Under current regulations generics manufacturers cannot update the labelling of their products until the brand-name manufacturer does so. Many potential hazards, however, are not discovered until years after drugs have been on the market, yet, these regulations mean that generics manufacturers can do little to warn doctors and patients about newly discovered information, potentially putting patients at risk.

A new rule being proposed by FDA could change this, enabling ‘the labelling of an approved drug to reflect certain types of newly acquired information in advance of FDA’s review of such change’ and creating parity between generics and brand-name drugmakers with respect to supplemental labelling requirements.

The decision by FDA comes two years after the US Supreme Court ruled in June 2011 that generics makers were pre-empted by federal law from being sued for failing to provide adequate label warnings about potential side effects [1]. Then in June 2013 the same court ruled that generics makers could not be sued by patients for any injuries. This is due to the fact that generics manufacturers either need FDA to order a label change or the brand-name manufacturer to do it first.

The new rule could potentially open up generics makers to law suits, such as that of Mutual Pharmaceutical versus Bartlett, with lawyers for injured patients arguing that generic drugs were unreasonably dangerous if they could have changed their labelling to give extra warnings but didn’t.

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Generic pre-emption raises its ugly head again

Reference

1.  GaBI Online - Generics and Biosimilars Initiative. Generics manufacturers do not have to change drug safety labels in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Aug 2]. Available from: www.gabionline.net/Generics/News/Generics-manufacturers-do-not-have-to-change-drug-safety-labels-in-the-US

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