In December, Department of Health and Human Services Secretary Kathleen Sebelius overruled scientists and ordered the FDA to refrain from approving “Plan B” emergency contraception for over-the-counter use. I’ve been back through what Secretary Sebelius has said about how science should inform FDA decisions, and found this in her testimony before the Senate during her confirmation hearing in 2009:
“If confirmed as Secretary, I will work to restore trust in the FDA as the leading science-based regulatory agency in the world. I will do so by working to strengthen the FDA’s ability to meet the pressing scientific and global challenges of the 21st century, and by sending a clear message from the top that the President and I expect key decisions at the FDA to be made on the basis of science – period.”
During the 2008-2009 presidential transition, UCS and many other organizations urged the incoming Obama administration to make public commitments to uphold strong scientific integrity standards. This was especially important for agencies like the FDA, which had experienced its share of political interference in science.
President Barack Obama talks with Health and Human Services Secretary Kathleen Sebelius in the Oval Office, Nov. 4, 2010. (Official White House Photo by Pete Souza)
In early January, UCS senior scientist Francesca Grifo and four emergency contraception experts brought our concerns about the Secretary’s unprecedented decision to the President’s Council of Advisors on Science and Technology. The testimony received coverage in the Washington Post.
The FDA did attempt to make the emergency contraception decision on the basis of science—period—as is required by the law that governs how FDA should approve drugs. It’s unfortunate that the Secretary stepped in to stop the agency from doing its job. That’s certainly not a clear message from the top.