Lawmakers Caution FDA on Preemption Changes in Proposed Labeling Rule

摘要

Members of both chambers of Congress questioned a proposed FDA labeling rule, saying it would delay safety warnings and help pharmaceutical and device manufacturers avoid state product liability lawsuits. The rule would require firms to submit labeling changes being effected (CBE) modifications for agency review only when companies have new evidence about a safety issue that either was unknown to the agency or has a greater severity than previously understood (WDL, Jan. 21).