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.

GAO officials have publicised their records which show that it takes the FDA an average of four years to debar convicted medical practitioners from working with them. 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.

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.

presenting false data at clinical trials was the dominant charge amongst the doctors. 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. 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. Proposals include that no company director should be allowed to hold a senior position within the FDA and those doctors who break the law should be prosecuted.

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Filed under: California Mental Health

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