S.Amdt. 6468

1. Adds SEC. 730. PILOT PROGRAM ON ENSURING PHARMACEUTICAL SUPPLY STABILITY at the end of subtitle B of title VII

   Adds a section

   Inserted: SEC. 730. PILOT PROGRAM ON ENSURING PHARMACEUTICAL SUPPLY STABILITY.

   Inserted: (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.

   Inserted: (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--

   Inserted: (1) located in the continental United States; and

   Inserted: (2) at the greatest risk of pharmaceutical supply chain disruption, as determined by the Secretary.

   Inserted: (c) Elements.--In carrying out the pilot program under subsection (a), the Secretary of Defense shall--

   Inserted: (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);

   Inserted: (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

   Inserted: (3) ensure guaranteed access by the Department of Defense to the vendor managed inventory approach specified in paragraph (2).

   Inserted: (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.

   Inserted: (e) Initial Report.--

   Inserted: (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.

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   Inserted: (2) Elements.--The report required under paragraph (1) shall include--

   Inserted: (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);

   Inserted: (B) a plan for the implementation and management of the pilot program; and

   Inserted: (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.

   Inserted: (f) Final Report.--

   Inserted: (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.

   Inserted: (2) Elements.--The report required under paragraph (1) shall include--

   Inserted: (A) measurements of key performance indicators identified in the report required under subsection (e);

   Inserted: (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

   Inserted: (C) recommendations for expansion of the pilot program, including any legislative or

   Inserted: 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.

   Inserted: (g) Definitions.--In this section:

   Inserted: (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).

   Inserted: (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)).

   Inserted: (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.

   Original wording

   At the end of subtitle B of title VII, add the following:

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As printed