Breaking News from "The Gray Sheet" - August 11, 2009
CDRH Director Daniel Schultz is resigning from the agency after discussions with new FDA Commissioner Margaret Hamburg, the longtime FDA employee told staff in an Aug. 11 memo. Read more...
CDRH Director Dan Schultz Resigns
CDRH Director Daniel Schultz is resigning from the agency after discussions with new FDA Commissioner Margaret Hamburg, the longtime FDA employee told staff in an Aug. 11 memo.
Following talks with Hamburg, Schultz says they came to a "mutual agreement" that his resignation "would be in the best interest of the center and the agency."
Schultz's resignation does not come as a complete surprise. Over the past year, the director has been under fire from Congress and the public following a series of letters from internal FDA whistleblowers alleging corruption in the agency.
The letters accused Schultz, Office of Device Evaluation Donna Bea Tillman and other unnamed FDA managers of coercing and intimidating staff into modifying device evaluations, and called for their resignation.
Schultz expressed regret at leaving the agency after 15 years in the device center. The former surgeon has served as director since 2004, when he replaced David Feigal.
Schultz joined FDA in 1994 as a medical officer in the General Surgery Branch of CDRH, and served in several other review divisions before heading the Office of Device Evaluation and, eventually, the center.
– Jessica Bylander
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