FDAnews Drug Daily Bulletin

FDA May Allow Generic Makers to Change Labels; Could Affect Liability

Feb. 19, 2013
The FDA is considering changing regulations to allow generic manufacturers to alter their labeling in certain circumstances — a move some observers say could lead to increased liability for the companies. Generic drug labels are required by law to mimic the labels of their brand counterparts. In recent years, this has preempted generic companies from failure-to-warn lawsuits. But this preemption protection could be lost if the FDA changes the regulations governing generic-drug labeling, the Justice Department said.
Washington Drug Letter