The Food and Drug Administration has been heavily criticised by pharmaceutical consultants working for the US Government Accountability Office or GAO, for hiring doctors to supervise clinical trials who had been previously charged with criminal activity. The FDA are breaking their own rules with this activity by failing to debar anyone who holds a criminal record from working for the Administration.

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. 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. 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.

Prescribing medicine without a license, fraud and lying during clinical trials were other charges that doctors had been committed of. Three doctors continue to work for the FDA even though they have public criminal conviction charges.

One of the main charges that the doctors had been found guilty of was falsifying clinical trial 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. And medical devices are one of the most contentious issues in this whole affair. 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. 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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Filed under: California Mental Health

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