Clinical-Trial Fraud Gets DOJ’s Attention

Speaking at a recent conference, a Department of Justice official warned against the dangerous consequences of clinical-trial fraud and said it’s become an enforcement priority.  He cited recent clinical-trial fraud enforcement actions in Florida and suggested more may be on the way. This kind of misconduct, he says, serves to “undermine confidence in the health care industry as a whole.”

A client alert from law firm Ropes & Gray reports on the speech and its implications. “Scientific misconduct in clinical trials raises a number of risks, including criminal prosecution, FDA regulatory enforcement, and False Claims Act liability, in addition to reputational damage,” the attorneys write. “In order to minimize legal risk, manufacturers should act now to ensure trial sites and investigators have adequate training and procedures in place, and that those compliance protocols are tested and audited.”