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Delay in Generics Labeling Rule Leaves Patients at Risk

Statement of Michael Carome, Director of Public Citizen’s Health Research Group

The U.S. Food and Drug Administration (FDA)’s postponement to April 2017 of an important patient safety rule endangers the millions of us who take prescription medications. The FDA is plainly bowing to industry pressure and, in the process, prioritizing industry profits over patient health and safety. At this point, we worry about the agency’s commitment to finalizing the rule, which it acknowledged in 2013 would improve drug safety.

Information about serious risks often comes to light after generic versions of a medication are on the market, as documented in a 2013 Public Citizen report. Currently, brand-name manufacturers are permitted to make safety updates without prior FDA approval. Generic manufacturers, however, are not permitted to update warnings to reflect new safety information unless instructed to do so by the FDA.

The proposed rule, issued in November 2013 in response to a 2011 Public Citizen petition (PDF), would solve that problem by giving generic manufacturers the ability to update labeling to provide warnings about newly discovered risks without prior FDA approval – as brand-name manufacturers have been able to do for 30 years.