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This article was originally published in The Tan Sheet

Executive Summary

OTC MATERIAL EXTENT/MATERIAL TIME ISSUE "SHOULD BE SETTLED THROUGH RULEMAKING," but "only after [FDA] has identified the key issues and settled on the numerous policy issues that are lurking there," FDA Deputy Chief Counsel for Administration Kenneth Baumgartner told the Food & Drug Law Institute on Dec. 15. FDA "has to identify the key issues and resolve the numerous policy issues . . . before we can move into this very important area," Baumgartner said. Earlier this year, FDA indicated its intent to re-examine the "intent and scope" of FD&C Act language requiring that OTC ingredients be marketed to a "material extent" and for a "material time" in the U.S. in order to be eligible for monograph status. FDA has received several petitions asking the agency to accept foreign marketing data to establish monograph eligibility for certain sunscreen ingredients, anti-plaque products and phytomedicines. Before defining material extent and time, Baumgartner said, FDA must consider "the impact of settling the . . . issue on the various types and classes of drugs, both Rx and OTC, that FDA regulates." "What will be the impact on eligibility for being considered in the over-the-counter drug review?" Baumgartner asked. "One of the key issues is whether it was the intent of the over-the- counter drug review to be a snapshot of the market that existed in 1972 or whether it is [to] continue through the present time." Baumgartner also emphasized that the agency must resolve whether it will accept foreign marketing data or domestic marketing data generated under an approved NDA for a decision on material time and extent. In addition, he noted that FDA must decide whether it will allow interim marketing of ingredients or products that are tentatively determined to meet material extent and time requirements while the final monograph is being developed. Baumgartner noted that other questions to be considered include: "As each monograph is complete, can new ingredients or new indications ever lawfully enter the market without an NDA?" and "Can illegal marketing that is without a required NDA on the domestic market ever establish material extent or material time?" Another issue is whether material extent and time determinations for an ingredient or product for one dosage or indication could be transferable to a different dosage or a "closely related" indication, Baumgartner pointed out. Washington, D.C. attorney Stephen Mahinka (Morgan, Lewis & Bockius) maintained that the material extent/material time issue is a "simple and direct problem" and urged FDA to develop "a more flexible approach." He said: "I think clearly the development of new public health concerns, new products and claims" during the more than 20-year monograph review process "make the FDA's inflexible, static approach unnecessary, unwarranted and poor public policy." Mahinka maintained that FDA should "promptly move" to establish "standards for determination for marketing for material extent or material time," "set out the type and nature of evidence necessary and appropriate" and "make clear that foreign marketing data can be used to [make] determinations." Mahinka authored a citizen petition on behalf of BASF AG in 1989 requesting FDA to accept foreign marketing data to establish material extent and time.

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