Porzio Life Sciences Enforcement Action Update: DOJ Will Focus On Clinical Trial Fraud With New Enforcement Policies

February 15, 2022

By Porzio Life Sciences

Arun G. Rao is the Deputy Assistant Attorney General for the Consumer Protection Branch (CPB) of the United States Department of Justice (DOJ). Deputy Assistant Attorney General Arun G. Rao recently spoke at the Food & Drug Law Institute’s (FDLI) Enforcement, Litigation, and Compliance Conference in Washington, DC. In his speech, Rao focused on recent activity related to COVID fraud, opioids, and notable enforcement actions. Rao also announced that the DOJ plans to particularly focus on clinical trial fraud.

Rao emphasized the growth of the CPB, noting that the agency has expanded significantly in recent years, and currently employs more than 90 prosecutors and more than 100 support personnel working on enforcement actions involving violations of the Food, Drug, and Cosmetic Act (FDCA). The CPB works closely with the Food and Drug Administration (FDA) to enforce the FDCA, resulting in both civil and criminal penalties. Rao emphasized recent prosecutions against companies and individuals who falsified clinical trial data. According to Rao, the CPB will devote substantial attention to these cases because they can create considerable risks to consumers and because fake studies can "undermine confidence in the healthcare industry as a whole.”

Rao focused on several recent instances of CPB’s enforcement in the area of clinical trial fraud. For example, a clinical trial fraud scheme was committed by five individuals at Unlimited Medical Research of Miami, Florida. The clinical trial at issue was designed to investigate the safety and efficacy of an asthma medication in children between the ages of four and eleven. According to court documents, the individuals falsified medical records to reflect scheduled patient visits, administered drugs, and payments received by study subjects, all of which never actually occurred. Many of the individuals pleaded guilty, resulting in prison terms. A trial is scheduled next year for one remaining individual.

In a second case, eight individuals were charged in connection with a clinical trial fraud scheme that took place at Tellus Clinical Research, Miami, Florida. Court documents allege that the individuals falsified data and medical records by simply inventing clinical trial participants who did not exist. The clinical trial in question was intended to evaluate various medical conditions, including opioid dependency, irritable bowel syndrome, and diabetic nephropathy.

As stated in the News Release, "[f]raud in clinical trials poses significant risks to the American public. . . Fabricated clinical trial data can have dangerous consequences if relied upon by the FDA, drug researchers, and medical doctors when making material decisions about the safety, efficacy, and clinical use of drug products."

A copy of the DOJ News Release outlining the Deputy Assistant Attorney General's remarks is available here.

For more information regarding DOJ enforcement, please see the Government Prosecutions section of the Enforcement Actions Database.

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