GAO: Debarment Rules Should Extend to Medical Device Sector

The U.S. Food and Drug Administration (FDA) should extend disqualification of doctors convicted of crimes from overseeing clinical trials or conducting research for the agency to the drugs, biologics and medical devices sectors, according to a report by the Government Accountability Office (GAO).

GAO reviewed laws, regulations and FDA files through Nov. 5, 2008, for investigators, study coordinators and sub-investigators for whom FDA pursued debarment since receiving debarment authority in 1992; and all clinical investigators for whom the FDA pursued disqualification since the agency adopted its current process for beginning proceedings in 1998.

The GAO found in its report that for the 52 disqualification proceedings that were reviewed, the time from the start of a proceeding to its conclusion ranged from 26 days to 11 years. In general, proceedings initiated in 1998 through 2001 generally took longer than those begun more recently.

The GAO cited a lack of deadlines for proceedings and other priorities set by the agency as causes. FDA has made or planned changes that could improve timeliness, but the effects of such actions have yet to be seen, according to the report.

For the complete report,click here.