Generic drugmakers ramp up campaign against FDA label proposal

By Toni Clarke WASHINGTON (Reuters) - Generic drugmakers are furiously campaigning against a proposed U.S. rule that would require them to change the prescribing information on their products if they receive new safety information, which they say would open them to product liability lawsuits. The rule would overturn regulations that have been in place for three decades that prohibit generic drugmakers from updating safety data on their labels without such changes first being made by the company that developed the drug. The Food and Drug Administration, which issued its proposal in November, said the change is designed to "create parity" between branded and generic drug makers with respect to labeling changes, and remove an unnecessary impediment to the prompt communication of safety data. Generic drugmakers say the proposed rule would raise the cost of drugs and lead to confusion among consumers.



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