12/8/2011 8:41:48 AM
A decision by U.S. regulators to approve unrestricted over-the-counter access to Teva Pharmaceutical Industries Ltd. (TEVA)’s emergency contraceptive was overruled by the Obama administration, the first time in history for such a reversal. Secretary of Health and Human Services Kathleen Sebelius ordered Margaret Hamburg, the Food and Drug Administration chief, to reject the application by Petach Tikva, Israel-based Teva, citing potential sales to girls younger than age 17. Hamburg said she was ready yesterday to approve sales of Plan B One-Step (TEVA) without a prescription to women of all ages based on “science-based evidence.” The FDA said it was the first time HHS has overruled an agency approval.
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