FDA SEEKING COMMENTS ON FOREIGN MARKETING EXPERIENCE OF ANTIPLAQUE PRODUCTS
This article was originally published in The Tan Sheet
Executive Summary
FDA SEEKING COMMENTS ON FOREIGN MARKETING EXPERIENCE OF ANTIPLAQUE PRODUCTS to aid the agency in formulating a new policy on whether to allow overseas marketing data in petitions for monograph status. In July 16 letters to over 20 antiplaque product manufacturers, FDA Monograph Review Staff Director William Gilbertson noted that "we welcome your comments and those of other interested individuals in developing this policy." Under the FD&C Act, FDA requires that ingredients must be marketed "to a material extent and for a material time" for monograph eligibility. FDA has interpreted the statutory language to mean U.S. marketing. At a Food and Drug Law Institute meeting in May, Gilbertson reported that FDA is developing a general policy guideline that would allow the agency to consider foreign marketing experience in monograph petitions ("The Tan Sheet" May 24, p. 1). In the letters to the antiplaque product manufacturers, Gilbertson noted that "the agency is currently re-examining the intent and scope of [that] statutory language" with the "ultimate goal" of establishing a "formal policy (or perhaps an applicable regulation) that will encompass and address the various ingredients in an orderly and consistent manner." FDA also is re- evaluating its "long-standing policy that foreign marketing of an ingredient is not adequate to allow an ingredient into the OTC drug review," he said. Gilbertson emphasized in the letters that how FDA proceeds with antiplaque products may serve as a model for other product categories, such as sunscreens and phytomedicines. FDA currently is evaluating petitions submitted by sunscreen manufacturers and the European-American Phytomedicines Coalition that ask the agency to recognize European marketing experience. Gilbertson informed the antiplaque product manufacturers that "at this time," the Office of OTC Drug Evaluation is "unable to determine whether the marketing information you have provided establishes the eligibility of your ingredients(s) for marketing under the OTC drug review procedures." However, "in the interest of completing the antiplaque review," Gilbertson said, "your data will be evaluated" by FDA's Dental Products Panel plaque subcommittee. "The marketing status of your ingredient(s) will be determined at a later date," Gilbertson added. The plaque subcommittee is scheduled to hold its inaugural meeting on Aug. 2-3. Not intended to address specific antiplaque products, the session is expected to cover general antiplaque product regulatory issues and discuss the subcommittee's role in the review process. Gilbertson noted at the May FDLI meeting that the plaque subcommittee would be responsible for reviewing all "the newly devised plaque products that are out there," a process he predicted would take several years. Gilbertson concluded his letter to antiplaque firms by clarifying that any ingredient currently marketed for antiplaque- related use in the U.S. may continue to be marketed "at the same dosage and in the same dosage form during the course of the OTC drug review of antiplaque products." The FDAer emphasized, however, that the agency is not precluded from adopting a "position requiring relabeling, recall, or other regulatory action" of marketed antiplaque products. If a product is not currently marketed for antiplaque use in the U.S., "you may not market it" in the U.S. "during the period that the ingredient is under review" by the plaque subcommittee of FDA's Dental Products Panel unless it is the subject of an approved NDA, the agency underscored.