FDA Plan B initiative criticized from all sides

An attempt by the US Food and Drug Administration to end the impasse caused by the delayed decision on over-the-counter sales for Barr Pharmaceuticals Plan B oral emergency contraceptive (levonorgestrel; Marketletters passim), has met with criticism from all quarters, both supporters and opponents of the drug's approval finding fault in the agency's announcement.

Plan B is an emergency contraceptive which is often referred to as the "morning after pill," making it - in the eyes of abortion opponents - effectively an "abortion pill." By allowing OTC status for the drug, campaigners argue that this would allow children to obtain access to it, without parental or physician supervision. Taking these arguments into account, the FDA has announced that "it is proceding to work with Duramed, a subsidiary of Barr Pharmaceuticals, to resolve the remaining policy issues," with a view to restricting OTC sales to women over 18 years. The FDA has written to the drug firm, proposing a framework for resolving outstanding issues in the Plan B application.

With the announcement timed to within 24 hours of acting FDA Commissioner Andrew von Eschenbach's appearance before a US Senate confirmation hearing, which will decide on whether he is confirmed in the position, a pro-Plan B campaigning group, the Center for Reproductive Rights, described the move as "highly suspect." Nancy Northup, the CRR's president, said: "while we hope the FDA has finally decided to stop playing politics with Plan B, we remain skeptical, especially given the new requirements the FDA is placing on Barr Pharmaceuticals in order to 'appease the administration's constituents'." In addition to the Senate hearing, a court was due in the same week to consider a subpoena application by the CRR for documents about the FDA and any intervention by the White House in the Plan B appraisal.