Obama administration blocks OTC Plan-B pill

First time in history that government has overruled FDA, sparks controversy

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First time in history that government has overruled FDA, sparks controversy

In a move that has shocked women’s advocates, doctors groups and the presidents base of voters, top officials in the Obama administration have blocked plans to allow the morning after pill to be sold on store shelves.

Kathleen Sebelius, the Health and Human Services Secretary, halted the decade long push for the morning after pill out of concern that pre-teen girls could have access to the pill. The Secretary invoked her power under the Federal Food, Drug, and Cosmetic Act to overrule the FDA’s previous determination that Plan B is safe and should be available to any woman of child bearing age.

As of now the pill will remain available to adult women with a prescription.

FDA Commissioner Dr. Margaret Hamburg (left) and Heath and Human Services Secretary Kathleen Sebelius (right). The two women are publicly clashing over the availability of the morning after pill, Plan B. Photos via FDA and Wiki Commons, respectively.

“Secretary Sebelius took this action after careful review,” Obama spokesman Nick Papas said. “As the secretary has stated, Plan B will remain available to all women who need it, and the president supports the secretary’s decision.”

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Critics of the decision were quick to point out the fuzzy logic of the Health and Human Services Secretary’s announcement. The decision, according to Dr. Robert Block of the American Academy of Pediatrics, is “medically inexplicable”. He added, “I don’t think 11-year-olds go into Rite Aid and buy anything,” let alone a pill that costs nearly $50, said Dr. Cora Breuner, a professor at the University of Washington.

Dr. Margaret Hamburg, commissioner of the FDA, said the decision was “highly unusual” and in a public statement, stated:

I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, and I agree with the Center 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.

Republicans, however, were quick to praise the Obama administrations decision. Sen. Chuck Grassley, R-Iowa said, “This is the right decision based on a lack of scientific evidence that it’s safe to allow minors access to this drug, much less over-the-counter.”

Religious activist and vocal opponent of Plan B stated, “Take the politics out of it and it’s a decision that reflect the concerns that many parents in America have.”

But members of the American Society for Reproductive Medicine have a different take on the politics of the decision. “We are very disappointed that Secretary Sebelius opted to insert herself into what should be a scientific decision made by the experts at FDA,” said president Dolores J. Lamb. “The data are clear that emergency contraception can be safely used by adolescent women without requiring a prescription. Sadly, it appears that once again our leaders are putting political expediency ahead of reproductive health.”

http://abcnews.go.com/Health/wireStory/block-otc-morning-pill-sparks-outrage-15110454#.TuCpCGMk6nA

http://www.cnn.com/2011/12/07/health/hhs-morning-after-pill/?hpt=hp_bn3

 

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