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Executive Summary

HHS IG PRESSES FDA TO BUILD A CALENDAR OF EVENTS FOR EACH ANDA REVIEW in a comprehensive management information system (MIS). The HHS Inspector General's Office and FDA continue to discuss the MIS needs of the agency's Office of Generic Drugs to address the problems in the generic drug review process that have surfaced in the past year. The HHS Inspector General outlined the weaknesses of FDA's generic drug management information system (MIS) in a draft report sent to HHS Assistant Secretary for Health Mason in late January. After receiving comments from Mason's office, the IG released its final report on July 6. The IG's draft report made five recommendations on how FDA can improve its generic drug MIS, including: (1) correcting information in the MIS database to accurately reflect the assignment of applications to reviewers; (2) using the MIS to produce additional information to enable FDA to track the progress of applications, in elapsed days, through the review process and to compare and analyze variations in ANDA approval times; (3) adding information to the MIS on deficiencies found in ANDA reviews; (4) using the MIS to determine whether current resources are being used effectively; and (5) disclosing in reports required for federal agencies that there is a material internal control weakness in the generic drug MIS. In March comments on the IG draft report, FDA, under the rubric of the Public Health Service, agreed with the IG's recommendations that the agency correct information in the database and use the MIS to better determine FDA resource needs in the generic area. However, FDA only partially concurred with the IG's recommendations that additional information be included on the MIS database to improve tracking of reviews and that ANDA deficiencies be included in the database. FDA suggested that several of the events that the IG wanted to include in the MIS database -- such as the date a chemist begins review of an ANDA, receipt of inspection reports, and drug sample testing results -- "are dealt with effectively in regular FDA management oversight meetings" and, therefore, should not be included in the MIS. The IG, however, in the final report expressed its differences with the agency. "We believe that these events are very important events in the generic drug approval process," the IG report states. The IG noted that knowing when a chemistry review begins might flag ANDA review discrepancies among reviewers or possible manipulation of reviews. The IG also recommended that the dates of receipt of inspection reports should be included in the MIS "to ensure that facilities requiring inspections as part of the ANDA approval have been inspected." And regarding testing of samples, the IG pointed out that several reviewers at the agency involved in manipulation of ANDA reviews several years ago were approving ANDAs before sample validation results were on file at the agency. With regard to including a notice of ANDA deficiencies in the MIS, FDA agreed with the idea in concept, but suggested that the agency address the issue by doing a one-time study of ANDA deficiency letters that would be completed by June of next year. Instead, the IG suggested that FDA develop a code that would flag ANDAs based on the kind of deficiencies that have turned up in the submission. In addition, FDA disagreed with the IG's fifth recommendation, noting that HHS Secretary Sullivan had reported material weaknesses in the generic approval process to the White House and Congress in December. In response to the comments, the IG recommended, instead, that FDA "revise" its action plan for generic drugs "to incorporate those actions necessary to correct weaknesses in the generic drug MIS."

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