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In Overruling FDA on Plan B, Sebelius Puts Politics Before Scientific Evidence

Andrew Beck,
Senior Staff Attorney, Reproductive Freedom Project,
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December 8, 2011

On Wednesday, Health and Human Services Secretary Kathleen Sebelius took the unprecedented step of overruling the Food and Drug Administration’s decision to allow the emergency contraceptive Plan B One-Step to be sold over-the-counter to consumers of all ages. Plan B One-Step has been approved for over-the-counter sale to people 17 and older since 2009, and when the manufacturer asked the FDA to remove the prescription-only status for those under 17, the Center for Drug Evaluation and Research (“CDER”) conducted a scientific study.

CDER’s scientific determination — based on the totality of the data and a risk/benefit assessment — was that Plan B One-Step was not only safe and effective for teenagers, but also that teenagers understood how to use it. FDA Commissioner Dr. Margaret Hamburg “reviewed and thoroughly considered the data, clinical information, and analysis provided by CDER,” and 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.”

This should have been the end of the story. And in a world in which science always trumped politics, it would have been.

In 2009, President Obama issued a memorandum stating that the “public must be able to trust the science and scientific process informing public policy decisions.”

But sadly, that’s not what happened yesterday. Despite President Obama’s promise to put science before politics; despite CDER’s scientific study of Plan B, and despite Commissioner Hamburg’s evidence-based determination that the drug is safe and effective for women of all ages, Secretary Sebelius ordered the FDA to retain the prescription-only status for those under 17. Secretary Sebelius’ move to overrule the FDA’s decision is unprecedented — until Wednesday, no HHS Secretary had ever vetoed an FDA pharmaceutical approval.

Let’s hope President Obama remembers his promise to put science before politics, and overturns Secretary Sebelius’ decision.

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