Final Rule on Labeling Changes Pushed Back to July 2016

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PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-01-06-2016, Volume 12, Issue 1

FDA sets a July 2016 deadline for the final version of the rule on labeling changes for approved drugs and biologics.

The deadline for FDA’s final rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, has been extended to July 2016 according to a notice on the Office of Information and Regulatory Affairs website. The rule revises and clarifies procedures for changes to the labeling of an approved drug and applies to new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs). FDA has extended the deadline to address industry comments and concerns. 

According to FDA, 80% of drugs in the marketplace are generic drugs approved in ANDAs. ANDA holders, however, are not allowed to use the changes being effected (CBE) supplement process NDA and BLA holders use to update product labeling to reflect updated safety information. The notice states that, “this regulatory difference recently has been determined to mean that an individual can bring a product liability action for ‘failure to warn’ against an NDA holder, but generally not an ANDA holder. This may alter the incentives for generic-drug manufacturers to comply with current requirements to conduct robust postmarketing surveillance, evaluation, and reporting, and to ensure that their product labeling is accurate and up-to-date. Accordingly, there is a need for ANDA holders to be able to independently update product labeling to reflect certain newly acquired safety information as part of the ANDA holder's independent responsibility to ensure that its product labeling is accurate and up to date.”

FDA hopes the rule would allow for timely communication of safety related labeling changes and encourage generic-drug companies to work actively with the agency. The Food, Drug, and Cosmetic Act gives FDA the authority over the labeling for drugs and biologic products.


In a statement on its website, Generic Pharmaceutical Association (GPhA) President and CEO Chip Davis said, “GPhA is pleased that FDA will continue to evaluate the wide range of concerns expressed over the currently proposed changes to generic drug labeling requirements. GPhA continues to support the Expedited Agency Review, a better way forward that strengthens the communication of drug safety information without putting patients at risk … The FDA is the only entity with all of the data needed to recommend a safety information change. Instead, the EAR suggests time parameters for the FDA to take action and encourages the adoption of e-labeling for real time information sharing rather than continuing the reliance on paper label changes that take months or years to adopt. The EAR also takes important steps to make sure that multiple different labels do not exist for products with the same active ingredients, safety and efficacy.”