Generics Lobby Floats Alternative To FDA Drug Labeling Plan

Law360, New York (January 30, 2014, 2:38 PM EST) -- The Generic Pharmaceutical Association on Wednesday denounced the U.S. Food and Drug Administration's plan to let generics makers independently change their warning labels, floating an alternative to a proposal it said would create an “exponentially increasing litigation risk” for its members.

In an 11-page white paper, the GPhA all but accused the FDA of abandoning its long-held opposition to such label updates in order to help trial lawyers whose state failure-to-warn lawsuits against generic-drug manufacturers were barred by the U.S. Supreme Court's 2011 decision in Pliva...
To view the full article, register now.