FDA Inactive Ingredient Database Update

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Junior Webb
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FDA Inactive Ingredient Database Update ExcipientFest April 28-29, 2015 Susan Zuk, Acting Branch Chief Office of Policy for Pharmaceutical Quality OPQ, CDER, FDA 1 What is the IID?

1 FDA Inactive Ingredient Database Update ExcipientFest April 28-29, 2015 Susan Zuk, Acting Branch Chief Office of Policy for Pharmaceutical Quality OPQ, CDER, FDA 1 What is the IID? The Inactive Ingredient Database (IID) provides information on inactive ingredients present in FDA-approved drug products. Once an inactive ingredient has appeared in an approved drug product for a particular route of administration, the inactive ingredient is not considered new. If a particular inactive ingredient has been approved in a certain dosage form and route of administration at a certain potency, a sponsor could consider it safe for use in a similar manner for a similar type of product. <select> About this Database 2 1

2 What is the IID? Higher level of existing ingredient New Ingredient New route of administration/ dosage form Ingredient query Is it new? Is it > IID? Is it a new route? Is it a new dosage form? IID 3 Who uses the IID? MDI? Interactions? Impurities? NDA/ANDA Review Filing Decisions IID Novel? >IID? Clinical Decisions Population? MDI? Exposure? AE? AE: adverse events MDI: maximum daily intake CC: controlled correspondence Product Development IID = MDI? Inquiry (CC)? Pharm/Tox? 4 2

History of IID Changes Drug Product Reference File 1987-2013 Formula ingredients entered into database Ingredients in liquids converted to percentages Substance Registration System 2011 2013 UNII

3 History of IID Changes Drug Product Reference File Formula ingredients entered into database Ingredients in liquids converted to percentages Substance Registration System UNII codes assigned to ingredients Preferred ingredient names added Office of Business Informatics (OBI) Integrity System present Standardizing units Adding missing entries Entering backlog of product formulas 5 IID Limitations Inaccurate potencies Inaccurate ingredient names Ingredients listed in percentage Unit dose rather than MDI No distinction between pediatric and adult doses Backlog Limited search features No links to structure/properties/toxicology 6 3

4 Excipient Working Group Began 2011 Multidisciplinary team Purpose: to address concerns with the IID Laid groundwork for prototype IID IPEC/GPhA quarterly meetings 2014 Draft IID Q&A Guidance 7 IPEC Concerns Inaccuracies in IID Percentages in IID Novel excipient definition Reference to Type IV drug master files (DMF) not recognized Reference to GRAS, food additive and cosmetic ingredient regulations not recognized Nomenclature changes Family approach to pharm-tox still pending IPEC-OGD IID Committee meeting minutes 8 4

5 Current Progress 1. Clean-up is underway to correct inaccuracies and add missing data 2. Data integrity verification by OBI 3. QC by OPQ 4. Archival versions of IID are available 5. Acceptance of archival IID potencies 6. Acceptance of Type IV DMFs for flavoring substances 9 Current Progress 7. Quarterly IID postings to resume after initial Spring 2015 report 8. Office of Pharmaceutical Quality (OPQ) now owns the IID 9. IID project is a high priority for CDER 10 5

6 Current Progress How can we improve our system? Discussions with internal users OGD Division of Filing Review OGD Division of Clinical Review OPQ and OGD Directors Database Improvement Plans Seeking a better database Relevant links Multiple search functions 11 Spring 2015 IID Numbers Inactive Ingredients 13,347 14,000 11,788 12,000 10,000 8,000 6,000 New entries 3815 Product formulas to be entered 4, ,000 0 IID 2013 Integrity 2015 Integrity only 2015 Backlog of Products 12 6

7 Timeline for IID updates Spring 2015 next IID publication Initial Integrity IID report 2152 additional ingredients since last IID Resume quarterly publication schedule Include backlog and newly approved products October 2015 IID publication Clean-up complete 13 Database Clean-up 8 Areas of Revision 1. Correct null values for potency 2. Correct null values for ingredients 3. Verify extreme values >500 mg >100% 4. Verify potencies that differ in new and old version of IID 5. Verify records that are only in old IID 6. Verify application numbers in new and old system 7. Verify products missing UNII codes and make corrections 8. Verify records found only in new system 14 7

8 Communication of Changes Notification of changes to the IID on the web dex.cfm About this Database Industry-FDA public meetings Face-to-face stakeholder meetings 15 Future State 1. MDI for all excipients 2. Elimination of backlog 3. Real time revisions 4. Notification of revisions 5. Increased productive dialog with industry 6. Continuous database improvements 7. Structured filing of composition to automatically populate IID 16 8

9 How can you help? We welcome input from stakeholders. Inform OPQ of inaccuracies in the IID. Include UNII codes in the composition statement. Include the maximum levels of excipients based on product MDD in addition to unit dose in the application. General questions and corrections: IID specific questions can be submitted through controlled correspondence responses: 17 Ideas? Questions? 18 9

10 Acknowledgments Office of Business Informatics, CDER Bob Iser, OPF, OPQ, CDER Naiqi Ya, OPF, OPQ, CDER Ashley Boam, OPPQ, OPQ, CDER OGD Excipient Working Group IPEC Thank you 19 10

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