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Health Risk Assessment and Mitigation Workshop Day 2 Meeting March 30, 2021 Page 1 1 Nitrosamines as Impurities in Drugs; Health Risk 2 Assessment and Mitigation Workshop 3 4 5 6 7 Moderated by Anne Painter 8 Tuesday, March 30, 2021 9 9:00 a.m. 10 11 12 Virtual Public Workshop 13 Food & Drug Administration (FDA) 14 Washington, DC 20001 15 16 17 18 19 20 Reported by: Irene Gray 21 JOB No.: 4377527 22 www.CapitalReportingCompany.com 202-857-3376 Meeting March 30, 2021 Page 2 1 A P P E A R A N C E S 2 List of Attendees: 3 Anne Painter, Host 4 Dr. Aisar Atrakchi, Panelist 5 Dr. Gerhard Eisenbrand, Panelist 6 Dr. Soterios Kyrtopoulos Ph.D, Panelist 7 Dr. Joseph Guttenplan, Panelist 8 Dr. Mark Cronin, Panelist 9 Dr. Errol Zeiger, Panelist 10 Dr. John R. Bucher, Panelist 11 Dr. Jerry M. Rice, Panelist 12 Dr. Stephen S. Hecht, Panelist 13 Dr. Richard H. Adamson, Panelist 14 Dr. Michael DiNovi, Panelist 15 Dr. Sruthi King, Panelist 16 Dr. David Keire, Panelist 17 Dr. Deborah Johnson, Panelist 18 Dr. Timothy McGovern, Panelist 19 Dr. Robert T. Dorsam, Panelist 20 21 22 www.CapitalReportingCompany.com 202-857-3376 Meeting March 30, 2021 Page 3 1 C O N T E N T S 2 PAGE 3 Welcome by Aisar Atrakchi 5 4 Exposure and Risk Assessment: 5 Question 5 discussion by panelists 5-49 6 Chemistry: 7 Question 6 discussion by panelists 49-92 8 Question 7 discussion by panelists 92-144 9 Workshop questions by panelists 144-187 10 Summary and Conclusion by Dr. Atrakchi 187-192 11 Adjourn by Dr. Atrakchi 192-193 12 13 14 15 16 17 18 19 20 21 22 www.CapitalReportingCompany.com 202-857-3376 Meeting March 30, 2021 Page 4 1 P R O C E E D I N G S 2 MS. PAINTER: Hi, everybody. Thank you 3 so much for joining day two of our workshop on 4 nitrosamines as impurities in drugs. Before we get 5 started, we just wanted to do another reminder of the 6 house rules for today's workshop. 7 As a reminder, everybody who is not 8 speaking, please keep your phone on mute. And all 9 attendees will be muted, and only panelists will have 10 the ability to unmute themselves. 11 If you are using the video feature, 12 only the panelists that will be engaging in today's 13 discussions will have their video feature turned on. 14 If you are not speaking, please have your video 15 feature turned off. 16 Regarding any questions and discussion, 17 please submit any questions that you would like to 18 have answered by using the Q and A feature to the 19 bottom center of your screen in Zoom. Any questions 20 that you do submit, we do have a team of moderators 21 who are monitoring the Q and A chat box. If you see 22 that your question has been dismissed, that means it www.CapitalReportingCompany.com 202-857-3376 Meeting March 30, 2021 Page 5 1 has been received by the team and sent to the 2 moderators for review. 3 If you are a panelist who will be 4 speaking, please utilize your chat feature, as the 5 host will prompt you when it is time for you to 6 present. When using the Q and A chat box, the 7 moderators and the workshop host will work together to 8 monitor the questions, and they will make sure that 9 they are addressed as time allows during the workshop. 10 And additionally, today's meeting 11 presentation and recording will be made available on 12 the webpage later this week. 13 Thank you. 14 DR. ATRAKCHI: Good morning, good 15 afternoon, and good evening, and welcome back to the 16 second and last day of the workshop on nitrosamines as 17 impurities in drugs. We had a productive and 18 informative day yesterday and look forward to the 19 discussions today. We continue with the remaining 20 questions, starting with question five, the last one 21 under Exposure and Risk Assessment. 22 Question five: Should the regulatory www.CapitalReportingCompany.com 202-857-3376 Meeting March 30, 2021 Page 6 1 limits for nitrosamines listed for food and water, or 2 amount formed endogenously be considered in 3 determining the acceptable intake of nitrosamines in 4 drugs? 5 Considering the abundance of 6 nitrosamines, in and around us, should these amounts 7 be taken into consideration to determine an acceptable 8 intake in medicines. Keep in mind, one takes a drug 9 as a patient to gain benefit to treat a disease or 10 illness. It is not a choice that one makes. And the 11 American public expects their medicines to be safe. 12 However, as a personal choice, we eat 13 how much we eat, and what we eat and drink -- is our 14 own choice. Some authors -- and also, from 15 yesterday's discussion -- stated that endogenous 16 production of nitrosamines and their precursors are a 17 more important source of exposure than exogenous 18 intake. 19 It is also important to keep in mind 20 that in order to estimate the dietary intake, it is 21 not only of nitrosamines, but in addition we need to 22 estimate nitrates and nitrides, and not focus only on www.CapitalReportingCompany.com 202-857-3376 Meeting March 30, 2021 Page 7 1 diets that are rich in these compounds -- i.e., not a 2 biased assessment. 3 So, with that, I would like to start 4 with Dr. DiNovi. 5 DR. DINOVI: Yeah. Good morning. And 6 thank you. So, this question has bothered me -- I 7 guess is the right thing to say -- since we first 8 started discussing it, because it is just -- there are 9 lots of things, here, that are -- it is not obvious on 10 the surface. 11 As an exposure assessor modeler -­ 12 purely as a numerical person, I would say the answer 13 is, no. Because the regulatory limits do not actually 14 impact the inputs into my exposure assessment models. 15 But clearly, a bigger answer has to be, 16 yes. And as we discussed extensively yesterday, as 17 more and more information becomes available about the 18 endogenously formed nitrosamines, that would certainly 19 impact how you choose to pick an acceptable intake, 20 which is, of course, a risk management mitigation 21 metric. 22 The limits themselves -- it sounds www.CapitalReportingCompany.com 202-857-3376 Meeting March 30, 2021 Page 8 1 contradictory but setting a limit does not impact 2 exposure very much. Unless you are in a position 3 where many -- and I am thinking in terms of food, 4 which is my world. Unless you are in a position where 5 many of the products would become unacceptable at a 6 level that you have chosen for safety -- so then, you 7 are brining in all sorts of economic impacts -- which 8 I do not think we are discussing, here -- the limits 9 are typically set in a way that balances the ability 10 to measure the numbers -- for example, at -- although, 11 I do not think that is particularly a problem, here -­ 12 with the cost, both in time and effort. We discussed 13 this briefly yesterday, on getting here. 14 So that is why you can hear in my voice 15 there is a hesitancy to just say -- you know, yes or 16 no -- which is my normal choice for yes/no questions. 17 But you clearly are going to have to take especially 18 the endogenous formation into account when you get to 19 the end, if the endogenous level is as we have heard 20 three orders magnitude higher than the drugs, there 21 would be no impact in picking an acceptable level from 22 a numerical risk assessment point of view. www.CapitalReportingCompany.com 202-857-3376 Meeting March 30, 2021 Page 9 1 As you said yesterday, Dr. Atrakchi, 2 you do not want them in there at all. So, the CDER's 3 goal is to get them out. And that is a separate 4 question from my world modeling the risk. And I will 5 be interested in hearing what my colleagues have to 6 say. So, I will pass it along, now. Thank you. 7 DR. ATRAKCHI: Thank you, Dr. DiNovi. 8 Dr. Kyrtopoulos? You are on mute. We 9 could move to Dr. Eisenbrand and go back to 10 Dr. Kyrtopoulos in a moment. 11 DR. EISENBRAND: Yeah. Thank you, 12 Dr. Atrakchi. This is Gerhard Eisenbrand speaking. 13 Well, I have made this -- I have 14 commented on this point yesterday, already. And 15 again, I would like to repeat that in my opinion, it 16 would be a pragmatic way of using the dietary 17 exposure, for instance, as a point of reference for 18 the potential to validate or evaluate the potential 19 risk coming from drug connected exposure. 20 And while I, personally, would prefer 21 to use, for the time being, the dietary exposure, is 22 that it seems to me that although the data are, sort www.CapitalReportingCompany.com 202-857-3376 Meeting March 30, 2021 Page 10 1 of, 10 years old or some about that -- the database 2 about the dietary exposure -- it still is valid, in a 3 sense. And of course, one can confirm this -- I 4 think, within a very reasonable timeframe, to be sure 5 that the date had not moved very much, if at all.
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