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On Sept. 26, 2022, U.S. Rep. A. Donald McEachin (D-Va.) introduced legislation that would compel the Food and Drug Administration (FDA) to issue a long-overdue commonsense rule to allow generic-drug companies to promptly update safety warnings in their product labeling.[1]
Prompted by a 2011 Public Citizen petition,[2] the FDA in 2013 actually had proposed a rule essentially identical to the one that McEachin’s legislation would mandate.[3] That proposed rule would have promoted patient...
On Sept. 26, 2022, U.S. Rep. A. Donald McEachin (D-Va.) introduced legislation that would compel the Food and Drug Administration (FDA) to issue a long-overdue commonsense rule to allow generic-drug companies to promptly update safety warnings in their product labeling.[1]
Prompted by a 2011 Public Citizen petition,[2] the FDA in 2013 actually had proposed a rule essentially identical to the one that McEachin’s legislation would mandate.[3] That proposed rule would have promoted patient safety by extending to generic-drug 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 40 years. However, in a troubling reversal, the FDA in 2018 caved to industry pressure and announced that it was withdrawing the proposed rule.[4]
Tellingly, the FDA’s 2018 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 generic-drug makers, increased drug prices and led to confusing variations among labels when the same generic drug is marketed by more than one company.[5] But the FDA disregarded previous arguments made by Public Citizen and other patient advocates that strongly rebutted these baseless concerns.
Moreover, the FDA’s 2018 announcement made no mention of the overwhelming public health benefits of the proposed rule that the agency had emphasized when it was first released for public comment in 2013.[6] 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.
The need for such a rule is more critical than ever given that approximately 90% 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 come on the market.
The FDA’s withdrawal of its proposed rule in 2018 represented a flagrant disregard for public health because it continued 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. Rapid passage of Congressman McEachin’s legislation would close this dangerous loophole once and for all.
References
[1] U.S. Congressman A. Donald McEachin. Press release: McEachin introduces legislation addressing patient safety gap in generic drug labeling. September 26, 2022. https://mceachin.house.gov/media/press-releases/mceachin-introduces-legislation-addressing-patient-safety-gap-generic-drug. Accessed September 28, 2022.
[2] Public Citizen. Petition to the Food and Drug Administration regarding generic drug labeling. August 29, 2011. https://www.citizen.org/wp-content/uploads/1965.pdf. Accessed September 28, 2022.
[3] Food and Drug Administration. Proposed rule: Supplemental applications proposing labeling changes for approved drugs and biological products. 78 Fed. Reg. 67985. November 13, 2013. https://www.govinfo.gov/content/pkg/FR-2013-11-13/pdf/2013-26799.pdf. Accessed September 28, 2022.
[4] 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 September 28, 2022.
[5] Ibid.
[6] Food and Drug Administration. Proposed rule: Supplemental applications proposing labeling changes for approved drugs and biological products. 78 Fed. Reg. 67985. November 13, 2013. https://www.govinfo.gov/content/pkg/FR-2013-11-13/pdf/2013-26799.pdf. Accessed September 28, 2022.
