[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.
                                 ______