April 24, 2006 -- FDA Urged to Monitor Postmarket Drug Safety

The federal Food and Drug Administration (FDA), which requires manufacturers of drugs to conduct tests of their safety and efficacy before the drugs are approved for sale, has no authority to require the companies to conduct investigations after the drugs are on the market. Concerned about recent reports of adverse effects from approved drugs, the Government Accountability Office (GAO) looked at four drugs with safety problems—Arava, Baycol, Bextra, and Propulsid—and found that the FDA "lacks clear and effective processes for making decisions about, and providing management oversight of, postmarket safety issues." To improve the situation, the GAO is suggesting that Congress give the FDA authority to require drug sponsors to conduct postmarket studies when needed and urges the Food and Drug Administration to step up its procedures for handling reports of drug problems. The full text of the GAO report is at www.gao.gov/new.items/d06402.pdf