The Food and Drug Administration, considered to be the most trusted federal agency, is under attack for trying to do what it does bestprotect the publics health by approving therapeutics that are both safe and effective.
Unlike the generic drug scandal at the end of the 1980s, the latest attacks challenge the FDAs credibility as a regulatory agency. They include a hesitancy to take action over cardiac risks of COX-2 inhibitor pain-killers like Vioxx, Celebrex, and Bextra, and a delay in identifying possible suicide risks for teenagers taking antidepressants such as Zoloft, Paxil, and Prozac.
The pressure has led the FDA to propose a new oversight and openness group within the Office of Drug Safety, a subunit of the Office of New Drugs. Together with concerns about the 2002 renewal of the 1992 Prescription Drug User Fee Act, this combination has led some critics, most notably Iowa Senator Charles Grassley, to label the FDA as simply too cozy with drugmakers. These critics suggest that the Office of Drug Safety should be an independent body.
I strongly disagree with Senator Grassley and believe, based on more than 20 years in the pharmaceutical and biotechnology field, that the FDA is prudent in its regulatory decisions, which are based on a strategy that science and safety, not politics, drive its decisions.
That is why I believe the Office of Drug Safety, with its new Drug Safety Oversight Board, should remain within the FDA. It would be comprised of FDA officials and medical experts from other federal agencies with outside medical experts and consumer representatives serving as consultants.
Who else is better at understanding both drug safety and efficacy issues?
The new oversight board can also respond to critics who claim that the current Office of Drug Safety is unlikely to get officials who approve therapeutics to admit that they might have made a mistake in approving a product.
The proposed board, and other possible FDA reforms, will be debated at IBCs Drug Discovery Technology and Development World Congress, to be held August 811, in Boston, featuring Acting FDA Commissioner Lester Crawford.