The court battle is over, the political fight is done and Teva Pharmaceutical Industries' ($TEVA) Plan B One-Step is the designated "morning after" pill approved for over-the-counter sales regardless of age.
After a court fight that dragged on for years and political in-fighting that pitted the head of the FDA, Margaret Hamburg, against her boss, Health and Human Services Secretary Kathleen Sebelius, on Thursday the FDA approved the drug. The approval followed a court order from a federal judge who had struck down the administration's limits on making the drug available.
"Over-the-counter access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States," the FDA's Janet Woodcock said in a statement.
While there are other similar contraceptives on the market, only Teva's product is approved without restrictions and only its one-pill version was approved, the L.A. Times points out. A two-pill treatment is not included in the FDA approval, but Teva is likely to have exclusivity for only a short while. Other drugmakers are expected to seek and get approval of their products.
The issue of prescription-free availability of emergency contraceptives has been fraught with controversy. It sparked a rare public intervention from Sebelius, who overruled the FDA's 2011 decision to make emergency contraceptives widely available and limited access for girls under 17. But pressure from women's rights groups and a federal judge's order to lift the restrictions resulted in an April compromise from the FDA to allow Teva to sell Plan B One-Step to girls as young as 15. Sebelius' move drew fire--especially from U.S. district court judge Edward R. Korman, the judge in the case, who called it "obviously political" in his decision. He labeled the FDA's limits as "arbitrary, capricious and unreasonable" and ordered the agency to lift restrictions.
- here's the announcement
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