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This article was originally published in The Gray Sheet

Executive Summary

A group of national experts on device compliance would review major enforcement actions recommended by FDA district offices under a proposal put forth by the House Energy and Commerce oversight subcommittee in its June 1 report on the device center. The group is needed, the subcommittee maintains, because "neither the FDA's previous labyrinthine enforcement review process, nor the current review process, has any systematic way to re-examine the factual premises of a proposed action." The experts would enable the agency "to independently corroborate facts for cases in which a major injunction, major recall, or similarly strong enforcement action may be or is recommended by the district office," as well as in cases where "FDA has reason to believe the district office efforts have been inadequate." The subcommittee suggests that the group could be based either at FDA headquarters or scattered in the FDA regions and would be "on call to examine inspector findings, review the plant involved, and submit appropriate analyses to headquarters." FDA's Center for Devices and Radiological Health also should "develop internal controls on enforcement action to assure consistency," the House panel states. The subcommittee argues that the "lack of timely inspections, inspector training, a poor management information system, and an historical reluctance to provide guidance all segments of the medical device industry has left the identification of deviations and the accompanying enforcement actions largely up to the personal interpretation of the district office inspector. Combined with the [district offices'] authority to issue warning letters, this lack of consistency has created a counterproductive relationship between the district offices and the industry." "It appears that FDA now takes aggressive enforcement action, yet lacks the controls and training to avoid inconsistent or arbitrary decisions that could result from, or otherwise be associated with, the stepped-up enforcement efforts," the report adds. If FDA Commissioner "Kessler's intent in adopting a new enforcement policy was to get the attention of the medical device industry, he undoubtedly has achieved the desired effect. However, merely getting industry's attention without articulating FDA's expectations, can lead to a confused and demoralized industry that is no better able to comply with the law." The subcommittee cites additional weaknesses in enforcement procedures that may be interfering with compliance. For example, the panel faults FDA for failing to issue adequate information on enforcement actions. "There needs to be a system for disseminating guidance both to industry and the FDA field offices on what triggers a warning letter, what a firm can expect when it responds to an inspection, what makes FDA categorize a recall as mandatory, and what conditions trigger injunctions, seizures, and consent decrees." The subcommittee also echoes several criticisms of FDA's enforcement of device good manufacturing practices regulations raised in a General Accounting Office report released at a subcommittee hearing in March 1992 ("The Gray Sheet" March 30, 1992, p. 7). The agency suffers from "an insufficient number of inspectors to conduct timely inspections" and "untrained inspectors who cannot, or will not, distinguish between 'significant' and 'nonsignificant' GMP violations," according to the report. FDA should establish an "ongoing training program for device inspectors," the panel concludes.

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