FDA Under Fire For Drug Safety
A federal investigation concluded Monday that the FDA offices responsible for monitoring drug safety lacked structure and organization. The report argued for a restructuring that will give the agency greater authority to order drug companies to conduct safety studies on their post-market products. Agency officials currently lack explicit power to order drug makers to conduct safety studies on drugs post-market drugs. Lawmakers are especially concerned about the FDA’s safety monitoring practices in light of the recent safety problems with Merck’s Vioxx and Pfizer’s Celebrex. Some lawmakers are charging that there is an inherent conflict of interest in the current structure. Officials who deem a new drug safe may be disinclined to call for a safety trial after the drug has hit the market since this would seemingly contradict a previous judgment. Advocates of a restructuring want to give the FDA more power to order drug safety trials for post-market drugs. Lawmakers also want to separate marketing of new drugs from the safety monitoring of already-marketed drugs since this gives rise to a conflict of interest. Agency leaders and drug manufacturers, however, have thus far resisted such a separation. President Bush has made his bid for a new permanent commissioner of the FDA, Andrew von Eschenbach, who is the current acting Commissioner of the FDA. If he receives confirmation by the Senate, he will undoubtedly confront many challenges. “The FDA needs to make big changes,” Senator Grassley, R-Iowa, told reporters in Washington D.C.