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GPhA challenges FDA guidance on size and shape of generic pills Posted 30/10/2015

In June 2015, the US Food and Drug Administration (FDA) published guidance on the size, shape and other physical attributes of generic tablets and capsules [1]. However, the Generic Pharmaceutical Association (GPhA) has raised a number of concerns about the guidance.

FDA published its guidance in an effort to address concerns that differences in the physical characteristics of medicines, e.g. size and shape of the tablet or capsule, may affect patient compliance or could lead to medication errors. In its guidance the agency sets limits on how much the physical characteristics of generics should vary from originators.

The GPhA has objected to these requirements stating that the guidance ‘imposes arbitrary requirements even in the absence of known safety issues’. The association is also questioning the legality of the guidance, stating that ‘the premise of the guidance, that generic drugs must mimic the reference listed drug in size and shape, has no basis in law’.

The GPhA also points out that, due to patent protection, generics makers may sometimes be required to develop a tablet or capsule that differs in dimensions in order to make the lower cost generic drug product available to patients. The GPhA adds that ‘a generic version of a product that differs from the size and/or shape recommendations set forth in the guidance does not automatically raise safety issues.’

The GPhA believes that rather than making this a ‘de facto’ regulatory requirement FDA should evaluate differences in generic drug product dimensions ‘on a case-by-case basis to assess actual risks’.

The association also states that ‘the guidance creates a new life cycle management tool for NDA [new drug application] sponsors to stifle and delay access to lower cost generic medicines’.

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1. GaBI Online - Generics and Biosimilars Initiative. FDA wants generics to be physically same as originators [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 30]. Available from: www.gabionline.net/Guidelines/FDA-wants-generics-to-be-physically-same-as-originators

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