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HHS INSPECTOR GENERAL NO LONGER INVESTIGATING FD&C ACT CRIMINAL VIOLATIONS

Executive Summary

HHS INSPECTOR GENERAL NO LONGER INVESTIGATING FD&C ACT CRIMINAL VIOLATIONS, Rep. Dingell (D-Mich.) complained in a Nov. 15 letter to FDA Deputy Commissioner Benson. "The memorandum of understanding between yourself and" HHS Inspector General Richard Kusserow "regarding the possible professional assistance in criminal cases was permitted to expire on Sept. 30, 1990," Dingell wrote. HHS Secretary Sullivan testified at a July 18 hearing of Dingell's House Oversight Subcommittee that FDA and the Inspector General had "a new agreement" to "enable experienced [IG] criminal investigators to work with FDA in criminal investigations" with the acceptance of the Justice Department ("The Pink Sheet" July 23, p. 6). However, Dingell considers Sullivan's testimony to have been misleading in that the agreement to which it referred was temporary. "In retrospect, this [FDA/IG] agreement appears to have been done by the department merely to deflect the subcommittee criticism of Secretary Sullivan at our July 18, 1990 hearing into enforcement problems regarding violations of the federal FD&C Act," the letter states. Dingell's letter was prompted by an alleged delay by FDA in initiating a criminal investigation into the Pfizer subsidiary Shiley. Dingell claims that Shiley had made "possible false and misleading statements to the FDA" about its Bjork-Shiley heart valve. According to Dingell, FDA in March indicated it would initiate such an investigation following Oversight Subcommittee hearings regarding Shiley's handling of valve failures. "As you are well aware," Dingell wrote Benson, "the subcommittee has expressed doubts regarding the competence of the FDA to conduct criminal investigations on its own." In July 1989, Sullivan delegated to the Inspector General authority for criminal investigations into felony violations of the FD&C Act. He rescinded that authority last January, Sullivan has testified, because the Justice Department "would be unwilling to defend" in court the legality of such an overlap of FDA/IG investigational authority. The FDA/IG/Justice agreement struck last summer was to have reinstituted the 1989 delegation with modifications. Dingell reportedly is disturbed that even that agreement is defunct and criminal investigations into FD&C Act violations are being abandoned.

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