More FDA Delays Over Plan B 'Not Surprising'

Agency critic says sifting through thousands of submissions 'doesn't change anything'

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TUESDAY, Nov. 8, 2005 (HealthDay News) -- 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.

"I still feel that way today," he said Tuesday from his Connecticut home. Davidoff was the second person to publicly resign over the Plan B issue. In late August, Susan Wood, the assistant commissioner for women's health and director of the Office of Women's Health at the FDA, resigned over the agency's delay on a decision.

"I'm not an expert in the bureaucratic mechanisms of the FDA," Davidoff said, "but now that this procedure has been set into motion, it will run its course."

Davidoff said he didn't believe that the decision on whether to allow Plan B to be sold over-the-counter needed to be handled this way. "If an issue is big enough -- look at the Vioxx case -- those who run the agency certainly can make decisions," he said.

"My objection to the Plan B matter is the same now as it was four months ago -- the decision to delay the advisory committee recommendation ran contrary to the scientific evidence."

Davidoff said that when he was acting as a consultant to the FDA, he asked staff members if the agency's leadership ever overruled advisory committee recommendations when the recommendation vote was heavily on one side or the other. "They told me it was quite unusual," he said.

More information

Here is the Aug. 26 statement from the FDA that gives the reasons for delaying the decision on Plan B.

SOURCES: Frank Davidoff, M.D., editor emeritus, Annals of Internal Medicine, Wethersfield, Conn; Reuters, Associated Press

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