CDRH Director Offers Resignation

Statement By POGO's DR. Ned Feder, Staff Scientist,

“Daniel Schultz announced today that he is resigning as director of the Center for Devices and Radiological Health (CDRH) -- the FDA’s center responsible for the safety of medical devices. He is resigning “by mutual agreement” with FDA Commissioner Margaret Hamburg. This appears to be a polite way of saying he was forced to resign. This is welcome news. This important FDA Center has been in desperate need of new leadership.

Dr. Schultz’s resignation offers a long-awaited opportunity for openness and reform. This was a critical first step, but FDA Commissioner Margaret Hamburg still has significant work ahead. Among the needed reforms is dealing quickly and openly to correct the harm caused by retaliation against the extraordinary number of CDRH whistleblowers who have reached out to the Congress, the media and public interest groups including POGO. It is also essential to investigate the allegations made by these insiders, particularly of improper influence over FDA decisions to approve medical devices. Until it is clear that the culture of fear at CDRH is over, it will be impossible to restore integrity to the important work of the CDRH.”

POGO Resources:

The FDA's Deadly Gamble with the Safety of Medical Devices

February 18, 2009

This was a POGO report focusing on Daniel Schultz's questionable decisions. We posted several follow-up letters to Schultz asking what he would do to correct the problem.

Powerful Leader Takes Command of a Battered FDA: Irresistible Force Meets Immovable Object

May 19, 2009

In this Commentary we pressed Commissioner Hamburg to deal with several problems at the FDA, including the whistleblower problem mentioned in today's notice. Although Schultz isn't mentioned by name, the whistleblowers in the Commentary and those in today's notice are the same ones.