Dec. 13, 2018

FDA Rule Withdrawal Fails to Modernize Generic Labeling and Endangers Patient Safety

Statement of Dr. Sidney Wolfe, Founder and Senior Adviser, Public Citizen’s Health Research Group

Note: Today, the U. S. Food and Drug Administration (FDA) announced that it will withdraw a 2013 proposed rule, prompted by a 2011 Public Citizen petition, which would have allowed generic drug makers to immediately update safety labels describing new risks to consumers without prior agency approval. The rule would have promoted patient safety by extending to generic manufacturers the ability to make labeling updates more quickly, as brand name companies can do now. Almost 90 percent of prescriptions in the U.S. are for generic medications.

The withdrawal of today’s rule represents a flagrant disregard for public health and common sense because it continues to immunize generic manufacturers from any liability if patients are injured or killed by a generic medication, even when warnings about serious risks known to the companies are missing from the labels. The rule would have promoted patient safety by extending to generic manufacturers the ability to make more rapid labeling updates.

The FDA is plainly bowing to industry pressure and, in the process, prioritizing industry profits over patient health and safety.

###