FDA's Plan B refusal continues political storm

The political fallout over the longstanding application by US drugmaker Barr Laboratories to market the Plan B oral contraceptive (levonorgestrel, Marketletters passim) for non-prescription use contines. A deposition made by former US Food and Drug Administration Commissioner Lester Crawford to the US District Court in New York, was released by the Center of Reproductive Rights (a pro-abortion campaigning organization), which claims that his evidence supports the claim that the FDA rejected non-prescription marketing of Plan B improperly and in violation of the FDA's own rules.

Dr Crawford was quoted as having supported the opening of a 60-day public consultation into Plan B approval, which started in August 2005, because, although the scientific basis for approving the drug was sound, he was faced with "many difficult and novel policy and regulatory issues," in particular the issue of how to enforce keeping the drug out of the reach of young women below the age of consent. Dr Crawford insisted in his statement, which was made during May but only made public this month that "there was no talk of denial."

In seperate news, the FDA denied a petition from more than 60 family planning and health groups appealing for the non-prescription approval to market Plan B. The decision, which was released in a letter dated June 9, was based on the agency's view that the petitioners do not have the standing to make such a request and that data supplied in support of the petition did not satisfy the statutory requirements.