The consumer group Public Citizen is asking the US Food and Drug
Administration (FDA) to allow generic drugmakers to update their product
labeling with warnings about newly discovered risks associated with
their drugs. Currently, FDA prohibits generics companies from updating
labeling, even if they learn about a potential risk of a drug that is
not covered in its labeling. Brand-name drugmakers, on the other hand,
can update label warnings before getting FDA approval. Generic
drugmakers must match drugs’ labeling to their brand-name equivalents.
“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,” said Dr. Sidney Wolfe, director of Public
Citizen Health Research Group in a press release. “Filling this
regulatory gap would help to protect patients.”
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