The Food and Drug Administration (FDA) has issued a proposed rule which, if finalized, will expand the scope and consequences of clinical investigator disqualifications.1 Under the proposed rule, issued April 13, an investigator disqualified from receiving specified test articles (i.e., investigational drugs (including biologics) and devices and new animal drugs) will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA, including drugs, biologics, devices, new animal drugs, foods (including dietary supplements, infant formulas, food, and color additives), and tobacco products. FDA is accepting comments on this proposed rule through July 12, 2011.

Under the current rules, FDA may consider the disqualification of a clinical investigator for repeatedly or deliberately failing to comply with the requirements for conducting a clinical investigation or submitting false information in a required report to the FDA or investigational sponsor.2 Should the investigator be disqualified, he or she may no longer receive the particular type of test article involved in the disqualifying study. Thus, under the current rule, if an investigator is disqualified as a result of a drug study, he or she may no longer receive investigational drugs. The investigator may, however, receive investigational devices.