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DOJ Enforcement: Talking With US FDA Is Not Enough To Get Credit For Self-Disclosure

 
• By Brenda Sandburg

Remediation of a problem with FDA is one factor the DOJ considers in assessing whether a company gets credit for self-disclosure of misconduct prior to a criminal investigation, but it wants companies to come directly to the department to divulge wrongdoing.

Disclosure
Companies must self-disclose misconduct directly to Department of Justice to get credit to avoid guilty plea • Source: Shutterstock

The US Department of Justice’s new policy of giving companies credit for voluntarily self-disclosing corporate misconduct has raised questions about whether communicating problems to the US Food and Drug Administration could count as timely disclosure.

Amanda Liskamm, director of DOJ’s Consumer Protection Branch, was asked about FDA’s role during a panel discussion at the Food and Drug Law Institute’s recent annual conference in Washington, DC....

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