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. 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. 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. There are also major concerns over the fact that three doctors continue to work with the FDA even though they are known convicted criminals.
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. 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.
Because the FDA is already breaking its own rules and laws governing it, there seems little reason to implement new regulations. New reforms should instead be applied so that there is no room for these laws to be broken. 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.
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