How do we know? The Government Accountability Office says so. In a new report, the GAO found that more than half of the debarment proceedings in its review took 4 or more years, and factors contributing to these time frames included internal control weaknesses in the debarment process and competing priorities among responsible staff (read the report).

As the GAO notes, the FDA has statutory authority to debar individuals who have been convicted of felonies or certain misdemeanors related to the development, approval, or regulation of a drug or biologic. For the 18 proceedings reviewed, the length of time from a conviction through debarment (or as of Nov. 5, 2008, for pending proceedings) ranged from about 1 year to nearly 11 years.

Factors that contributed to delays included: FDA staff faced competing priorities and the FDA had not established internal controls, such as time frames for completing steps in the debarment process. The FDA has made or planned changes that could improve timeliness, but the effects of such actions have yet to be seen. Not surprisingly, the GAO says the time taken for disqualification proceedings varied and proceedings took longer when the investigator contested disqualification.

For the 52 disqualification proceedings reviewed, the length of time from initiating a disqualification proceeding to its conclusion (or as of November 5, 2008, for pending proceedings) ranged from 26 days to more than a decade, with about one-third taking more than 2 years. In general, the more steps taken by the investigator to contest disqualification, the longer it took to complete the proceeding. Disqualification proceedings initiated in 1998 through 2001 generally took longer than proceedings that were initiated more recently.

Here’s an interesting catch: the FDA’s debarment authority doesn’t fully extend to medical devices, and its regs don’t extend disqualification for drugs and biologics to devices and vice versa. As a result, an individual may be debarred from involvement with drugs and biologics, but not from involvement with devices, regardless of the kind of misconduct. The FDA’s disqualification regs allow an investigator who is disqualified for conduct related to drugs or biologics to serve as an investigator for medical devices; likewise, an individual who FDA disqualified for conduct related to medical devices remains able to serve as a clinical investigator for drugs and biologics.

The GAO recommends the FDA do the following:
1 - to 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;
2 - amend its regs 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;
3 - monitor compliance with recently established time frames for debarment and disqualification proceedings and take appropriate action when those are not met.

“The F.D.A. views any deviation from its high standards for developing or marketing drugs and devices as a potential threat to patient safety and public health,” Norris Alderson, the FDA’s associate commissioner for science, tells The New York Times. “We will take strong action against anyone who chooses to ignore or flout the legal requirements for the products we regulate.”