FDAnews Drug Daily Bulletin

Pharma Blog Watch

Dec. 9, 2011
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The FDA’s Next Plan (Eye on the FDA Blog)
The Plan B oral contraceptive (levonorgestrel 1.5mg) has been available now for women age 17 and older. Recently, however, the FDA was considering making the drug available over the counter, easing access for the drug, blogger Mark Senak writes. In an unprecedented move, the U.S. Human & Health Secretary Kathleen Sebelius yesterday overruled the FDA and thwarted a move to ease access to the Plan B pill. “The action, if not unprecedented, is highly unusual and raises a number of questions on many fronts and from many sectors,” adding, “certainly for FDA-watchers, one of the most pressing involves assessing what impact, if any, this has on future FDA decisions?”