George Mason University Antonin Scalia Law School

The FDA’s Proposed Rule for Generic Drug Liability

Event Details

  • Date:
  • Venue: Rayburn House Office Building
  • Division: Civil Justice Academy

Program Description: The Food and Drug Administration proposed a rule in early November 2013 that could increase generic drug manufacturers’ exposure to civil liability. In 2011, the United States Supreme Court concluded that it was impossible for generic drug manufacturers to change their labels, thus preempting state law failure-to-warn claims. The proposed rule would change this and allow generic drug manufacturers to update labels on their drugs.  With this new power comes new responsibility and potential liability; generic drug manufacturers may no longer be shielded from failure-to-warn tort cases. Join us for a discussion of this new rule and its economic impact.


Alex Brill
Research Fellow, American Enterprise Institute and CEO, Matrix Global Advisors

Allison M. Zeive
Director, Public Citizen Litigation Group

Sheldon T. Bradshaw
Partner, Hunton & Williams and former Chief Counsel, Food and Drug Administration

For More Information, Contact: Congressional Civil Justice Caucus Academy