Theranos Cases Show How DoJ Looks Beyond The FDCA In Prosecuting Drug, Device Companies
Charges under wire fraud statute carry higher maximum prison sentences and are easier to explain than FDCA misbranding charges, Department of Justice officials say in dissecting the guilty verdicts and lengthy prison sentences for former leaders of the failed blood testing start-up.
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Former chief medical officer’s conviction for misbranding Suboxone does not warrant mandatory exclusion from healthcare programs, complaint argues. It says individuals in similar situations, specifically former Purdue execs, were subject to permissive exclusion.
If the commission does develop a rule, it would provide a vehicle for stronger enforcement in the area.
Move toward decentralized trials means sponsors may be working with naïve clinical investigators who lack experience, Greenleaf’s Cynthia Schnedar says; DoJ’s Gustav Eyler urges drug sponsors to look for oddities in clinical trial data and to voluntarily report potential misconduct.