Recent changes will speed FDA's process for barring non-compliant clinical trial investigators from future product research, agency staffers say.

FDA has developed new procedures for disqualification and debarment that set timeframes and assign responsibility for each step of the process to specific areas within the agency.

FDA has also centralized the disqualification process in its Good Clinical Practices Office. Previously, responsibility resided in the center that initiated the disqualification action. Debarments will be centralized in the Office of Enforcement, within FDA's Office of Regulatory Affairs.

"Members of Congress have expressed concern that the FDA has not adequately used its debarment and disqualification authorities," or that FDA is slow to act when these authorities are invoked, the agency wrote in an Aug. 7 press release.

The House Energy and Commerce Committee had asked the Government Accountability Office to review FDA's debarment and disqualification procedures, but GAO to date has not completed a report.

Of the 21 disqualification actions FDA has initiated since 2006, three are still pending.

With the changes, which FDA began introducing last summer, actions that were taking three to four years are going through in about a year, Joanne Less, director of FDA's Good Clinical Practices Office, said in an interview.

"It was taking too long," Less conceded. "We're hoping that having more consistent procedures with timeframes and clear lines of responsibility will help resolve these matters much more quickly than they had been in the past."

Inside The Disqualification Process

Current law allows FDA to disqualify researchers from conducting clinical testing when the agency determines that they have not followed human subject protection rules or have inaccurately reported study findings.

The process begins when a field agent inspects a trial site and comes back with preliminary findings of misconduct on the part of an investigator.

FDA headquarters then reviews the field recommendation, and issues either a warning letter or a Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE).

In fiscal year 2008, 15% of inspections of device clinical trial investigations were classified as violative - or as FDA terms it, "official action indicated" - up from 13% the year before.

The most common problems were failure to follow an investigational plan, investigator agreement or study protocol; failure to document cases of device exposure; and failure to obtain informed consent.

After receiving a disqualification notice, a clinical investigator has a chance to plead his or her case. If a final disqualification is issued, the investigator can no longer receive any investigational device, drug or biologic product.

Still No Debarment Authority For Devices

FDA is also authorized to debar investigators involved in drug trials, but not those involved in device trials, explains Matthew Warren, regulatory counsel in the FDA Commissioner's Office.

Individuals who have been debarred are prohibited from working for companies with an approved or pending drug application at FDA.

There have been calls from Congress to expand FDA's debarment authority to device investigators, as well, but that would require new legislation, Warren notes (¹ 'The Gray Sheet' Feb. 18, 2008).

FDA most recently began posting the names of clinical investigators with pending disqualification actions against them on its Web site, and plans to list pending debarments online, as well.

The Office of Good Clinical Practices hired a project manager to oversee the disqualification process, and the Office of Enforcement is looking to hire someone full-time to coordinate debarment actions.

- Jessica Bylander ( ² j.bylander@elsevier.com )

FDA Will Move Faster To Ban Bad Actors From Clinical Trials

More from Archive

More from Medtech Insight