Thursday, December 8, 2011

Former Kansas Gov. Kathleen Sebelius tells FDA to shut up, bars Plan B from pharmacy shelves

Posted By on Thu, Dec 8, 2011 at 11:09 AM

Kathleen Sebelius didnt really make anybody happy yesterday.
  • Kathleen Sebelius didn't really make anybody happy yesterday.
During the run-up to a presidential election, President Obama and the Democrats are being forced to walk a very fine line. They have to show their base that certain progressive-leaning promises have been kept (health-care overhaul, y'all!), while simultaneously pandering to undecided voters and Republicans who don't feel attached to the GOP crop of hopefuls. File Health and Human Services Secretary and former Kansas Gov. Kathleen Sebelius' move yesterday into the latter file.

Sebelius entered the history books yesterday by overruling the Food and Drug Administration's decision to make the Plan B morning-after contraceptive available over the counter for girls younger than 17. It's the first time that HHS has slapped down the FDA on a decision like this.

From the New York Times: "Although Ms. Sebelius had the legal authority to overrule the F.D.A., no health secretary had ever publicly done so, an F.D.A. spokeswoman said. Nor had such a disagreement been the subject of such extraordinary dueling press statements. Dr. Margaret Hamburg, the F.D.A.’s commissioner, issued a lengthy statement saying it was safe to sell Plan B over the counter, while Ms. Sebelius countered that the drug’s manufacturer had failed to study whether girls as young as 11 years old could safely use Plan B."

The decision is straight out of former President George W. Bush's Plan B playbook. Bush fought to keep the drug behind the counter and only available to women 18 and older. Both the most ardent Plan B supporters and opponents who think it's nothing more than an over-the-counter abortion pill can see that this is the thinnest veneer of logic that Sebelius could find to placate social conservatives ahead of the election.

Hamburg said in a statement that studies have repeatedly shown the medication to be safe. "Based on the information submitted to the agency, [Center for Drug Evaluation and Research] 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 diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a health-care provider," she said.

"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," Hamburg added.

And former FDA assistant commissioner Dr. Susan Wood — who quit her FDA job over Bush's fight over Plan B — tells the Times, the problem with Sebelius' reasons for telling the FDA to shut up is that there are plenty of potentially harmful medications on store shelves. "Acetaminophen can be fatal, but it’s available to everyone. So why are contraceptives singled out every single time when they’re actually far safer than what’s already out there?" she told the paper.

So the rules remain the same for Plan B. Anybody 17 and older can get it from behind the counter at pharmacies. Surely the conservatives and right-to-lifers — who loathe Sebelius like none other — will line up to donate to Obama and the Democrats now.

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