Today marks the one-year anniversary of the Obama administration’s decision to prevent the FDA from using the best available science in evaluating the emergency contraception drug Plan B. It was a setback in the Obama administration’s pledge to restore science to its rightful place and listen to scientists “even when it is inconvenient–especially when it is inconvenient.” In the interim, evidence has been mounting that the administration’s decision has placed unnecessary barriers to access to Plan B. It’s time for the administration to allow the FDA to revisit the decision.
On December 7, 2012, Department of Health and Human Services Secretary Kathleen Sebelius made history by overruling an FDA decision to approve Plan B for over-the-counter access. The move was unprecedented: never before had an HHS secretary overruled the FDA on a drug approval decision.
The decision was widely seen as political. “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,” said UCS senior scientist Francesca Grifo at the time. “The secretary’s decision undermines the ability of FDA to make drug approval decisions based on the best available science.”
UCS subsequently helped organize several experts to provide testimony to the President’s Council of Advisors on Science and Technology regarding the decision. Several scientists also wrote a valuable perspective in the New England Journal of Medicine.
In the year since, the American Congress of Obstetricians and Gynecologists has come out in favor of over-the-counter access, and the American Academy of Pediatrics has gone so far as to recommend that doctors preemptively give Plan B prescriptions to teens to overcome the unnecessary access barriers.
The drug has been extensively studied–and the FDA has a long and sordid history of being subject to political interference when it has attempted to objectively evaluate the drug’s safety and effectiveness. The science says that Plan B is safe and effective for all women of child-bearing age. It does not increase sexual activity. It is not dangerous. A great description of how the drug works can be found in this video.
A great coalition of science and reproductive health organizations are working to tell the stories of individuals unnecessarily denied access to emergency contraception, such as this Oklahoma couple. Today, UCS and the coalition sent a letter to Secretary Sebelius urging her to allow the FDA to revisit its decision. In addition, a public petition to Secretary Sebelius with the same request has drawn many thousands of signatures.
Now that we are past the election, there’s no excuse for allowing politics to continue to trump science on Plan B.
Support from UCS members make work like this possible. Will you join us? Help UCS advance independent science for a healthy environment and a safer world.