The Secretary of Health and Human Services has directed the FDA to issue a complete response letter indicating that Plan B One-Step (levonorgestrel tablets; Teva) will continue to be available by prescription only for females of childbearing potential who are <17 years of age. Plan B One-Step will continue to be available without a prescription for women ≥17 years of age.
The Center for Drug Evaluation and Research (CDER) determined that Plan B One-Step 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. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider. The FDA commissioner agreed with the CDER 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. The Secretary of Health and Human Services does not agree with this decision and has invoked her authority against the FDA’s decision.
For more information, visit www.fda.gov/NewsEvents/Newsroom/ucm282805.htm.