Feb 032012

On January 25, 2012, several current and former employees of the FDA filed a lawsuit in the District Court of Washington, D.C. The employees allege that they found that some medical devices were not safe or effective. Their supervisors went ahead and approved the devices anyway. These employees then contacted members of Congress. The FDA supervisors found out and took revenge against them. Targeting an employee for whistleblower activity is against the law. So these employees are suing the FDA.

The most important news about this lawsuit is that it shows the bias of the FDA in favor of approving new drugs and devices, even if they are not safe or effective. This lawsuit will expose the corruption within the FDA as the lawsuit progresses. With the very limited information available so far it appears that General Electric applied for approval of some radiological machine. The expert-employee of the FDA found that the machine was not safe because the patient received too much radiation. The supervisor overruled the expert and approved the device. The employee complained to Senator Grassely. Somehow the complaint leaked to the New York Times and the paper published an expose.

Obviously the supervisors and other high-position staff of the FDA favor the drug and device industry over the health and well-being of the American public. The reasons for such a favor are many. A lot of FDA staff finds employment with the drug companies after they leave the agency. Therefore they want to develop relationships with the drug company managers. The drug companies are in a position to put pressure on Congress and the members of Congress in turn put pressure on the FDA staff to approve as many drugs and devices as fast as possible. It is also possible that some members of FDA staff are already on the payroll of drug companies.

 Posted by at 1:05 pm