Judge gives FDA 30 days to make Teva's Plan B available to adolescents OTC

A federal judge has told the FDA to do exactly what the agency tried to do two years ago: make the "morning after" birth control pill freely available to girls of all ages without a prescription. 

U.S. District Judge Edward Korman in Brooklyn, NY, ruled the FDA's refusal to remove age limits for the pill had been "arbitrary, capricious and unreasonable," The New York Times reported. He gave the FDA 30 days to kill the limits on Plan B One-Step manufactured by Teva Pharmaceutical Industries' ($TEVA). Currently, women 17 or older don't need a prescription to get the so-called emergency contraception pills but all women have to show a valid ID to a pharmacist to buy the drug.

The FDA in 2011 had actually decided it was time for the birth control pill to be available to prevent unwanted pregnancies and made the controversial decision to allow girls as young as 11 to obtain Plan B. That led to a very public duel between FDA Commissioner Margaret Hamburg and HHS Secretary Kathleen Sebelius, who overruled the FDA decision in a move that was largely seen as caving in to political pressure. While Hamburg said FDA scientists concluded that it would be safe and effective for adolescent females to use Plan B, Sebelius said Teva hadn't studied it in girls as young as 11. Furthermore, she said there are "significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age." It was the first time an HHS chief had publicly contravened an FDA commissioner's decision.

No one from the FDA or HHS was ready to comment Friday morning on Judge Korman's ruling or if the government would appeal his decision. 

- read the the New York Times story
- more from Reuters story

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