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LTR 163: FDA’s New Risk Lens Under QMSR · Let's Talk Risk! Podcast

• 1:17
  SPEAKER_01: Hi, everyone, and welcome to
• 1:18
  SPEAKER_02: Let's Talk Risk!.
• 1:20
  SPEAKER_02: I'm your host, Naveen Agarwal.
• 1:21
  SPEAKER_02: Here we explore how leaders in medtech navigate uncertainty,
• 1:25
  SPEAKER_02: make better risk-based decisions,
• 1:27
  SPEAKER_02: and build safe and effective products to support sustainable growth.
• 1:30
  SPEAKER_02: Today, I'm super excited to welcome a very special guest,
• 1:33
  SPEAKER_02: someone who knows both the regulation and the law.
• 1:36
  SPEAKER_02: My guest today is Alison Mullen, who is the director at Hyman Phelps and McNamara PC.
• 1:42
  SPEAKER_02: Before joining the firm,
• 1:44
  SPEAKER_02: she had experience both in regulatory roles and legal roles
• 1:47
  SPEAKER_02: in many different big names, big names in medical devices.
• 1:51
  SPEAKER_02: So I'm very pleased to welcome Alison.
• 1:53
  SPEAKER_02: We're going to have a conversation about regulation and the law and how
• 1:57
  SPEAKER_02: the FDA is handling the QMSR transition,
• 2:00
  SPEAKER_02: what industry should be thinking about,
• 2:02
  SPEAKER_02: because she sits right in the middle of that.
• 2:05
  SPEAKER_02: With that, Alison, welcome to the show.
• 2:06
  SPEAKER_02: How are you today?
• 2:07
  SPEAKER_00: Thanks, Naveen.
• 2:08
  SPEAKER_00: Thanks for having me.
• 2:09
  SPEAKER_00: I'm good.
• 2:09
  SPEAKER_00: How are you?
• 2:10
  SPEAKER_02: I'm great, great.
• 2:11
  SPEAKER_02: Alyssa, I'm so excited to talk to you about this topic.
• 2:14
  SPEAKER_02: And just this morning,
• 2:16
  SPEAKER_02: I think,
• 2:16
  SPEAKER_02: or maybe yesterday,
• 2:17
  SPEAKER_02: we heard that FDA has issued the very first warning letter under QMSR, right?
• 2:23
  SPEAKER_02: Let's start by talking about what they say in that warning letter and why it is important.
• 2:27
  SPEAKER_00: They did.
• 2:28
  SPEAKER_00: It just got published this week.
• 2:30
  SPEAKER_00: The warning letter is actually from late this spring,
• 2:33
  SPEAKER_00: from the end of May,
• 2:33
  SPEAKER_00: from an inspection that happened just after QMSR took effect from February to March
• 2:39
  SPEAKER_00: of this year.
• 2:40
  SPEAKER_00: Not surprisingly, given the frequency.
• 2:43
  SPEAKER_00: We're seeing risk come up in warning letters.
• 2:46
  SPEAKER_00: The second citation in the warning letter relates to risk, and it's two parts.
• 2:52
  SPEAKER_00: This company that received the warning letter,
• 2:54
  SPEAKER_00: largely according to their registration and listing,
• 2:57
  SPEAKER_00: looks like they are a contract manufacturer.
• 3:00
  SPEAKER_00: So the first part of the risk-based observation talks about their process FMEAs.
• 3:06
  SPEAKER_00: But more broadly,
• 3:07
  SPEAKER_00: in their second part,
• 3:08
  SPEAKER_00: it says that
• 3:09
  SPEAKER_00: the risk management procedure is Do not define how risk management activities are
• 3:14
  SPEAKER_00: performed and documented,
• 3:15
  SPEAKER_00: who's responsible for conducting and approving risk management activities,
• 3:19
  SPEAKER_00: when risk management documentation must be updated,
• 3:21
  SPEAKER_00: and how post-market feedback data,
• 3:24
  SPEAKER_00: including complaints,
• 3:25
  SPEAKER_00: adverse events, and recalls is incorporated into risk management.
• 3:29
  SPEAKER_00: And that citation is all falling under Clause 7.1 for product realization under 13485.
• 3:37
  SPEAKER_02: So this is a very different way of writing about risk-related violations
• 3:42
  SPEAKER_02: or non-compliances than the previous 820 world, right?
• 3:46
  SPEAKER_02: Let us talk about what you notice as the difference in the language FDA is using now under QMSR.
• 3:52
  SPEAKER_00: Yeah, I think there are a couple of things that have certainly stuck out to us
• 3:56
  SPEAKER_00: as we've seen both 483s and now this most recent warning letter.
• 4:00
  SPEAKER_00: Certainly under the old QSR,
• 4:03
  SPEAKER_00: where we largely saw risk coming up was under design control and pretty discreet.
• 4:07
  SPEAKER_00: Yeah.
• 4:26
  SPEAKER_00: And it's about 20% roughly of observations are citing 7.1 now for risk management in
• 4:34
  SPEAKER_00: the last six months, I guess, since QMSR took effect.
• 4:38
  SPEAKER_00: And that combines both not having a risk management process
• 4:42
  SPEAKER_00: under product realization,
• 4:44
  SPEAKER_00: but also not having records maintained of those risk management activities.
• 4:48
  SPEAKER_00: So that's one thing, I think, just sort of this broader look at risk management.
• 4:54
  SPEAKER_00: But also,
• 4:54
  SPEAKER_00: you know,
• 4:55
  SPEAKER_00: we've got Almost 7.5% of observations citing ISO 13485 Section 4.1.2,
• 5:03
  SPEAKER_00: which just talks more generally about having to take a risk-based approach
• 5:08
  SPEAKER_00: to QMS processes.
• 5:10
  SPEAKER_00: I think this is...
• 5:10
  SPEAKER_00: This is where risk under the new QMSR is everywhere.
• 5:14
  SPEAKER_00: It's not sort of cleanly within design control the way that it often was
• 5:20
  SPEAKER_00: when it used to be under the QSR.
• 5:23
  SPEAKER_00: I think the other thing that this language I just read you
• 5:26
  SPEAKER_00: from this latest warning letter points out is this real focus on postmarket feedback
• 5:32
  SPEAKER_00: and that incorporation of postmarket feedback into The risk management process.
• 5:37
  SPEAKER_00: I think we've always known risk management wasn't.
• 5:40
  SPEAKER_00: I mean, you know this better than anybody, that it's not a static process.
• 5:45
  SPEAKER_00: But I think seeing it in a warning letter now and making sure companies understand
• 5:51
  SPEAKER_00: that that post-market data needs to be fed back into the process and have a process
• 5:56
  SPEAKER_00: for doing that is going to be incredibly important.
• 5:59
  SPEAKER_02: It's interesting all these points that you make, Alice,
• 6:02
  SPEAKER_02: and It seems to me that,
• 6:04
  SPEAKER_02: you know,
• 6:04
  SPEAKER_02: those of us who read warning letters and 483s as a hobby,
• 6:08
  SPEAKER_02: you know, we have been monitoring it for a long time.
• 6:10
  SPEAKER_02: Even under the old QSR,
• 6:13
  SPEAKER_02: the way FDA used to write their observation,
• 6:16
  SPEAKER_02: you could see the language they were using was based on risk,
• 6:20
  SPEAKER_02: but they were not able to cite a specific clause in the regulation.
• 6:24
  SPEAKER_02: And they would always talk about kappa or something else.
• 6:27
  SPEAKER_02: To me, it seems like now they have a new language.
• 6:30
  SPEAKER_02: Absolutely.
• 6:31
  SPEAKER_02: I think they've got many opportunities.
• 6:33
  SPEAKER_02: When we think about $13,485, I mean, risk is...
• 6:49
  SPEAKER_00: I think product realization is the natural one for it to fall into,
• 6:55
  SPEAKER_00: but I think the most interesting part is this is really having a risk-based approach
• 7:00
  SPEAKER_00: to the QMS processes at large.
• 7:03
  SPEAKER_00: That 4.1.2,
• 7:04
  SPEAKER_00: the fact that that is showing up as the area that's being selected
• 7:09
  SPEAKER_00: when entering 483 observations in FDA systems,
• 7:13
  SPEAKER_00: since that's not identified on the 483 itself,
• 7:17
  SPEAKER_00: so it's being entered on the back end.
• 7:19
  SPEAKER_00: I think that that's really interesting, right?
• 7:22
  SPEAKER_00: Because that's not saying it's not your actual risk management process.
• 7:27
  SPEAKER_00: That's just needing to think about risk throughout your whole QMS.
• 7:31
  SPEAKER_00: And how are you prioritizing risk?
• 7:33
  SPEAKER_00: How are you ensuring that you're thinking about risk when you're doing all aspects of your QMS?
• 7:42
  SPEAKER_02: So a question in my mind that comes to me right now, Alison,
• 7:45
  SPEAKER_02: and I would love your perspective on this,
• 7:47
  SPEAKER_02: is that What would prompt FDA to go beyond 7.1?
• 7:51
  SPEAKER_02: I mean, it seems to me that the easy entry point is 7.1 because it's so easy to see
• 7:56
  SPEAKER_02: if you have it or if you don't have it.
• 7:58
  SPEAKER_02: Now, they could stop there or they could go to 4.1.2b.
• 8:02
  SPEAKER_02: In your view, what would be some of those key things that will move them in that direction?
• 8:06
  SPEAKER_02: Because to me,
• 8:07
  SPEAKER_02: it's escalation of risk management across the board beyond just a couple
• 8:11
  SPEAKER_02: of problems here and there, right?
• 8:14
  SPEAKER_02: So what would prompt FDA to go beyond 7.1?
• 8:17
  SPEAKER_00: Well, I think when you think about who FDA is auditing,
• 8:21
  SPEAKER_00: you've got entities like initial importers that fall into the definition of
• 8:28
  SPEAKER_00: a manufacturer.
• 8:29
  SPEAKER_00: They're required to register and list.
• 8:31
  SPEAKER_00: They're subject to the QMSR.
• 8:32
  SPEAKER_00: There is a small part of 7.1 that they're responsible for.
• 8:37
  SPEAKER_00: There's a small part of product realization,
• 8:40
  SPEAKER_00: I should say, that they're responsible for, but not a lot of it.
• 8:44
  SPEAKER_00: So I think that there may be areas that for different entities
• 8:51
  SPEAKER_00: where they may not be undertaking much or...
• 8:55
  SPEAKER_00: Any of the product realization activities,
• 8:58
  SPEAKER_00: it may be that they're outsourcing a lot of that activity.
• 9:01
  SPEAKER_00: And if they've got a well-written quality agreement that assigns
• 9:08
  SPEAKER_00: the different obligations,
• 9:09
  SPEAKER_00: a well-written quality manual that says we're not responsible for much or any
• 9:15
  SPEAKER_00: of those product realization activities,
• 9:17
  SPEAKER_00: it may be that then when FDA is thinking about risk,
• 9:20
  SPEAKER_00: they may be defaulting more to 4.1.2 to look at that.
• 9:35
  SPEAKER_00: That leaves very little of product realization then left in their responsibility.
• 9:40
  SPEAKER_00: But when you think about their overall processes,
• 9:43
  SPEAKER_00: that puts the burden back on them to have to say,
• 9:45
  SPEAKER_00: well, okay, we're contracting out to a lot of different individuals.
• 9:49
  SPEAKER_00: How are we prioritizing the risk with who we're contracting to?
• 9:52
  SPEAKER_00: How are we prioritizing the risk with respect to Mm-hmm.
• 9:55
  SPEAKER_00: Mm-hmm.
• 10:13
  SPEAKER_02: Yeah, that's a great point.
• 10:15
  SPEAKER_02: Guys, if you're just joining,
• 10:16
  SPEAKER_02: my guest today is Alison Mullen,
• 10:18
  SPEAKER_02: and we are talking about the QMSR,
• 10:20
  SPEAKER_02: how FDA is responding to it,
• 10:22
  SPEAKER_02: and what we are seeing from FDA in the recent warning letters.
• 10:25
  SPEAKER_02: Alison, let's continue on that.
• 10:26
  SPEAKER_02: So yes, you made a great point that depending upon the role of the organization,
• 10:31
  SPEAKER_02: FDA may go directly to 4.1.2.
• 10:33
  SPEAKER_02: But what I have in mind for you really is our big manufacturers who do a lot
• 10:38
  SPEAKER_02: of different operations and processes And they are making a lot of devices in
• 10:44
  SPEAKER_02: that space.
• 10:45
  SPEAKER_02: I'm curious, what would prompt FDA to escalate their observations and actions beyond just 7.1?
• 10:52
  SPEAKER_02: Can you speak to that?
• 10:52
  SPEAKER_00: You know, I can't say that I've actually seen it yet, Naveen.
• 10:56
  SPEAKER_00: So this would be entirely speculation on my part, if that's okay with you.
• 11:00
  SPEAKER_02: Yes.
• 11:01
  SPEAKER_02: Well, on this show, opinion speculations are welcome.
• 11:05
  SPEAKER_02: We welcome that.
• 11:06
  SPEAKER_00: One of the areas I could certainly see that is if big manufacturers do have a lot
• 11:11
  SPEAKER_00: of different products.
• 11:12
  SPEAKER_00: I think 7.1 is pretty discreet to product realization.
• 11:17
  SPEAKER_00: 4.1.2 is much broader.
• 11:21
  SPEAKER_00: If you've got a wide range of devices,
• 11:24
  SPEAKER_00: how are you ensuring that from a risk perspective,
• 11:28
  SPEAKER_00: you are capturing That's part of your overall systems, right?
• 11:36
  SPEAKER_00: I think that could show up in 4.1.2 instead of
• 11:38
  SPEAKER_00: the more discrete product realization aspects in 7.1.
• 12:00
  SPEAKER_02: Yeah, I think that is absolutely where my mind is to.
• 12:05
  SPEAKER_02: There are many entry points for FDA to examine risk in an organization.
• 12:10
  SPEAKER_02: And the more complex, the more diversified it is, the more entry points they have.
• 12:14
  SPEAKER_02: And to me,
• 12:15
  SPEAKER_02: it seems like the more doors they are able to open and find
• 12:19
  SPEAKER_02: where risk-based decisions are not adequate,
• 12:22
  SPEAKER_02: the more They are sort of looking into 4.1.2 as a systemic issue.
• 12:28
  SPEAKER_02: Am I kind of overthinking this?
• 12:30
  SPEAKER_00: Like I said, I think 4.1.2 could be a sign in some cases of a systemic issue.
• 12:34
  SPEAKER_00: In other cases,
• 12:35
  SPEAKER_00: I think it could be a sign that FD just didn't have as big an entry point in 7.1
• 12:41
  SPEAKER_00: as they might have depending on the company type.
• 12:46
  SPEAKER_02: Yeah, yeah.
• 12:46
  SPEAKER_02: That makes a whole lot of sense.
• 12:48
  SPEAKER_02: Another point here is you might hear from a lot of people,
• 12:51
  SPEAKER_02: hey, we have been operating under ISO 13485 for a long time.
• 12:56
  SPEAKER_02: We have no problems.
• 12:57
  SPEAKER_02: We have risk management procedures.
• 12:59
  SPEAKER_02: We have a team.
• 13:00
  SPEAKER_02: We do all this and look at that.
• 13:02
  SPEAKER_02: Should they be worried?
• 13:03
  SPEAKER_02: Now, with the FDA looking into QMSR compliance in the context of 13485,
• 13:09
  SPEAKER_00: I'm not sure worried is necessarily the word that I would use,
• 13:13
  SPEAKER_00: but I definitely have seen a number of clients that have been particularly cocky,
• 13:19
  SPEAKER_00: I'd say, about the whole situation.
• 13:21
  SPEAKER_00: I'll say I think clients have fallen into one of two camps.
• 13:25
  SPEAKER_00: They're either so overly not concerned because they've been operating under 13485
• 13:30
  SPEAKER_00: for so long that they don't think that this change to QMSR is going to be I do,
• 13:35
  SPEAKER_00: from what I've seen from FDA so far,
• 13:36
  SPEAKER_00: I do think there could be a difference in how they get inspected by FDA,
• 13:39
  SPEAKER_00: for those that aren't participating in MD SAP, of course, than those who've been
• 14:02
  SPEAKER_00: Traditionally audited by their notified body under 13485.
• 14:06
  SPEAKER_00: I think the notified bodies,
• 14:07
  SPEAKER_00: at least in my experience,
• 14:09
  SPEAKER_00: have sort of looked to, well, do you have evidence of this?
• 14:14
  SPEAKER_00: Have you operated under it?
• 14:16
  SPEAKER_00: Well, yes.
• 14:16
  SPEAKER_00: Okay, good.
• 14:18
  SPEAKER_00: We could sort of check that box.
• 14:20
  SPEAKER_00: I think FDA is definitely going to a different depth with its analysis.
• 14:25
  SPEAKER_00: We've seen this for years, and I know you've seen this.
• 14:27
  SPEAKER_00: You and I have certainly worked on clients together where this has been an issue.
• 14:31
  SPEAKER_00: I think FDA is going to be more likely to challenge those methods
• 14:35
  SPEAKER_00: and those risk-based methods in a way that,
• 14:38
  SPEAKER_00: at least in my experience and as I've reviewed ISO audits in the past
• 14:42
  SPEAKER_00: that have been done by the notified bodies, I've not historically seen.
• 14:46
  SPEAKER_02: Yeah.
• 14:47
  SPEAKER_02: Well, one big difference is that unlike notified bodies, FDA can take as long as they want.
• 14:52
  SPEAKER_02: They don't have a clock ticking.
• 14:53
  SPEAKER_02: And if they could be there for two days or a month and they can come back.
• 14:57
  SPEAKER_02: We have a great question here, Alison.
• 14:59
  SPEAKER_02: I'm going to read this to you.
• 15:01
  SPEAKER_02: Could you please elaborate what are
• 15:02
  SPEAKER_02: the typical legal risks medical device manufacturers may face with new regulations
• 15:07
  SPEAKER_02: and are there any different than before?
• 15:09
  SPEAKER_00: So typical legal risks that they may face with new regulations,
• 15:14
  SPEAKER_00: I think the risk is that they certainly need to be in compliance.
• 15:19
  SPEAKER_00: I think there's a, well,
• 15:20
  SPEAKER_00: I think there's always a risk you should go back and check your quality agreements
• 15:23
  SPEAKER_00: with any entities that you are operating with.
• 15:26
  SPEAKER_00: It's certainly something I've seen in diligences recently
• 15:30
  SPEAKER_00: that agreements haven't necessarily been updated.
• 15:34
  SPEAKER_00: And that certainly is an issue where I think especially for a lot
• 15:38
  SPEAKER_00: of larger manufacturers,
• 15:40
  SPEAKER_00: I would often see have very detailed assignment matrices of who was responsible
• 15:45
  SPEAKER_00: for what, but they were organized by the QSR obligations.
• 15:49
  SPEAKER_00: And especially for older ones that didn't necessarily anticipate the QMSR shift,
• 15:53
  SPEAKER_00: they didn't include all of the obligations under the 13485.
• 15:58
  SPEAKER_00: And so checking those from a historical perspective will be important because
• 16:03
  SPEAKER_00: that is certainly something that when FDA comes in and if you're looking to say,
• 16:07
  SPEAKER_00: well,
• 16:08
  SPEAKER_00: here's why we don't have that covered as part of our quality manual,
• 16:11
  SPEAKER_00: you want to be sure you're Well, I think I'll be a little bit more
• 16:35
  SPEAKER_02: It seems to me that we have to go beyond this operating mindset that, hey,
• 16:41
  SPEAKER_02: we have procedures,
• 16:42
  SPEAKER_02: we have had no audit findings, we are in compliance, so we are good.
• 16:46
  SPEAKER_02: There's a difference between regulatory compliance and breaking the law.
• 16:50
  SPEAKER_02: So I'll be blunt by saying, hey,
• 16:52
  SPEAKER_02: Have a legal person actually look at that,
• 16:55
  SPEAKER_02: not just from a regulatory point of view,
• 16:56
  SPEAKER_02: but what the law says and what are the different laws you are subject to,
• 17:00
  SPEAKER_02: not just quality management.
• 17:02
  SPEAKER_02: I think there are many other laws.
• 17:03
  SPEAKER_02: So we'll move from there.
• 17:05
  SPEAKER_02: But I'm not curious to hear from you.
• 17:06
  SPEAKER_02: Oh, by the way,
• 17:07
  SPEAKER_02: before I go there,
• 17:08
  SPEAKER_02: guys, Please, I invite you to share your thoughts, questions, comments.
• 17:12
  SPEAKER_02: We have a great opportunity here with Alison to get a real legal perspective on
• 17:17
  SPEAKER_02: the topics that we talk about.
• 17:19
  SPEAKER_02: So, Alison, now I'm going to switch gears here.
• 17:21
  SPEAKER_02: Like, even FTA is operating under a new environment here, right?
• 17:24
  SPEAKER_02: They're investigators.
• 17:25
  SPEAKER_02: Everybody's trained under QSR.
• 17:27
  SPEAKER_02: They can get it wrong too, right?
• 17:28
  SPEAKER_02: So have you seen anything like that?
• 17:31
  SPEAKER_02: And if that happens, what should people do?
• 17:33
  SPEAKER_00: I mean, I think there always is opportunity to get it wrong.
• 17:36
  SPEAKER_00: I think we've seen, that's not just QMSR though, Naveen, right?
• 17:40
  SPEAKER_00: I've always looked at a 43 as sort of an opening argument.
• 17:43
  SPEAKER_00: FD is giving you their view.
• 17:46
  SPEAKER_00: You have to respond back.
• 17:47
  SPEAKER_00: I mean, even a warning letter only tells...
• 17:50
  SPEAKER_00: I'd say best case, 50% of the story, right?
• 17:53
  SPEAKER_00: And so I think that it's important to remember that when responding to.
• 17:59
  SPEAKER_00: And I think anytime,
• 18:02
  SPEAKER_00: at least I'm counseling a client and they're responding to whether it's a 483 or
• 18:05
  SPEAKER_00: a warning letter,
• 18:06
  SPEAKER_00: part of this is setting the record straight and making sure
• 18:09
  SPEAKER_00: that you're providing appropriate background because the person you're writing
• 18:13
  SPEAKER_00: to is not always the person that was in the room with you.
• 18:15
  SPEAKER_00: They're not the person that you provided the documents to.
• 18:19
  SPEAKER_00: It may be that the person,
• 18:20
  SPEAKER_00: the way the person asked you the question,
• 18:23
  SPEAKER_00: you may have given them one document and they came to a conclusion when
• 18:28
  SPEAKER_00: in fact you may have had two,
• 18:30
  SPEAKER_00: three, four other documents that might have helped to give additional color.
• 18:34
  SPEAKER_00: And so I think that that's just always such a big part of sort of storytelling
• 18:40
  SPEAKER_00: and making sure that you're providing that additional context with Mm-hmm.
• 18:43
  SPEAKER_00: Mm-hmm.
• 19:11
  SPEAKER_00: We're going to be paying super close attention to these because they're going
• 19:15
  SPEAKER_00: to tell a story too, right?
• 19:16
  SPEAKER_00: They're going to tell FDA's side of the story of where's FDA looking?
• 19:20
  SPEAKER_00: What are they seeing?
• 19:21
  SPEAKER_00: How are they thinking about these things?
• 19:23
  SPEAKER_00: We can sort of get a sense from the 483 of the different categories.
• 19:26
  SPEAKER_00: Yeah.
• 19:50
  SPEAKER_00: Because those are,
• 19:51
  SPEAKER_00: like I said,
• 19:52
  SPEAKER_00: I think that there's an opportunity for FDA to challenge methods in a way that
• 19:57
  SPEAKER_00: the notified bodies haven't in the past.
• 20:00
  SPEAKER_00: And there's that Medtronic warning letter from a number of years ago now.
• 20:04
  SPEAKER_00: When they talked about challenging Medtronic's methods for estimating risk,
• 20:09
  SPEAKER_00: and I'll just be curious to see if we start to see more observations like that
• 20:14
  SPEAKER_00: in warning letters,
• 20:15
  SPEAKER_00: but it's that kind of level of granularity that I think will be most informative
• 20:21
  SPEAKER_00: as we start to see that information come out so we can start to understand it.
• 20:26
  SPEAKER_00: But yeah, I do think FDA is going to get it wrong.
• 20:28
  SPEAKER_00: I think industry is going to get it wrong sometimes too,
• 20:31
  SPEAKER_00: and I think it's going to be Everybody's sort of finding their way
• 20:34
  SPEAKER_00: through this next step.
• 20:36
  SPEAKER_02: So two key points here I'm going to summarize what I heard from you is that
• 20:40
  SPEAKER_02: when you get a 483,
• 20:42
  SPEAKER_02: don't assume that you are completely wrong or it's completely right.
• 20:46
  SPEAKER_02: That's an entry point.
• 20:47
  SPEAKER_02: Think about it.
• 20:47
  SPEAKER_02: Think about how you would respond to the FDA and have empathy too,
• 20:51
  SPEAKER_02: because their writing may be also affected
• 20:54
  SPEAKER_02: by how much they understood what you presented to them.
• 20:57
  SPEAKER_02: So those two key points to keep in mind.
• 20:59
  SPEAKER_02: Now, you mentioned the Medtronic letter, and of course, that was very interesting.
• 21:03
  SPEAKER_02: We don't want to go into too much detail, but that is not the only example, Alison.
• 21:07
  SPEAKER_02: I've seen so many other examples where risk-related observations were hiding in
• 21:12
  SPEAKER_02: the narrative, but not really...
• 21:15
  SPEAKER_02: Connected to the regulation because of the way A20 was written.
• 21:18
  SPEAKER_02: So here's a question that I want to ask you.
• 21:21
  SPEAKER_02: Obviously, warning letter is an escalation.
• 21:23
  SPEAKER_02: By the time you get a warning letter, things are not looking good for you.
• 21:27
  SPEAKER_02: You have to work extra hard to satisfy FDA.
• 21:30
  SPEAKER_02: People used to work very hard.
• 21:31
  SPEAKER_02: Now, I've been in those situations where it took a lot of effort to respond.
• 21:36
  SPEAKER_02: Now, in the new world with the QMSR warning letter,
• 21:39
  SPEAKER_02: do you anticipate I'm not sure it's going to
• 21:49
  SPEAKER_00: be any more or less challenging.
• 21:53
  SPEAKER_00: I think what could be more challenging is having the warning letter lifted for those
• 21:58
  SPEAKER_00: who received warning letters pre-QMSR who hadn't opened their kappas yet under QMSR,
• 22:05
  SPEAKER_00: right?
• 22:05
  SPEAKER_00: Because we've got this transition that happened earlier this year.
• 22:08
  SPEAKER_00: We've got I got you, yeah.
• 22:37
  SPEAKER_00: You've opened your activities.
• 22:39
  SPEAKER_00: You've been doing all these remediation activities, presumably under the old standard.
• 22:43
  SPEAKER_00: And now all of a sudden FDA is going to come back in and inspect you under a new standard.
• 22:47
  SPEAKER_00: To me, that seems like it's not hiding the ball.
• 22:51
  SPEAKER_00: They plainly wrote it in the warning letter, but that's a shifting standard.
• 22:54
  SPEAKER_00: So I think those companies could actually be the ones that face the most difficulties.
• 22:59
  SPEAKER_00: That's a fair point.
• 23:00
  SPEAKER_00: Yeah, yeah.
• 23:25
  SPEAKER_00: And those, I think, could be some of the most challenging.
• 23:28
  SPEAKER_00: And I'll be curious to see how some of those play out.
• 23:30
  SPEAKER_02: What I'm going to say is that if you are in that situation, hire a good lawyer.
• 23:36
  SPEAKER_02: That is a very good one.
• 23:37
  SPEAKER_02: So, Alison, we are running short on time, but I do have a question I want to ask you.
• 23:40
  SPEAKER_02: You started your career in the regulatory world.
• 23:42
  SPEAKER_02: Then you went to law school.
• 23:43
  SPEAKER_02: You became a lawyer.
• 23:45
  SPEAKER_02: Walk us through your journey.
• 23:46
  SPEAKER_02: What was it like and how that could help a lot of people and colleagues in
• 23:51
  SPEAKER_02: the industry who might be considering the same career path?
• 23:53
  SPEAKER_00: I have thoroughly enjoyed it.
• 23:55
  SPEAKER_00: I think having come from in-house, I have an appreciation for what happens in-house Yeah.
• 24:26
  SPEAKER_00: I think having done both, it gives me a level of appreciation on both sides.
• 24:30
  SPEAKER_02: Wonderful.
• 24:31
  SPEAKER_02: So I hope many people would consider that because we certainly want this level
• 24:36
  SPEAKER_02: of expertise out there in the industry.
• 24:39
  SPEAKER_02: So Allison,
• 24:39
  SPEAKER_02: I want to give you a couple of minutes to just process your thoughts and think
• 24:43
  SPEAKER_02: about maybe two or three key takeaways we can share with our audience today.
• 24:47
  SPEAKER_02: In the meantime, guys, I'm going to share with you a very quick announcement.
• 24:51
  SPEAKER_02: We're going to take a couple of weeks of break.
• 24:54
  SPEAKER_02: We'll be right back.
• 25:24
  SPEAKER_02: It is based on the ChatGPT's thinking platform,
• 25:27
  SPEAKER_02: but it does not go outside the box that I have created for it.
• 25:31
  SPEAKER_02: And it is a coach.
• 25:31
  SPEAKER_02: It is not something that will give you a yes-no answer.
• 25:34
  SPEAKER_02: It's not going to give you a template.
• 25:36
  SPEAKER_02: It's designed to help you develop this muscle, which I call the risk judgment muscle.
• 25:42
  SPEAKER_02: And it will help you test your assumptions,
• 25:44
  SPEAKER_02: identify options,
• 25:45
  SPEAKER_02: opportunities,
• 25:46
  SPEAKER_02: especially when the risk decision is difficult and data is not available.
• 25:50
  SPEAKER_02: So if you're in a leadership position,
• 25:53
  SPEAKER_02: It's going to be a great coach and tool for you to engage with.
• 25:56
  SPEAKER_02: And I've tested this with many, many people with great feedback.
• 25:59
  SPEAKER_02: It's available now as a limited launch.
• 26:02
  SPEAKER_02: And if you're interested, please reach out to me and I'll share that information with you.
• 26:06
  SPEAKER_02: Alison, with that, the floor is yours.
• 26:07
  SPEAKER_02: Please share two or three key takeaways with us.
• 26:10
  SPEAKER_00: Thanks, Naveen.
• 26:11
  SPEAKER_00: Well, first, thank you for having me.
• 26:13
  SPEAKER_00: I appreciate it.
• 26:14
  SPEAKER_00: And it was wonderful talking to you as always.
• 26:17
  SPEAKER_00: I think the first takeaway is I don't think it's as easy to outsource risk as it used to be.
• 26:22
  SPEAKER_00: Risk is pervasive now.
• 26:24
  SPEAKER_00: It's not as discreet.
• 26:26
  SPEAKER_00: But even with that in mind,
• 26:28
  SPEAKER_00: don't forget to have a good quality agreement and check those quality agreements
• 26:31
  SPEAKER_00: that you do have with you.
• 26:34
  SPEAKER_00: I think it's one of the biggest areas that we as lawyers see,
• 26:37
  SPEAKER_00: whether it's in diligence or just in our everyday work,
• 26:41
  SPEAKER_00: that those contracts are either not well written or
• 26:43
  SPEAKER_00: the obligations are not well defined.
• 26:46
  SPEAKER_00: So check those quality agreements.
• 26:48
  SPEAKER_00: The other one is, I'm going to make a plug for the FDA Law Blog.
• 26:52
  SPEAKER_00: We will certainly have a post coming out on the warning letter itself,
• 26:56
  SPEAKER_00: but I think keeping an eye on those warning letters,
• 27:00
  SPEAKER_00: like we talked a lot about Naveen, I think they are going to be incredible.
• 27:03
  SPEAKER_00: Wonderful.
• 27:03
  SPEAKER_00: And we'll share the link to that blog in the show notes, guys.
• 27:06
  SPEAKER_00: So definitely check it out.
• 27:07
  SPEAKER_00: A lot of good information there, I'm sure.
• 27:09
  SPEAKER_00: Not just QMSR.
• 27:10
  SPEAKER_00: So it'll be a good way.
• 27:11
  SPEAKER_00: And Allison,
• 27:11
  SPEAKER_00: you know,
• 27:12
  SPEAKER_00: I'm going to be a little bit forward here and basically tell people if they want
• 27:15
  SPEAKER_00: to reach out to you.
• 27:33
  SPEAKER_02: They are free to contact you through LinkedIn, make a connection, have conversations.
• 27:36
  SPEAKER_02: This is a point of our community here.
• 27:38
  SPEAKER_01: So guys, thanks a lot for
• 27:39
  SPEAKER_02: attending today.
• 27:40
  SPEAKER_02: I appreciate it.
• 27:41
  SPEAKER_02: Alison, thank you so much for coming to the show.
• 27:43
  SPEAKER_02: I know you are busy, but your insights are so greatly appreciated.
• 27:48
  SPEAKER_02: I learned a lot from you today as well.
• 27:50
  SPEAKER_02: And I wish you all the best in your practice.
• 27:52
  SPEAKER_00: Thanks, Naveen.
• 27:52
  SPEAKER_00: Wonderful talking to you.