(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.
