FDA Wants Industry’s Views on How to Improve Excipients Database
The FDA is seeking input on how it can make its Inactive Ingredients Database more useful and user-friendly, following complaints by generic drug and excipient makers that the current format delays ANDA filings.
Specifically, the FDA wants to know how it can improve the nomenclature in the database — i.e. what are preferred ingredient names and synonyms, how excipient amounts should be identified, how the database can be updated to ensure completeness and accuracy and, if the database is restructured, how that should be done.
The feedback will be used to inform future guidance on use of the database, according to a notice in Aug. 20’s Federal Register.
The IID was launched in December 2002 to help the FDA evaluate the safety of excipients from a toxicology perspective when reviewing drug applications. But incomplete and inaccurate information and discrepancies in nomenclature related to excipients have made it hard for ANDA sponsors to make timely and quality submissions, IPEC Americas says.
The group has met quarterly with the FDA since December 2011 as part of a working group to help the agency resolve issues with the database and ultimately redesign it, says David Schoneker, director of global regulatory affairs at excipients maker Colorcon.
GPhA has also weighed in on the database, calling last year for a complete overhaul to better facilitate ANDA filings.
One of the key problems with the current database, according to Schoneker, is that it only provides precedent levels of use on a per dose basis, while an ANDA sponsor needs to know the maximum daily intake of an excipient — information that isn’t currently publicly available. This requires sponsors to submit controlled correspondences to the FDA, which must then manually research their files to find out the maximum daily intake for a specific use of the excipient. Since the MDI information does not currently reside in any FDA database, it may take months for them to respond.
Additionally, drugmakers who have used different grades of excipients than those listed in the database have received refuse-to-receive decisions from the FDA on ANDA submissions. Improving the database could reduce the number of “refuse to receive” responses and save industry and FDA resources expended trying to determine the acceptability of a particular excipient in a submission, Schoneker says.
IPEC has proposed the agency adopt a family-based approach for assessing the safety of excipients, similar to that used by the Center for Food Safety and Applied Nutrition, that considers safety data for all grades of an excipient — such as lactose — rather than specific levels.
Comments are due Oct. 19. View notice at www.fdanews.com/08-20-15-IDD.pdf. — Kellen Owings
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