The FDA: Is It “Fundamentally Broken”?

Nine scientists at the FDA sent a letter to President Obama on Wednesday to plead for major reform at the agency. Their central concern is with the agency’s scientific review process for medical devices, which they characterize as having beeen “corrupted and distorted by current FDA managers, thereby placing the American people at risk”. The letter detailed their allegations, such as threats of disciplinary action against scientists who dissented from management. It described the atmosphere at the agency as being one where “the honest employee fears the dishonest employee,” and where scientists cannot do their jobs without fear of reprisal. Ultimately, the agency was described as “fundamentally broken”.

The scientists further detailed their efforts to take their concerns to agency leaders, such as Commissioner Andrew Von Eschenbach, and the assistant commissioner for accountability and integrity, attorney Bill McConagha, but no changes have occurred. Worse yet, the problematic managers were not held accountable, but were promoted and rewarded.

Sources:

Dow Jones Newswires, January 8, 2009