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September 1996

United States v Najarian: A Postmortem on Regulatory Misdirection

Author Affiliations

Minneapolis, Minn

Arch Surg. 1996;131(9):911-914. doi:10.1001/archsurg.1996.01430210009001

THE RECENT prosecution and acquittal of well-known transplantation surgeon John S. Najarian, MD, of the University of Minnesota at Minneapolis has renewed controversy concerning how the Food and Drug Administration (FDA) functions. At the conclusion of the trial, the presiding federal judge took the unusual step of publicly criticizing the FDA for its decision to file criminal charges based on conduct that the court believed the FDA had been aware of for some 20 years. The poor oversight and decisions by the FDA in this case, coupled with its enormous influence on academic institutions, has further strained the relationship between regulators and academic medicine.

CASE HISTORY  On August 13, 1992, the deputy director of the FDA's Center for Biologic Evaluation and Research traveled to Minneapolis, Minn, to personally deliver a letter to University of Minnesota President Nils Hasselmo and Department of Surgery chairperson, Dr Najarian. This letter closed down the

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