The pharmaceutical consultants at the US Government Accountability Office (GAO) has criticised the Food and Drug Administration for allowing doctors and researchers with criminal convictions to work for the FDA as supervisors during clinical trials or as researchers. By failing to debar anyone with a criminal record from work activities with the FDA, the Administration is breaking its own rules.
On average, GAO found that it took the FDA an average of four years to get round to debarring doctors with a conviction. This is despite the fact that the administration is required by law to disqualify doctors who have been found guilty of fraud or other crimes. One dramatic case was that of a male doctor who had been convicted of a 53 criminal counts but went on to work for the FDA for 11 years.
Prescribing medicine without a license, fraud and lying during clinical trials were other charges that doctors had been committed of. There are also major concerns over the fact that three doctors continue to work with the FDA even though they are known convicted criminals.
presenting false data at clinical trials was the dominant charge amongst the doctors. They made up statistics for non-existent participants, did not follow the research plan of the trial or failed to gain the informed consent of trial participants. There is also a contentious issue over doctors who have been found to break the law over medical devices. Doctors who have broken the law can move their work into the medical device sector without breaking the law because there are no rules to stop this, and this puts the lives of millions of people at risk including those who suffer from asthma.
With the FDA already breaking rules and laws with no regard for the consequences, there seems little point in simply applying new regulations. Instead, they propose a wide reform of the whole health care system in America. Proposals include that no company director should be allowed to hold a senior position within the FDA and those doctors who break the law should be prosecuted.
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