Statement by Francesca Grifo, Director, UCS Scientific Integrity Program

Department of Health and Human Services (HHS) Secretary Kathleen Sebelius yesterday overruled a Food and Drug Administration (FDA) decision that the emergency contraceptive known as Plan B was safe to be sold over the counter to all females of childbearing age. Plan B contains levonorgestrel, a synthetic progestin that, when taken within 72 hours of unprotected intercourse or contraceptive failure, can effectively prevent pregnancy.

This is the first time a HHS secretary has overruled an FDA commissioner on a drug approval decision. This afternoon, the president supported the secretary’s move.

In her decision, Secretary Sebelius wrote: “Based on my review, I have concluded that the data submitted for this product do not establish that prescription dispensing requirements should be eliminated for all ages.”

The secretary’s conclusions were vastly different from drug safety experts at the FDA’s Center for Drug Evaluation and Research and Commissioner Dr. Margaret Hamburg, who believed that it “met the regulatory standard for a nonprescription drug and that Plan B One-Step should be approved for all females of child-bearing potential.”

Below is a statement from Francesca Grifo, director of the Union of Concerned Scientists’ Scientific Integrity Program:

“Secretary Sebelius, a non-scientist, overruled the conclusions of an independent scientific panel that arrived at its decision after careful analysis and consideration of the data. Plan B is considered safe for over-the-counter use not only by FDA scientists and advisors but also by countless esteemed medical associations, from the American Academy of Pediatrics to the American Medical Association.

“The secretary’s decision undermines the ability of FDA to make drug approval decisions based on the best available science. The president’s support for the secretary’s decision is unfortunate, as it is inconsistent with his own March 2009 memorandum on scientific integrity. 

“The FDA is charged with analyzing the data and making a scientific assessment of a drug’s safety and effectiveness. The agency needs to be able to do its job without fearing that the integrity of its work will be compromised. Secretary Sebelius and President Obama can certainly make a decision based on policy or even political considerations, but they should not justify that decision by claiming scientific authority. Judgment and scientific evidence are not the same thing.”

The Union of Concerned Scientists is the leading U.S. science-based nonprofit organization working for a healthy environment and a safer world. Founded in 1969, UCS is headquartered in Cambridge, Massachusetts, and also has offices in Berkeley, Chicago and Washington, D.C.