Pharmaceutical Consultants Detect Food And Drud Administration 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.
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. 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.
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. 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, they propose a wide reform of the whole health care system in America. 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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