Prevent A Clinical Trial From Turning Into A Criminal Trial – JD Supra

MoFo Life Sciences
On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and Cybersecurity Challenges in Clinical Trial Enforcement,” during the Food and Drug Law Institute’s Clinical Trials: Deconstructing Challenges and Providing Practical Insights Conference.  The panel featured a high-ranking attorney from the Department of Justice’s (DOJ) Consumer Protection Branch (CPB) and other regulatory compliance leaders to discuss key trends and issues in clinical trial enforcement that underscored the need to ensure appropriate compliance measures are in place to avoid future investigations.
Key takeaways regarding the trajectory of clinical trial fraud investigations and enforcement actions include:
One of the most notable comments from the panel was the confirmation that DOJ is looking not only at the activity of individuals (e.g., clinical trial site owners or executives) but also big corporate actors (e.g., sponsors or CROs), with a specific focus on the submission of false and misleading data to FDA and obstruction of FDA and other regulators. DOJ is also looking at cases where the data at the investigator level may be honest and accurate, but where sponsors may have decided to shape it a certain way or omit information—something that can be exacerbated in a biotech environment, where start-ups may be under pressure to show results for the next round of funding. The DOJ is also highly attuned to bad actors whose activities may subject clinical trial participants to harm, such as a clinical trial intentionally providing experimental treatment to a patient they know does not qualify to participate in the study.
DOJ gave a clear answer that FDA inspection classification is not determinative of whether DOJ will bring an action. While DOJ noted that FDA inspection classification is informative, they also noted that DOJ’s inspection and investigation tools differ from FDA. DOJ’s tools, such as search warrants, are designed to unearth criminal activity. Indeed, the DOJ further noted that a fraudulent actor may misrepresent their activities to FDA during an inspection, which means that a glowing inspection classification may just be one additional incidence of clinical trial fraud.
With the advent of clinical trial process digitalization due to COVID-19, clinical trial sites have intrinsically bound digital operations into their business models. However, the speed of incorporating these digital tools may not be matched with the necessary compliance mechanisms to ensure subject and data integrity. In the clinical trial timeline, there are four key digital concerns that industry must address to ensure compliance.
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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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