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Executive Summary

DEA SCHEDULING SHOULD BE CONSIDERED IN DETERMINING THE APPROVAL DATE of a new drug for which patent extension is sought, Schering-Plough maintained in Oct. 7 comments on FDA's proposed regs for implementation of the patent term restoration law. The firm suggested that FDA's regs "be revised to include a recognition that an [NDA] is not considered approved for the marketing of a drug product under Title II of the Act until both FDA approval and DEA [Drug Enforcement Administration] scheduling have occured." Roche, in separate comments to FDA, also requested that the agency revise the proposed rule to take DEA scheduling delays into account when determining the regulatory review period of a product. The firm stated that "the rule should be clarified so that . . . delays encountered, for example, by drugs subject to scheduling pursuant to the Controlled Substances Act . . . fall within the 'regulatory review period.'" Recently, both Schering and Roche have had products for which marketing was delayed by DEA scheduling. Both products, Roche's Versed (midazolam) and Schering's Dormalin (quazepam) were scheduled in February, two months after their December 1985 approvals. The proposed reg, published in the July 11 Federal Register, defines the approval date of a product, for purposes of determining patent term restoration, as "the date FDA notifies the applicant in writing that the application is approved." While the proposed reg distinguishes between an approval letter and an approvable letter ("which requires the applicant to take further substantive actions to meet certain conditions or supply additional information prior to marketing"), it does not specifically address marketing delays caused by DEA scheduling. In a recent legal dispute regarding the approval date of Norwich Eaton's Buprenex, the Ohio Federal Court ruled that the NDA was approved on the date of DEA scheduling. The March 3 ruling stated that because final labeling must include the DEA scheduling, the drug was not approved until it was scheduled ("The Pink Sheet" March 10, p. 3). Commenting on the due diligence section of the proposed reg, Schering noted that FDA has included several specific factors, such as "the length of the regulatory review period for comparable products, . . . which it considers relevant to" an assessment of due diligence. "Although certain of these factors may be relevant on particular occasions," Schering stated, "we consider the inclusion of these specific factors within the regulations to be inappropriate." Should "the agency decide to retain the list of specific relevant factors as part of its regulations, certain of these should nonetheless be deleted on an individual basis," Schering said. "The first of these is 'the length of the regulatory review period for comparable products.'" The firm maintained that "comparisons made on such a basis are entirely without validity since each regulatory review period is unique unto itself . . . and variations in both industry and agency resources . . . contribute to the actual length of a regulatory review period."

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