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Executive Summary

FDA's Generic Drug division is moving back toward normal levels of productivity in the wake of the ANDA disruption caused by the ongoing generic drug investigation, FDA Center for Drug Evaluation and Research Deputy Director Gerald Meyer told the National Association of Pharmaceutical Manufacturers' June 6 mid-year annual meeting in New York City. Commenting on the perception that the generic drug review process has been stopped or significantly slowed, Meyer stated: "The truth is that we did experience a two-week period in May that involved some serious slippage." However, he added, "we are moving applications and we are back to normal productivity at the present time." From May 12 to June 1, the generic division approved only one ANDA application -- Quantum Pharmics' timolol maleate tabs. For the entire month of May, FDA approved six ANDAs covering 13 different dosage forms, and two antibiotic applications. By comparison, in May 1988, the generic division approved ANDAs for 38 different product entities. During the first two weeks in May, a number of generic division employees went before Rep. Dingell's (D-Mich.) Energy and Commerce/Oversight Subcommittee to answer questions in closed hearings pertaining to allegations of favoritism in ANDA reviews. Meyer attributed the slowdown in the review process to the state of flux in the division's personnel. In addition to the recently announced management changes, Meyer said, the division has lost a total of four reviewers as a result of the investigation. Charles Chang, the former chief of ANDA Review Branch III, pleaded guilty to two counts of interstate travel in aid of racketeering on May 25. David Brancato resigned after pleading guilty to charges of receiving cash gratuities from officers of two generic drug companies. A third, unnamed reviewer is currently on administrative leave with pay from the agency, Meyer said. The reviewer is said to be from ANDA Review Branch I. A fourth reviewer, Walter Kletch, also from Branch I, has reportedly been temporarily detailed to the Division of OTC Drug Evaluation. Kletch was the only FDA witness to appear during the public portion of the subcommittee's May 3 hearing. However, he declined under the Fifth Amendment to answer questions. Kletch was subpoenaed to testify after he refused to be interviewed by the subcommittee. Meyer acknowledged that "there's no question that until we can fill those vacancies and resolve procedural questions, we're going to expect some further problems with review time." However, he emphasized that the management changes in the generic division represent Commissioner Young's temporary response to the investigation. "I want to point out that these reassignments should not be viewed as predictive of any future organizational approach or reflective of any particular fault of those suspected," Meyer said. Realignment of responsibilities in the generic drug division have resulted in a shift in ANDA approval authority to CDER Director Carl Peck, MD, and Meyer ("The Pink Sheet" May 22, T&G-1). Meyer noted that "Dr. Peck and I are personally reviewing and approving ANDAs. As a matter of fact, I have been signing most of the non-approvable deficiency and information letters . . . Dr. Peck has been signing approval and approvable letters." The deputy director of the generic division, Kent Johnson, "has continued to sign correspondence concerned with labeling," Meyer added. The FDAer noted that he and Peck are also available for meetings with generic companies "We will be glad to meet with you," Meyer said, "if there is some issue that cannot be resolved at the review level" by Terselic, Jerussi or Johnson. Peck has expanded his role in approving ANDA applications by reviewing the bioequivalence sections of ANDAs. Meyer noted that Peck's "own experience and expertise has permitted him to personally review the bioequivalence portions of the ANDAs to assure that they are accurate, to assure that they are consistent." Peck does not intend to review bioequivalence studies "over the long term," according to Meyer, but "he is trying at the moment to learn that process [and] learn what is done." Peck's review can add to the bioequivalence review time, Meyer acknowledged. "It can add a week or two in some cases, if it's a problem that he can't resolve himself." Meyer added, however, that the bioequivalence review meetings have been changed "from biweekly, which is what they were . . . to weekly to give Carl [Peck] a chance to resolve [problems] on a more prompt basis." Peck met with Dingell's staff on June 5 to discuss the generic drug program, Meyer reported. At the meeting, Peck reportedly provided the hill staffers with results of re-reviews by the agency of the bioequivalence studies of certain products. The bioequivalence analyses were said to have been requested by Dingell in a May letter to Commissioner Young. The letter reportedly addressed generic versions of SmithKline's antihypertensive Dyazide (triamterene/hydrochlorothiazide). Dingell's subcommittee asked FDA in March for the Summary Basis of Approval reports for ANDAs of numerous drugs, including triamterene/hydrochlorothiazide. The subcommitee also requested the names of all FDA staff involved with the review of and policy regarding the generic versions of four products: Dyazide, Mylan/Lederle's Maxzide, Marion's Carafate and Wyeth-Ayerst's Premarin ("The Pink Sheet" March 27, p. 7). In response to allegations of inconsistencies in ANDA reviews made at the subcommittee's hearings, Meyer said FDA is investigating questions of inconsistency and that "clear, documented, uniform consistency of scientific reviews and actions are a prime consideration of our current efforts." Mylan claimed at the hearing that its diazepam ANDA was deliberately delayed by FDA so that three firms could receive approval on the same day ("The Pink Sheet" May 15, p. 12). Meyer noted that the importance of consistent reviews is being emphasized to the staff. "We are making a pronounced effort to have a better, more precisely documented audit trail of reviews, to not only assure consistency, but to provide very visible evidence of that consistency." During the question-and-answer session following his speech, Meyer was asked whether the position of senior chemist, held by Jerussi, will be a permanent one to assure that the three review branches use the same criteria for ANDA reviews and that the review times for ANDAs are similar. Meyer responded that it "is certainly an option" and that "we feel very good about the assistance that Bob Jerussi is giving us." Another option that is being considered for the restructuring of review procedures is "trying to assign applications on the basis of expertise in areas . . . so that people who are particularly well-trained with a particular kind of product class will review those consistently," Meyer said. He also noted that Peck is willing to consider comments from industry on new operating procedures for the genetic division.

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