Regulatory Focus™ > News Articles > FDA to Release Major Generic Drug Labeling Rule in July 2016

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Posted 03 December 2015 | By Zachary Brennan 

FDA to Release Major Generic Drug Labeling Rule in July 2016


The US Food and Drug Administration (FDA) has now said it will release in July a controversial and major final rule that would allow generic drug companies to update their labels with new safety information like their reference product counterparts have done for almost 30 years.


Under current FDA regulations, generic drug companies with abbreviated new drug applications (ANDAs), unlike companies with new drug applications (NDAs) and biologics license applications (BLAs), cannot independently update product labeling with newly acquired safety information.

That means that when a generic company notices a safety issue that has yet to either crop up or be indicated on its reference product’s label (or the reference product is no longer even produced), the generic company cannot do anything to notify the public of an imminent concern, which raises serious liability issues.

As the proposed rule notes, the current regulatory difference between ANDA holders and NDA and BLA holders means that an individual can bring a product liability action for "failure to warn" against an NDA holder, but generally not an ANDA holder.

As Focus has extensively reported in the past (Read our Regulatory Explainer on the regulation of generic drug labeling), FDA has long been interested in making it easier for all drug companies—not just innovative manufacturers—to update safety labeling.

FDA first unveiled the proposed rule in November 2013, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, but has been deliberating, holding public meetings, and re-opening the federal docket for more comments (the last comment period closed in April).

If finalized, the rule would permit a sponsor of a generic drug to immediately issue a labeling change for any safety-related change, starting a process intended to allow differences to exist between the generic drug, the brand-name reference product and other approved generic drugs on a "temporary basis."

The labeling change application to FDA would need to contain information such as the basis for the labeling change and available data to support the change, such as adverse event data, published literature or epidemiologic studies.

“The rule may encourage generic drug companies to participate more actively with FDA in ensuring the timeliness, accuracy, and completeness of drug safety labeling

in accordance with current regulatory requirements,” FDA says.

New Rule’s Pushback

Without going into much detail, FDA now says it’s “considering several alternatives” described in the more than 23,000 comments submitted to the public docket and considering the financial implications and benefits that would be associated with a final rule, which it plans to release sometime in July, after twice pushing back its release date.

And unlike some in the generic industry, who oppose the rule (to the point of suing FDA) and claim it would expose them to billions of dollars in new legal liabilities, patient advocacy groups are angered by the delay and are pushing for FDA to finalize the rule as quickly as possible.

“The agency should resist pressure from the pharmaceutical industry and finalize a rule that will protect patients,” Dr. Michael Carome, director of the Public Citizen Health Research Group, said in a statement on Thursday. “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 Generic Pharmaceutical Association, meanwhile, said Thursday that it's "pleased" FDA will continue to evaluate the wide range of concerns expressed with the agency's proposal, which would require "generic manufacturers to update labels based on incomplete information without first receiving FDA approval. However, no single manufacturer has access to the full range of available data — the proprietary data from clinical studies or the data held by each individual applicant holder."

Rule on Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

Public Citizen


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