ANTI-PLAQUE CLINICAL OUTCOME MEASURE IS "CRITICAL QUESTION"
This article was originally published in The Tan Sheet
ANTI-PLAQUE CLINICAL OUTCOME MEASURE IS "CRITICAL QUESTION" for FDA's Plaque Subcommittee to resolve as it lays the groundwork for an OTC monograph for anti-plaque dental products, FDA Dental Products Panel Chairman Paul Robertson, DDS, University of Washington, suggested at the group's inaugural meeting Aug. 2-3. Addressing members of the Dental Products Panel and the newly formed Plaque Subcommittee, Robertson observed that "a critical question that clearly the panels in the past have not come to grips with is what is the appropriate outcome measure for anti- plaque activity." Robertson predicted "that given the data that has been accumulated over the last decade, we might very well have a quite different answer to that question than we would have had 10 years ago." He asked the panel and subcommittee to consider whether the appropriate outcome measure for anti-plaque product efficacy should be prevention of dental caries or whether gingivitis or other periodontal diseases should be assessed. The panel chairman suggested that "one of the first things" the subcommittee will have to do is to come up with useful definitions for "plaque" and "anti-plaque products." "For example," Robertson queried, "does [plaque] include calculus? Is it a microbial film?" Once the subcommittee has come to some agreement on how to define "plaque" and how to measure efficacy outcomes, Robertson predicted that the subcommittee will have to address the "major questions that . . . have been plaguing the agency": whether anti- plaque products are drugs or cosmetics and whether plaque is tied to other "specific oral diseases" such as gingivitis and periodontal diseases. In an opening day presentation to the Plaque Subcommittee and the Dental Products Panel, liaison Jeanne Rippere outlined the agency's expectations from the expert group in what amounts to the first OTC panel review in the 12 years since the panel phase of FDA's OTC drug review was concluded in 1981. Rippere, a microbiologist with Office of OTC Drug Evaluation, told the group that they will be reviewing the safety, efficacy and risk/benefit ratio of various anti-plaque ingredients and combinations of ingredients. "We have safety and effectiveness data on various ingredients and combinations of ingredients from hydrogen peroxide to sodium lauryl sulfate," she noted. In addition, Rippere noted that the subcommittee will be asked to review such product claims as "reduces dental plaque," "prevents the formation of dental plaque," "prevents tartar," and "prevents or treats gingivitis." Ultimately, the subcommittee is charged with determining "whether specific ingredients or claims can be safely marketed under an OTC drug monograph or whether they can only be marketed under an approved new drug application that would be either OTC or Rx for prescription use only," Rippere noted. Following its deliberations, the subcommittee is expected to convey its recommendations to the panel and the panel will make its final recommendations to FDA in a panel report that will serve as the basis for a proposed monograph, Rippere said. At one point during the panel's discussion, Robertson asked for a clarification of FDA's definitions of "old" drug (which can be considered for monograph status) and "new" drug (which can only be marketed with an approved new drug application) in the context of the anti-plaque products. Rippere indicated that FDA would rely on the panel's judgment. The anti-plaque product review presents a unique problem for FDA since companies did not begin to market products with anti- plaque claims until the early 1980s. In 1989, FDA took the position that such claims represented "new" drug claims in a series of regulatory letters sent to nine marketers of anti-plaque products. The letters stated that none of the products had been on the market prior to FDA's Dec. 4, 1975 cut-off date for the OTC review. Recently, FDA issued letters to over 20 anti-plaque product manufacturers soliciting comments on whether to allow foreign marketing data in petitions for monograph status ("The Tan Sheet" July 19, p. 9). The effort is part of a broad agency re-evaluation of the "intent and scope" of FD&C Act language requiring OTC ingredients to be marketed "to a material extent and for a material time" in order to be considered "old" drugs and, therefore, be eligible for monograph status. The subcommittee will be asked to review 369 volumes of data from approximately 30 manufacturers that responded to FDA's call for data in a Sept. 19, 1990 Federal Register notice. Those data have not been placed in the public administrative files and none of the data reviewed by the Plaque Subcommittee will be made public until 30 days after publication of the panel's report and the proposed monograph on anti-plaque products, FDA said. In addition, Rippere noted that the subcommittee will consider new data at upcoming subcommittee meetings. FDA formed the Dental Products Panel by expanding the function of the former Dental Devices Panel to serve "at times as an over- the-counter (OTC) drug advisory panel" in a final rule published in a Dec. 19, 1989 Federal Register notice. FDA decided to initiate a new review of anti-plaque claims because the two previous FDA oral products panels (Dental and Oral Cavity) that met in the 1970s did not specifically evaluate the effectiveness of oral products for plaque removal.
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