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Recommend Ed Silverman - Should The FDA Be An Independent Agency? (Email)

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PHARMALOT

By Ed Silverman // December 14th, 2011 // 8:58 am

http://www.pharmalot.com/2011/12/should-the-fda-be-an-independent-agency/

The outrage and hand-wringing continues over the unprecedented decision last week by US Human & Health Services Secretary Kathleen Sebelius to overrule the FDA and thwart a move to ease access to the Plan B pill, which is also known as the morning after pill. The move has generated intense debate that the White House politicized the FDA in favor of promoting sound science.

Those who supported approval of the pill saw the move as not only dangerous, but ironic, given that President Barack Obama had made a point, earlier in his administration, of insisting that decision making must favor science, not politics. Now, though, he is being widely criticized, by some, for pandering to conservatives as he campaigns for re-election. The FDA had favored making it possible for girls who are 17 and younger to get the pill without a prescription.

Yesterday, 14 US Senators wrote Sebelius for an explanation. “We ask that you share with us your specific rationale and the scientific data you relied on for the decision to overrule the FDA recommendation. On behalf of the millions of women we represent, we want to be assured that this and future decisions affecting women’s health will be based on medical and scientific evidence” (see here).

To opponents, Plan B is problematic because the pill prevents a fertilized egg from implanting in the womb, which equate this with abortion. But supporters of greater access argue that nearly half of all pregnancies are unintended, and that preventing teenage girls from gaining easier access denies them a safe and effective way to prevent unintended pregnancies (see more here).


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