GAO Recommends Strengthening FDA's Ability to Respond to Shortages

Dec 22, 2011

The Government Accountability Office (GAO) issued a report recommending that FDA’s ability to respond to drug shortages be strengthened. The report was released in conjunction with a Senate hearing before the Committee on Health, Education, Labor, and Pensions on Dec. 15, 2011, on the subject of drug shortages. The report reviews trends in prescription drug shortages, identifies the reported causes of selected shortages, describes FDA’s response to drug shortages, and evaluates the extent to which FDA can protect public health through its response to drug shortages.

According to the report, FDA responds to drug shortages by taking actions to address the underlying causes of the shortage and to enhance availability. The report notes that when informed in advance of a potential shortage, FDA has increasingly been able to prevent shortages from occurring. But the report concludes, “FDA is constrained in its ability to protect public health from drug shortages due to its lack of authority to require manufacturers to report actual or potential shortages to the agency or the public, or to require manufacturers to take certain actions to prevent, alleviate, or resolve shortages. As a result, the agency’s approach to managing drug shortages is predominately reactive.”

The GAO recommends that Congress consider establishing a requirement for manufacturers to report any circumstances that could affect the supply of their drugs. In addition, GAO recommends that FDA enhance its ability to respond to potential shortages by developing an information system to manage data about shortages.

See related Pharm Tech article:

Taking Drugs off the Short List (blog post)