Generic Drug Labeling Rule -- Postponed

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  • 12/04/2015

FDA Postpones Generic Drugs Safety Update Rule Again

Drug Industry Daily

After pushing a proposed patient safety rule back yet again, the FDA has received criticism for putting patients at risk.

The rule - which would empower generic drugmakers to update labeling to provide warnings about newly discovered risks to patient safety without prior FDA approval - now is expected to be final in July 2016, after being delayed several times following its proposal in 2013.

Under current FDA regulations, NDA and BLA holders are permitted to make safety updates without agency approval, but generic drugmakers cannot do so unless instructed to by the FDA.

Public Citizen's Health Research Group described the postponement as a "safety gap" for patients who take generic medications.

"The agency should resist pressure from the pharmaceutical industry and finalize a rule that will protect patients," says Michael Carome, director of the Public Citizen Health Research Group.

GPhA and PhRMA are pushing an alternate plan that would make the FDA the central arbiter of all labeling changes - for NDA and ANDA holders alike - once the first generic version hits the market (DID, May 27).

Peter Pitts, president and founder of the Center for Medicine in the Public Interest and a former FDA associate commissioner, also has underscored the importance for such a rule, noting there have been several high-profile recalls of generic drugs because they did not deliver the outcome they were supposed to.

"How can you communicate the fact that bioequivalent does not mean identical?" Pitts rhetorically asks.

Pitts, however, notes that the rule would be a significant addition to the Food, Drug and Cosmetic Act, and would need to be carefully worded legally. He tells DID that his educated guess for the postponement of the rule is because of the high volume of comments being examined from a legal perspective.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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