Amid Congressional Pressure, FDA Steps Up Efforts

The Food and Drug Administration recently announced it has stepped up its efforts to prevent non-compliant investigators and others from participating in new product development. FDA's procedures for debarment and disqualification have been enhanced to better protect participants in clinical studies and for ensuring the safety and effectiveness of the medical products marketed to the American public.

Compliance with FDA's statutes and regulations is key to protecting clinical study participants and the general public. The new debarment and disqualification procedures will also help ensure that sponsors of clinical studies do not unknowingly use individuals who potentially may be debarred or disqualified by FDA.

"The FDA views any deviation from its high standards for developing or marketing drugs and devices as a potential threat to patient safety and public health," said Norris Alderson, FDA's associate commissioner for science. "We will take strong action against anyone who chooses to ignore or flout the legal requirements for the products we regulate."

Under current law, FDA can ban, or debar, individuals known to have broken the law from working for companies with approved or pending drug applications at the FDA. The agency can also disqualify researchers conducting clinical testing of new drugs and devices, when FDA determines that they have not followed the rules intended to protect study subjects. Further, FDA can disqualify a clinical investigator who has, for example, manipulated data so as to inaccurately report study findings.

Some members of Congress have expressed concern that the FDA has not adequately used its debarment and disqualification authorities. Congress has also noted that when these authorities are invoked, the agency is slow to remove such individuals from the drug or device development process. Members of the House Energy and Commerce Committee have asked the Government Accountability Office to examine FDA's debarment and disqualification procedures.

FDA conducted a similar review of its processes and concluded that the agency should enhance its procedures to ensure it can act quickly, when needed, to further safeguard clinical trial subjects and the drug and device development processes. The revamped debarment and disqualification procedures, which include increased staffing and centralized coordination, ensure that more rapid, transparent and consistent actions are taken. In the short time these measures have been in effect, according to the FDA, the number of debarment actions has risen considerably and the times for resolving both disqualification and debarment actions have been reduced significantly.

The agency has also taken steps to ensure that sponsors involved in the testing and development of new medical products have ready access to information about FDA's debarment and disqualification actions. FDA has already added to its Web site a single page where all pending and completed disqualification proceedings can be found and is currently doing the same for debarment proceedings.

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