The Food and Drug Administration (FDA) announced last week that generic versions of Plan B One Step will now be available over-the-counter to women of all ages.
The FDA removed age and point-of-sale restrictions on Teva Pharmaceutical’s Plan B One Step in June 2013, but the agency also gave Teva a three-year protection from generic competition, meaning that generic versions of the emergency contraception (EC) could only be obtained behind the pharmacy counter and only be obtained without a prescription by women over 17 years old. By retaining these restrictions, the FDA effectively limited access for low-income women and girls.
Kathleen Uhl, Acting Director of the Office of Generic Drugs in the Department of Health and Human Services (HHS) Center for Drug Evaluation and Research announced the policy shift, stating that the FDA would lift the restrictions on generic competitors of Plan B One Step effective immediately. Although generic pills will have a label indicating the medicine is intended for people 17 and older, ID is no longer a requirement for access.
“This is a significant leap forward in obtaining full over-the-counter status for emergency contraception and we commend the FDA for this decision,” said Jessica Arons, President and CEO of Reproductive Health Technologies Project. “EC can be used safely and effectively by people of all ages and it should be available without unnecessary and arbitrary barriers.”
Media Resources: ThinkProgress 3/3/2014; NPR; 3/2/2014; Department of Health and Human Services; Reproductive Health Technologies Project 2/27/2014; Feminist Newswire 6/11/2013
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