Public Citizen: FDA should change generics labeling rules

Public Citizen is asking the FDA to change its rules and allow generic drugmakers to update the labeling on their products. The change would address a recent U.S. Supreme Court ruling that generics makers aren't liable for safety warnings on their drug labels because the labeling duplicates the language on branded versions.

Patients had sued some generics companies, accusing them of failing to warn about side effects--even after the firms were alerted to the problems. But current FDA rules don't allow these drugmakers to change their labeling. Makers of branded meds can update product warnings on their own, but generics makers can't.

As Pharmalot reports, two patients had claimed in court filings that labels could be changed under state law without FDA approval. They said patients can't be sure about drug safety if generics makers aren't held liable for a lack of adequate warnings. However, the Supreme Court cited FDA rules, saying generics makers couldn't independently change their labels to satisfy state law when federal regs require their labels duplicate those of their branded counterparts.

Public Citizen is now calling on the FDA to make a change. "Drug safety would benefit if generic manufacturers--who already have access to real-world information about adverse events--could use FDA procedures currently in place for brand-name manufacturers to revise labeling to warn of risks," Sid Wolfe, who heads the Public Citizen Health Research Group, said in a statement (as quoted by Pharmalot).

- see Public Citizen's petition
- read the Pharmalot post

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