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Thursday, February 20, 2014

Generic drug makers fight rule on health risk warnings

Drug safety is a concern of all injuured workers. Better regulation will improved the ultimate medical delivery system of a workers' compensation program. Today's post was shared by FairWarning and comes from

Companies that make generic drugs, the medications most Americans buy, are fighting to kill a proposed federal regulation that would require them for the first time to warn patients of all the known health risks of each drug they sell.

The proposed rule change by the Food and Drug Administration "would be nothing short of catastrophic," said Ralph G. Neas, president of the Generic Pharmaceutical Assn., an industry trade group. It could raise healthcare costs and "create dangerous confusion" for doctors and patients, he said.

At issue is a legal loophole created by Supreme Court rulings that drew a sharp distinction between brand-name drugs and lower-cost generics, which are the same products but usually are marketed under their chemical names.

In 2009, the high court confirmed drug makers could be sued if they failed to warn patients that a brand-name drug carried a serious potential health risk.

The decision upheld a $7-million jury verdict for Diana Levine, a Vermont violinist whose lower arm was amputated after she was injected with an anti-nausea drug made by Wyeth. The drug sometimes caused gangrene if injected into an artery.

But the Supreme Court majority flipped when confronted with a generic drug that also caused a horrible side effect.

Last year, a 5-4 ruling tossed out a $21-million verdict awarded by a lower court to Karen Bartlett, a New Hampshire woman who was disfigured, badly burned and nearly blinded after she had a rare,...

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