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Executive Summary

ANDA SUMMARIES FOR FDA INSPECTIONS: REQUIREMENT UNDER CONSIDERATION by the agency, Division of Generic Drugs Acting Director Richard Terselic noted in Jan. 10 comments on FDA's proposed ANDA regs. "With regard to application submission requirements, we are thinking about asking for applicants to submit a summary that would be used by FDA field staff in verifying compliance with the promises made in the complete application," Terselic said. "We would like the regs to provide us flexibility in establishing the requirement for a new summary such as discussed, or other special submissions." The possibility of a summary requirement reflects FDA's interest in greater enforcement in the post-generic drug crisis period. The concept appears to be an outgrowth of the heightened inspection efforts undertaken during the generic drug investigation. As part of the agency's massive review initiatives during the investigation, FDA inspectors brought ANDAs to inspection sites to compare ANDA commitments with actual manufacturing practices. Terselic noted that the division is also "reconsidering" its policy on granting in vivo waivers. Office of Generic Drugs Acting Director Burlington "may wish to revise the criteria stated [in the regs] on granting waivers," Terselic said. One area the agency may be interested in clarifying is waivers for intravenous v. intramuscular and intrathecal products. The proposed reg states that FDA will waive in vivo bioequivalence requirements for intravenous products but is silent on intramuscular and intrathecal dosage forms. Terselic objected to a number of the "operational aspects" of the proposed reg, such as provisions for 90-day conferences, end of review conferences, and other meetings, because of the potential burden on the generic drugs group. Noting that the regs were originally drafted when "everyone in the generic drug industry was considered to be honest and competent to make good drugs and thus a process that emphasized speed was well justified," Terselic said: "The burden I see coming to the generics group related to such things as the 90-day meeting and end of review meeting provisions, and the time limits on processing amendments would come at a time when the program is going through a major change in terms of much greater expectations toward care in review and documentation." Both Terselic and Division of Generic Drugs Director of Chemistry Robert Jerussi, PhD, suggested that the regs be revised to require submission of complete ANDAs. "To accept applications without the completed bio study and start the statutory 180 day review period because 'current agency practice' at the time of writing these proposed regulations allowed submission of a bio protocol rather than the data is simply wrong," Jerussi said. "Agency 'practice' at that time was to stamp out approvals and accepting incomplete applications was part of agency policy. The statement [in the regs] that 'the agency intends to continue this practice' flies in the face of the generic drug disaster, the Dingell hearings and what FDA has learned from them," he said. Jerussi also suggested that the provision allowing for hearings on ANDA decisions be revoked unless user fees are implemented. "This remedy should not be available for abbreviated applications but should be for 505(b) applications because of the tremendous differences in cost of presenting each application to the agency," Jerussi said. "If user fees are instituted for abbreviated applications, then hearing requests should be entertained."

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