FDA scraps proposal to let generic makers update labeling sans review

FDA scrapped a proposal to let generic makers independently update safety data on labels due to concerns of inconsistency and negative market impact, according to a Dec. 13 statement by FDA Commissioner Scott Gottlieb and Director of FDA's Center for Drug Evaluation and Research Janet Woodcock.

The agency proposed the rule in 2013 in the wake of a Supreme Court decision that said manufacturers of generics are not liable for patient injuries because they cannot update labels to strengthen warnings (see "FDA Moves for Generic Companies to Change Labels")...