FDA Withdraws Proposed Rule in Efforts to Modernize Generic Drug LabelsBy
The US Food and Drug Administration (FDA) is withdrawing a proposed rule from 2013 that, if finalized, would have allowed generic drug makers to independently—meaning, without prior FDA review and approval—update and promptly distribute new safety information in drug labels. Currently, only branded drug makers can do so.
The FDA proposed the rule in November 2013, calling it Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. “We heard from manufacturers that they believed this change would have imposed on them significant new burdens and liabilities,” FDA Commissioner Scott Gottlieb and Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research, said in a December 13, 2018 agency statement. “We heard arguments that the proposed rule could impose new costs on generic manufacturers that might have raised the price of generic drugs to patients, potentially impacting patient access to generic medicines. And, among other challenges, the new policy would have resulted in labels for the same drug that varied between different generic manufacturers, for some period of time.”
The FDA says among the challenges identified with the proposed rule was the ability of generic manufacturers to collect safety information to inform label changes. “We heard that generic drug companies don’t generally receive or possess all the data necessary to evaluate post-marketing safety information to support these changes on their own,” Gottlieb and Woodcock said in the statement.
The agency says it is still working to ensure the best possible information about the safety of drug products. “And let us be very clear – the withdrawal of the 2013 proposed rule does not change the ongoing obligations under the FDA’s current regulations for all brand and generic drug manufacturers,” the FDA heads said in their statement. “These regulations already require drug manufacturers to take steps to update their product labels when new information becomes available that cause the label to become inaccurate, false, or misleading. This responsibility isn’t only for brand drug manufacturers. It also applies to generic manufacturers.”
New information regarding the risks and benefits of a drug may become available over time from various sources. This includes real-world data like post-marketing adverse drug experience reports and published literature. The FDA notes new information can make updates to product labels necessary. Currently, generic drug manufacturers can and are required to propose certain updates to product labels by submitting adequate information about the proposed safety-related change (in the form of a prior approval supplement). The FDA will then determine whether the change is appropriate and whether the label for the corresponding brand drug and other generic drugs should also be revised.
The FDA says it is also advancing other initiatives to facilitate efforts to keep drug product labels up-to-date throughout the product lifecycle. “To this end, the FDA has undertaken a new program to update the labels on certain generic cancer drugs with modern safety and efficacy information,” Gottlieb and Woodcock said. “Consistent with our current authorities, the FDA expects to play a more proactive role to identify and facilitate updates to these older generic drugs, to give prescribers and patients access to the most up-to-date information to guide treatment decisions. This is an important undertaking, because having out-of-date drug labels can depress use of generic drugs, reducing consumer access to these lower-cost medicines.”