Scientists criticize the FDA for "serious misconduct" in approving unsafe or ineffective medical devices
The scientists claimed that they have documentary evidence of the FDA administration "corrupting scientific review of medical devices" by ordering agency experts to reverse their opinions. The agency's assistant commissioner for integrity and accountability characterized this documentary evidence as "compelling" and sufficient to justify disciplinary action. Bush-era administrators had dismissed the claims after administrative review, suggesting the aggrieved scientists "move forward" and allegedly leaving them open to reprisals by the very managers they had criticized.
This issue gains greater importance when one considers that the US Supreme Court recently approved the Bush administration's request to grant preemptive immunity from state court negligence actions for all medical devices approved by the FDA. Scientists and physicians have criticized the grant of immunity to FDA-approved devices or medications, pointing out that these state court negligence actions have served a valid watchdog function that has protected patient safety.