While speaking at the Food & Drug Law Institute’s Enforcement, Litigation and Compliance Conference in December, Deputy Assistant Attorney General Arun Rao identified clinical trial fraud as one of four key areas of enforcement focus by the Consumer Protection Branch of the U.S. Department of Justice (“DOJ”).1 Rao warned against the “dangerous consequences” of research fraud (often referred to as “research misconduct”), which he said serves to “undermine confidence in the health care industry as a whole.”
Rao’s remarks come at a time of increasing focus on scientific misconduct in clinical trials. Rao cited two recent clinical trial fraud enforcement actions in southern Florida that involved allegedly fabricated data, and he suggested that more enforcement actions may be on the way.
The COVID-19 pandemic will likely intensify such enforcement efforts. The Food and Drug Administration (“FDA”) and other agencies (including the National Institutes of Health (“NIH”) and the Office for Human Research Protections) have published guidance on the conduct of clinical trials during the COVID-19 pandemic to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (“GCP”), and minimizing risks to trial integrity. The extensive government funding of clinical trials and basic science research during the pandemic will only increase regulators’ interest in investigating allegations of potential data integrity issues. Accordingly,...
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