Obama administration appeals Plan B ruling

FDA approves the emergency contraceptive OTC for women as young as 15 years

 

Last month’s federal ruling that the government must make Plan B One-Step (levonorgestrel—Teva) available OTC with no age or point-of-sale restrictions is on hold until May 28, and FDA has announced approval of the emergency contraceptive OTC for women as young as 15 years.

This article updates pharmacist.com’s previous coverage of the issue.

On May 1, the Obama administration filed a notice of appeal and a motion to stay last month’s federal ruling.

The government had asked that the U.S. Court of Appeals for the Second Circuit overturn an April 5 opinion by U.S. District Judge Edward R. Korman and that Korman stay his order pending the appeal. instructs FDA to “make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions within thirty days,” as he wrote in that ruling.

But on May 10, Korman denied the motion for a stay pending the government’s appeal in a , concluding that the “appeal is frivolous and is taken for the purpose of delay.”

Then on May 13, the government filed the motion for a stay pending appeal in the U.S. Court of Appeals for the Second Circuit, and the appeals court ordered that the motion be submitted to its motions panel on May 28. The temporary stay of Korman’s April 5 decision was therefore extended until May 28.

The government’s May 1 appeal was filed a day after FDA announced approval on April 30 of a pending application to make the emergency contraceptive available OTC for women as young as 15 years—independent of the litigation, according to .

Under FDA’s approval of Teva’s amended application, Plan B One-Step 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 emergency contraceptive will be available in retail outlets with an onsite pharmacy—generally available in the family planning or female health aisles, and available for sale during the store’s normal operating hours whether or not the pharmacy is open.

All product cartons will have a security tag to prevent theft, FDA wrote in the news release. The product 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 buy the product.

Before Korman’s April 5 memorandum and order to make Plan B One-Step available OTC for all ages and FDA’s subsequent approval of the product for women as young as 15 years, Plan B One-Step required a prescription for girls younger than 17 years and could only be purchased at a pharmacy and required government-issued proof of age.

Watch for June Pharmacy Today articles covering counseling opportunities for community pharmacists when providing care to patients purchasing Plan B products and the issue of patient access.