Plan B approved for over 18 OTC sale by FDA

The US Food and Drug Administration has granted over-the-counter marketing permission for New-Jersey-based drugmaker Barr Pharmaceuticals' Plan B (levonorgestrel) emergency contraceptive, for women 18 years and older. Under 18 year-olds will continue to require a prescription for the drug.

The decision comes after three years of controversy and has involved delays to the nomination of Acting FDA Commissioner Andrew von Eschenbach to his position on a permanent basis (Marketletters passim). Plan B works by preventing pregnancy when taken within 72 hours of sexual intercourse, which makes it an "abortion pill" in the eyes of opponents of the drug.

In a statement, the FDA said: "today's action concludes an extensive process that included obtaining expert advice from a joint meeting of two FDA advisory committees and providing an opportunity for public comment on issues regarding the scientific and policy questions associated with the application to switch Plan to OTC use."