Noting that the Defense Logistics Agency (DLA) categorizes 27% of drugs on the US Food and Drug Administration's (FDA's) Essential Medicines List as "very high risk," a bipartisan group of senators has asked the Department of Defense (DoD) to release information on the implementation of measures to reduce risks to the military pharmaceutical supply chain.
In a March 18 letter to DoD Secretary Lloyd Austin III, a group led by Senators Elizabeth Warren (D-Mass) and Marco Rubio (R-Fla) asks the DoD to describe its progress in implementing Section 860 of the Fiscal Year 2023 National Defense Authorization Act (NDAA).
The NDAA stemmed from Warren and Rubio's Strengthening Supply Chains for Servicemembers and Security Act, which directed the DoD to develop guidelines for risk management of its pharmaceutical supply chain, report on supply chain risks, and establish a working group to develop policies for scarce-drug allocation.
Quality failures, single-source drugs, overseas plants
Reasons behind the shortages include quality failures, single-manufacturer drugs and ingredients, and the overseas location of a high proportion of drug makers supplying the US market—58% in 2022. "This exposes the drug supply chain to potential safety risks, as federal regulators have a reduced ability to conduct oversight in India, China, and other foreign countries," the senators wrote.
They cited a recent report that said, "Some generic versions of [tacrolimus, an immune suppressant given to prevent organ rejection], given to soldiers who have lost limbs in combat, might not work." Intas Pharmaceuticals, tacrolimus's Indian manufacturer, was also responsible for shortages of cancer drugs after an FDA investigation found serious deficiencies, forcing the plant to close, the letter noted.
This exposes the drug supply chain to potential safety risks, as federal regulators have a reduced ability to conduct oversight in India, China, and other foreign countries.
In addition to information on remediation actions, the senators asked the DoD to detail by April 1 all military supply chain disruptions, disclose whether it intends to release the findings of the Report on the Department of Defense Pharmaceutical Supply Chain Risks, and provide an update on the implementation of responsiveness testing of the DLA's contingency contracts for medications.