The US Government Accountability Office GAO has used pharmaceutical consultants to look into people working for the FDA and the results are a damning criticism that the Food and Drug Administration hires criminally convicted doctors to work for it in clinical trials. 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.
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.
presenting false data at clinical trials was the dominant charge amongst the doctors. They created participants to bulk out data, faked the consent of some participants and neglected medical histories. 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.
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.
