American Medical News
NEWS IN BRIEF — Posted June 17, 2013
The U.S. Dept. of Justice announced that it would abandon its legal challenge against a ruling that allows women and girls of all ages to access emergency contraceptives without a prescription. In a June 10 letter to Edward Korman, a judge with the U.S. District Court for the Eastern District of New York, the department said it would lift age restrictions on one form of the so-called morning-after pill in compliance with Korman’s April order.
On April 4, Korman overturned a 2011 policy by the Dept. of Health and Human Services that required a girl 16 or younger to get a prescription before she could obtain an emergency contraceptive. HHS previously had rejected a recommendation by the Food and Drug Administration to expand availability of such birth control.
After the decision, the FDA announced that it would make a one-pill brand of emergency contraception, Plan B One-Step, available over the counter to girls and women 15 and older. On May 13, the Justice Dept. asked the appellate court to block Korman’s decision temporarily pending an administration appeal. On June 5, the 2nd U.S. Circuit Court of Appeals partially denied the request, granting a stay of the decision on one-pill versions of the Plan B contraceptive but leaving intact the expanded access to the two-pill variants because the Justice Dept. “failed to meet the requisite standard.”
In its June 10 letter to Korman, the Justice Dept. said it has complied with the court’s judgment by taking steps to make Plan B One-Step available over the counter without age or point-of-sale restrictions. In a same-day statement, the FDA said it has asked the manufacturer of Plan B One-Step to submit a supplemental application seeking approval of the one-pill product to be made available over the counter without restrictions. Once the FDA receives that supplemental application, the agency intends to approve it promptly, the statement said.