POLITICAL observations & opinions

* OPINION: Health and Human Services Secretary Kathleen Sebelius’ directive overruling the Food and Drug Administration’s decision to make emergency contraception available over the counter for all women, including girls under 17, was not only unprecedented, it was substantively without merit … yet Obama supports Sebelius

Posted by Lew Weinstein on December 9, 2011

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Kathleen Sebelius ... Obama's weak 2nd choice ... remember Tom Daschle?

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UPDATE (12/9/11) …

Sharon Camp writes on CNN Opinion (12/9/11) …

  • Health and Human Services Secretary Kathleen Sebelius’ directive overruling the Food and Drug Administration’s decision to make emergency contraception available over the counter for all women, including girls under 17, was not only unprecedented, it was substantively without merit.
  • After a thorough and months-long review of the evidence, the FDA’s Center for Drug Evaluation and Research determined that the contraceptive, Plan B One-Step, was safe and effective for teens, and that teens on their own understood what the product did — and didn’t do — and how to use it.
  • Based on these expert findings, the FDA commissioner, Margaret Hamburg, concluded that Plan B One-Step was “safe and effective and should be approved for nonprescription use for all females of childbearing potential.”
  • The FDA decision overruled by Sebelius would have made emergency contraception available, alongside condoms and pregnancy tests, on the shelves of pharmacies, grocery stores and other retailers, giving women of all ages at risk of unintended pregnancy timely access to this safe and effective backup contraceptive method.
  • And time is of the essence here: Although Plan B can help prevent pregnancy for up to three days after intercourse, it is more effective the sooner it is taken.
  • Sebelius, who is not a scientist and who offered no evidence to contradict the FDA’s conclusions, said she based her decision on her personal belief that adolescents as young as 11 might not understand how to use emergency contraception without guidance from a health care professional.

Sharon Camp is president and CEO of the Guttmacher Institute, a nonprofit organization that works to advance sexual and reproductive health.

read the entire article at … http://www.cnn.com/2011/12/09/opinion/camp-sebelius-pill/index.html?eref=rss_us&utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+rss%2Fcnn_us+%28RSS%3A+U.S.%29&utm_content=Netvibes

UPDATE (12/8/11) …

  • President Barack Obama on Thursday offered support to Department of Health and Human Services Secretary Kathleen Sebelius for her controversial decision on Plan B.
  • “When it comes to 12-year-olds or 13-year-olds, the question is can we have confidence that they would potentially use Plan B properly,” Obama said in brief remarks at the White House.
  • Sebelius on Wednesday overruled the Food and Drug Administration by refusing to allow emergency contraceptives to be sold over the counter to girls under age 17.

For more information… http://www.politico.com

LMW COMMENT … Sebelius was wrong. So is Obama.

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as reported in the NYT (12/7/11) …

  • Health and Human Services Secretary Kathleen Sebelius overruled the Food and Drug Administration’s decision Wednesday that emergency contraceptives be sold freely over the counter, including to teenagers 16 years old and younger.
  • Under the law, Ms. Sebelius has the authority to overrule the agency, but no health secretary has ever done so, according to an F.D.A. spokeswoman.
  • In a statement, the commissioner of the drug administration, Dr. Margaret A. Hamburg, wrote that all the studies and experts agreed that young women would benefit from having easy access to Plan B.
    • The agency’s scientists, she wrote, “determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted disease.”
    • ”Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider,” she wrote.
    • After reviewing the scientists’ determination, Dr. Hamburg wrote that she agreed “that there is adequate and reasonable, well-supported and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.”
  • But on Wednesday morning, Ms. Sebelius sent Dr. Hamburg a note saying that she did not agree, so the agency was rejecting the application for the change.

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LMW COMMENT … I wrote the following to the New York Times … 

I am very confident that FDA Commissioner Hamburg made an informed and proper decision, after careful review and thought. Secretary Sibelius made what seems to be a political decision. I wonder if Sibelius ever discussed this with Hamburg before overruling her. If so, kudos to Hamburg for sticking to her guns. If not, shame on Sibelius.

By the way, did Sibelius have anything to say, anything at all, during the long debate over health care. I don’t recall any contribution from her.

Sibelius, perhaps you remember, is another example of President Obama’s failure to fight for what he wanted.

Tom Daschle was supposed to be the Secretary, and wouldn’t he have added judgment and muscle to the Obama administration. But there was some past tax issue, not major and already resolved, and suddenly Daschle disappeared. My bet is that had Obama been willing to fight, Daschle would have stayed.

After Daschle was gone, Sibelius was appointed, and she has never come close to what Daschle would have been.

my comment can be found at … http://www.nytimes.com/2011/12/08/health/policy/sebelius-overrules-fda-on-freer-sale-of-emergency-contraceptives.html?comments#permid=46

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One Response to “* OPINION: Health and Human Services Secretary Kathleen Sebelius’ directive overruling the Food and Drug Administration’s decision to make emergency contraception available over the counter for all women, including girls under 17, was not only unprecedented, it was substantively without merit … yet Obama supports Sebelius”

  1. Chris said

    How can this be an issue when the National Defense Authorization Act passed 93-7? That seems like a more important news event.

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