Ethics: August 2009 Archives

The long-time head of the FDA's Center for Devices and Radiological Health (CDRH), Daniel Schultz, will resign. Schultz describes his impending resignation as the result of a "mutual agreement" with the new FDA chief, Margaret Hamburg, reports the AP. His announced departure from the center comes after months (if not years) of discontent among the center's scientists, 9 of whom alleged that the agency was "fundamentally broken" in recent letters to the House Energy and Commerce Committee and Obama's transition team. The scientists also reported that FDA managers "ordered, intimidated and coerced" the scientists to manipulate data during product reviews.

In response to the scientists' complaints, the FDA conducted its own internal investigations last year. The first was led by William McConagha, the FDA's Assistant Commissioner for Integrity and Accountability. A follow-up investigation was conducted by Schultz himself, who concluded that "FDA physicians and scientists need to 'move forward,'" according to the scientists' letters. They also alleged that Schultz allowed management reprisals against FDA device reviewers, including threats of job loss and "illegal and improper employee performance evaluations." 

Schultz, a medical doctor, is/was a career FDA officer who was appointed CDRH Director in 2004.

Photo of Daniel Schultz from the FDA.