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This article was originally published in The Tan Sheet

Executive Summary

FDA LETTERS ON PLAQUE PRODUCTS SEEK TO CLARIFY "MATERIAL TIME"/"MATERIAL EXTENT" definition, which serves as the basis for the agency's determination of monograph status eligibility. In letters sent the week of March 15 to companies marketing oral health care products with anti-plaque claims, FDA reportedly is telling firms that specific dosage information must be included when companies attempt to persuade the agency that their products have been marketed "for a material time and to a material extent." FDA called for data on anti-plaque claims for dental and oral health care products in a September 1990 Federal Register notice. However, "what we got in terms of their comment on marketing history ranged from informative to very uninformative," explained Michael Kennedy, director of FDA's OTC Drug Policy Staff. Speaking at a March 24 meeting of the Food and Drug Law Institute, Kennedy complained that companies, when asked to provide information on material time and material extent, expressed it in vague terms such as "gallons and gallons for years and years or tons and tons for decades." This "doesn't give us the information we need," he said. Consequently, FDA is asking the companies to "express the information in doses," Kennedy explained. For example, "if you've got a 10-milliliter dose, [and] you sell it in 100-milliliter bottles and you sold a thousand bottles a year, that comes out to 10,000 doses," he said. The letters request that companies provide information on "how many doses [sold] for how many years, for exactly what indications" and in which countries they were sold, Kennedy outlined. FDA is "actively" considering applying its initiative to clarify material time/material extent to other product categories marketed outside the U.S. that have not been addressed in the monograph process. At a March 25 FDLI session, Kennedy explained that petitions from manufacturers of phytomedicines, sunscreens, and dental/oral health care products with anti-plaque claims have all "asked that we establish standards for this magic question of material time and material extent, and establish criteria for admitting foreign ingredients" in OTC drug monographs. This initiative "is under very active current consideration," he said, adding that "it is quite likely that we may decide to handle this as a single common issue" as opposed to dealing with phytomedicines, sunscreens and anti-plaque products separately. Options currently being considered by FDA would essentially "reduce the standards for material time and material extent," Kennedy stated, and would attempt to establish "some sort of rules as to what former marketing [and] what former records would or would not be considered in the review." The European-American Phytomedicines Coalition filed a petition with FDA in July 1992 proposing that phytomedicines marketed in Western Europe for a material time and to a material extent be considered by FDA for U.S. OTC marketing. Similarly, Givaudan and other sunscreen manufacturers petitioned FDA in 1990 to include the broad-spectrum UVA filter avobenzone in the sunscreen tentative final monograph based on foreign testing and marketing data. Kennedy also informed the FDLI session that FDA's dental products panel is expected to meet "in the fall" to discuss anti- plaque claims for dental and oral health care products. Last fall, FDAers were predicting that the panel could meet as early as this spring. FDA said at the time that two new voting members would be added to the already-existing dental products panel. The two new members would be part of a special five-person subcommittee responsible for discussing plaque issues. Kennedy noted, however, that further down the road, FDA may decide to merge the plaque subcommittee with the OTC Drugs Advisory Committee. "That's certainly a possibility, it's under consideration, and it will come about any time soon," he said.

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