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Executive Summary

GENERIC CONJUGATED ESTROGENS: REP. DINGELL SEEKS FDA EXPLANATION for alleged procedural delays in the agency's handling of the product. In a Nov. 29 letter to Center for Drug Evaluation & Research Director Carl Peck, MD, Dingell (D-Mich.) asked that the agency send the House Oversight Subcommittee "a written report on FDA actions on conjugated estrogens taken subsequent to [Peck's] November 1989 testimony, including an explanation of the procedural problems and actions taken to prevent their recurrence." Dingell requested that the report be sent by December 28. The congressman added that the report also should include "FDA's views on the recent multiple lot recalls of Duramed's and Zenith's conjugated estrogen products, and Duramed's decision to discontinue production of its conjugated estrogen products." Dingell expressed unhappiness with delays both in removing from the market generic products that FDA considered bio-inequivalent to Wyeth-Ayerst's Premarin and in setting standards for approval of generic competitors for the brandname product. "Given the recent osteoporosis indication for the innovator conjugated estrogen product (Premarin) and the absence of suitable (AB rated) competition, this drug could easily become the largest seller in the U.S.," Dingell said. "You may recall that your office revoked the protocol regarding the appropriate measure of bioequivalence between Barr's product and that of the innovator, Wyeth-Ayerst, after Wyeth intervened in the approval process," he reminded Peck. FDA took "several procedural missteps" in reviewing Barr's ultimately disapproved ANDA for generic conjugated estrogens -- a situation that Peck "agreed last November warranted an apology to Barr," the congressman added. Regarding FDA's "long process of withdrawing the approvals of existing generic competitors," Dingell said: "It is not satisfactory to provide testimony to this subcommittee regarding safety concerns and then to drop the ball in following up on those concerns." Dingell noted: "On Feb. 13, 1990 the FDA published a Notice of Opportunity for Hearing on the possible withdrawal of generic conjugated estrogens manufactured by Duramed and Zenith, among others." The action was based on FDA's belief that the previously approved generic products were "potentially bio-inequivalent to Premarin tablets." However, FDA since has "informed the subcommittee staff that there have been two substantial delays, one of six weeks and one of eleven weeks, in the FDA's decision on the preliminary procedural issue of whether to grant a hearing," Dingell said. "The first delay was in your regulatory affairs group, whose task it was to simply examine, on a timely and efficient basis, the filings in response to the February notice to see whether scientific review within FDA was warranted," he noted. Peck has "agreed," Dingell observed, that "this task could have been done in no more than two hours." Dingell said "the second delay was reportedly caused by the routing of an unmarked box to, and its misplacing within, the Office of Generic Drugs." Congress presumes FDA is "uniquely capable" of evaluating the safety and efficacy of drug products, the congressman noted, "even when your own advisory committee disagrees with the agency, as was the case in this instance," Dingell noted. However, he declared, "the subcommittee has particular worries when continuing procedural gaffes undermine the FDA's ability to address your stated safety concerns." He added: "At some point you and Mr. Meyer [Peck's deputy director] ought to accept responsibility for this rather incredible series of events and either fix these and other problems concerning the FDA's regulation of generic drugs or step aside and allow others to try."

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