Dr. Gottleib was the man at FDA who stood in the way of scientific reviewers who said the advisory committee properly concluded that Plan B was safe and effective for Over The Counter (OTC) Use. The reason OTC is so important for this drug is that it is most effective within 72 hours of intercourse - that usually means before Sunday night!
At FDA, Scott Gottlieb, MD, Deputy Commissioner for Medical and Scientific Affairs at the Food and Drug Administration announced today that he will leave the agency effective January 16, 2007, to return to the American Enterprise Institute, a Washington-based "think" tank, where he was previously a Resident Fellow prior to joining FDA.
Gottlieb's political connections and financial interests raised questions in his appointment from the beginning. His appointment has been compared to FEMA's appointment of Michael Brown, who also had lttle relevant experience in an important public safety job. Gottlieb, a neo-con policy wonk, had not practiced medicine, and had little scientific experience. It seemed to be another placement by Dick Cheney as a reward for activities related to the Florida recount.
Gottlieb, who has strong ties to the pharmaceutical industry, made Bush’s right-wing supporters happy when he overrode an FDA advisory panel’s 23-4 decision to make Plan B, aka the morning-after pill, available over the counter. The unusual move prompted Sue Wood, director of Women’s Health at the agency, to resign.
His determination to stop Plan B was inconsistent with his usual position that FDA reviewers are too obsessed with drug safety, at least involving companies where he holds stock:
The real problem with drug development is not the loudly proclaimed issue of drug safety but the growing shortage of newer, more effective medicines that can treat or prevent the most costly and devastating diseases. The problem, as the FDA's Dr. Scott Gottlieb notes, "Is... the development process itself is not keeping up at a fast enough pace to match the progress on the discovery end."