Crawford outs FDA irregularity

Former FDA head Lester Crawford has testified that the agency's intended response to Barr's prescription-to-OTC switch application for Plan B (emergency contraception) was not to deny the switch to allow sales of the drug without a prescription to females 17 and older.

Former FDA commissioner Lester Crawford, in a sworn statement, said he had reserved the right to decide whether to loosen the sales restrictions on the prescription-only emergency contraceptive pills. His account of that unusual and perhaps unprecedented move, given in a deposition over a lawsuit against the FDA, confirmed earlier testimony given by two senior agency officials who said he'd shut them out of the decision-making process.

But Crawford said his Aug. 26, 2005, announcement that the agency was delaying its decision on Plan B wasn't a move toward denying over-the-counter sales. Instead, it was a bid for time to work out how to enforce restricting nonprescription sales to women 17 and older. Girls 16 and younger would still need a prescription. [Guardian]

Barr had suggested a "behind the counter" plan for the drug - a plan similar to that applied to cigarettes which, based on Crawford's assertion that the FDA was just trying to work out an acceptable plan, should have been acceptable to the agency. Instead they delayed any decision to work out something different since a girl under the age of 17 could possibly get access to the drug without a prescription if they accepted the behind the counter suggestion by Barr. Interestingly, it's always "possible" for someone who doesn't have a prescription for a medication to get access to and use it (even children), so this argument holds less water than a colander.

Mark McClellan is next in the queue for a deposition on the issue. In the meantime, science and common sense continue to take a back seat to religious hystrionics.

Tags: health care; contraception; reproductive rights; fundamentalism; FDA; Plan B

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