FDA to Fix Accountability Imbalance for Generic Drug Manufacturers

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For Immediate Release: November 8, 2013

Contact: Katie Gommel
American Association for Justice
202-965-6645
katie.gommel@justice.org

FDA to Fix Accountability Imbalance for Generic Drug Manufacturers

Washington, DC—The following is a statement from American Association for Justice President Burton LeBlanc on the U.S. Food and Drug Administration’s (FDA) new proposed rules on generic drug labeling:

“All Americans deserve access to justice. We applaud the FDA for taking the necessary steps to fix the accountability imbalance between brand name and generic drug manufacturers.

“If no one is accountable, no one is safe.”

 

Background

  • In 2011, the U.S. Supreme Court decided in Pliva v. Mensing that generic drug manufactures were not responsible for updating their warning labels, even when new side-effects were known.
  • Senate Judiciary Committee Chairman Patrick Leahy (D-Vt.), Senator Senator Al Franken (D-Minn.), Senate HELP Committee Chairman Tom Harkin (D-Iowa), Senate Aging Committee Chairman Bill Nelson (D-Fla.), Representatives Chris Van Hollen (D-Md.), Henry Waxman (D-Calif.), Bruce Braley (D-Iowa), Matthew Cartwright (D-Pa.) and other lawmakers have long called for the FDA to act on this important patient safety issue. 
  • Public Citizen filed a citizen petition with the FDA addressing the Mensing decision. The American Association for Justice filed comments in support of this petition.
  • Over 20,000 people have signed an online petition calling on the FDA to act.
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