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

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.

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 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...