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UPSHER-SMITH URGES GENERIC APPROVAL REVIEW BOARD

Executive Summary

UPSHER-SMITH URGES GENERIC APPROVAL REVIEW BOARD be established by FDA, consisting of agency and industry representatives, as a way to improve communications between the groups. The Minneapolis company suggested the creation of the board to function as an ombudsman and prevent a repeat of the type of concerns about favoritism and the opportunities for favoritism that precipitated the recent investigations of FDA's generic review effort. Upsher-Smith suggested that a review board could "meet every two-three months and act like an ombudsman to openly discuss any specific problems or complaints...and develop responses to the concerns." The need exists, Upsher-Smith said, "for improved and increased communication between FDA staff and industry representatives." The main areas of missed communications, the company indicated, "include communications regarding the status of an application and the accessibility of reviewers to answer questions about the application." The board could also "publish a monthly report which would cover the issues discussed and the responses to each concern." Similarly, Lederle recommended that the Office of Generic drugs establish a system under which companies can appeal FDA decisions. "FDA should set up a mechanism for handling appeals by ANDA holders and applicants who disagree with FDA's interpretation or implementation of laws or regulations." Lederle added that "fear of retaliation is still an industry concern." Barr Labs, one of the most vocal of the firms criticizing previous ANDA procedures, advised the agency in comments that FDA "must improve the fairness of generic drug review policies and procedures." Suggestions for a level playing field include proper management of submitted information, consistency in its decisions, and establishment of standards for finding whether approvals or bioequivalence determinations can be withdrawn retroactively. The Pharmaceutical Manufacturers Association stated, in its comments, that "the single most important administrative requirement for the responsible management of the Generic Drug Program is close and careful monitoring of the review process by FDA senior staff." The association continued: "In order to effectively monitor the system, there must be a tracking system in place that will allow supervisory personnel to identify aberrations in the process of review and approval." PMA also suggested that Summary Basis of Approvals should be generated for generic drug approvals so that "any member of the public can obtain a document describing the review leading to approval and examine the scientific basis for such action."
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