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In a disturbing reversal, the Food and Drug Administration (FDA) on Dec. 13, 2018, announced that it was withdrawing a 2013 proposed rule that would have allowed generic drug companies to promptly update safety warnings in their product labels.[1]
The proposed rule, which was prompted by a 2011 Public Citizen petition, would have promoted patient safety by extending to generic manufacturers the ability to rapidly make important safety updates in product labeling without first...
In a disturbing reversal, the Food and Drug Administration (FDA) on Dec. 13, 2018, announced that it was withdrawing a 2013 proposed rule that would have allowed generic drug companies to promptly update safety warnings in their product labels.[1]
The proposed rule, which was prompted by a 2011 Public Citizen petition, would have promoted patient safety by extending to generic manufacturers the ability to rapidly make important safety updates in product labeling without first obtaining FDA approval for the changes, as brand-name drug companies have been able to do for more than 30 years.
Tellingly, the FDA’s December announcement parroted unfounded objections to the proposed rule that had been raised by the generic-drug industry. In particular, the agency highlighted industry concerns that the proposed rule would have imposed “significant new burdens” and “new costs” on genericdrug makers, increased drug prices and led to confusing variations among labels when the same generic drug is marketed by more than one company. But the FDA disregarded previous arguments made by Public Citizen and other patient advocates that rebutted these baseless concerns.
Moreover, the FDA’s announcement made no mention of the major public health benefits of the proposed rule that the agency had emphasized when it first released the proposal in 2013.[2] At that time, the agency correctly noted that the proposed rule would have strengthened the incentive for generic-drug companies to maintain robust monitoring for new serious adverse effects caused by their products, an incentive that essentially vanished because of a 2011 U.S. Supreme Court decision in a case involving a patient who was severely injured by a generic drug.
The agency also emphasized in 2013 that its proposal would help ensure that generic drug product labeling contains the most up-to-date and accurate warnings and other safety information and that newly acquired safety information for generic medications is made promptly available to health care providers and patients.
The need for such a rule was more critical than ever given that approximately 90 percent of all prescriptions dispensed in the U.S. are generic medications and the reality that new information about serious risks often comes to light after generic versions of a drug are on the market.
The FDA’s withdrawal of its proposed rule represents a flagrant disregard for public health because it continues to immunize generic-drug manufacturers from any liability if patients are injured or killed by a generic medication, even when warnings about serious risks known to the companies are missing from the labels. The FDA plainly bowed to industry pressure and, in the process, prioritized industry profits over patient health and safety.
References
[1] Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, M.D. and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D., on efforts to modernize generic drug labels while maintaining the efficiency of generic development. December 13, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628339.htm. Accessed January 3, 2019.
[2] Food and Drug Administration. Proposed rule: Supplemental applications proposing labeling changes for approved drugs and biological products. 78 Fed. Reg. 67985. November 13, 2013.
