In November 2013, FDA issued a proposed rule that would speed the dissemination of new safety information about generics to health professionals and patients by allowing generics makers to use the same process as brand-name drug manufacturers to update safety information in the product labelling [1].

‘GPhA shares the FDA goals to promote and protect public health,’ said Mr Ralph Neas, President and CEO of GPhA. ‘However, the proposed rule creates a scenario where disparate and potentially conflicting information from multiple manufacturers for single medicines could be widespread, causing confusion and putting patient safety, access and savings at risk.’

GPhA and PhRMA and their supporters call for an alternative to the proposed rule which they say can achieve all of FDA’s objectives related to efficient communication of important safety information [2]. In a letter to FDA, supply chain participants, minority health groups and others wrote ‘We fully support the science-based alternative called the Expedited Agency Review (EAR), which has the support of both generic[s] and brand-name drug manufacturers because it relies on the FDA to review new safety information for multi-source products and requires FDA to take action on a label change made on all multi-source products within a defined time period.’

EAR would establish defined time parameters for FDA to take action on a label change made either following FDA’s receipt and review of ‘new safety information’ from a multi-source application holder or following review of data received through the Sentinel System and/or other databases including global sources that are suggestive of a need for a label change [3].

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References
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 2015 May 22]. Available from: www.gabionline.net/Policies-Legislation/FDA-to-allow-generics-makers-to-change-labelling  
2.   GaBI Online - Generics and Biosimilars Initiative. Alternative proposal for generics labelling [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 22]. Available from: www.gabionline.net/Policies-Legislation/Alternative-proposal-for-generics-labelling 
3.   GaBI Online - Generics and Biosimilars Initiative. Drug manufacturers call for revision to FDA safety labelling rule [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 22]. Available from: www.gabionline.net/Policies-Legislation/Drug-manufacturers-call-for-revision-to-FDA-safety-labelling-rule 

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