FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

DOJ Offers Drugmakers ‘Get out of FCA Litigation Free’ Card

May 16, 2019
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The Department of Justice is offering drug companies on the receiving end of False Claims Act litigation a chance to walk away without crippling fines—as long as they disclose the fraud, cooperate with investigators and fix any underlying problems.

Companies would still be liable for the government’s actual losses and would still have to pay the costs of investigations and awards to whistleblowers, but the new guidelines  lower the temperature for drug companies that face hundreds of millions—and sometimes billions—of dollars of risk in government fraud investigations. The False Claims Act allows for treble damages plus individual fines for each offense.

Under the new DOJ guidelines, companies can earn partial and full “points” for disclosing potential fraud early, or for “meaningful assistance” in an investigation.

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