FDA Will Move Faster To Ban Bad Actors From Clinical Trials

Article perview reprinted from "The Gray Sheet" - August 17, 2009

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

FDA Will Move Faster To Ban Bad Actors From Clinical Trials

Article perview reprinted from "The Gray Sheet" - August 17, 2009

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.

- Jessica Bylander

Download this full article and the rest of the “The Gray Sheet” issue when you sign up for a 30-day, risk-free trial. Click here

To find out about more about more about Elsevier Business Intelligence's medical device publications and databases, multi-user access and/or advertising with Medical Devices Today, please contact Sean Smith at 240-221-4535 or [email protected].