That promise was betrayed this past week when Health and Human Services Secretary Kathleen Sebelius overruled the FDA commissioner — and all of the physicians and scientists at the FDA — in blocking the agency’s decision to allow an emergency contraceptive to be available over the counter for all who need it.
I resigned from the FDA in 2005 after serving for five years as assistant commissioner for women’s health. I left because of my frustration that this safe and effective emergency contraceptive pill, Plan B, had been repeatedly blocked from going on sale over the counter. It was clear to me at the time that the recommendations of all the medical and scientific experts, both inside and outside the FDA, were being overruled by ideology, to the detriment of women and limiting their access to medicines.
I never understood the objection to emergency contraception. Preventing an unintended pregnancy seems like it should be common ground for those battling over reproductive rights. Yet controversy has surrounded Plan B, in part because of misinformation from those who actually oppose access to contraception.
Plan B, its newer one-pill form Plan B One-Step and the generic version, are just higher doses of the hormone found in regular birth-control pills. (They are not RU-486, the prescription medication that induces abortion.) They work primarily by blocking ovulation, through the same mechanisms found in many birth-control pills. Plan B is most effective when taken as soon as possible, so having it available easily and quickly without having to see a doctor for a prescription is key. That was the logical next step in 2003, when the company that makes Plan B first submitted an application to sell the drug over the counter. This request had the support of national physician organizations from the beginning.
It has been more than eight years since that first application, and it has been more than fiveyears since the FDA partially approved over-the-counter sales of the drug, to anyone 18 or older. In 2009, a federal court ruling forced the FDA to lower the age restriction to 17 and directed the agency to revaluate the need for any age restriction at all.
Throughout this process, the science has been solid that the drug is safe and should be available to anyone who needs it. But today — and into the future, thanks to Sebelius’s decision — though women 17 or older do not need a prescription for Plan B, it is still available only behind the pharmacy counter. As long as it is a prescription product for those younger than 17, it will have to stay there, limiting women’s urgent access to emergency contraception.