Bill introduced to allow generics to change labelling

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Bill introduced to allow generics to change labelling

INICIO/Políticas y legislación | Posted 27/04/2012 0 Post your comment

A new bill aims to address a recent Supreme Court decision that threatens to undermine the safety of consumers taking generic drugs.

To date generics manufacturers have been exempt from having to change labels to reflect new safety concerns until after the brand-name drugmaker changes their labelling [1]. However, this could soon change if a bill introduced on 18 April 2012 by Senate Judiciary Committee Chairman Patrick Leahy gets its way. The legislation is co-sponsored by Senators Al Franken, Jeff Bingaman, Sheldon Whitehouse, Sherrod Brown, Christopher Coons and Richard Blumenthal and would permit generics manufacturers to proactively improve warning information on labelling even before the brand-name drugmaker does.

Senator Leahy said, ‘The Mensing decision creates a troubling inconsistency in the law with respect to prescription drugs, … if a consumer takes the brand-name version of drug, she can sue the manufacturer for inadequate warnings. If the pharmacy happens to give her the generics version, she will not be compensated for her injuries.’

Senator Whitehouse said ‘consumers of generic prescription drugs should have the same rights as those who are prescribed brand-name drugs’, while Senator Brown added that ‘regardless of whether they use generic or brand-name drugs, Ohioans should have full access to information regarding the safety of their prescriptions’.

Companion legislation is expected to be introduced in the House of Representatives by Congressmen Chris Van Hollen and Bruce Braley.

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Reference

1. GaBI Online - Generics and Biosimilars Initiative. Generics will not have to change their labelling [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Apr 27]. Available from: www.gabionline.net/Generics/News/Generics-will-not-have-to-change-their-labelling

Source: Senator Leahy