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FDA GENERIC DIVISION TIGHTENING STANDARDS FOR EXPEDITED REVIEW

Executive Summary

FDA GENERIC DIVISION TIGHTENING STANDARDS FOR EXPEDITED REVIEW of ANDA and AADA (abbreviated antibiotic drug application) supplements. The new policy is outlined in a March 29 "policy and procedure guide" from Division of Generic Drugs Acting Director Richard Terselic. Under the policy, the division "will generally no longer consider a circumstance that is reasonably foreseeable or part of the ordinary risks of doing business which can simply have a positive or negative economic impact only on a single generic firm as sufficient to justify granting an expedited review." Requests for expedited review, Terselic said, "should be based upon reasonable expectation that interruption in supply would cause severe economic hardship or a significant unmet therapeutic need." FDA previously received and granted a large number of requests for expedited review of ANDA/AADA supplements. Tightening the standards and formalizing the criteria for expedited review is part of the agency's broader effort to standardize the ANDA review process following the generic drug scandal. The policy guide lists four situations where expedited review will generally be granted: (1) supplements relating to "pending legal/regulatory action or need by the government's drug purchasing program"; (2) supplements relating to "federal or state legal or regulatory actions, including mandated formulation changes or labeling changes"; (3) supplements pertaining to an event "outside the control of the applicant" that "could not have been reasonably and adequately planned for" -- such as a natural disaster or the abrupt discontinuation of supply of the active ingredient; and (4) the relocation of a facility "undertaken for the purpose of maintaining or significantly enhancing assurance of high manufacturing standards (for instance, gaining sufficient space to prevent intermingling of materials, improving air handling, etc.)." In the case of a facility being relocated, the policy guide advises that the request for expedited review should be submitted at least four months in advance of the actual change-of-site supplemental application. In addition, the request for expedited review "must clearly delinerate how the move will result in increased assurance of manufacturing standards so that the division can arrange for orderly processing and review," FDA noted. * A second policy guide describing the flow of action letters throughout the Office of Generic Drugs was also issued by Terselic on March 29. The series of flow charts on FDA review and sign-off procedures indicate several changes from previous policy. For instance, the Division of Bioequivalence will no longer send out approval letters on bio studies. From now on, FDA will inform a sponsor of results of a bio study review only if deficiencies are found. Among other changes, requests for waivers of bio study requirements will now have to be approved at the Office level (i.e., the Office of Generic Drugs will have to approve the request as well as the Division of Generic Drugs). Office level approval will also be required for bio study protocols of drugs not previously approved as generics.
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