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FDA has withdrawn the proposed rule that would have allowed generic-drug makers to independently update and distribute new safety information in drug labels.
On Dec. 13, 2018, FDA Commissioner Scott Gottlieb, MD, announced that FDA was withdrawing the 2013 proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, that would have allowed generic-drug makers to update and distribute safety information in their drug labeling. The action comes after consideration of the cost such a rule may have imposed on generic-drug manufacturers. In addition, the agency is updating labels on certain generic cancer drugs with new safety and efficacy information so that prescribers and patients have the most up-to-date information.
“These actions are part of our ongoing commitment to promote a framework that ensures that generic drug labels reflect up-to-date, science-based information to inform patients and providers, while also balancing the need to maintain a pathway for the development of generic drugs that is modern, efficient and low cost.
“As with all decisions we make, we carefully weighed the potential benefits of this proposed rule against the challenges it could impose. We want to provide background on this process, the FDA’s decision and the overarching public health considerations that were weighed. And, more broadly, we want to outline some of the current efforts the FDA is undertaking to help modernize generic labels,” Gottlieb said in a statement.