NMA: Nonprescription Medicines Academy

FDA Okays Wider Use of Plan B One-Step Emergency Contraceptive

May 29th, 2013

On April 30, the FDA announced that it had approved an amended application submitted by Teva Women’s Health, Inc., to market the emergency contraceptive Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years of age and older.

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.” Plan B One-Step will be packaged with a product code prompting a cashier to request and verify the customer’s age; a customer who cannot provide age verification will not be able to purchase the product. Plan B One-Step will be available for sale during normal operating hours in retail outlets with an onsite pharmacy, whether the pharmacy is open or not.

The FDA action related to Plan B One-Step does not affect the prescription status of other emergency contraceptive drugs marketed in the United States. Plan B (available from generic manufacturers) consists of two doses of levonorgestrel 0.75 mg taken 12 hours apart; it requires a prescription for women younger than 17 years of age. Ella (ulipristal) remains a prescription-only product.

The FDA action related to Plan B One-Step also is independent of pending litigation. On April 5, 2013, a federal judge in New York ordered the FDA to grant a 2001 citizen’s petition that sought to allow nonprescription access to Plan B for women of all ages and/or make Plan B One-Step available without age or point of sale restrictions. The FDA has appealed that ruling. Teva’s application to market Plan B One-Step for women 15 years of age and older was pending with the agency prior to the ruling; the FDA decision is not intended to address the judge’s ruling.