Pharmaceutical Consultants Uncover FDA Law 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. 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 sensational when you consider that the FDA is required by law to disqualify any doctor who has been criminally charged in the past. 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.
Other cases involve medical professionals who have committed fraud or prescribed medicines 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 also a contentious issue over doctors who have been found to break the law over medical devices. 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.
Because the FDA is already breaking its own rules and laws governing it, there seems little reason to implement new regulations. Instead many critics are calling for a wide reform of the whole health care regulatory system. There should be no room for a company executive to move into a senior role at the FDA, drug companies and the FDA should not think of each other as friends but the FDA needs to be seen as a regulatory body with the power to punish the companies; On top of this, doctors who have been found to break the law should be prosecuted and excluded from the health profession entirely.
