In Overruling FDA on Plan B, Sebelius Puts Politics Before Scientific Evidence
On Wednesday, Health and Human Services Secretary Kathleen Sebelius took the unprecedented step of overruling the Food and Drug Administration鈥檚 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 (鈥淐DER鈥) conducted a scientific study.
CDER鈥檚 scientific determination 鈥 鈥 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 鈥渞eviewed and thoroughly considered the data, clinical information, and analysis provided by CDER,鈥 and agreed that 鈥.鈥
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 鈥.鈥
But sadly, that鈥檚 not what happened yesterday. Despite President Obama鈥檚 promise to put science before politics; despite CDER鈥檚 scientific study of Plan B, and despite Commissioner Hamburg鈥檚 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鈥 move to overrule the FDA鈥檚 decision is unprecedented 鈥 until Wednesday, .
Let鈥檚 hope President Obama remembers his promise to put science before politics, and overturns Secretary Sebelius鈥 decision.