January 4, 2012
Robert Steinbrook, MD
On December 7, 2011, Health and Human Services Secretary Kathleen Sebelius overruled the US Food and Drug Administration’s (FDA’s) decision that levonorgestrel emergency contraception (sold under the brand name Plan B One-Step) was safe and effective for all women of childbearing potential, regardless of their age, and should be approved for sale as a nonprescription drug. Plan B One-Step is a single-dose 1.5-mg tablet of levonorgestrel that should be taken as soon as possible and within 72 hours after an episode of unprotected intercourse.
Emphasizing a concern about nonprescription use by the youngest girls of reproductive age, Sebelius wrote to Margaret Hamburg, MD, the FDA commissioner that the studies submitted to the agency “do not include data on all ages for which the drug would be approved and available over the counter” and “do not establish that prescription dispensing requirements should be eliminated for all ages.”1 Although the Health and Human Services (HHS) secretary has the legal authority under the Food, Drug, and Cosmetic Act to reverse an FDA decision, Sebelius was apparently the first to ever do so.
Plan B One-Step is manufactured by Teva Women’s Health and sells for about US $50. The FDA has approved the drug for use without a prescription in women aged 17 years or older and with a prescription for those who are younger. Most who use emergency contraception are 17 years or older. The pills are dispensed from behind the counter at pharmacies and clinics; they are more difficult to obtain than they would be if they were in the aisles of pharmacies, grocers, and other retailers, as are condoms and spermicides. A generic product that consists of two 0.75-mg pills of levonorgestrel (sold under the brand name Next Choice) is also approved under the same dual status.
Federal agencies know that decisions involving sexual matters are often controversial. But virtually no one foresaw the extraordinary reversal of an FDA decision about drug approval by a secretary in President Barack Obama’s cabinet, a decision the president said that he fully supported.