Medical researcher debarment too slow, says US agency


US medical researchers who are to be debarred have been allowed to practise for up to 11 years after their debarment has been set in motion.

In a recent review of the US Food and Drug Administration (FDA) by the Government Accountability Office (GAO), it was found that “more than half of the debarment proceedings in GAO’s review took 4 or more years”. It was also noted that “internal control weaknesses”, such as the lack of a time frame for the process of debarment, led to an extended period where offending doctors could still practise.

The FDA monitors clinical research involved with new drugs, biologics (commercial biotechnological products), and has the ability to debar or disqualify doctors engaging in misconduct such as fraud. Other offences include neglecting to report adverse patient responses to clinical trial drugs and the forgery of patient consent documents.

However, the FDA’s ability to debar or disqualify does not extend to the irresponsible use and/or proliferation of medical devices, “and its regulations do not extend disqualification for drugs and biologics to medical devices and vice versa.”

Republican Representative Joe Barton, of Texas, expressed concern about the FDA’s tardy debarment processes in a press release, saying: “I think it is especially inexcusable that the agency can't seem to quickly and consistently debar even convicted felons”.

The GAO acknowledged the Agency’s revisions to debarment processes made over the past year, designed to improve the timeliness of debarment proceedings, but also stated that “the effects of such actions have yet to be seen.” ~ Government Accountability Office Sept 2009, Wall Street Journal Oct 22, 2009




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