Mara Gandal-Powers, Fellow

Today, despite all evidence showing that Plan B One-Step should be available over-the-counter to all women no matter their age, the Secretary of HHS, Kathleen Sebelius, told the FDA that it could not make Plan B One-Step available without a prescription for women under 17. This isn’t just speculation about what happened behind closed doors – this is straight from the horse’s mouth in the form of a letter from Secretary Sebelius to FDA Commissioner Margaret Hamburg, M.D. Determinations of drug safety should be left to scientists, not political appointees. President Obama has said this himself – and ironically the White House Office of Science and Technology Policy is currently working to implement a policy to ensure the integrity of scientific work across the government. And so, it appears that these principles don’t apply when the women’s health is at issue.

Secretary Sebelius’ letter says she decided to intervene because there isn’t not enough research showing that girls of the youngest reproductive age, those as young as 11, could understand when the medication is needed and how to use it. But according to an article in The Washington Post earlier this week, Plan B One-Step’s manufacturer provided the FDA two studies as part of its petition to remove the age restriction. One study showed that between 72 and 96% of girls ages 12 to 17 understood the packaging. The second study showed that girls ages 11 to 16 could use the product properly and safely. The research is there. It was reviewed by FDA scientists. The FDA Commissioner herself stated that the scientists found the research conclusive that Plan B One-Step should be available without prescription for women under 17. The final score should be Science-1, Politics-0. Instead it’s the other way around.