July 6, 2022

Medical researcher debarment too slow, says US agency

US government watchdog calls for faster debarment of offending doctors

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

Jared Yee