GAO Downgrades Rating of FDA’s Action Plans for Postmarket Drug Monitoring and Shortages

In its latest biennial report to Congress on high-risk government programs, the GAO downgraded its rating of the FDA’s action plans, saying CDER, CBER and CDRH’s long-term strategies lack adequate details and performance measures.

The office called on the agency to routinely analyze data it collects on postmarket safety and drug shortages, and to gather more reliable information on enforcement actions related to drug compounders.

The report found shortcomings in the FDA’s management of drug shortages.