January 12, 2010

Pharmaceutical Consultants Detect FDA Rule Breaking

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.

On average, GAO found that it took the FDA an average of four years to get round to debarring doctors with a conviction. And this comes even though the FDA are required by law to immediately disqualify any doctor who has been charged with fraud or any other type of crime. The FDA seems to be ignoring these laws to such an extent that one doctor worked at the FDA for 11 years even though he had been previously charged with 53 counts of criminal activity.

Other cases involve medical professionals who have committed fraud or prescribed medicines without a license. 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. Participants were made up, they had their consent forced on them and some of the doctors failed to stick to the research plan entirely. And medical devices are one of the most contentious issues in this whole affair. At present there are no laws to prevent doctors barred from medicine to work in the medical device industry which means that they could be endangering the lives of millions of people, like asthma sufferers.

With the FDA already breaking rules and laws with no regard for the consequences, there seems little point in simply applying new regulations. Instead many critics are calling for a wide reform of the whole health care regulatory system. 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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