A Statement by U.S. Department of Health and Human Services Secretary Kathleen Sebelius
Plan B One-Step is an emergency contraceptive, sometimes referred to as the “morning after pill.” Plan B One-Step is currently labeled over the counter to women ages 17 years and older, but is sold behind the pharmacy counter. It is available by prescription only to women 16 years and younger. My decision does not change any current availability of the drug for all women…
The Secretary of the Department of Health and Human Services is responsible, acting through the FDA Commissioner, for executing the Federal Food, Drug, and Cosmetic Act. Today’s action reflects my conclusion that the data provided as part of the actual use study and the label comprehension study are not sufficient to support making Plan B One-Step available to all girls 16 and younger, without talking to a health care professional. Plan B One-Step will still be available over the counter to women ages 17 and older.
Because I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age, I have directed FDA to issue a complete response letter denying the supplemental new drug application (SNDA) by Teva Women’s Health, Inc..