New GAO Report – Oversight of Clinical Investigators

By Susan J. Matthees –

Last month the Government Accountability Office ("GAO") published a new report ("GAO report") on the oversight of clinical investigators.  The report is critical of FDA’s oversight of clinical investigators, citing numerous instances where FDA did not take timely action to respond to situations where debarment or disqualification of a clinical investigator was at issue. 

Under Federal Food, Drug, and Cosmetic Act ("FDC Act") section 306, there are certain situations in which FDA must or may debar an individual (including a clinical investigator) from providing any service to a person who has an approved or pending drug application.  In a mandatory debarment, FDA must debar an individual if he or she has been convicted of a felony under federal law for conduct relating to the regulation of a drug.  A mandatory debarment is permanent.  In a permissive debarment, FDA may debar an individual if he or she has been convicted of a misdemeanor under federal law or a felony under state law if the conduct relates to the development or approval process of a drug, or if the individual has been convicted of certain felonies not related to drug development.  Permissive debarment is for a period of time up to five years. 

Pursuant to FDA regulations, FDA may also disqualify investigators (i.e., determine that an investigator is not entitled to receive investigational drugs or devices) who repeatedly or deliberately fail to comply with FDA regulations or report false information to FDA or a trial sponsor.  21 C.F.R. §§ 312.70, 812.119. 

The GAO reviewed 18 debarment proceedings and 52 disqualification proceedings and found that debarment proceedings ranged in length from 26 days to more than a decade.  More than half of the debarment proceedings took over 4 years, and the median length for a proceeding was 4.4 years.  The median length for a disqualification proceeding was 2.5 years, with over a third of the proceedings taking more than 2 years. 

The GAO report cites internal control weakness and limited resources as factors in delay.  The report also comments that FDA’s overall authority “is limited . . .  because FDA’s regulations do not extend a clinical investigator’s disqualification for investigational drugs and biologics to investigational devices and vice versa.”  The report includes the following recommendations (GAO Report page 43):

• Pursue debarment authority for medical devices that is consistent with the current debarment authority for drugs and biologics and prohibit any debarred individual from involvement with drugs, biologics, and medical devices.

• Amend FDA regulations to ensure that those who have engaged in misconduct found sufficiently serious to warrant disqualification for one investigational medical product are not able to continue to serve as clinical investigators for any.

• Monitor compliance with recently established time frames for debarment and disqualification proceedings and take appropriate action when those are not met.

According to the report, FDA is working to improve its debarment and disqualification procedures and will “endeavor to incorporate” the GAO’s recommendations.   FDA also stated that the Agency would be drafting a guidance document to explain the disqualification process.  No timeframe was given for completion.