By Steve Brozak
1.19.2009 | Food and Drug Law Institute
FDA is a troubled agency in need of fundamental reorganization. It has been criticized by Congressional watchdogs for years and recently, staff members sent a letter to Congress highlighting some of the problems they see within the agency. On October 14, a group of scientists and physicians in the FDA’s Center for Devices and Radiological Health (CDRH) wrote to Representative John Dingell (D-MI) saying “managers at CDRH with no scientific or medical expertise in devices, or any clinical experience in the practice of medicine have ignored serious safety and effectiveness concerns of FDA experts and have ignored scientific regulatory requirements.” The letter further accused FDA management of knowingly “allowing a continuation of management reprisals” against those who raised these and other concerns.
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