Brave scientists and physicians working for the FDA speak out against it’s corruption
America urgently needs change at FDA because FDA is fundamentally broken, failing to fulfil its mission, and because re-establishing a proper and effectively functioning FDA is vital to the health of the nation.
The purpose of this letter is to inform you that the scientific review process for medical devices at FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk. Through this letter and your action, we hope that future FDA employees will not experience the same frustration and anxiety that we have experienced for more than a year at the hands of FDA managers because we are committed to public integrity and were willing to speak out. Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around.
This is an excerpt from a letter written by FDA scientists and doctors accusing top FDA officials and attorneys of violating laws, suppressing and altering scientific findings and conclusions, abuse of power and authority, and retaliation against those who have spoken out. The scientists’ and physicians’ names have been withheld for their protection.
The letter also states that the Director of the Office of Device Evaluation (ODE) has:
- Ordered physicians and scientists to ignore FDA Guidance documents.
- Knowingly allowed subordinates to issue written disciplinary actions for failure to change scientific opinions.
- Issued illegal documents that are not publicly available and would circumvent scientific and legal requirements.
- Failed to properly document significant decisions.
- Made and allowed false statements in FDA documents.
- Allowed manufacturers to market unapproved devices.
- Removed Black Box warnings FDA experts recommended.
- Bypassed FDA experts and failed to properly label devices.
- Excluded FDA experts from meetings when manufacturers didn’t want them there.
Three specific device approvals referenced were:
- Interference by former FDA chief Andrew von Eschenbach in approval of a knee device.
- A computer-aided mammography device’s approval over the unanimous vote against it by all FDA experts after a phone call from Congressman Christopher Shays.
- Daniel Schultz’s approval of a device to prevent scar tissue in spite of the scientists’ unanimous opinion against it..
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