GAO Recommends FDA Continue Its Work on Postmarket Safety Issues

December 17, 2009
Angie Drakulich

Angie Drakulich was editorial director of Pharmaceutical Technology.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The Government Accountability Office recommended that the US Food and Drug Administration Commissioner develop a comprehensive plan for transferring additional regulatory authorities from the Office of New Drugs to the Office of Surveillance and Epidemiology to address weaknesses in the agency's oversight of postmarket drug safety.

In a report released Dec. 9, 2009, the Government Accountability Office (GAO) recommended that the US Food and Drug Administration Commissioner develop a comprehensive plan for transferring additional regulatory authorities from the Office of New Drugs (OND) to the Office of Surveillance and Epidemiology (OSE) to help address weaknesses in the agency’s oversight of postmarket drug safety. The plan should include timefames and steps to ensure resources are properly aligned, says the report.

GAO has made several recommendations regarding FDA’s postmarketing work over the past few years, including a 2006 report that the agency better define the roles of the OND and OSE offices. In this new report, GAO examines what FDA is doing to improve its decision-making regarding the safety of marketed drugs, its access to data on drug safety issues, and its capacity to fulfill its postmarket drug safety workload.

Overall, GAO notes that although “FDA is beginning to address previously identified weaknesses in its oversight of postmarket drug safety issues…challenges remain.” Some positive steps include the agency’s Safety First Initiative, which involves formalizing interactions between OND and OSE and providing OSE with added responsibilities. To date, FDA has transferred premarket review responsibility from OND to OSE and plans to transfer to additional postmarket responsibilities (for reviewing certain types of drug safety studies).

“FDA is also revising its program for resolving scientific disputes, but these changes have not increased its independence, as GAO recommended” in a previous report. FDA also plans to implement new systems in 2010 to improve the timeliness, quality, and analysis of reports of adverse events associated with human drug use; to increase funding for contracts with private companies; and to continue developing the Sentinel System, a network of external data providers intended to enhance drug safety surveillance, among other efforts.

Yet, because of the agency’s huge workload, it has been difficult for OND and OSE staff to meet their responsibilities in full, says the GAO report. An increase in staff is needed (perhaps double the staff for OSE by fiscal year 2011), says GAO. In addition, the agency needs help fulfilling several committee vacancies to help in its decision-making.