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FDA v. Utah Medical

This article was originally published in The Gray Sheet

Executive Summary

Independent members of the firm's board affirm "full and unanimous support" of Utah Medical's decision to pursue FDA dispute resolution through the federal court process "because of the fundamental refusal by FDA managers to communicate," according to an Aug. 16 company release. The Department of Justice filed a complaint Aug. 9 seeking to halt Utah Medical sales after an FDA inspection cited persistent QSR lapses dating to 2001, although the company maintains it is in compliance with QSR (1"The Gray Sheet" Aug. 16, 2004, p. 6). "We understand that the company's position is unusual, and may appear unwise to some shareholders, [but] I assure you that we haven't been provided another reasonable alternative," board member Stephen Bennett, MD, asserts. For example, a May 2004 request for non-binding mediation was rejected by the agency, according to the company. On Aug. 20, the firm instituted a 10% discount on all U.S. hospital orders as a "reward" for customer loyalty in the face of FDA's "unfair" charges...

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