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Executive Summary

ANDA submission deadlines to allow FDA to "batch" first generic approvals at the time the innovator product's patent expires was one of several suggestions included in a draft proposal from the Generic Pharmaceutical Industry Association's panel on ANDA reform. The committee presented the draft proposal at its first and only-planned public meeting held June 20. The proposal resulted from previously-held closed committee meetings. The GPIA panel's plan, called the "Alternate Proposal for Approval of Generic Drugs," recommends that FDA "set a specific date for a drug coming off patent where all submissions prior to that date will be considered equally 'first in.'" Agency reviewers, the draft proposal explains, would then "consider all submissions meeting the deadline concurrently, announcing approvals and disapprovals for this package of submissions simultaneously." The GPIA panel's plan was suggested as an alternative to FDA's current policy of reviewing ANDA applications on a "first in, first reviewed" basis. The panel said it proposed the change because the present policy "does not benefit the U.S. public, and in fact often encourages bad science and the temptation to 'cut corners,' even to the point of criminal misconduct as we have witnessed during the on-going generic drug scandal." The proposal also recommends that FDA, "together with a relevant specialty medical or scientific society," sponsor a public workshop "to review the chemistry and pharmacokinetic/pharmacodynamic data base" for an innovator product 18-30 months before patent expiration. The workshops, the GPIA panel suggested, could also be used as a forum for discussing "the possible bioequivalence criteria for the drug." After the workshop, FDA would announce the deadline date for submission of "first-in" ANDAs, which would be six to nine months before patent expiration. The idea of reviewing ANDA submissions prior to patent expiration and then bundling the approvals was suggested by House Energy & Commerce Committee Chairman Dingell (D-Mich.) in an April 6 letter to FDA ("The Pink Sheet" April 16, p. 6). Committee member Leslie Benet, PhD, University of California-San Francisco, commented that the alternate proposal has the advantage of providing FDA with the opportunity of seeing more than one application at a time...[in] my experience of submitting applications that's often a great disadvantage to the agency of actually not knowing sufficient information about the drug when they see the first couple of applications." In a presentation at the June 20 meeting, FDA Office of Generic Drugs Acting Director Bruce Burlington, MD, said the idea of "batching" applications presents "a number of administrative problems...not the least of which is the fact that that there seems to be a misconception that we ever get an application that goes through on a first cycle." However, he added that "there's a kernel [or] concept here that is attractive and that certainly could be worked on to see what can be done from a practical viewpoint." Burlington said that the agency is currently attempting to reduce the number of review cycles for ANDAs by developing a checklist for sponsors to see if their applications are complete. FDA is also analyzing applications that went through multiple cycles over the preceding five years, he said. The analysis will be published so that sponsors can identify where deficiencies have been so that in the future such problems could be remedied in advance of filing. FDA Center for Drug Evaluation and Research Director Carl Peck, MD, said the proposal "looks like it will be helpful." The idea of the workshop, he commented, is "to engage in a public discussion of the revelance [of the] underlying science and what's missing from it and typically there are some holes." Peck noted that experts could help identify those helps "so it would be perfectly obvious to anyone whether there's a question on a metabolite, a question of nonlinearity, a question of stereoisomers or whatever." The discussion would put "all the competitors on fair notice that part of the challenge is to fill in that gap, conceivably in the course of the first application that's submitted." Both Peck and Burlington pointed out that the agency is in the process of forming a generic drug advisory committee that would address problems or issues that come up, such as bioequivalence testing criteria. Peck suggested that the panel consider using the advisory committee as the forum for these workshops "at least as a first response." Burlington raised the issue of whether the Waxman/Hatch generic exclusivity provision for successful patent challenges could be fitted into the GPIA panel's proposal. In response, Benet said that the panel "[hadn't] thought about it at all." In discussing CDER's workload, Peck noted that 185 "blockbuster drugs" are expected to come off patent by 1995. Burlington added that "in terms of setting priorities for the advisory committee, 185 is 37 per year, obviously we can't do that with an advisory committee. In fact, four or six might be a more realistic goal." The GPIA panel also resurrected the concept of a monograph program for generic drugs. The monograph was the core of a proposed set of drug amendments in 1979. Under the plan, the manufacturer of the innovator drug would be required to provide all the necessary information for bioequivalence as a pre-condition to NDA approval. Rep. Dingell had also proposed this approach in his April letter to FDA. Commenting on the idea, Burlington said that "a monograph program merits serious consideration." Although, he added, "such a system ...would complement preapproval review" and not "replace" it. Burlington noted that the advantages of a monograph system would be "to assure the pharmacy and medical communities that the generic products were more likely to be equivalent to the innovator" and it would "set forth potential bioequivalence standards." A disadvantage, he added, would be substantial foregoing of proprietary and trade secret information." Indicative of the panel's independence from the generic industry association, GPIA President Dee Fensterer expressed the association's opposition to batching of ANDA applications. "If someone wants to invest the time, the science and financial resources in earlier development of a particular product," Fensterer stated, "they should not be disadvantaged from that by having a deadline system." Fensterer also expressed reservations about convening public workshops on drugs coming off patent, suggesting that the FDA generic advisory committee represents the "better approach." * Also appearing before the panel were executives of two contract research labs, Harris Laboratories President and CEO James McClurg and Biodecision Inc. President Robert Lecher. Both endorsed disclosure by contract labs of any financial stake they have in a product being tested but pointed out that their own organizations prohibit royalty arrangements or other payments tied to a product's financial performance. When asked by panel members why other labs should not be held to the same standard, both McClurg and Lecher expressed concern about government overregulation of the contract lab industry. The committee was established by the Generic Pharmaceutical Industry Association to examine the generic drug industry and FDA's ANDA approval process ("The Pink Sheet" Feb. 12, p. 14). The group plans to issue a public report of its findings this fall. Comments on suggested changes in policies or procedures for industry and FDA will be accepted by the panel until June 30. The panel members met with a group of FDAers on April 17. At that meeting, FDA said it would appoint an official liaison to the committee to facilitate its work. Burlington was later named to take on that responsibility; however, Office of Drug Standards Special Assistant to the Director Thomas McGinnis is the day-to-day contact for the panel, GPIA said.

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