The US Food and Drug Administration has delayed a decision on whether to approve an over-the-counter version of the emergency contraceptive product, Plan B, but plans to complete its review of the application in the near future, Barr Laboratories has revealed.
The company says it remains optimistic that Plan B will win the green light for OTC sale even though the proposal was knocked back in May last year, when the agency issued a surprise not approvable letter, going against the recommendations of its advisory panel [[07/05/04b]], [[17/12/03a]]. The ruling came in for much criticism and sparked allegations of political interference, with lawmakers even calling for the resignation of the agency’s acting head, Lester Crawford, saying: “The FDA’s decision to ignore its own scientific advisory board and its own staff clearly demonstrates that the leadership would rather pander to conservative interests than protect women’s health and wellbeing.”
Barr re-filed the product last summer after the FDA offered the company dual status, meaning the product could be made available as an OTC drug in the over-16s, and by prescription only for the under-16s [[23/07/04b]]. In a statement, Barr said that the FDA had hoped to complete its review by January 21, but had informed the company that it would not be able to do so.
Plan B has been available in the USA with a prescription since 1999, having been shown to reduce the risk of pregnancy by 89% if taken within 72 hours of unprotected intercourse. Emergency contraception is currently available in 101 countries, 33 of which do not require a prescription.