Kaiser Daily Women's Health Policy Report Summarizes Opinion Pieces Discussing Plan B Emergency Contraceptive, USA:
"A Government Accountability Office report released on Monday found many 'unusual' aspects regarding FDA's 2004 rejection of Barr Laborartories' application to allow nonprescription sales of the emergency contraceptive Plan B, including atypical involvement of senior staff and a 'novel' rationale for rejection of the application. FDA in May 2004 issued a 'not approvable' letter in response to the application, citing inadequate data on Plan B use among girls under age 16. The decision contradicted the recommendations of two FDA advisory panels, which in December 2003 voted 23-4 to recommend that Plan B be sold without a prescription. In addition, the letter was signed only by Steven Galson, then acting director of FDA's Center for Drug Evaluation and Research, and not by members of the FDA review team, as is routine. Galson later acknowledged that he made the decision to reject the application on his own and did not follow the recommendations of his staff. According to the report, high-level officials at FDA told some staff members as early as January 2004 that the agency would reject the application even though the scientific review was not completed until April 2004 (Kaiser Daily Women's Health Policy Report, 11/15)."
BB sticks his nose where it doesn't belong. Welcome to the new millennium, where some bureaucrate in Washington makes biological decisions for you so you don't have to. Because, after all, you wouldn't want to miss out on the regret of a moment's weakness (or the result of an uninvited attack).
Saturday, November 19, 2005
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11/13 - 11/20
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