FDA announced in the Federal Register of 15 October 2014 that the agency will conduct a survey of patients and pharmacists to gain an understanding of both groups’ perception of certain attributes of differences in generics for the same drug product.

While generics are required to be pharmaceutically equivalent and bioequivalent to the brand-name drug, generics made by different manufacturers may differ substantially from their brand-name therapeutic equivalents and from each other in their physical appearance, e.g. colour, shape or size of pills.

Since patients may receive generics from different manufacturers when refilling their prescriptions, FDA is concerned that changes in the appearance of their drugs may cause ‘patient confusion and concerns about the safety and effectiveness’ of the generics.

FDA adds that ‘studies indicate that patients are more likely to stop taking their generic medications when they experience a change in their drugs’ physical appearances, leading to harmful clinical and public health consequences as well as increased healthcare costs from avoidable morbidity and mortality’.

The aim of the survey is ‘to provide additional information that may help guide regulatory policy or pharmacy business practices.’ FDA intends to conduct surveys of pharmacists and patients about their perceptions and experiences with appearance change of generics. The survey is intended to further FDA’s understanding of the relationship between changes in pill appearance and non-adherence to prescribed therapeutic regimens.

The announcement follows FDA’s publication of its draft guidance for industry on the size, shape, and other physical attributes of generics, which the agency released for comment in December 2013 [1]. The results of the surveys are expected to ‘guide regulatory policy’, i.e. could change the requirements of the guideline.

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FDA to release guidance on generic tablet size

Reference
1.   GaBI Online - Generics and Biosimilars Initiative. US guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Nov 28]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-generics 

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