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