News & Analysis as of

Qui Tam Rulemaking Process

Venable LLP

The Administrative False Claims Act: 10 Fast Facts That Matter

Venable LLP on

The Administrative False Claims Act (AFCA), enacted in December 2024, expands agency authority and recovery limits, making the AFCA a more powerful tool for recouping government funds lost to alleged false claims—a...more

Akin Gump Strauss Hauer & Feld LLP

False Claims Act - Year In Review: Five Decisions That Will Affect the Future of FCA Litigation - The Salcido Report: False Claims...

Key Points: - False Claims Act plaintiff cannot use discovery to satisfy Fed. R. Civ. P. 9(b). - Payment of fair market value is a dispositive defense in FCA actions alleging a violation of the Anti-Kickback Statute. ...more

Mintz - Health Care Viewpoints

FDA Hardens Its Stance on Intended Use and Off-Label Use and Industry Responds

From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more

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