Five years after proposing a rule that would have given generic drugmakers responsibility for their own drug labels—a move that would have exposed them to more lawsuits—the FDA has changed its mind.
Current rules require generics makers to adopt the official labeling, including safety warnings, used by the brands they’re knocking off. The rule change would have freed them to make their own changes. Now, the generics companies will keep their legal shield against patient lawsuits.
Why abandon the proposal? The FDA said it identified some unintended consequences. Generic drugmakers don’t normally collect postmarketing safety data they would use to update their labels, the agency said. Plus, different labels on generics and brands could confuse patients and prescribers.
“It runs contrary to the goals of the generic approval process, which requires generic medicines to have the same label as the reference listed drug,” FDA Commissioner Scott Gottlieb and Center for Drug Evaluation and Research Director Janet Woodcock said in a statement.
The FDA officials also said the rule could raise costs for generic drugmakers and, in turn, raise generic prices. That’s exactly what the FDA has been working to prevent with a series of measures designed to boost competition and lower prices.
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While the trade group for generic drugs, the Association for Accessible Medicines, praised the move, others criticized the FDA for its turnabout. Public Citizen, for one, said it “fails to modernize” labeling and endangers patient safety. The withdrawal “represents a flagrant disregard for public health and common sense because it continues to immunize generic manufacturers from any liability if patients are injured or killed by a generic medication,” said Sidney Wolfe, Public Citizen’s Health Research Group founder.
They’ll be shielded “even when warnings about serious risks known to the companies are missing from the labels,” Wolfe added in his statement.
For his part, David Gaugh, senior vice president of regulatory and scientific affairs at AAM, said the FDA “correctly recognized the need for consistency and the potential for adverse consequences.”
FDA officials proposed the rule in 2013 after the Supreme Court ruled patients can’t sue generic drugmakers for failing to warn about risks. If generic drugmakers can’t update their own labels, the court reasoned, they shouldn’t be liable for failing to raise red flags. Before that, the court had ruled that branded companies can be liable for inadequate warnings on generic medications.