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Executive Summary

FDA DEBARMENT PROCEEDINGS CONSTITUTIONALITY LIKELY WILL BE ARGUED IN COURT "in the next few months," FDA Deputy Chief Counsel for Regulations and Hearings Linda Horton predicted March 24 at a Food & Drug Law institute meeting in Washington, D.C. "I think we're probably going to be in court sometime in the next few months [on[ the constitutionality of the statute because it applies retroactively to people who were [convicted] prior to enactment of the Generic Drug [Enforcement] Act " of 1992, Horton stated. Horton added: "I can't predict the outcome, but it should be a very interesting case." Judicial review of debarments could go before the D.C. Court of Appeals or to the district courts. She noted that "FDA has initiated debarment proceedings...somewhere between 10 and 20 persons and...all of the requests for hearing have raised legal issues." The most recent round of requests for debarment hearings includes former Bolar VP-Operations Charles DiCola, ex-Bolar Director of Quality Assurance Arnold Mendell and ex-American Therapeutics VP-Regulatory Affairs and Quality Control Daphne Pai. Other recent hearing requests were filed for former Pharmaceutical Basics, Inc. Exec VP Raj Maktari, former FDA generic drug review chemist Walter Kletch, ex-manager of product development at Superpharm Liaquat Hossain and Constantine Kostas, a clinical investigator who fabricated data in studies of Miles' antibiotic Cipro. Many of the requests for hearings include arguments about the constitutionality of debarring individuals after they have been convicted and served their sentences ("The Pink Sheet" Jan. 25, p. 8). In a March 5 statement to support his request for a hearing, for example, Mendell argues that his "alleged crimes" occurred prior to the effective dates of the Act and "neither punitive statutes nor punitive regulations can be applied to conduct that occurred prior to the effective dates of their provisions." He noted that "to do so violates constitutional prohibitions against retrospective and ex post facto applications of laws." Mendell also claimed that, in addition to his sentence, "for the agency to impose an additional penalty of lifetime debarment from the only livelihood available to respondent flies in the face of society's decision to prohibit, by constitutional fiat, double punishment and bills of attainder." Mendell was sentenced to 18 months imprisonment for shipping adulterated drugs and obstructing an FDA investigation.

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