FDA Raises Debar

By Aimee Hummel, CIS Compliance Manager
aimeehummel@cis-partners.com

On August 8, 2009, the FDA announced that they are revamping their disbarment and disqualification procedures. This decision was made after the FDA’s internal review concluded that it needed to act quicker to ensure the safety of clinical trial participants. Their procedures are also being enhanced to ensure the safety and effectiveness of the medical products marketed to the American public.

Before this, members of Congress had claimed that the FDA has been slow to remove individuals from the drug development process and have not adequately used its debarment and disqualification authorities, which caused major concern. The changes made include increased staffing and centralized organization. They also have designated an administrative law judge as a presiding officer and have assigned the good clinical practice program to oversee the disqualification process. The FDA believes these changes will result in more rapid, transparent and consistent actions. [3]

For those not familiar with this process, the FDA has the authority to disqualify researchers from conducting clinical testing on new drugs and devices when they have repeatedly or deliberately broken the rules. These rules are intended to protect study participants and the general public. Under the FDA’s statutory debarment authority, they may also ban, or “debar” individuals and companies convicted of certain felonies or misdemeanors related to drug products. “Once individuals have been subjected to “debarment,” they may no longer work for anyone with an approved or pending drug product application at FDA. Debarred companies may no longer submit abbreviated drug applications.” [2]

FDA began disqualifying clinical investigators in the early 1960’s and have since disqualified approximately 190 clinical investigations. From 2006 to present, FDA initiated 21 disqualification actions. Since FDA received its debarment authority in 1992, it has debarred 75 individuals convicted of crimes related to drug products. Until this year, the agency had averaged two or three debarment proceedings per year, over the past decade. Since October 2008, however, FDA has formally initiated debarment proceedings against five individuals, and debarred two others.[2]

Since the new changes have been made, the number of debarment actions has risen considerably, and the time taken to resolve both disqualification and debarment actions has reduced significantly. Among the improvements, FDA has also made sure that all participants in testing and development have access to the necessary debarment and disqualification information. Thia information will also ensure that sponsors of clinical studies do not use individuals who may have been disqualified or debarred. Disqualification and Debarment information is available on the FDA website, where you can view all pending and completed disqualification proceedings and all completed debarment proceedings; they are working on doing the same for pending debarment proceedings.

By increasing transparency and enhancing their systems, the FDA will continue to increase the level of protection of the public health. [1]

Information on pending and completed disqualifications can be found at: www.fda.gov/ICECI/EnforcementActions/DisqualifiedRestrictedAssuranceList/ucm131681.htm

Information on completed debarment action can be found at: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090279.htm

Sources:
1 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm176040.htm
2 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm176043.htm
3 http://www.outsourcing-pharma.com/content/view/print/255930