The Inner Workings of the FDA Regarding Plan B (Emergency Contraceptive Pill) There will be no Plan B. Not without a prescription, anyway. Last week we got an unusual peek into the inner workings of the FDA. And what we saw isn't what you'd call "by the book." This peek was provided by a report from the Government Accountability Office (GAO), which found some eye-opening irregularities in the FDA rejection of over-the-counter (OTC) status for an emergency contraceptive pill called Plan B. Similar to RU-486 and commonly referred to as "the morning-after pill," pregnancy is generally avoided when Plan B is taken within 72 hours of unprotected sex. This drug has been available in the U.S. with a prescription since 1999. In December 2003, an FDA advisory committee voted 23 to 4 to recommend the change in availability. But according to the GAO report, two top officials at the FDA told staff members that the application would be rejected before the completion of a scientific review of the application. The report described this sort of involvement by top officials as "very, very rare," and characterized the choice to ignore both the advisory committee recommendation and the scientific review as "unprecedented." Over the past decade, the FDA has reviewed 23 applications to change a drug's availability from prescription to OTC. The FDA decided against the advisory committee's recommendation only once: in the case of Plan B. I'm not going to debate whether or not such a pill should be available OTC. I'll leave that to TV pundits and politicians to scream over. But this situation goes far beyond the pro-life vs. pro-choice issue. It exposes an extraordinary willingness on the part of FDA officials to tamper with a drug's approval process. If political pressures trump science, do friendships within the drug industry trump science? Do drug company contributions to political campaigns trump science? And, as always, it leads us back to the question of who and what the FDA is really trying to protect. Sources:
"Report Details F.D.A. Rejection of Next-Day Pill" Gardiner Harris, The New York Times, 11/15/05, nytimes.com
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