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FDA urged to revise generic drug risk rules
- Publisher：
- Publication：2011/9/2
The US Food and Drug Administration (FDA) has been urged to amend regulations preventing generic drug manufacturers from updating labelling, allowing them to warn patients about associated drug risks.
FDA regulations currently prevent makers of generic drugs 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.