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The Food and Drug Administration (FDA) today acknowledged that it has issued a “Not Approvable” letter to the sponsor of an application to make the Plan B emergency contraception product available without a prescription. In its letter to the sponsor, FDA outlined the additional information that would be required to gain approval to market Plan B over-the-counter.
FDA based its action primarily on the lack of data concerning OTC use of the product among adolescents younger than 16 years old. The sponsor’s application contained no data in subjects under 14 years of age and very limited data in adolescents 14 to 16 years old.
FDA’s letter to the sponsor notes that the application does not provide adequate data to support use of Plan B by young adolescent women without the intervention of a physician. The letter also points out that the sponsor’s March 11th amendment of its application to allow marketing of Plan B by prescription only to young women under 16 years of age was not complete. As a result, the agency was unable to do a complete review on that amendment during this review cycle.
Dr. Steven Galson, Acting Director of FDA's Center for Drug Evaluation and Research (CDER), said “Although we did not have sufficient data to approve this application now, I will be working toward the expeditious evaluation of Barr's response to the Not Approvable letter. If Plan B is approved for nonprescription use, it would dramatically increase access to this product and will represent an important incremental step forward in contraceptive availability in the United States. Wide availability of safe and effective contraceptives is important to public health. I look forward to supporting CDER's important continued role in ensuring improved availability of these products."
Although U.S. law prohibits FDA from discussing pending applications because they contain commercial confidential information, in this instance the sponsor of Plan B, Barr Research, has allowed FDA to comment in general terms on the status of Barr’s application to make Plan B available as an OTC product, and on the agency’s action.
Additional information on FDA’s action is available, in question and answer format, on the web at http://www.fda.gov/cder/drug/infopage/planB/default.htm.
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