The FDA announced Wednesday it will not allow Plan-B One-Step — the contraceptive billed as the “morning-after pill” — to be marketed over-the-counter on store shelves next to condoms and other contraceptive products.
Currently, the drug is available at the pharmacy, and women must either provide a prescription for it or show identification proving they are at least 17 years old. However, this past February, the drug’s manufacturer, Teva Women’s Health, applied to have FDA remove the prescription-only status for women under 17 and make Plan B completely non-prescription.
Today’s announcement, which came at the end of FDA’s deadline for deciding the matter, highlighted the disagreement on the issue between FDA commissioner Margaret Hamburg, MD, and Kathleen Sebelius, secretary of the Department of Health and Human Services (HHS).
Hamburg said in a statement that there was “adequate and reasonable, well-supported, and science-based evidence” that Plan-B was safe, effective, and should be approved for non-prescriptive use for all women of child-bearing potential.
However, she added, “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.”
In a separate statement, Sebelius wrote that the approval would allow all females of childbearing age — as young as 11 years old, she noted — to purchase the product over-the-counter. She added that amid concerns for “cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age” she was denying the drug’s move to over-the-counter.