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The Plan B brand of emergency contraceptive pills soon may be available direct from Canadian pharmacists if the green light is given by government regulators.
Women’s Capital Corp. (WCC) of Washington, DC, marketer of the Plan B brand of emergency contraceptive pills, and Paladin Labs of Montreal, the Canadian distributor of the drug, have submitted an application to Health Canada to grant nonprescription status to the product. The application also is cosponsored by the Society of Obstetricians and Gynecologists of Canada and the Canadian Pharmacists Association, both based in Ottawa. WCC and Paladin Labs have asked for priority review that would allow for Canadian approval in less than a year.
Plan B is available only by prescription in most of Canada, although it is available without a prescription in British Columbia and Quebec. (Contracep-tive Technology Update included information on the British Columbia program in its article, "Emergency contraception: Direct from the pharmacist," January 2001, p. 1.)
The company also plans to submit a U.S. application for nonprescription status to the Food and Drug Administration (FDA) in summer of 2002 following the completion of a clinical study. The study mimics actual over-the-counter (OTC) distribution at research sites in five U.S. cities: Houston; Boston; Phoenix; Grand Rapids, MI; and Seattle. The FDA is continuing to review a separate petition for OTC distribution of emergency contraception filed in February 2001 by some 70 medical and advocacy organizations. (See the CTU article, "Emergency contraception: Going over the counter?" in the February 2001 issue, p. 17.)