FDA Debarment and Disqualification Processes
This post was written by Paul Sheives.
The GAO issued a report entitled "Oversight of Clinical Investigators: Action Needed to Improve Timeliness and Enhance Scope of FDA's Debarment and Disqualification Processes for Medical Product Investigators." Among other things, the report raises concerns about the length of time associated with FDA disqualification proceedings. The GAO also found that FDA rules allow an investigator who is disqualified for conduct related to drugs or biologics to serve as an investigator for medical devices; likewise, an individual disqualified for conduct related to medical devices still may serve as a clinical investigator for drugs and biologics. In the report, the GAO recommends that the FDA Commissioner: pursue extending FDA’s debarment authority; extend disqualification to include drugs, biologics, and medical devices; and ensure the timely completion of debarment and disqualification proceedings. FDA agreed with GAO’s recommendations.
