FDA has disqualified more than 130 clinical trial investigators since 1964 for failing to follow certain regulations regarding data integrity and patient safety. Twenty-five of those investigators have been disqualified since 2001, and 7 of them were disqualified in the first half of this year. That doesn’t say much for 2008 as we still have six months to go.

Beyond the fact that disqualifications seems to be on the rise, there is the issue of case delays. The ever-overburdened FDA has as many as 12 open suits—some of which have been open for a decade—against researchers who allegedly violated rules to protect patients and ensure accurate data, according to Bloomberg News.

The problem with unresolved cases is that researchers still have access to investigational new drugs and trial patients.

“There’s just no excuse for not invoking the authority FDA already has to rapidly disqualify liars from taking any further role in these drug studies,” says US Rep. Joe Barton (R-TX) in House Energy and Commerce Committee website article. He and a few other Congressmen have been trying to get the GAO to take action on this matter. Read his March letter to GAO.

FDA has the right to disqualify or “totally restrict” a clinical study investigator from conducting further research if they repeatedly or deliberately fail to comply with current requirements, or if the researcher repeatedly or deliberately submits false information to the trial sponsor or to FDA itself. Once disqualified, the researcher can no longer receive investigational drugs, biologics, or devices. The agency can also apply a lesser “restricted” classification to individuals; these investigators are still able to work with investigational products but have some limitations that they agree upon with FDA. But until these classifications are made, researchers are free to carry out their work.

The latest person to receive the so-called Scarlet letter, is Maria Anne Kirkman Campbell, who pleaded guilty to fraud in 2003 after working on a Sanofi-Aventis SA antibiotic study. Even though her case took place five years ago, Campbell just received her disqualification status last month.

Check out FDA’s disqualified list and let us know your thoughts on this issue.