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Label Updates For Generics

Drugs: FDA rule would allow changes to safety information, could expose industry to failure-to-warn lawsuits

by Glenn Hess
November 15, 2013 | A version of this story appeared in Volume 91, Issue 46

Credit: Shutterstock
Generic drug makers would be responsible for updating product labels with newly discovered safety information under a proposed FDA rule.
Prescription pills, drug bottles, instructions and warnings.
Credit: Shutterstock
Generic drug makers would be responsible for updating product labels with newly discovered safety information under a proposed FDA rule.

A proposed Food & Drug Administration rule would allow producers of generic drugs to independently update their product labels with newly discovered safety information. But such a move could open the industry to lawsuits by patients who could claim that those companies did not sufficiently warn them of a drug’s dangers.

FDA’s action is prompted by recent Supreme Court decisions that have shielded generic drug manufacturers from legal liability. In 2011 and again this year, the justices have ruled that generics companies can’t be sued because, under current FDA rules, only brand-name drug makers are responsible for safety warnings. Generics firms are required to copy the FDA-approved label from the brand product and cannot alter the language.

Consumer groups welcomed FDA’s proposal, saying it will fill a regulatory gap that poses a risk to patient safety. “Many potential hazards are not discovered until years after drugs have been on the market. Yet currently, generic drug manufacturers can do little to warn about newly discovered information,” says Sidney M. Wolfe, director of Public Citizen’s Health Research Group.

The Generic Pharmaceutical Association, an industry trade group, says it is concerned that “multiple versions of critical safety information will lead to unnecessary confusion … with harmful consequences for patients.”

The U.S. Chamber of Commerce says the proposed rule could ultimately raise the cost of generic drugs. “FDA’s proposal writes a prescription for mega lawsuits against generic drug makers by plaintiffs’ lawyers alleging that generic labels are somehow inadequate,” says Lisa A. Rickard, president of the chamber’s Institute for Legal Reform.

Under the proposed rule, generic drug makers would be able to update their product labeling when new safety information surfaces in the same way brand drug manufacturers do today. FDA would then evaluate whether the proposed change to a generic drug label is justified.

“More than 80% of prescriptions filled in the U.S. are for generics, so we want to make sure that generic drug companies actively participate with FDA to ensure that product safety information is accurate and up-to-date,” says Janet Woodcock, director of the agency’s Center for Drug Evaluation & Research.



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