WLF Urges FDA to Adopt “Expedited Agency Review” in Lieu of Allowing Unilateral Generic Label Changes

On April 28, 2015 Washington Legal Foundation filed formal comments with the Food and Drug Administration urging the agency to adopt the Expedited Agency Review (EAR) proposal submitted by several pharmaceutical industry trade groups, in lieu of FDA’s own proposal to permit generic drug companies to make unilateral changes to their product labels. WLF argued that the EAR proposal ensures that new safety information about FDA-approved drugs would reach doctors and consumers much more quickly than under the labeling regulations proposed by FDA.