FDA has proposed a new rule which would allow generics makers to change their labelling in the same way as brand-name manufacturers [1]. The agency is now considering more than 100 responses to the proposed rule: ‘Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products’, which, if accepted, would allow generics makers to change their safety labels without prior FDA review and without immediate access to the drug’s complete safety data.

A random phone survey of 150 physicians, 150 physician assistants and 150 pharmacists carried out on behalf of the GPhA found strong reservations about many of the rule’s key provisions among all three groups. The survey showed that 81% of those surveyed believe that FDA approval should be required prior to generics safety label changes.

During the survey, 60% of healthcare providers also said that the proposed rule would have at least ‘some’ impact on their willingness to recommend generics in the future. ‘Given that generics use has generated more than US$1.2 trillion in savings to the US healthcare system over the past decade, and saved US$217 billion in 2012 alone, this could undermine the sustainability of our healthcare system’, according to NCH President and CEO, Mr John Rother.

Other key findings of the survey included that:

• 79% of respondents had not heard of the proposed new rule/change
• Healthcare providers believe that multiple versions of labelling for the same drug would lead to confusion
• Most respondents believe the new rule would have a negative impact on their time:
         – 71% anticipate the new rule would increase the amount of time they need to spend with their patients reviewing patient history and the new labels
         – 74% believe it would have at least some impact on the time they will need to spend researching labelling differences
• Most respondents (68%) believe they would not have the time required to keep current with the labelling changes
• 77% of respondents (85% for pharmacists) are at least somewhat concerned the proposed new rule could impact their legal liabilities

Full survey results are available on the GPhA website.

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Reference
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 Aug 1]. Available from: www.gabionline.net/Policies-Legislation/FDA-to-allow-generics-makers-to-change-labelling

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