The Department of Defense is designing a program to assess the safety of widely used generic drugs amid concerns over their quality, Bloomberg reported June 7.
Military officials are reportedly in talks with Valisure, an independent lab that screens generic drugs for quality and safety issues, to monitor the medications the department purchases for millions of military members and their families.
The proposed program comes amid worsening generic drug shortages in the U.S., many of which are spurred by quality issues. The White House has developed a task force to explore whether such testing could be expanded to address these quality issues. If successful, the military's pilot program could serve as a model for Medicare or the Department of Veterans Affairs, sources told Bloomberg.
The military's proposed program is similar to one Oakland, Calif.-based Kaiser Permanente launched more than two years ago. The health system uses Valisure to screen generic drugs for quality issues. In some instances, Kaiser may switch manufacturers if an issue is detected. In other circumstances, the issues may be severe enough to warrant a recall, which Kaiser can start preparing for before it's even announced, according to Sean Buhler, Kaiser's vice president of pharmacy strategic sourcing and procurement.
The testing offers "an additional assurance for our members' safety and care beyond the current testing that the FDA is mandating," Mr. Buhler told Bloomberg.
The FDA has defended the quality of drugs sold in the U.S. and pushed back against the need for additional quality checks from labs such as Valisure. The FDA contends that third-party labs don't use the same protocols as drugmakers and warned that inaccurate results could worsen drug shortages. Last December, the agency sent Valisure a letter outlining numerous methodological deficiencies involving its testing program.
"Protecting patients is the highest priority of the FDA," agency spokesperson Jeremy Kahn told Bloomberg. "The FDA continues to work to build a safe, secure and agile drug supply chain so that American patients have the medications they need — medications that have been carefully reviewed by the FDA for safety, effectiveness and quality."
Valisure has stood behind its drug testing program, with a spokesperson telling Bloomberg that its tests are faster, less expensive and still accurately detect quality issues.
Editor's note: This article was updated June 12 at 5:25 p.m. to include additional information.