FDA defends generic drug label proposal at U.S. House hearing

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FDA defends generic drug label proposal at U.S. House hearing

(Reuters) - The U.S. Food and Drug Administration on Tuesday defended its proposal to require generic drugmakers to update the prescribing information on their products if they become aware of new safety information, a move the industry says will open them to product liability lawsuits and raise drug costs. Speaking at a hearing before a U.S. House of Representatives health subcommittee, Dr. Janet Woodcock, the FDA's top pharmaceuticals official, said the move is needed to "create parity" between branded and generic drug makers regarding labeling changes. Generic drugmakers are not currently allowed to alter the labels on their products without prior agency approval since generic drugs are supposed to be the same as their brand name counterparts, from the active ingredient to dose strength to the information on the label.

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