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Executive Summary

NDA DATA FALSIFICATIONS: U.S. ATTORNEY GENERAL PURSUING FOUR CASES actively, including two which have been sent to grand juries. The NDA cases were disclosed in a recent list of 213 cases the HHS Inspector General's Office has investigated as possible felony violations of the FD&C Act. One additional case has been transferred to another federal investigative agency, with another case referred to the Department of Justice. Of the six, four were turned up through other IG investigations, and two were steered to the IG by FDA. The IG is additionally reviewing four separate complaints of "fraudulent new drug applications." The complaints are in preliminary stages of review, and the IG has not yet determined whether there is enough evidence of possible wrongdoing to warrant further investigation. The listing of cases was provided as background material for a presentation by the IG at a May 14-15 conference on the "1990 NDA Pipeline." The conference was cosponsored by International Business Communications and F-D-C Reports. Sixty-six of the 213 cases listed by the IG already have been or will be referred to the Justice Department's Officer of Consumer Litigation (OCL). Forty-seven cases have been transferred to other investigative agencies, but also could be sent to OCL. Seventy-five cases have been or will be closed. Almost all of the 213 cases were opened in 1989. Other cases listed as under active grand jury include one investigation of a "fraudulent ANDA." In addition, there have been 16 allegations of distribution of counterfeit drugs, all of which have been transferred to Justice, and four alleged failures to report adverse drug reactions. Three of the latter have been transferred already to Justice. Most of the remaining cases involve illegal distribution of drug sampleq 4'ZHTY escription Drug Marketing Act, or trafficking in anabolic steriods.

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