FDA Device Center Loses Another Top Staffer

Full article reprinted from "The Gray Sheet" - September 14, 2009

CDRH's associate director for regulations and policy Kate Cook is leaving the device center to join FDA's biologics center, the agency confirmed last week.  Read more...

FDA Device Center Loses Another Top Staffer

Full article reprinted from "The Gray Sheet" - September 14, 2009

CDRH's associate director for regulations and policy Kate Cook is leaving the device center to join FDA's biologics center, the agency confirmed last week.

Cook joined CDRH in early 2008 for what was supposed to be a four-month detail, replacing acting associate director for regulations and policy Mark Raza, who returned to the FDA Office of Chief Counsel (1 'The Gray Sheet' Jan. 28, 2008).

Cook's four-month acting position stretched into a year-and-a-half stint, during which time she was second-in-command to CDRH Director Dan Schultz.

Her move comes on the heels of Shultz' resignation from the agency last month (2 'The Gray Sheet' Aug. 17, 2009). The former director said he came to a mutual agreement with FDA Commissioner Margaret Hamburg that his exit "would be in the best interest of the center and the agency."

For the past several months, device center management has been under fire from Congress and the public following a series of letters from a small group of internal CDRH whistleblowers alleging corruption within the center.

Cook was never directly implicated in any of the whistleblower letters, and an FDA spokeswoman said her move was likely not related to any perceived scandal.

Schultz's interim replacement, Jeffrey Shuren from the FDA commissioner's office, started Sept. 2. A nationwide search for a permanent CDRH director continues.

Prior to joining CDRH, Cook was associate chief counsel for biologics at FDA and, before that, associate chief counsel for enforcement.

The FDA staffer received her J.D. from the New York University School of Law.

Nancy Stade, a former attorney in FDA's Office of Chief Counsel, will fill Cook's vacated position.

- Jessica Bylander

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