GAO Report Evaluates FDA Drug Oversight

April 24, 2006 — 

The Government Accountability Office (GAO) has issued its findings from a study conducted at the request of the Senate Committee on Finance and the House of Representatives Committee on Energy and Commerce which evaluated the Food and Drug Administration's (FDA) safety oversight of post-approval pharmaceuticals.

The GAO report (GAO-06-402 ) evaluated the structure of FDA with regards to its ability to monitor and respond to drug safety issues following initial approval and marketing. In this report GAO (1) describes FDA's organizational structure and process for postmarket drug safety decision making, (2) assesses the effectiveness of FDA's postmarket drug safety decision-making process, and (3) assesses the steps FDA is taking to improve postmarket drug safety decision making.

To improve the decision-making process for postmarket drug safety, GAO suggests that the Congress consider expanding FDA's authority to require drug sponsors to conduct postmarket studies when needed. In addition to some interagency organizational clarifications, GAO also recommends that FDA systematically track postmarket drug safety issues, revise and implement its draft policy on major postmarket safety decisions, and improve the dispute resolution process.

For this study, the GAO reviewed the FDA oversight of four human drugs which have recently experienced safety issues including Arava, Baycol, Bextra and Propulsid. No veterinary drugs were included and the potential implications of the study findings on veterinary pharmaceuticals and drug sponsors were not addressed. The FDA, however, through its Center for Veterinary Medicine (CVM) does have regulatory authority over the approval and use of veterinary pharmaceuticals.

On April 18th, FDA announced the appointment of Paul Seligman, M.D. as the first Associate Center Director for Safety Policy and Communication in the Center for Drug Evaluation and Research (CDER). In this newly created position, Dr. Seligman will provide oversight of drug safety issues and policies and manage the staff who disseminate safety information to healthcare professionals and patients through FDA's website. The creation of this position may help address some of the organizational issues discussed in the GAO report.

Source:
Government Accountability Office, GAO-06-402
FDA News, April 18, 2006