Plan B Will Not Be Over The Counter After All

Despite recommendations from the FDA, Health and Human Services secretary Kathleen Sebelius has decided not to allow the Plan B emergency contraceptive pill to be sold without a prescription to kids under 17. A statement issued today by FDA commissioner Margaret Hamburg reads, in part,

I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, and I agree with the [Center for Drug Evaluation and Research] that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.

However, this morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency's decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential. Because of her disagreement with FDA's determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved. Following Secretary Sebelius's direction, FDA sent the complete response letter to Teva today. Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17.

In a statement of her own, Sebelius explained, "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." Thus, it remains impossible for teenagers to buy over the counter a medicine that's arguably safer than aspirin.

Plan B: HHS Prevents Morning After Pill From Hitting Drug Store Shelves [ABC]
Statement From FDA Commissioner Margaret Hamburg, M.D. On Plan B One-Step [FDA.gov]