Plan B OTC Revisted

Posted by Admin on July 31, 2006

For years the movement of the Plan B drug to over the counter status has been a controversial issue, but in 2003 the FDA made their first step towards making the change. One of their advisory panels voted 23 to 4 in favor of making the drug available over the counter; the application was, however rejected. The outcome has troubled many who believe its cause is politics: according to a report by the Government Accountability office, a non partisan Investigative Unit of Congress, there were several irregular actions taken by the FDA that were “unprecedented.”

Jennifer Brown, Vice President, Legal Director of Legal Momentum, a women’s reproductive right’s organization also argues that the cause of a delay has been politics, “With half of all pregnancies in the country unplanned you think the federal government would jump at a chance to improve contraceptive access for American women and men and instead the have delayed and delayed. The delay we believe has been one of the worst examples of the federal government pandering to the religious right.”

The FDA did not give up though; Barr, the drug’s maker, suggested that they seek approval for sale without prescription only to those sixteen and older. Barr did exactly that and since July, 2004 putting Plan B over the counter has remained in limbo. Until today that is, the FDA reversed itself earlier saying that is had reviewed about 47,000 comments from the public and an overwhelming majority supported over the counter sales.

Bruce Downey, CEO of Barr Pharmaceuticals, told us how Barr has been dealing with Plan B, “We have proposed fifteen and under as the OTC limit. Our original proposal was no age limit, but FDA came back to us and said our data from our studies included a very small number of fifteen and under teenagers.”

 Jennifer Brown hopes for the best, “I don’t think it is just window dressing, I think they will move forward for access for women eighteen and over, the great disappointment here is the FDA’s own scientist said this drug is safe and should be readily available to women without regard for their age.”

 Plan B can prevent pregnancy if taken within 72 hours of unprotected intercourse and in that time it can lower the risk of pregnancy up to 89%. Women should therefore have easy access because the sooner it’s taken the better and that translates to availability over the counter. It’s even believed that by Plan B being over the counter it could halve the nation’s 3 million unintended pregnancies.


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