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Executive Summary

FDA GENERIC DRUG REVIEW MANAGEMENT QUESTIONED by Rep. Dingell's (D-Mich.) House Oversight Subcommittee in a series of queries attached to June 25 letters to Center for Drug Evaluation and Research Director Carl Peck, MD, Deputy Director Gerald Meyer and Office of Generic Drugs Director Roger Williams, MD. For example, the subcommittee asked Williams the extent of his authority over generic drug approvals. "Who currently has the authority to approve ANDAs?" the subcommittee asked the OGD director. "Have you ever been instructed, directly or indirectly, to slow down the approval of any ANDA?" Many subcommittee questions communicate criticism of agency management decisions. "Why are ANDAs assigned to reviewers who are on vacation or on temporary duty elsewhere?" Williams was asked. The subcommittee also asked the OGD director to comment on outside consultants' conclusions that division chemists are "inadequately trained," that there are no division-wide standards for the review of ANDAs" and that the drug review system "allows for individual chemists to have extraordinary power over the success or failure of an individual company's ANDA and [promotion of] 'arrogance in some individuals.'" The questions had been prepared for an Oversight Subcommittee hearing held June 5; however, the hearing was truncated by calls for members to vote on the House floor, and the FDAers neither presented their testimony nor answered questions orally from the subcommittee ("The Pink Sheet" June 10, p. 10). The subcommittee asked that written responses be provided by July 8. Peck was asked why SmithKline Beecham has not been required by FDA to reformulate the antihypertensive/diuretic Dyazide. "Your office has received studies (including Bolar's) that indicate that SmithKline's Dyazide may not be bioequivalent to itself, lot to lot," the subcommittee noted. "Why hasn't the agency required SmithKline to reformulate so that bioequivalence can be more easily established?" The subcommittee also asked Peck to address specific charges made in reports by three outside consultants who examined FDA's generic drug review system -- American Pharmaceutical Association official Arthur Kibbe, PhD, HHS Inspector General Special Agent James Kopf and pharmaceutical chemistry consultant John Zarembo, PhD. Peck was asked to respond to "Kibbe's statement that your activities have had a 'negative impact on productivity while not addressing the area (chemistry) that needed expert help'" "Kopf's conclusion that your re-review of ANDAs brought the system to a virtual standstill, and while your intentions were good, they were not practical as a manager of CDER" "Zarembo's conclusion that you had not assigned enough authority to others beside yourself to approve ANDAs." The subcommittee also suggested that Peck did not provide sufficient management guidance for correcting problems in FDA's generic drug review system. "When you appointed Richard Terselic and Robert Jerussi to replace Marvin Seife, you allegedly gave them little or no guidance except to 'go fix the problem,''' the subcommittee maintained. "Why was so little top-level guidance provided to this critical area, while at the same time you were re-doing lower-level bioequivalence work?" Meyer was asked why he publicly has understated the severity of the generic drug crisis. "In a public speech you have insisted that the problems were created by a few bad apples in the Division of Generic Drugs," the subcommittee said. "What is your justification for such a position?" The subcommittee also appeared to challenge Meyer's competence as a manager. "During the past three years you have been the chief administrative officer of the Center for Drugs." During that time the Center's Generic Drugs Division and Compliance Office have "been shown to be negligent or worse in its regulation of the generic industry. Why should the subcommittee have any confidence that you have the ability or the will to efficiently clean up this administrative mess?"

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