HealthDay News — The FDA has approved over-the-counter sale of Plan B One-Step emergency contraceptive to women 15 years of age and older without a prescription, in a compromise that falls short of no age restriction access recommended last month by U.S. District Court Judge Edward Korman.
The approved application is based on an actual use study and label comprehension data, submitted by the drug’s manufacturer Teva Women’s Health, that demonstrated women in this age group use Plan B One-Step properly without the intervention of a healthcare provider.
The data indicated that women age 15 years and older understood that the product was not for routine use and would not protect them against sexually-transmitted diseases.
Plan B One-Step, a single-dose pill (1.5 mg levonorgestrel tablet) taken within three days of unprotected sexual intercourse to decrease the possibility of unwanted pregnancy, will be available on the shelves in retail outlets with an onsite pharmacy, generally in the family planning or female health aisles.
The FDA says the product will now be labeled “not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified.” The previous age limitation for purchasing the emergency contraceptive without a prescription was 17 years.
Teva has said it is willing to conduct an audit of the age verification practices to ensure that the age limitation is being followed. Additionally, to prevent theft, Teva has arranged to have a security tag placed on all product cartons.
“The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease,” Margaret A. Hamburg, MD, Commissioner of the FDA, said in a press release.