On April 30, FDA published in the Federal Register final regulations amending the scope of its clinical investigator disqualifications. Now when the Commissioner determines that a clinical investigator is ineligible to receive one kind of test article (drug, device, animal drug), the clinical investigator is also ineligible to conduct any clinical investigation that supports an application for research or marketing for other FDA-regulated products, including foods and tobacco products. FDA amended its regulations “to protect the rights and safety of subjects involved in FDA-regulated investigations, and help[s] to ensure the reliability and integrity of the data used to support the marketing of products regulated by FDA.”
According to FDA, the final rule was based on a recommendation from the General Accounting Office (“GAO”) in September 2009. The GAO Report, Oversight of Clinical Investigators: Action Needed to Improve Timeliness and Enhance Scope of FDA’s Debarment and Disqualification Process for Medical Product Investigators, stated that it was “critical for FDA to take action–and to have the authority to take action–to prevent clinical investigators . . . who engaged in serious misconduct from doing it again, whether in research that involve drugs, biologics, or devices.” FDA is also amending its regulations for informal hearings under 21 C.F.R. Part 16 by changing the scope of certain provisions that were “inadvertently omitted.”
FDA proposed the rule in the Federal Register on April 13, 2011 and received only two comments. FDA, however, managed to convert one of the filed comments to ten points to address in the preamble to the final rule. First, FDA clarified the “repeatedly or deliberately” language in the regulations for when a clinical investigator may be disqualified for repeatedly or deliberately failing to comply with FDA’s applicable clinical investigations regulations or deliberately submitting false information to the sponsor. FDA said “repeatedly” means more than once, which can be more than one time in a single study or in more than one study. “Deliberately” means “willful” conduct or with reckless regard, such as knowingly failing to comply with FDA’s regulations or falsifying data. In another point, FDA clarified that FDA will place no limits on how far back FDA will investigate to find applications or submissions that may have been affected by a disqualified investigator. In yet another point, FDA summarized the notification process for how sponsors become aware of an clinical investigator’s ongoing disqualification process, including redacted letters on FDA’s website. In the final point, FDA indicated how FDA notifies sponsors that clinical investigators have been reinstated–once again, primarily FDA’s website.