees on
Armed Services of the Senate and the House of Representatives
a report on the design of the pilot program.
(2) Elements.--The report required under paragraph (1)
shall include--
(A) an identification of the military medical treatment
facilities selected under subsection (b) and the generic
drugs, as well as their active ingredients, selected for the
pilot program pursuant to subsection (a);
(B) a plan for the implementation and management of the
pilot program; and
(C) key performance indicators to measure the success of
the pilot program in ensuring the availability of generic
drugs and active pharmaceutical ingredients selected for the
pilot program.
(f) Final Report.--
(1) In general.--Not later than 180 days after the
termination date under subsection (d), the Secretary of
Defense shall submit to the Committees on Armed Services of
the Senate and the House of Representatives a final report on
the results of the pilot program.
(2) Elements.--The report required under paragraph (1)
shall include--
(A) measurements of key performance indicators identified
in the report required under subsection (e);
(B) an analysis of the success of the pilot program under
subsection (a) in preventing shortages of commonly used
generic drugs within the military medical treatment
facilities selected under subsection (b), including the speed
and agility of drug production; and
(C) recommendations for expansion of the pilot program,
including any legislative or
[[Page S6612]]
administrative proposals the Secretary determines would
reduce supply chain risk to commonly used generic drugs and
their active pharmaceutical ingredients under the military
health system.
(g) Definitions.--In this section:
(1) Active pharmaceutical ingredient.--The term ``active
pharmaceutical ingredient'' has the meaning given such term
in section 744A of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-41).
(2) Generic drug.--The term ``generic drug'' means a drug
(as defined in section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321)) that is approved pursuant to
section 505(j) of such Act (21 U.S.C. 355(j)).
(3) Pharmaceutical supply chain disruption.--The term
``pharmaceutical supply chain disruption'' means a disruption
described in the report of the Inspector General of the
Department of Defense titled ``Evaluation of the Department
of Defense's Mitigation of Foreign Suppliers in the
Pharmaceutical Supply Chain'' (DODIG-2021-126) and published
on September 20, 2021.
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