Despite the Food and Drug Administration’s finding that Plan B One-Step, an emergency contraceptive, is safe, effective, and should be approved for nonprescription use by all women of childbearing potential, the drug remains unavailable without a prescription for those under 17 years old.
Dr. Margaret Hamburg, FDA Commissioner, announced her agency’s analysis and finding Dec. 7, but noted that Health and Human Services Secretary Kathleen Sebelius had overruled the decision.
In a memo, Ms. Sebelius disagreed with the FDA’s decision to extend approval of Plan B One-Step for nonprescription use by all women of childbearing potential based on her stated concern that the studies submitted to the FDA do not include data on girls of all ages who would be granted nonprescription access to the drug.
"It is commonly understood that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age, which I believe are relevant to making this determination as to non-prescription availability of this product for all ages," she said.
Plan B One-Step, a 1.5-mg levonorgestrel tablet, was first approved by the FDA in 2006 for use without a prescription by females aged 17 years and older, and by prescription only for girls younger than 17 years. The pill has been shown to reduce the chance of pregnancy after unprotected sex.
In February 2011, drug manufacturer Teva Pharmaceuticals appealed to the FDA to lift the prescription-only requirement for females younger than 17 years, triggering a review of the evidence by the FDA Center for Drug Evaluation and Research.
"Based on the information submitted to the agency, [the Center for Drug Evaluation and Research] determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases," Dr. Hamburg said in her statement. "Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a health care provider."
However, because of the HHS secretary’s objection, the FDA has issued a response letter to Teva stating that Plan B One-Step is not approved without a prescription for females younger than 17 years.
The product will remain on the market and available to females of all ages, with no prescription necessary for females aged 17 years and older.