FDA Targets Misconduct in Drug and Device Development
On August 7, 2009, the FDA announced its enhanced procedures for debarment and clinical investigator disqualification with, among other things, increased staffing and centralized coordination, to ensure more rapid, transparent and consistent actions. The FDA notes that in the short time these measures have been in effect, the number of debarment actions has risen considerably while the times for resolving disqualification and debarment actions have been reduced significantly. The FDA also is posting disqualification and debarment proceeding information on its website to provide clinical study sponsors with ready access to information about FDA's actions. These policy changes are in response to concerns expressed by members of Congress that the FDA has not adequately used its debarment and disqualification authorities.
