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OTC INDUSTRY FUNDING FOR SCIENTIFIC REVIEW PANEL PROPOSED BY FORMER AGENCY LAWYER; PANEL COULD HANDLE NEW OTC INGREDIENTS & CLAIMS IN POSTMONOGRAPH ERA

Executive Summary

The OTC industry should fund the establishment of a scientific review panel to examine marketing applications for new OTC drug ingredients, claims, and formulations, former agency lawyer Marsha Gardner proposed at the Sept. 26-28 annual meeting of the Regulatory Affairs Professionals Society. "It's time for the private sector to fund a credible scientific review of OTC ingredients, just as [the Cosmetics, Toiletries & Fragrances Association (CTFA)] did with the Cosmetic Ingredient Review for cosmetic ingredients," Gardner maintained. She suggested that the panel "should also consider potential Rx-to-OTC switch ingredients." Currently VP-International Affairs for the CTFA, Gardner recommended that the panel "be set up as an exact analog to the OTC Review. It would be subject to the same conflict-of-interest requirements as the OTC panels, and it would contain -- as does the Cosmetic Ingredient Review -- the appropriate consumer and FDA observers. It would be entirely separate from any industry group, although it would be industry funded." An independent panel is needed, Gardner argued, because FDA's new drug reviewers are overburdened with prescription drug evaluations and cannot make room for OTC drug issues when faced with such concerns as AIDS and Alzheimer's disease. "After reviewing all the available data, the panel would prepare a report and submit the data to FDA," she explained. "The agency would then evaluate the report, just as it did the OTC advisory committee reports, and it would proceed into the next stage of the rulemaking process." After a report is filed, Gardner suggested that marketing could be allowed "if the agency did not dissent with the committee's findings." She contended that the NDA route for adding to the list of OTC drug conditions cannot accommodate the estimated 100,000 industry requests that could be submitted to FDA in the years following completion of the OTC Review. FDA's OTC Drug Division Director William Gilbertson agreed with Gardner's estimate of potential NDA submissions for OTC drug marketing. The idea of 100,000 NDAs for OTC products "is no exaggeration because with each final rule . . . anything that is different from that monograph" is subject to an NDA, he noted. "That's not something that the agency wants, or you want, in terms of regulating this marketplace in the future." At the RAPS annual meeting last year, Gilbertson suggested the use of monograph supplements to deal with the influx of monograph changes once the OTC review is completed ("The Pink Sheet" Sept. 21, p. 9). The concept has the advantage of offering market exclusivity to approved petitions for a specified time period as an inducement for submission of data. Under the monograph supplement idea, a drug would be added to the appropriate monograph after expiration of its exclusivity period. Gardner said such an approach "has merit." She advised FDA to consider any approach "that enables the agency to deal with the deluge . . . of OTC applications." FDA is preparing for OTC drug regulation in the postmonograph era by considering a variety of alternatives. "We will be changing the thrust of our division," Gilbertson said. "It has been suggested that we take on medical officers; that's one of the possibilities to deal with these things." Gilbertson pointed out that the OTC Review is beginning to wind down -- about 70% (54) of the tentative final monographs have been published. The "few big ones remaining," he noted, include the proposals for internal analgesics, antiseptics, antimicrobials, weight control products, and sunscreens. Twenty-three of 85 final monographs (27%) have been completed, including antacids, "major components of the cough/cold market," and ophthalmics. Gilbertson estimated that there will be more than 300 ingredients listed [as Category I] in the final monographs -- about 325 out of 728. "It's interesting to note that in the Category III area, there are less than 10% of those actively being looked at by interested manufacturers," he added. "There is also a sharp increase in interest in new claims for old drugs," such as aspirin for myocardial infarction and acute unstable angina, and psyllium for lowering cholesterol, he said. "So we're going to see more interest in these old ingredients, not just in switch drugs." Gilbertson said the question of how to approve professional labeling for products listed in an OTC monograph must also be addressed. Under the monograph, aspirin currently carries professional labeling for myocardial infarction, transient ischemic attack, and acute and stable angina, he noted. "Does that necessarily mean general recognition? I know FDA doesn't particularly want to have NDAs for aspirin." The OTC Division director said the question "is being looked at very carefully internally right now, whether it will be our policy of continuing to put professional labeling into monographs." He said it is "beginning to look like" the current practice "will be maintained." However, Gilbertson said the agency is considering whether an "alternative regulatory mechanism [is available or even necessary] to handle this." There is general agreement, Gilbertson stated, "that there needs to be some kind of premarket approval for these before these labeling claims appear." He questioned whether "the monograph [is] a legally viable mechanism to continue to do it," if FDA does not require an NDA or ANDA. He suggested that FDA might need to establish "something like a professional labeling application." The agency is early in its concept development. Gilbertson suggested: "All I can say right now is tune in next year." Gardner noted that yet another proposal for approving new OTC ingredients is the drug master file approach. Under the plan, she said, FDA would establish a DMF, containing information that "would be available to anyone interested in using a pioneer ingredient in a different formulation." Gardner pointed out that the proposal, based on the patent/ANDA amendments of 1984, would "provide that once a pioneer drug has been approved, anyone may file an ANDA . . . as long as the application" cites prior approval. The DMF approach presents a problem, Gardner acknowledged, in that "separate applications of some sort must be filed for every new formulation." She noted that if FDA were "faced with the necessity of approving an individual NDA or ANDA for each of the formulations for every company" that wanted to market a new ingredient, "the agency would sink under the sheer weight of the paper involved."
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