The industry newsletter, The Gray Sheet and the Wall Street Journal both reported that Daniel Schultz, MD, Director of the Center for Medical Devices and Radiological Health (CDRH) offered his resignation to Dr. Margaret Hamburg, the new FDA Commissioner. Schultz said that the resignation was an agreement between him and Hamburg stating that Dr. Hamburg agreed his resignation “would be in the best interest of the center and the agency.” That doesn’t look good on your CV.
Dr. Schultz was under many clouds of suspicion. There have been serious charges leveled at the management of CDRH by employees conducting scientific review of new medical devices submitted to FDA. This is actually a very big deal. The Gray Sheet article is attached on the Blogroll as, “2: Schultz resigns.” I am very curious who else will be resigning in the Hamburg Era.
UPDATE: The Wall Street Journal reports on Dr. Janet Woodcock, Dr. Schultz’ counterpart at the Center for Drug Evaluation and Research, having conflict of interest problems. Read their coverage on the Blogroll: “11WSJ: Drug chief accused of conflict.”