FDA Shields Drug Companies from Responsibility for Harmful Over-the-Counter Drug Ingredients

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FDA Shields Drug Companies from Responsibility for Harmful Over-the-Counter Drug Ingredients 

For Immediate Release: September 17, 2008

Contact: Jennifer Fuson
202.965.3500, ext. 8369

Preemption Clause Included in Rule goes beyond Agency’s Authority

Washington, DC—The Food and Drug Administration (FDA) has gone beyond its statutory authority by including language in a proposed rule on over-the-counter drug ingredients that would give manufacturers complete immunity from lawsuits, according to comments filed today by the American Association for Justice. (AAJ).
The proposed rule changes the status of some ingredients used in over-the-counter drugs, making the ingredients subject to additional FDA approval before being used.  Once the ingredients get FDA approval, manufacturers no longer can be held accountable should the ingredients cause harm because of preemption language included in the rule.  Seven federal agencies have issued over 60 rules with preemption language in the preamble that give corporations immunity from lawsuits.   

“What the FDA has done is contrary to their mission of protecting consumers.  By giving drug manufacturers complete immunity from lawsuits through this small addition to a rule, there is little incentive for them to make sure the over-the counter drugs they market and sell are safe.  This puts consumers at risk,” said AAJ President Les Weisbrod.   “Government regulation alone cannot guarantee drugs are safe and giving corporations complete immunity from government-approved drugs goes too far,” added Weisbrod.

AAJ is asking the FDA to revise the proposed preamble language to eliminate any reference to preempting state law.  Congress has expressed intent to permit consumers to bring state law claims against drug manufacturers in the Food and Drug Administration Amendments of 2007 and in numerous floor statements.

For a copy of AAJ’s comments, please contact the AAJ communications office.

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