As expected, FDA was taken to the woodshed yesterday, as experts told a Congressional committee that the agency was underfunded, understaffed, overburdened, and seriously behind the times. And Commissioner Andrew von Eschenbach, contrary to usual committee practice, was forced to listen to hours of testimony before he was given his chance to speak.
Also as expected, the experts pleaded for more FDA funding. One said the agency needed double its $2 billion annual budget and a 50 percent increase in staffing, because more than 100 statutes have increased the FDA's duties since 1988, without additional money to handle them. Several congressional reps agreed that FDA needs more money. But the Government Accountability Office report that was one of the hearing's subjects pointed out that the FDA also "has opportunities to better leverage its resources." The GAO suggests that, to persuade Congress to give it more funding, the FDA should detail exactly how it would use the additional money.
Meanwhile, as part of their probe of Sanofi-Aventis' antibiotic Ketek, the same Congressional committee was preparing subpoenas for FDA officials. At the top of its list: Health and Human Services honcho Michael Leavitt, who oversees the agency. Others include two FDA investigators and one former investigator. The investigation is focused on whether Sanofi knew about "substantial data integrity problems" with a study when it was submitted to the FDA. The company has said that it acted in good faith in conducting that study; it's cooperating with the investigations.