Regulatory Focus™ > News Articles > 2019 > 10 > Industry Calls on FDA to Expand on Inactive Ingredient Database Guidance

Industry Calls on FDA to Expand on Inactive Ingredient Database Guidance

Posted 17 October 2019 | By Michael Mezher 

Industry Calls on FDA to Expand on Inactive Ingredient Database Guidance

Drugmakers and industry groups are calling on the US Food and Drug Administration (FDA) to expand and clarify its recent draft guidance on how to use its inactive ingredient database (IID).
The 13-page draft guidance, released for comment in July, provides recommendations for drugmakers on using FDA’s IID, an online repository of information about excipients used in FDA-approved products, during drug development.
According to FDA, drugmakers can reference inactive ingredients listed in the database in marketing applications as any excipient used in an approved drug product for a specific route of administration “generally is not considered new and may warrant less extensive assessment the next time it is included in a new drug product for the same route of administration.”
FDA also agreed to make enhancements to the IID under the reauthorization of the Generic Drug User Fee Amendments (GDUFA II) to allow users to query information on maximum daily intake and maximum daily exposure information for different routes of administration by October 2020.
In its comments, the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) complains that much of the information about how the database should be used is mostly relegated to footnotes.
The group suggests moving some of the information from the footnotes to new sections in the final guidance and adding “more details for how information within the database should be used.”
The generic drug industry group Association for Accessible Medicines (AAM) said it appreciates the draft guidance but calls on FDA to make several additions to the final version.
“With the GDUFA II commitment and the issuance of this draft guidance, much progress has been made in communication and transparency of FDA’s current thinking,” AAM writes.
However, AAM says it would like additional guidance from FDA on how to justify the use of an excipient when its proposed use differs from the referenced IID listing in nomenclature, molecular weight, viscosity or grade.
AAM also asks FDA to clarify how abbreviated new drug applications (ANDAs) will be handled when an excipient included in an application is changed in the IID after the application is submitted. AAM says it believes “that ANDA should be received if it meets all other applicable filing requirements,” and that the excipient “should then be deemed a review issue.”
Additionally, AAM says it is concerned “with the accuracy and integrity of the information in the IID,” noting that there have been inconsistencies with the maximum potency per unit dose listed for certain excipients in different versions of the database.
AbbVie adds that it believes the guidance should be expanded to include biologics license applications (BLAs) submitted to the Center for Drug Evaluation and Research and to include information on different grades of excipients.
In its comments, Gilead says it is concerned about how current the information in the IID is and that “it would be helpful if an acceptable update schedule for the database could be defined.” In the draft guidance FDA says it will update the database “on an ongoing basis” and provide details about those updates in a quarterly notice. Teva adds to this by requesting that FDA post information about changes to the IID on its website and develop a manual of policies and procedures explaining how it updates the database.
In its comments, the United States Pharmacopoeia (USP) says it believes the guidance will “help reduce discrepancies between the IID and USP-NF monograph names by aligning preferred terms for single substance excipients with the USP-NF excipient monograph official title” and that USP will work to update the names of multiple substance excipients when there is a lack of alignment with the IID.
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