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FDA Approves Plan B for OTC Sales for Consumers 18+; Under 18 Will Still Need Prescription On August 24, 2006, the FDA approved Plan B for over-the-counter (OTC) sales for consumers 18 and older. Women 17 and younger will still need a prescription. Click here for more comprehensive information and resources. Compare different ways to access EC (PDF-68K). Pharmacy Access in an OTC Environment The FDA decision to make Plan B an OTC product for consumers 18+ will not change the current availability of EC through a pharmacist-initiated prescription in the nine states that allow it. Currently Washington, California, Alaska, New Mexico, Hawaii, Maine, New Hampshire, Massachusetts and Vermont allow pharmacists to directly dispense emergency contraception to a woman without her having to first get a prescription from a provider. Vermont is the most recent state to pass pharmacy access legislation. The pharmacy access model will be more critical now than ever for younger women, undocumented women or women without proof of age to obtain fast, convenient access to EC. Click here for a Women’s Enews story on EC in pharmacies at the state level. Brief History of the Plan B OTC Application The application for making EC over the counter was first submitted in April 2003, by Women’s Capital Corporation, the initial marketer of Plan B. Containing strong safety, actual use, and label comprehension data, the application was officially filed June 20, 2003. In February 2004, Barr Laboratories acquired Plan B and continued to support the OTC application. Although the FDA Reproductive Health Drugs and Non-Prescription Drugs Advisory Committees overwhelmingly recommended to switch EC to OTC, the FDA delayed its decision from the initial February 20, 2004 deadline to May 21, 2004, requesting more time to look at data on adolescent use. On May 6, 2004, the US Food and Drug Administration (FDA) rejected an application to switch Plan B (a dedicated EC product) to over-the-counter (OTC) status. The FDA offered Barr Laboratories two alternatives for future submissions: 1) to provide additional data on use by adolescents and 2) to outline and support marketing plans for dual access: nonprescription for women 16 and older, and prescription for women younger than 16. On July 22, 2004, Barr Laboratories submitted information to support marketing for dual access to Plan B: non-prescription for women 16 years and older and prescription-only for women under 16. On January 21, 2005, the FDA informed Barr that it was unable to complete its review of the application. The FDA is expected to rule on the Plan B dual access application on September 1, 2005. Many medical groups support over-the-counter access to EC, including the American Medical Association and the American College of Obstetricians and Gynecologists who have formal resolutions stating EC is so safe it should be OTC. EC is currently available behind-the-counter in the UK, Australia, and New Zealand. On April 20, 2005, the Canadian Health Minister announced Plan B availability behind-the-counter in Canada. The amendment was published in the Canada Gazette on May 4, 2005. For a comprehensive and up-to-date look at the OTC switch in the US — including support and opposition, history, reports from the committee hearing, letters of support, and press coverage — as well as specific information about EC pharmacy access activity in other states, Canada, and Australia, please visit www.go2ec.org.
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