Waiting for Plan B — The FDA and Nonprescription Use of Emergency Contraception

Abstract

The proposal to switch levonorgestrel emergency contraception (sold under the brand name Plan B) to over-the-counter status in the United States is in limbo. In May, the Food and Drug Administration (FDA) rejected the application of Barr Pharmaceuticals for nonprescription sales of Plan B. Dr. Steven Galson, the acting director of the FDA's Center for Drug Evaluation and Research, wrote that the company had “not provided adequate data to support a conclusion that Plan B can be used safely by young adolescent women for emergency contraception without the professional supervision of a practitioner licensed by law to administer the drug.” . . .