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. In one case it took the FDA 11 years to disqualify a doctor who had been convicted of 53 charges including covering up a patient’s suicide during a clinical trial.

Prescribing medicine without a license, fraud and lying during clinical trials were other charges that doctors had been committed of. There are even three doctors who continue to work with the FDA despite knowledge that each of them have a criminal conviction.

The most common charge that the doctors had committed was that of falsifying criminal data. 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. Under present FDA rules, a doctor who has been convicted of a criminal offence is not prohibited from practicing in the medical device industry, which could be putting the lives of millions of people at risk, especially since inhalers used to treat asthma are thought of as a medical device.

Critics do not see any benefits of introducing new rules as the FDA has already flouted many of the laws that currently govern it. New reforms should instead be applied so that there is no room for these laws to be broken. Prosecutions for doctors found to be breaking the law, company executives barred from senior roles in the FDA and a stricter relationship between the FDA and drug companies.

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