by: ASRMOfffice of Public Affairs
Published in ASRM Bulletin Volume 15, Number 18
Late Tuesday, FDA approved the application of Teva Women’s Health to allow women 15 and older buy the company’s Plan B One-Step emergency contraceptive pill without prescription.
Plan B One-Step will be available in retail stores with an onsite pharmacy, generally in the family planning or female health aisle. It will be for sale during normal store operating hours whether or not the pharmacy is open. The product will be labeled “not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified,” with a product code to prompt a cashier to verify the customer’s age. Women who do not provide age verification will not be permitted to purchase the product. Teva will also put a security tag on all product cartons to prevent theft.
In their press statement, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm350230.htm, FDA officials indicate that their decision was not influenced by the April 5 federal court order that Plan B be made available over-the-counter to all women without age restrictions, as Teva’s application was pending prior to the court order.
Although Judge Korman’s order directed FDA to approve over-the-counter access to emergency contraception for all women within 30 days, it is now stayed. Wednesday evening, the Department of Justice appealed the decision in Tummino v. Hamburg arguing that the court exceeded its authority in its ruling despite the support of evidence-based research and an FDA recommendation for all ages access.
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