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FDA delays finalization of generics labelling rule Posted 05/12/2014

The US Food and Drug Administration (FDA) is delaying the issue of its controversial rule on generics labelling changes, which was expected to be finalized in December 2014, until autumn 2015.

The new rule, which was proposed by FDA on 8 November 2013, would allow generics makers to change their labelling in the same way as brand-name manufacturers already do. FDA believes that this will speed the dissemination of new safety information about generics to healthcare professionals and patients [1].

The proposal, however, has been criticised by generics makers over concerns that different versions of drug labels could cause confusion among patients and would increase the cost of generics. The Generic Pharmaceutical Association (GPhA) claims that the cost of added litigation could add US$4 billion to the nation’s annual healthcare bill [2].

FDA sought comments from the public on the proposed rule and, although the comment period closed on 13 March 2014, the agency is still reviewing the more than 100 total responses it received. This, it is believed, is the reason for the delay.

A letter, addressed to FDA and the Office of Information and Regulatory Affairs, from Congressman Steve Israel and Congressman Timothy Bishop has also raised serious concerns with the rule, calling it ‘problematic’ and ‘harmful’. They also expressed the opinion supported by many others that ‘the FDA alone has the authority and access to the complete data to update the labels of generic medicines’.

Mr Ralph G Neas, President GPhA, summed up the problems with the proposed rule, saying, ‘as written, the rule is bad policy, bad for public safety and bad for public health’.

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1.   GaBI Online - Generics and Biosimilars Initiative. FDA to allow generics makers to change labelling [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Dec 5]. Available from: www.gabionline.net/Policies-Legislation/FDA-to-allow-generics-makers-to-change-labelling 
2.   GaBI Online - Generics and Biosimilars Initiative. FDA’s labelling proposal will increase cost of generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Dec 5]. Available from: www.gabionline.net/Reports/FDA-s-labelling-proposal-will-increase-cost-of-generics 

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Source: GPhA, WSJ

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