June 26, 2013
Restrictions Lifted on Sale of Plan B One-Step,
Not Two-Pill Version
Central Islip, NY—At least one type of emergency contraception is being moved from behind the counter at pharmacies.
Access limitations and age restrictions were lifted for OTC availability of the emergency contraceptive Plan B One-Step, according to the FDA.
The FDA announcement followed court approval of a recent proposal, which included an agreement to promptly review and approve a requested supplemental application from Teva Women’s Health, the manufacturer of Plan B One-Step, that the one-pill product be made available without any restrictions.
Sales of the two-pill version, called Plan B, will continue to be restricted for purchase to those 17-years-old and older, however. The FDA cited concerns that young girls could have more problems understanding and following instructions on the two-pill version.
Judge Edward Korman of the U.S. District Court for the Eastern District of New York called the FDA’s plan “sufficient.”
“On the assumption that the Commissioner of Food and Drugs entertains the good-faith belief that the products should be treated differently, the defendants' proposal is sufficient to comply with my order,” he added in response to objections by the plaintiffs, who represented several reproductive rights groups.
Korman ruled in April that the FDA was required within 30 days to make available levonorgestrel-based emergency contraceptives without a prescription and without point-of-sale or age restrictions. The Obama Administration, which had established the requirements, promptly appealed.
The FDA then approved a supplemental application from Teva Women’s Health, which markets the emergency contraceptive products, to make the Plan B One-Step OTC to consumers ages 15 and up. Teva also agreed to make the product available in retail outlets with an onsite pharmacy, usually in the family planning or feminine health aisles, and allow its sale during the retailer’s normal operating hours, whether or not the pharmacy was open.
In his ruling, the judge said the agreement between Teva and the FDA still left in place “burdensome point-of-sale and photo identification requirements.”
Earlier this month, in response to the stay of Korman’s ruling by an appeals court, the Justice Department said it would drop its appeal.
Previously, pharmacies were required to restrict access to both Plan B formulations to women 17 and older.
|U.S. Pharmacist Social Connect