Pharmaceutical Consultants Find Law Breaking Doctors Working With The Food And Drug Administration

Wednesday, January 27th, 2010 at 9:21 am

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. This is a damning indictment of the FDA who has even been found to be breaking their own rules when they fail to debar these personnel when they are discovered to hold a criminal record.

It takes the FDA an average of four years to debar anyone working for them with a criminal conviction as shown in the results of the GAO enquiry. 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.

There are many similar cases to this where doctors have committed fraud, bribery and prescribing medicine without a license. Three doctors continue to work for the FDA even though they have public criminal conviction charges.

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 major concern over criminal doctors’ involvement in the criminal device industry. 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.

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. 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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