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Hotline Posts Tagged ‘off-label’

ella’s Approval by the FDA: Regulatory Fail

Posted by John Jansen (August 19, 2010 at 4:57 pm)

ellaAlthough the FDA last week approved the drug “ella” (ulipristal acetate) for prescription use, the controversy over how it works — Is it a contraceptive, or an abortifacient, or both? — shows no signs of going away any time soon.

According to the New York Times, the members of the FDA’s advisory committee that voted to approve it were largely indifferent to this question; all they concluded, in their wisdom, is that it’s supposedly “safe and effective”.

ella’s Manufacturers: It’s Exclusively a Contraceptive

Meanwhile, ella’s manufacturers are going to great lengths to claim that it functions only as a contraceptive and not as an abortifacient. Witness David Archer, whom Slate calls an “expert” for ella’s manufacturer, HRA Pharma of Paris: [Continue reading ...]

Tags: , , , , , , , , . Posted in Abortion, Contraception, Health Care, Law and Politics | 1 Comment »