FDA Urged to Revise Regulations on Generic Drug Labelling
FDA currently prevents generic drug makers to update labels even if they are made aware of an unstated risk to the consumer, as they must remain identical to the original brand-name product.
The US FDA has been urged to revise regulations that prevent generic drug manufacturers from updating labelling, allowing them to warn patients about associated drug risks.
FDA regulations currently prevent generic drug makers to update labels even if they are made aware of an unstated risk to the consumer, as they must remain identical to the original brand-name product.
However, manufacturers of brand-name medications are entitled to alter their labels without FDA approval, a rule that advocacy group Public Citizen has labelled as illogical.
The disparity was highlighted in the US Supreme Court in June 2011 during the case of Pliva vs Mensing.
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