FDA Seeks to Expand Rules on Clinical Investigator Disqualification

By Nisha P. Shah –

On April 13, 2011, FDA issued a proposed rule that would expand the scope of clinical investigator disqualification.  76 Fed. Reg. 20575, Apr. 13, 2011.   The proposed changes are in response to a September 2009 report by the Government Accountability Office (“GAO”) on FDA’s Oversight of Clinical Investigators, which recommended that FDA extend the disqualification to include ineligibility to receive any FDA-regulated investigational products, regardless of what type of FDA-regulated product was being investigated by the clinical investigator when the serious misconduct occurred.  Comments to the proposed rule are due on July 12, 2011. 

Under the draft rule, a clinical investigator, including a sponsor-investigator, disqualified pursuant to 21 C.F.R. Parts 312 (drugs and biologics), 511 (animal drugs), or 812 (devices) will be ineligible to receive “any test article.”  Specifically, the investigator will be disqualified from conducting any investigation that supports an application for a research or marketing permit for FDA-regulated products, including “drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products.”

Several changes are intended to harmonize the drug, biologic, animal drug, and medical device clinical investigator disqualification regulations.  For instance, similar to the device regulations, FDA is proposing to add to 21 C.F.R. Parts 312 (drugs and biologics) and 511 (animal drugs) a requirement that the applicable FDA Center notify the investigator in writing of the alleged violations when the Center has information indicating that a clinical investigator has “repeatedly or deliberately” failed to comply with the relevant requirements or has “repeatedly or deliberately” submitted to FDA or to the sponsor of the investigation false information in any required report.  For purposes of the disqualification rules, the Agency is also clarifying that an investigator includes a sponsor-investigator. 

The proposed rule also will add a notification to the reviewing institutional review board (“IRB”) about the investigator’s disqualification, in addition to the current notification requirements to the investigator and sponsor.  The notification to all parties will explain the basis for FDA’s determination.  For example, the notification to the sponsor will list the investigator’s violations and include instructions concerning ongoing studies and any approved products containing the investigator’s data. 

Another change is to add that when the Agency “determines that an investigation may not be considered part of a research or marketing application, or a notification or petition submission, this determination does not relieve the sponsor of any obligation under any other applicable regulation to submit to FDA the results of the investigation.”  Further, FDA is proposing to harmonize the regulations and clarify that if the Commissioner determines, after the unreliable data submitted by the investigator are removed from the application, that the continued approval of the FDA-regulated product cannot be justified, “the Commissioner will proceed to withdraw” approval or clearance of the product in accordance with applicable provisions of the Federal Food, Drug & Cosmetic Act (FFDCA).  Finally, to harmonize the regulations, FDA is proposing that an ineligible investigator may be reinstated when the investigator has presented adequate assurances to the Agency that the investigator will conduct any clinical investigation in compliance with the applicable regulations.