The Government Accounting Office ("GAO") published a new report on the oversight of clinical investigators titled, “Oversight of Clinical Investigators: Action Needed to Improve Timeliness and Enhance Scope of FDA’s Debarment and Disqualification Processes for Medical Product Investigators.” The report offers a critical look at the process FDA uses in such oversight by 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"), debarment is mandatory if an individual 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 a clinical 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.
Since the seriousness of these charges are profound, GAO’s report reviewed factors contributing to delays in FDA’s debarment and disqualification proceedings such as (1) the length of time FDA’s debarment proceedings have taken and the factors contributing to the length of time they have taken, (2) the length of time FDA’s disqualification proceedings have taken and the factors contributing to the length of time they have taken, and (3) statutory and regulatory limitations to debarment and disqualification.
The GAO reviewed 18 debarment proceedings and 52 disqualification proceedings between May 13, 1992—when FDA was first given the authority to take such actions—through September 9, 2008. The results of the report found that debarment proceedings ranged in length from 26 days to more than a decade. For debarment proceedings, 13 involved clinical investigators and 5 involved study coordinators. 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.
GAO also reported that permissive debarment proceedings generally took longer than mandatory proceedings. Of the 11 completed debarment proceedings, 5 were permissive debarment proceedings that took 4 or more years from conviction to debarment, with a median of 5.0 years. In contrast, six completed mandatory debarment proceedings took from just over 1 year to just over 6 years from conviction to debarment, with a median of 3.1 years.
Also for debarment proceedings, those involving individuals generally took longer to complete. Five of the 18 proceedings we reviewed involved individuals who responded to FDA’s proposal to debar letter by requesting a formal hearing to contest debarment. These proceedings took from 6 months to about 6 years, with a median of 2.2 years, from FDA’s issuance of a proposal to debar letter
As a result of such delays, the report acknowledged that the 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.
Accordingly, the FDA identified several factors that contributed to the length of time taken to complete the debarment proceedings. These factors included:
– A lack of systematic procedures to help ensure timely communication of information relevant to debarment (such as conviction information);
– A lack of policies, expectations and procedures for FDA staff that established time frames for debarment actions;
– Limited resources due to competing priorities;
– A lack of communication between staff responsible for debarment and other FDA staff having information on convictions
Although some of these factors are being dealt with presently by the FDA, the report addresses that the results are still unknown, and problematic. For example, implementing the new time frames that FDA has established for debarment and disqualification could be challenging because some of these time frames are substantially shorter than the times FDA actually took in the proceedings we reviewed. Additionally, given the agency’s competing priorities, it remains to be seen whether FDA will dedicate sufficient resources to debarment or disqualification proceedings to meet the time frames.
GAO summarized its report by offering recommendations to strengthen FDA’s oversight of clinical investigators (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.
The problems with FDA’s oversight into debarment and disqualification highlights the limited resources and time the agency has. By continuing such an inefficient process, the FDA is preventing companies and researchers from creating life saving devices and medicines that will save lives. While it is important to have oversight, these proceedings must be made timelier to help more patients, and to keep businesses funding such breakthroughs in order to advance science and educate physicians.