Abstract
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
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
