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FDA’s NEWARK DISTRICT OFFICE COMPLETED ONLY 34% OF ITS PLANNED INSPECTIONS IN FISCAL 1991, INSPECTOR GENERAL FINDS; NEWARK CLEARED OF MISMANAGEMENT

Executive Summary

FDA's Newark District Office completed only a third of its budgeted inspections during fiscal year 1991 due to understaffing and a lack of experienced investigators, according to an investigation by the HHS Office of the Inspector General. The Newark office completed only 113 of the 335 inspections for which it had received funding, or 34%, the IG found. The main reason for this shortcoming, said IG, was that, as of Nov. 29, 1991, the Newark office was operating with "18% less investigators than is authorized" (60 investigators instead of 73). In addition, 76% of the investigators at NDO had less than a year-and-a-half of experience. With purview for all of New Jersey, the Newark District Office is responsible for the state "with the highest concentration of drug manufacturing firms." The Newark Office is not alone in its inability to meet inspection goals; the report notes that "no district was able to meet its goal with respect to the number of inspections planned." However, of FDA's 21 district offices, NDO ranked 19th in FY 1990 in terms of the number of inspections. It ranked fifth in terms of effectiveness, measured as "the number of times an inspection resulted in a serious enforcement action." While faulting the Newark district office for failing to meet its target number of inspections, the IG concludes that there is "no evidence to support allegations that NDO management inhibited the proper inspection of generic drug manufacturers and other firms regulated by FDA." The investigation was ordered last year by House Energy & Commerce/Oversight Subcommittee Chairman Dingell (D-Mich.) to answer two questions: if management at NDO inhibited the inspection of generic drug firms; and whether the district office's ability to enforce the FD&C Act was compromised by mismanagement. Dingell ordered the investigation, carried out in March 1991, as a follow up to his March 1991 hearing concerning communication problems between the Chicago District Office and FDA headquarters. Allegations of diversion of funds and mistreatment of employees were also investigated by the IG. The IG concluded that NDO's lack of productivity could "adversely impact FDA's ability to complete its mission of regulating generic drug manufacturers and others through inspections." The problem "could merit the attention of senior departmental officials," the report adds. To help NDO reach its goals, the report recommends that "FDA should, as soon as possible, perform internal control reviews focusing on its regional office responsibilities and performance of inspections." The investigation also probed charges that NDO management had removed experienced investigators from generic drug inspections and replaced them with newer investigators. After reviewing computerized and hard-copy management forms listing participants in a sample of 72 inspections carried out over a three-year period, the IG did not find "that any investigators had been replaced" by other FDA investigators during that time. The IG also said that charges were unsubstantiated that NDO management harassed investigators into terminating inspections of generic companies prematurely. The IG investigators additionally explored allegations of diverted funds and the removal of documents prior to an internal review. "Our review did not disclose any diversion of funds or that documents had been removed improperly from the district office," the report states. However, the investigation did reveal that in 1988, $15,800 were "obligated and expended improperly" instead of being returned to the Treasury Department. The report makes three recommendations in addition to the internal control review of FDA's regional offices to improve efficiency: "remind regions of proper practices for reobligating unused funds that should be...returned to the Treasury"; "expedite hiring to fill authorized investigator positions transferred from the Mid-Atlantic Regional Office" to alleviate NDO's staffing shortage; and "continue monitoring corrective actions to increase inspections and meet performance goals."
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