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Clinical Data Fraud Involving CROs Attracting US Justice Department Attention

 
• By Sue Sutter

Submission of manipulated clinical data to support product approval is a ‘major concern’ for the DoJ, consumer protection branch director Gusav Eyler says, adding that some of the problems relate to outsourcing of trials. Also, DoJ and HHS OIG are using data analytics to identify outliers in prescribing and reimbursement claims.

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The DoJ is looking not only at misleading promotions but also whether clinical data supporting a drug's approval are manipulated. • Source: Shutterstock

The US Department of Justice is increasingly focusing enforcement attention on issues related to clinical trial data fraud, particularly where contract research organizations are involved.

Speaking at the Food and Drug Law Institute’s recent conference on advertising and promotion of medical products, Gustav Eyler, director of the DoJ’s consumer protection branch, said that in investigating...

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