Noting that the Protection Logistics Company (DLA) categorizes 27% of medicine on the US Meals and Drug Administration’s (FDA’s) Important Medicines Record as “very excessive danger,” a bipartisan group of senators has requested the Division of Protection (DoD) to launch info on the implementation of measures to scale back dangers to the army pharmaceutical provide chain.
In a March 18 letter to DoD Secretary Lloyd Austin III, a bunch led by Senators Elizabeth Warren (D-Mass) and Marco Rubio (R-Fla) asks the DoD to explain its progress in implementing Part 860 of the Fiscal Yr 2023 Nationwide Protection Authorization Act (NDAA).
The NDAA stemmed from Warren and Rubio’s Strengthening Provide Chains for Servicemembers and Safety Act, which directed the DoD to develop pointers for danger administration of its pharmaceutical provide chain, report on provide chain dangers, and set up a working group to develop insurance policies for scarce-drug allocation.
High quality failures, single-source medication, abroad crops
Causes behind the shortages embrace high quality failures, single-manufacturer medication and components, and the abroad location of a excessive proportion of drug makers supplying the US market—58% in 2022. “This exposes the drug provide chain to potential security dangers, as federal regulators have a diminished potential to conduct oversight in India, China, and different international international locations,” the senators wrote.
They cited a latest report that mentioned, “Some generic variations of [tacrolimus, an immune suppressant given to prevent organ rejection], given to troopers who’ve misplaced limbs in fight, won’t work.” Intas Prescribed drugs, tacrolimus’s Indian producer, was additionally chargeable for shortages of most cancers medication after an FDA investigation discovered critical deficiencies, forcing the plant to shut, the letter famous.
This exposes the drug provide chain to potential security dangers, as federal regulators have a diminished potential to conduct oversight in India, China, and different international international locations.
Along with info on remediation actions, the senators requested the DoD to element by April 1 all army provide chain disruptions, disclose whether or not it intends to launch the findings of the Report on the Division of Protection Pharmaceutical Provide Chain Dangers, and supply an replace on the implementation of responsiveness testing of the DLA’s contingency contracts for drugs.