FDA CRIMINAL INVESTIGATORS COULD BE REQUESTED IN HHS LEGISLATIVE PROPOSAL
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 The move was rescinded, under pressure from the Department of Justice, this past January.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."
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth