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Executive Summary

HHS is considering requesting that criminal investigators be placed on staff at FDA, the department's General Counsel, Michael Astrue, told the Senate Committee on Governmental Affairs at a March 8 hearing. There currently are not criminal investigators assigned to FDA, Astrue noted. Asked by committee Chairman Glenn (D-Ohio) whether the legislative proposal for strengthening the agency's enforcement efforts, under review by the Office of Management and Budget for the past six weeks, requests criminal investigators for FDA, Astrue responded that it did not. However, he noted that HHS is considering asking OMB to amend the proposal to include assignment of criminal investigators to the agency. HHS announced last summer that it would recommend legislation to enhance FDA enforcement authority in the wake of disclosures from investigations into the generic drug industry ("The Pink Sheet" Aug. 21, p. 13). Glenn's interest in the proposal revolves around HHS Secretary Sullivan's July 1989 redelegation of enforcement authority for felonious violations of the FD&C Act from FDA to HHS' Office of the Inspector General. The move was rescinded, under pressure from the Department of Justice, this past January. "I am concerned that the shocking problems uncovered in FDA's regulation of the generic drug industry -- leading to eight convictions already -- will impair public confidence in all generic drugs," Glenn said in his opening statement. The rescission of the Inspector General's criminal enforcement authority was made "I believe, under pressure from the Justice Department," the senator continued. Through the rescission, HHS "has rejected a valuable resource -- the criminal investigative capabilities of the HHS Inspector General."

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