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FDA Delay in Safety Rule Leaves Patients Nationwide at Risk

Completion Date for Generic Labeling Rule Now Set for July 2016

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA)’s postponement to July 2016 of a significant patient safety rule leaves open a safety gap for the millions of patients who take generic medications, Public Citizen said today. The agency proposed the rule in 2013 in response to a 2011 Public Citizen petition (PDF).

Currently, brand-name manufacturers are permitted to make safety updates without prior FDA approval. But generic manufacturers are not permitted to update warnings to reflect new safety information unless instructed to do so by the FDA.

The FDA’s proposed rule would solve that problem by giving generic manufacturers the option to update labeling to provide warnings about newly discovered risks to patient safety without prior FDA approval– much as brand-name manufacturers have been able to do for nearly 30 years.

The FDA has not yet finalized the labeling rule and has several times delayed its expected completion date. In its recently issued regulatory agenda, the FDA has now pushed the date back even further, to July 2016.

“The agency should resist pressure from the pharmaceutical industry and finalize a rule that will protect patients,” said Dr. Michael Carome, director of the Public Citizen Health Research Group. “The agency should move expeditiously to finalize its proposed rule, which will better protect patients by ensuring they have timely access to updated safety information.”

The FDA’s proposal reflects the reality that 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.

Under a longstanding FDA rule, adopted in the 1980s at the urging of the pharmaceutical industry, brand-name manufacturers are permitted to make safety updates without prior FDA approval. That rule enables updated warnings to reach physicians and patients as soon as possible. After generics enter the market, however, brand-name market share drops precipitously, and brand-name manufacturers are much less vigilant about labeling updates. Further, brand-name manufacturers often stop making a product for which there is a generic version and, at that point, are not monitoring the product or considering labeling updates.

The FDA’s proposed rule would promote patient safety by extending to generic drug manufacturers the ability to make labeling updates, and by providing a process for other makers of a particular medication promptly to follow suit.