FDA guidance on excipients questioned

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FDA guidance on excipients questioned

Home/Guidelines | Posted 03/04/2015 0 Post your comment

The International Pharmaceutical Excipient Council of the Americas (IPEC-Americas) has written to the US Food and Drug Administration (FDA) outlining major concerns related to the agency’s guidance on inactive ingredients in abbreviated new drug applications (ANDAs).

The FDA guidance, entitled ‘ANDA submissions – Refuse-to-Receive Standards Guidance for Industry’ (RTR guidance), includes information related to inactive ingredients that IPEC-Americas believes contradicting its own ongoing long standing work with key stakeholders from the Office of Generic Drugs Expert Working Group. The working group has been working towards addressing key FDA and industry concerns with regards to the current FDA Inactive Ingredients Database (IID).

In their letter to FDA, IPEC-Americas Chairman Mr John Giannone and Chair-Elect Ms Priscilla Zawislak, note that concerns they had raised previously relating to inactive ingredients were not adequately addressed in the RTR guidance. In addition, the guidance as it stands is ‘inconsistent with some established historic practices within the Center for Drug Evaluation and Research,’ they write. ‘This type of misinformation can only create confusion for excipient manufacturers and ANDA sponsors.’

IPEC-Americas argues that FDA has relied too heavily on current data captured in the IID, which contains much ‘inaccurate, incomplete and missing information’. The database has not been updated since October 2014 [1], they note.

‘The current guidance extends the definition of a novel excipient to inactive ingredients that are currently listed in the IID with an established safe history of use in a related route of administration or at a relatively lower level of use,’ they write. FDA’s current definition of a novel excipient ‘will stifle innovation in generic drug development’.

IPEC-Americas disagrees with FDA that a New Drug Submission route should be used for a product which contains an excipient that may not have precedence of use in the IID in a corresponding route as that proposed in the ANDA.

The RTR guidance ‘will and has resulted in increased confusion for industry’, conclude Giannone and Zawislak, who now call on FDA to revise their guidance in line with discussions it has had with IPEC-Americas.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA publishes guidance on ANDAs for new strengths [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 3]. Available from: www.gabionline.net/Guidelines/FDA-publishes-guidance-on-ANDAs-for-new-strengths

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Source: IPEC-Americas