Pharmaceutical Consultants Uncover FDA Law Breaking

Saturday, March 13th, 2010 at 12:30 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. 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.

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. Participants were made up, they had their consent forced on them and some of the doctors failed to stick to the research plan entirely. There is major concern over criminal doctors’ involvement in the criminal device industry. 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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