An announcement Tuesday that the U.S. Food and Drug Administration may take months to review thousands of comments on over-the-counter sales of the so-called morning-after pill “doesn’t surprise” a noted physician who resigned as an FDA consultant in August. “This [examining submissions] could go on indefinitely and really doesn’t change anything,” said Dr. Frank Davidoff, who added that the FDA’s August decision to delay approval of over-the-counter sales of the Barr Pharmaceuticals drug was not necessary. The morning-after pill, known as Plan B, is a combination of hormones that can prevent pregnancy if taken within 72 hours of unprotected sex. It is available in the United States only with a prescription. And its move to go over-the-counter has become a hot issue, with critics of the agency calling the delay politically motivated. In deciding to delay approving the sale of Plan B without a prescription on Aug 26, the FDA overruled an overwhelming majority vote by its advisory committee in December 2003. Despite agreement among advisers that the pill was safe and effective, the the agency said it didn’t have enough information on the ramifications of over-the-counter sales and sought further public comment. Apparently, its staff now has a lot of reading to do. FDA Deputy Commissioner Dr. Scott Gottlieb said Tuesday that the agency has received as many as 10,000 submissions since it requested public comment in August, according to a Reuters report. And those could take months to review, Gottlieb told attendees at a health summit in New York City. According to the Associated Press, at the end of the two-month comment period on Nov. 1, an FDA spokeswoman said the agency had recorded 2,268 comments so far. When he resigned as an FDA advisor, Davidoff, editor emeritus of the Annals of Internal Medicine, said he could only conclude the FDA’s decision was based on some issue other than science.
