https://mailchi.mp/a93cd0b56a21/the-weekly-gist-june-9-2023?e=d1e747d2d8

Published this week in Bloomberg, this article explores the Department of Defense (DOD)’s rationale for reportedly piloting a partnership with Valisure, an independent laboratory, to test the quality of the generic drugs it purchases for military members, veterans, and their families. 

The DOD’s current plan is to follow the example of Kaiser Permanente, which contracted with the same drug testing company to ensure quality standards for generic drugs that exceed Food and Drug Administration (FDA) requirements. While the FDA has discouraged the use of third-party testing programs, recent stories of toothless enforcement for troubled manufacturing facilities have weakened the agency’s credibility.

The Gist: Amid the current backdrop of drug shortages and cost concerns, this article shines a light on the lesser-known issue of quality oversight of generic drugs. This is especially important as generic medications make up around 90 percent of all prescriptions dispensed in the US. 

With generic drug production, largely a low-margin business, moving overseas, the FDA has increasingly struggled to perform oversight and quality control—though Valisure’s scientific methods have been criticized both in court and by the FDA itself. 

While Pentagon officials have labeled the vulnerabilities in our drug supply chain a threat to national security, the problems the DOD is hoping to resolve are the same ones faced by all purchasers of generic drugs in the US.