Generic Drug Makers Fight Rule on Health Risk Warnings

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.

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.

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Source: L.A. Times