If a stay is granted, it will allow the bad-faith, politically motivated decision of Secretary Sebelius, who lacks any medical or scientific expertise, to prevail — thus justifiably undermining the public’s confidence in the drug approval process.U.S. District Judge Edward R. Korman • In a statement denying a stay of his ruling allowing the morning-after pill to be sold over the counter to people under the age of 17. Korman’s opinions on this case have been extremely harsh towards Heath and Human Services Secretary Kathleen Sebelius and the Obama administration, due to Sebelius’ 2011 decision that blocked an FDA recommendation on the matter.
[HHS Secretary Kathleen Sebelius’] action was politically motivated, scientifically unjustified, and contrary to agency precedent.Federal Judge Edward R. Korman • Denouncing, in very unambiguous terms, the decision by Health and Human Services Secretary Kathleen Sebelius to block the FDA’s decision that morning-after emergency contraception be made available over the counter, as opposed to requiring a prescription for girls age 16 or younger. Sebelius, with the vocal support of President Obama, had blocked the FDA’s proposed lifting of the rule in 2011 — Obama commented at the time: “I think it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine.” Judge Korman’s take? That the decision, in the midst of a contentious election season, was “arbitrary, capricious and unreasonable.” source
Previously, the pill required a prescription for girls aged 16 or under. In 2011, Health and Human Services secretary Kathleen Sebelius made a controversial move, blocking an FDA recommendation that the pill be available over-the-counter to anyone.
Politico reveals three members of President Obama’s cabinet who willbe retained in Term Two. No huge shockers here, although there were whispers a few months back that Holder might be resigning after the election. There’s no word as to exactly how long Holder, Sebelius and Shineski will stay on, but unlike Tim Geithner, Hilda Solis and Hillary Clinton, they won’t be leaving anytime soon.
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 [to increase access to Plan B].Fourteen Democratic Senators • In a letter to HHS Secretary Kathleen Sebelius, who last week overruled an FDA recommendation that Plan B, the emergency contraception, be available without prescription to minors. In the words of Greg Sargent, who reported the story, “it isn’t every day that 14 Senators aggressively call out their own party’s Health and Human Services Secretary.” Then again, a lot of Senate Democrats are up for re-election next year, so there is an element of realpolitik at play. source (via • follow)
» Time for Plan C: The manufacturer of the drug, Teva Women’s Health (unrelated to the sandal manufacturer), had requested FDA approval to allow unrestricted, over-the-counter sale of Plan B One-Step (currently, girls below the age of 17 must obtain a prescription before purchasing the drug). The FDA approved it, but Sebelius, citing “significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age,” ordered the FDA to revoke its approval.
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