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Theranos Cases Show How DoJ Looks Beyond The FDCA In Prosecuting Drug, Device Companies

 
• By Sue Sutter

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.

Man with telescope
Department of Justice is increasingly looking beyond the Food, Drug and Cosmetic Act in bringing criminal charges against regulated companies. • Source: Shutterstock

Guilty verdicts and lengthy prison sentences for the two former leaders of the failed blood testing start-up Theranos Inc. show the advantage for prosecutors in bringing charges outside the federal Food, Drug and Cosmetic Act, current and former Department of Justice officials said.

Allegations of fraud and conspiracy involving firms and products regulated by the Food and Drug Administration can be easier for...

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More from Legal & IP

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• By Brian Bossetta

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• By Elizabeth Orr

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• By Elizabeth Orr

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More from Policy & Regulation

Permanent FDA Top Lawyer Expected After HHS Counsel Confirmation

 
• By Sue Sutter

Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.

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• By Brian Bossetta

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Medtechs Wait For Dividend As UK Spending Review Prioritizes Healthcare And NHS

 
• By Ashley Yeo

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