Consumer group urges FDA to allow timely updates to generic drugs’ warning labels

A leading consumer-advocacy group wants the government to allow generic drugmakers to update their products’ warning labels when new risks are discovered without having to first go through the time-consuming federal bureaucracy.

Public Citizen filed a petition Monday with the Food and Drug Administration urging regulators to allow generic drugmakers to update warnings and precautions on product labels, just as brand-name drugmakers can. The discrepancy came into public view in June when the U.S. Supreme Court ruled that patients harmed by inadequate warnings on generic drugs cannot sue for damages, while people who take brand-name versions of the same drugs can — an “absurd consequence” of current law, Supreme Court Justice Sonia Sotomayor said.

“The action we are requesting would bring FDA regulation in line with the realities of the pharmaceutical market and help to ensure that drug labeling provides adequate warnings to patients based on information that comes to light after the drug is approved for marketing,” Allison Zieve, director of the Public Citizen Litigation Group, said in a statement. Generic drugs account for a majority of all prescriptions, and about 90 percent of prescriptions for which a generic version exists.

The petition also urges the FDA to reiterate generic drugmakers’ obligation to inform the FDA whenever a manufacturer becomes aware of information suggesting an association between its product and a hazard not adequately disclosed on the labeling, Public Citizen said.