FDA Defends Proposal Requiring Generic Drugmakers to Update Safety Information

on 04/04/2014

The U.S. Food and Drug Administration’s top pharmaceuticals official appeared before the House of Representatives health subcommittee to defend the organization’s proposal requiring generic drugmakers to update safety information if they become aware of changes. Currently, generic drugmakers are not allowed to alter their labels prior to the branded company updating their label information since generics are supposed to be the same as their brand name counterparts.

The FDA official said the move is needed to “create parity” between branded and generic drug manufacturers regarding labeling changes. The pharmaceutical industry says this move will open them to product liability lawsuits and raise drug costs.

The discrepancy between branded company drugs and generic drug labels is part of the Hatch-Waxman Act of 1984.  The legislation exempted generic drug manufacturers from costly clinical trials if they could prove, based on laboratory tests, their drugs were the same as the branded drug being copied.  Generic drugs are supposed to have the same active ingredients and dosage strength as a brand name counterpart.

A Supreme Court ruling in 2011 decided the FDA’s prohibition on label changes meant generic drug manufacturers couldn’t be held accountable for failure to warn against risk. A consumer cannot sue a generic drug manufacturer if they are injured while taking the drug while a consumer injured while taking a brand name drug can have legal recourse.

If a generic drug has injured you or someone you love, please contact the lawyers at Watts Guerra.

Tags: Pharmaceutical Mass Torts, FDA

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