A woman from Minnesota who developed a severe neurological disease after taking a generic drug is part of a case before the Supreme Court. She and the other plaintiffs argue that the manufacturer knew of this side effect but failed to put it on the drugâÄôs label until years later.
Federal law requires generic drugs to mimic the label of their brand-name equivalents exactly. While brand-name companies can be liable for failing to warn customers of the risks involved with taking their drugs, generic companies argue that their hands are tied because they are not allowed to change their labels.
To keep prices low, generics need not do additional safety testing. If they exactly mimic name-brand drugs, this should not be a problem. However, one-third of generic drugs no longer have a brand-name equivalent. If someone discovers a new side effect, federal law does not require any update to the label.
If generic drug companies are not held responsible in these cases, no one is. This is the situation in the case before the Supreme Court.
Failing to hold anyone responsible for informing consumers of the risks of certain medications is unacceptable. Generic drug makers are allowed to advise the Food and Drug Administration âÄî which does have the power to change labels âÄî when they become aware of additional risks of their medication, and they should be legally obligated to do so.
But there should also be a change in federal law that allows generics to add warnings to protect consumers. Generic drug companies should not be held to the standard of name-brand companies so prices stay low. But they should bear responsibility when they know the risks of medication and do not publish them.