FDA performs poorly in post-market drug monitoring: GAO report

The FDA is doing a poor job of monitoring drugs after they are approved for the market, a report released by the Government Accountability Office (GAO) this week said. “FDA lacks a clear and effective process for making decisions about, and providing management oversight of postmarket drug safety issues,” the report said. “We observed that there is a lack of criteria for determining what safety actions to take and when to take them.” With eight directors of its safety office in the last 10 years, the FDA “has not effectively overseen post-market drug safety issues, and as a result, it is unclear how [the FDA] can know that important safety concerns have been addressed and resolved in a timely manner,” the report went on to say. The GAO report also said evidence of mismanagement was visible in the way the agency handled safety issues associated with the Bayer’s cholesterol-lowering drug Baycol, Pfizer’s painkiller Bextra, the rheumatoid arthritis drug Arava and the heartburn drug Propulsid—all of the drugs, except Arava, were pulled off the market—with delays due to infighting and disorganization within the FDA. The GAO report findings were released this week by Senate Finance Committee chairman Charles Grassley (R-Iowa), who, in 2004, requested the report along with House Energy and Commerce Committee chairman Joe Barton (R-Texas) following the withdrawal of Merck’s painkiller Vioxx from the market. FDA spokeswoman Susan Bro said the agency is already responding to some of the findings of the report. “The FDA welcomes the GAO report and is currently leading a comprehensive and urgent effort to transform the methods our medical and scientific staff use to manage safety issues associated with prescription medicine use in the US,” Bro told The Washington Post. “Many significant reforms have already taken shape and are leading to improvements in how we communicate drug benefit and safety information to physicians and patients.”

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