FDA recommended to continue work on postmarket safety issues

December 18, 2009
Angie Drakulich

Angie Drakulich was editorial director of Pharmaceutical Technology.

Pharmaceutical Technology Europe

The Government Accountability Organization (GAO) has recommended the FDA Commissioner to 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 Government Accountability Organization (GAO) has recommended that the FDA 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 a report from the GAO.

The GAO has made several recommendations regarding the 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 the 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 fulfil its postmarket drug safety workload.

Overall, the GAO notes that although the 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 the OND and OSE, and providing the OSE with added responsibilities. To date, the FDA has transferred premarket review responsibility from the OND to OSE, and plans to transfer to additional postmarket responsibilities (for reviewing certain types of drug safety studies).

"The FDA is also revising its programme for resolving scientific disputes, but these changes have not increased its independence, as GAO recommended," explained a previous report.The 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.

Because of the agency's huge workload, however, it has been difficult for the 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 the GAO. In addition, the agency needs help fulfilling several committee vacancies to help in its decision-making.

www.gao.gov