Public Citizen: FDA Delay in Safety Rule Leaves Patients Nationwide at Risk

From our press release:

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.

Here's the whole release, the government's page showing the status of the rule, and our original petition in 2011 seeking this fix.

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