Contrary to a rule suggested by the Food and Drug Administration (FDA) in 2013 that would have allowed injured parties to hold generic drug manufacturers legally responsible for harm caused by medications, the agency recently withdrew its own proposal. The proposal essentially shields drug manufacturers from product liability lawsuits.
The proposal, known as the Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, would have allowed generic drug companies to independently update and distribute new safety information on the labels of their products without prior FDA review and approval. Generic drug companies are currently required to follow labels produced by brand name companies.
FDA officials proposed the 2013 rule after the U.S. Supreme Court held that patients cannot file lawsuits against generic drug companies for neglecting to warn them about potential risks. In other words, since generic companies are not allowed to update their own labels, they should not be held liable for failing to issue warnings. Prior to this ruling, the court previously held that brand name drug companies could be legally liable for inadequate warnings on generic medications.
FDA regulations to change labels for accuracy and cost effectiveness
The FDA’s current regulations for all brand and generic drug manufacturers already require drug manufacturers to take steps to update their product labels when new information becomes available that renders the label inaccurate, false, or misleading. This responsibility applies to both brand name and generic manufacturers. As generic drug makers become aware of new safety information that does not appear on the drug label, they must also report it to the agency. This could subsequently result in safety changes that are directed by the FDA that would apply to all versions of the drug.
The FDA said it abandoned the proposed rule because of some unintended consequences. According to a statement issued December 13 by FDA officials, Scott Gottlieb and Janet Woodcock ultimately believe abandoning the proposed rule would eliminate confusion between providers and patients:
“We heard from manufacturers that they believed this change would have imposed on them significant new burdens and liabilities…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. “
The agency is, however, updating the labels on certain generic cancer medications with current safety and efficacy information.