The Food and Drug Administration is proposing that generic drug manufacturers use the same process as brand-name drugmakers to update product labeling in an announcement made just months after the U.S. Supreme Court ruled on the issue.
The way the law currently stands can mean that generic-drug makers are not liable in instances where patients say they were not warned of the risks from certain drugs.
A draft rule issued Friday would allow generic-drug makers to update product labeling with new safety information before the FDA reviews and approves the change—a process that brand-name pharmaceutical companies follow today.
As a drug becomes more widely used, more information often becomes available about its risks and benefits.
“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 the FDA to ensure that product safety information is accurate and up to date,” said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
The Generic Pharmaceutical Association, though, expressed concern that multiple versions of safety information would cause confusion for providers.
The Supreme Court this year threw out a jury verdict awarding $21 million to a patient who suffered from skin reactions after taking a generic of the anti-inflammatory drug sulindac that wasn't labeled with a warning for that risk.
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