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This article was originally published in The Tan Sheet

Executive Summary

FDA's "EVOLVING" EFFICACY STANDARDS FOR MONOGRAPH INGREDIENTS AND CLAIMS are becoming increasingly stringent and are more likely to involve clinical trials to support Category I (safe and effective) status, Bristol-Myers Squibb Regulatory Affairs Director Jean Grieve maintained at a July 12 session of the Drug Information Association's annual meeting in Chicago. "Today, if a manufacturer attempted to argue that his Category III product or claim should be given Category I status solely based upon acceptable use in the marketplace . . . I think that they would be sorely disappointed," Grieve said. For instance, Grieve noted that FDAers have indicated that "there may be a challenge" to the Category I status of vaginal contraceptives, a product category that has "forty to fifty years in the marketplace and no efficacy issues on record with the FDA." However, she asserted that FDA is now concerned "that there are no clinical studies demonstrating efficacy" of vaginal contraceptives. Moreover, data intended to support monograph drugs "must be able to withstand the traditional rigor and scrutiny applied by new drug evaluation reviewers" because the "monograph division doesn't have sufficient staff in this area" and calls on NDA reviewers, Grieve said. "There is no second or separate standard applied by new drug evaluation for monograph drugs," she added. The monograph review process has certain disadvantages compared with the new drug review, Grieve indicated. It does not allow interaction with the data reviewer "in a non-public forum," and does not prevent "competitive challenges" while the data are being evaluated, she said. The public setting of monograph drug review "may also force FDA to take a position on the acceptability of data prior to the time when they otherwise might do so and also minimize the opportunity for further data gathering by the sponsors," Grieve contended. "All of this goes on," she continued, "in an environment where a competitor may be 'stirring the pot'" to "gain competitive advantage." Another unfavorable example "of the evolving monograph review process," according to Grieve, is "the question of clinical significance in the data." She characterized the question as a "relatively new twist" in the process that was "not asked in the early days." FDA "must be convinced that the claim you want is not formulation-specific," she said. This criterion "is difficult for any individual manufacturer to measure up to, particularly if you're the only manufacturer in a specific [product] category," she maintained. Options for demonstrating that a claim is not formula- specific, Grieve explained, include: "testing numerous varying formulations and dosage forms" that "you may have no intent to market" in order to "demonstrate the claim's utility"; and "establish an objective test criteria and methodology as an objective measure of a claim; or deviation from the final monograph." Grieve concluded that "deviation from the final monograph may indeed become the route of choice to follow but also has limitations from a marketing point of view." Also affecting the monograph review process is FDA's Nonprescription Drugs Advisory Committee, Grieve said. She asserted that the committee "brings with it an additional new layer of review and issues and focus which we've not had to deal with in prior monograph review processes." Grieve claimed that NDAC's decisions are "not always consistent with the science of the issues," echoing complaints voiced by Sandoz Drug Registration and Regulatory Affairs Director Mark Gelbert, PhD, at another DIA session (see related story, p. 2). "I don't think the standards have [necessarily] changed, but I believe the process has, and one more addition to that process is the Nonprescription Drugs Advisory Committee," Gelbert commented. He noted that the chairman of the advisory committee, Randy Juhl, PhD, "has said on a number of occasions . . . that the NDAC should not be restricted to applying old scientific standards to the evaluation of OTC drugs." Gelbert quoted Juhl as warning at a recent advisory committee meeting that "there is a progression that is going to occur regardless of what decisions the agency has subjected your products to in the past. When this group of scientific advisors comes in here, they'd like some standards." Participants at the DIA session also concurred that enhanced adverse drug reporting for OTCs could potentially change the landscape of OTC regulation. Gelbert pointed out, for example, that ADRs may reveal situations under which "a manufacturer may be asked by FDA to run some additional safety studies using today's methodology." FDA is putting the finishing touches on a proposal requiring adverse event reporting specifically for OTCs; the proposal is due out in the fall. The OTC system will be separate from an FDA-wide adverse reporting system called MedWatch, which was launched in June ("The Tan Sheet" June 7, p. 13). After the OTC adverse reporting program is proposed, the Nonprescription Drug Manufacturers Association expects to hold a conference to discuss compliance with the ADR proposal.

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