Generic Labels Don’t Match Brands 78 Percent of the Time, Study Finds

December 26, 2012
Generic drugs fail to mirror the labels of their branded counterparts almost 78 percent of the time, despite an FDA mandate that bioequivalent products have identical warning labels, a new study finds. The findings suggest regulators may need to consider new strategies for harmonizing labels, the authors conclude. Lead author Jon Duke, Indiana University School of Medicine, supports a recent proposal put forth in the New England Journal of Medicine that calls for “consensus” drug labels containing all safety information on a given drug regardless of the manufacturer. The labels could be updated in real time, he said.
Washington Drug Letter