Branded drugmakers can change their U.S. labeling without FDA's permission, so they're vulnerable to state lawsuits alleging they failed to warn of a product's safety risks. But generics makers have to use the exact same labeling as their branded counterparts. So, can they also be sued for neglecting disclosure about safety problems?
As the New York Times reports, that's the question Supreme Court justices are entertaining in a case pitting three patients against generics makers who marketed copycat versions of Reglan, a stomach drug marketed by Wyeth. The women developed tardive dyskinesia, a neurological disorder, after taking the drug.
If the justices uphold a lower court's decision that the generics companies can indeed be liable, that could be a watershed decision for copycat drugmakers, the companies' attorney told the NYT. "This would totally change the way generics do business," Jay P. Lefkowitz told the paper. "Brand companies do safety and efficacy testing; generics do sameness testing," he added. "Generics are required to make copies of the drugs and by definition make copies of the labels."
But the plaintiffs' counsel said the generics makers shouldn't be "immune from liability" when branded drugmakers could be held liable for the same labeling. The justices themselves debated a bit on whether a generics firm should be responsible for "asking FDA for labeling changes, given that they can't make those changes themselves. Overall, the court appeared to be evenly divided. But we won't know for sure until this summer, when an opinion is expected.
- read the NYT piece