FDA Proposed Rule Would Restore Generic Drug Accountability

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For Immediate Release: March 13, 2014

Contact: Katie Gommel

American Association for Justice

202-965-6645

katie.gommel@justice.org

 

FDA Proposed Rule Would Restore Generic Drug Accountability

Rule would allow those harmed by generic drugs to hold manufacturers accountable

Washington, DC— The American Association for Justice (AAJ) is filing comments in support of the U.S. Food and Drug Administration (FDA) proposed rule to allow generic drug manufacturers to independently update their warning labels.

Currently, over 80% of all prescriptions in the U.S. are filled with the generic version of a drug. The U.S. Supreme Court ruled in Pliva v. Mensing that generic drug manufacturers cannot independently update their warning labels, even when new side-effects are known. This ruling created two systems – one for patients who use name-brand drugs and one for patients who use the generic.  As a result, thousands of Americans have had their court cases dismissed merely because they took the generic instead of the brand name drug.

The FDA’s proposed rule will significantly increase prescription drug safety for American consumers and patients,” AAJ President Burton LeBlanc said in the comments. “The proposed rule takes account of both the need for accurate warnings and the need for sameness, and proposes regulatory changes that will further both of these goals.” 

The FDA’s new rulemaking would allow generic drug manufacturers to update their warning labels using the same process that brand name drug companies currently use.

 “The proposed rule will make consumer safety information more accessible and available sooner,” LeBlanc added in his comments. “In addition, the proposed rule will ensure that generic pharmaceutical manufacturers are responsible if they fail to warn the public of a known safety hazard associated with their products.”

In November 2013, the FDA proposed rulemaking to allow generic drug manufacturers to independently update their warning labels when new side-effects are known. Since then, over 20,500 consumers have called on the FDA to enact this rule through an online petition.

Read AAJ’s full comments here and the real stories of Karen and Kira, patients injured by generic drugs whose justice has been denied as a result of Mensing

For more information on generic drugs, visit www.takejusticeback.com/Generic_Drugs.

 

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