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FDA’s GENERICS REVIEW PROCESS TAKEN OFF OMB’s "HIGH RISK" LIST; GENERIC DRUG DIVISION REFORMS INCLUDE RANDOMIZING REVIEWER ASSIGNMENT FOR APPLICATIONS

Executive Summary

FDA's generic drugs approval program has been removed from the Office of Management and Budget's list of "high risk" areas, FDA Office of Generic Drugs Director Roger Williams, MD, informed office personnel in March 12 memorandum. The generics review process was scratched from the list in mid-January, apparently after FDA Commissioner Kessler assured OMB that the generic drugs office was implementing reforms suggested by the HHS Office of the Inspector General in several reports on the program. While it has been removed from the list of high priority areas for IG attention and internal reforms, the generic drugs program remains a "material weakness" in the eyes of OMB, Williams noted. The office still faces "stringent reporting requirements and continuing audits," he said. The program was designated a "high risk" area in 1989, following revelations related to the generic drug scandal. Certain generic drug application reviewers were found to have given preferential treatment to some generic firms and delayed ANDAs of others. Following several audits of the generics office, the IG issued three reports in 1989 and 1990 addressing vulnerabilities in the ANDA review process, the drug master file review process and the management information system. In response, FDA developed an action plan to assure safety and overall quality of generic drugs and strengthen and ensure fairness throughout the review process. The Office of Generic Drugs has been conducting extensive assessments of policies and procedures related to the review process. It has made regular progress reports and presentations to OMB and the IG's office, Williams noted. "These meetings often involved difficult negotiations to determine what corrective actions remained to be accomplished to restore the integrity of the review and approval process," he observed. By December 1991, however, there were still enough remaining areas of concern to keep the office on OMB's high risk list. Williams noted that Kessler "sent a written commitment to OMB pledging to address three remaining issues of concern: a policy for the assignment of generic drug applications; a chemistry review reference document; and an independent quality control review function." The generic office director said that FDA instituted the necessary changes by Dec. 30, as promised, and Kessler notified OMB in January of the new policies and procedures. After protracted negotiations with the IG, FDA has agreed to implement a pharmacology class-based and randomized ANDA application assignment system. The agency had argued for a non-randomized system in which ANDAs would be assigned by pharmacology class and non-randomly to reviewers who have had experience with similar drug submissions. However, the IG insisted on a totally randomized system. FDA ultimately compromised and is currently working on a protocol for the random assignment of ANDAs by pharmacology class that will run for several months as a pilot program before a final policy and procedure guide is issued. OGD resolved the issue of an independent quality control review function by assigning Chemistry Review Divisions chief Robert Jerussi, PhD, to double-check chemistry reviews. In response to the IG's perception that Jerussi would not be truly independent if he reported to Williams, FDA officially has detailed the chemistry branch director to the Center for Drug Evaluation and Research director's office. The switch gives CDER Director Carl Peck, MD, and Deputy Director Gerald Meyer, not Williams, responsibility for evaluations of Jerussi's performance. Addressing the third concern of OMB, the office has generated a chemistry review reference document that directs chemists to relevent policy and procedure guides for certain drug components and compositions. A draft of the document is currently being circulated in the office for comments. On Dec. 30, the generics office issued its "Policy and Procedure Guide on Drug Master File (DMF) Reviews." The document includes a checklist to be completed for each ANDA reviewed to help supervisory chemists determine whether required reviews of DMFs were conducted. The guide identifies data resources that may be used by reviewers to minimize unnecessary re-reviews of DMFs. In addition, it states that review of facilities' DMFs for both U.S. and foreign firms are not required because field inspectors already conduct such reviews, and explains under what circumstances review of other types of DMFs are required. FDA's DMF review practices in the ANDA approval process came under investigation by the House Energy & Commerce/Oversight subcommittee due to revelations that certain chemists in the generic drugs division had not conducted DMF reviews themselves but had relied on reviews previously performed by other chemists ("The Pink Sheet" July 22, 1991, T&G-3). In a memo to staff accompanying the DMF guide, Williams noted that the DMF system "has been the subject of intense scrutiny by the [IG] and Congress over the past two years" and that it is expected that "at some future date [the office] will be subject to a follow-up audit to check on [its] adherence to the policy." Another sign that OGD is getting back on its feet is the recent decision by Peck that the drug evaluation chemists would no longer be needed to conduct reviews of ANDAs. NDE chemists came to the assistance of generic reviewers in October 1990 in an effort to reduce the backlog of ANDAs that had accumulated. Between October 1990 and February 1992, NDE chemists received 438 ANDA/AADA original and amended applications, of which 426 had been completed and sent to OGD. Recently, CDER and the OGD set up a coordinating committee to discuss management issues that affect both areas. The informal group, which includes Williams and Office of Drug Evaluation I Assistant Director for Chemistry Charles Kumkumian, PhD, met for the first time March 5. FDA said the group will meet once a month to discuss how the two offices can harmonize the way they manage drug reviews, including how innovations used by CDER, such as expedited review, might be implemented by the Office of Generic Drugs.

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