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Status of making Plan B® Emergency Contraceptive Pills available Over-the-Counter On April 21, 2003, the manufacturer of Plan B® (a progestin-only emergency contraceptive) submitted an application with the FDA to make Plan B available over-the-counter (OTC). The Reproductive Health Drugs and the Nonprescription Drugs advisory committees, met on December 16, 2003 to debate and make a recommendation to the US Food and Drug Administration (FDA) on whether to allow Plan B to be sold OTC. The committees and panel of experts voted overwhelmingly that the FDA make Plan B available without a prescription. The panel agreed that Plan B meets the FDA's criteria for determining drugs appropriate for OTC use. It treats a condition that patients can diagnose themselves and is safe and effective when used without direct prescriber supervision. Plan B is simple to use, is not addictive, and has no known health hazards when self-administered. The leading medical and public health organizations agree with the panel's recommendation, including the American Medical Association (AMA), and the American College of Obstetrics and Gynecology (ACOG). Over 70 of these organizations submitted oral and/or written comment to the FDA panel and signed on to a letter drafted and circulated by ARHP, in support of OTC access to emergency contraception. Click here to read ARHP's Organizational Sign on Letter in Support of EC OTC On May 6, 2004, the FDA issued a not approvable letter to the manufacturer of Plan B. The manufacturer, Barr Research, Inc, submitted a formal response on July 22, 2004 that provided additional information supporting the marketing of Plan B as a prescription-only product for women 15 years of age and younger and a nonprescription product for women 16 years of age and older. The FDA is currently considering this response and is expected to make a decision on or before January 20th. Additional Resources from the Reproductive Health Technologies Project (RHTP): The document below, compiled by RHTP, are in Adobe Acrobat PDF format. You will need the free Acrobat Reader 3.0 or 4.0 to open it. If you don't have Acrobat Reader and want to download it click here.
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