IPEC Americas GPhA FDA OGD Conference Call, Inactive Ingredient Database (IID) September 19, 2014 F2F and WebEx

Transcription

1 IPEC Americas GPhA FDA OGD Conference Call, Inactive Ingredient Database (IID) September 19, 2014 F2F and WebEx Attendees FDA STAFF ORGANIZATION: DHHS/FDA/ JOB POSITION e Mail Bob Iser CDER/OMPT/CDER/OPS/IO Associate Director for Policy Development (Acting), OPS robert.iser@fda.hhs.gov Naiqi Ya CDER/OMPT/CDER/OPS/OGD/DCIV Acting Director, Division of Chemistry IV, Generic Drug naiqi.ya@fda.hhs.gov Chemistry, OPS Jennifer Liang CDER/OMPT/CDER/OPS/OGD/DCIV Chemist, Div. of Chemistry IV jennifer.liang@fda.hhs.gov Huong Huynh CDER/OMPT/CDER/OPS/OGD/DBII Pharmacologist, Division of Bioequivalence huong.huynh@fda.hhs.gov Jeen Min CDER/OMPT/CDER/OPS/OGD/DLPS /OB Orange Book staff Jeen.Min@fda.hhs.gov Johnny Young James Osterhout Jia Jian Shen Kristin Davis Leyla Rahjou Esfandiary CDER/OMPT/CDER/OPS/OGD/DLPS /RSB CDER/OMPT/CDER/OPS/OGD/DCR CDER/OMPT/CDER/OSP/OBI/DDQC SS CDER/OMPT/CDER/OGD/OGDP/DL RS CDER/OMPT/CDER/OC Director (Acting), Division of Filing Review Senior Regulatory Reviewer, Division of Clinical Review Operations Research Analyst Policy Advisor Pharmacist johnny.young@fda.hhs.gov james.osterhout@fda.hhs.gov Jiajian.shen@fda.hhs.gov Kristin.davis@fda.hhs.gov Leyla.Rahjou Esfandiary@fda.hhs.gov Iain Margand CDER/OMPT/CDER/OGD/ORO/DFR Division of Filing Review iain.margand@fda.hhs.gov Mike Jones CDER/OMPT/CDER/OPS/OGD/IO OGD Policy michael.jones@fda.hhs.gov IPEC MEMBERS MEMBER COMPANY Title e Mail David Schoneker Colorcon Director, Global Regulatory Affairs DSchoneker@colorcon.com Katherine Ulman Dow Corning Healthcare Global Regulatory Compliance Manager Katherine.l.ulman@dowcorning.com Priscilla Zawislak Ashland Inc. Global Regulatory Affairs Manager pszawislak@ashland.com Ann Van Meter Dow Wolff Cellulosics Senior Quality Systems Specialist vanmetma@dow.com Kim Beals IPEC Americas Staff Executive Director Kim.beals@ipecamericas.org Meera Raghuram (phone) The Lubrizol Corporation Manager, Global Regulatory Affairs & Strategies GPhA Title e Mail Lisa Tan, R.Ph. (phone) Generic Pharmaceutical Association Associate Vice President Science and Regulatory Affairs Meera.Raghuram@lubrizol.com ltan@gphaonline.org

2 Attendees... 1 Meeting Summary Agenda Items for September 19 Meeting... 2 a. Timing and planning for next F2F meeting with broader team (including policy and tox people) to cover the following:... 3 b. Status update on Phase I FAQs and IID Improvements Bob Iser... 3 c. Impact on inactive ingredients review process due to new guidance s current member experience inconsistent messages... 3 d. Phase II FAQ Continue Work from last Teleconference New Business/ Other items... 4 Meeting Summary 1. Agenda Items for September 19 Meeting Dave Schoneker opened the meeting by sharing a slide presentation that bridged the history of the first FDA OGD IID EWG and IPEC Americas meeting back in December 2011 in order to provide a historical perspective for the new FDA attendees. (See Exhibit 1) Dave re emphasized the need for the FDA to consider families of products when reviewing safety data. One of the slides from Dave s presentation showed a graph of controlled correspondence from 2004 to 2014 (slide 9, Exhibit 1). He noted that the up tick starting in 2011 could be partially attributed to members of IPEC Americas increasing communication efforts to the global industry to utilize the controlled correspondence process to address specific questions or concerns they encounter with regards to IID information in the IID Database. Dave also noted concerns about the current backlog of controlled correspondences and the prioritization plan for pre and post Oct 1, 2014 controlled correspondence submissions. He noted that FDA might receive a bolus of resubmissions of existing controlled correspondence pending with FDA in order to obtain a goal date. FDA agreed that to meet internally regarding the use of a family approach for safety assessments while the IPEC Americas/GPhA team would develop a plan to address the issues and concerns of the FDA at the level of granularity that they had requested. In addition, the IPEC Americas/GPhA team will be preparing a summary document, from previous meeting minutes, that discusses/proposes the use of the family approach for reference to safety data. The IPEC Americas/GPhA team requested that FDA develop a process specific plan that can facilitate the one time review of a family of ingredients. Jim Osterhout asked about publication of the family approach in a peer reviewed journal. It was noted by both Dave and Priscilla that peer reviewed journal references had been previously provided for review to the FDA and that they would resubmit the references again for review. Page 2 of 6

3 a. Timing and planning for next F2F meeting with broader team (including policy and tox people) to cover the following: Per the request of members from the IPEC Americas/GPhA team, it was recommended that the next meeting should allocate additional time to cover the following three areas. 1. Overview and background on IID issues with Excipients: IPEC Americas/GPhA to provide a 2 3 page background document as pre read. 2. Discussion of pharm tox data on excipient families: IPEC Americas/GPhA requested attendance from the FDA pharm tox and clinical staff to start having meaningful dialogue. IPEC Americas/GPhA is planning to have industry tox experts from some member companies who will be able to answer key questions that FDA might have. What are the real risks? 3. Possible options and practical solutions that will benefit both the FDA and industry: A more interactive meeting where the team discusses possible solutions and next steps. FDA and the IPEC Americas/GPhA will work together to schedule a follow up meeting with consideration given to GDUFA activities. b. Status update on Phase I FAQs and IID Improvements Bob Iser The first set of FAQs has been put into a draft guidance document and the target is to post before the end of the year. Once this guidance has been posted, IPEC Americas/GPHA, and anyone else, will be able comment on the draft guidance. Bob further stated that the focus for FDA was to get the IID accurate and complete. Lisa Tan provided the following comments and proposals: FDA should focus on all the improvement aspects of the IID that this team has been discussing for the past 3 years and not solely focus on the accuracy and completeness. o Incorporation of all the improvement points (e.g., Maximum Daily Intake (MDI), synonyms to chemical names, family approach) are vital to increasing the utility of the IID for both FDA and industry o Improvements could also could alleviate some FDA workload issues Lisa further stated that there is a concern that the FDA is still referencing the IID to make regulatory decisions o She noted that using the current IID, has had an impact on innovation and the industry s compliance with FDAs standards for quality and safety. c. Impact on inactive ingredients review process due to new guidance s current member experience inconsistent messages 1) ANDA RTR The RTR guidance has been finalized; however, anyone can submit comments on any guidances after they are implemented. FDA reviews those comments and revises the guidances, if necessary. IPEC Americas/GPhA representatives noted that the current RTR Guidance, would require a complete set of tox data to be submitted in the ANDA filing to support ingredient levels greater than those listed in the IID or the use of a grade not currently listed in the IID. IPEC Americas/GPhA stated this was inconsistent and contradicted the team s objectives and communication to stakeholders. Also, IPEC Americas/GPhA representatives noted that in past meetings with the FDA, information could be acceptable from a filing perspective was Page 3 of 6

4 discussed (e.g., exact location, by page number, of the tox studies in a DMF in lieu of complete study reports). FDA stated that ingredients could be found acceptable for filing based on the other mechanisms noted in the guidance (i.e., precedent of human use in an approved product or reference to a controlled correspondence). It was agreed that further discussion on data needed for filing is necessary. 2) Controlled Correspondence IPEC Americas/GPhA stated that information communicated on this draft guidance suggests that missing IID data would not be considered a controlled correspondence (not given a number or tracking). In addition, the guidance notes that any correspondence related to missing or inaccurate information in the IID should come directly from ANDA sponsors (not suppliers who have knowledge of such). IPEC Americas/GPhA will be submitting its comment to this docket. IPEC Americas/GPhA request that FDA provide other alternatives by which non ANDA sponsors can submit such inquires to FDA, noting that a majority of the discovered discrepancies in the IID were discovered by supplier inquires. FDA noted that IPEC Americas/GPhA should include this as a comment to the docket for the controlled correspondence guidance, and emphasized that we do want stakeholders to inform us about missing and incorrect information in the IID. Lisa provided a historic look at the process changes for controlled correspondences. She stated that OGD had made process changes in how it handled incoming controlled correspondences. She indicated that the spike in 2011 also could be attributed to this change. She further commented on the current limiting definition of a controlled correspondence and how it could potentially restrict industry s ability to comply with the FDA current standard for quality. 3) ANDA RTR Lack of Proper Justification of Impurity Limits Did not have time to comment on this. d. Phase II FAQ Continue Work from last Teleconference No time to work on Phase II FAQs. 2. New Business/ Other items Dave and Priscilla stated that the 2014 GPhA Fall Technical Pre Conference Break out Session had sessions that were going to address many of the comments and questions related to the use of excipient families when assessing the risk and safety of certain materials. A link to the GPhA program and a summary of the session/speakers can be found below. _Agenda_.pdf Meeting adjourned at 12:00 pm. Bob and Dave to work on setting up the next meeting per the request above. Page 4 of 6

5 Exhibit 1 IPEC-OGD Meeting Inactive Ingredient Database Issues with ANDAs Page 5 of 6

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