Saturday 20 January 2018

US watchdog to rule on generic drugs packaging

THE US Food and Drug Administration will propose a drug packaging rule by September that should create parity between generic and brand-name drugmakers, but open up the former to lawsuits. The proposed rule will empower generic makers to change labelling and safety information on their products, outside of what is already prescribed by the original brand-name manufacturer.

This means people who are injured by a generic product will be able to sue the generic manufacturer. This has ramifications given that a boom in generics is expected over the next five years as some of the world's biggest medicines lose their patents.

Irish Independent

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