Hey, guys. Welcome to the podcast. Today, my guests are Jessica McClint and Melody Davis of Versant Learning. And we discuss MSL compliance 101 and the most common issues in MSL related gray areas, which is really interesting topic. And I think a lot of people are gonna learn a lot from this. So hope you enjoy it. Welcome to MSL talk with Tom Caravella, a podcast specifically designed for MSLs and all things field medical. Hey there, Jess and Melody. How are you guys doing today? Doing good.
How about you? Well. Thank you. Awesome. Awesome. Thank you so much for joining me. I'm really excited. And just for all of the folks listening in, these are two friends that I've gotten to know through the business, through the industry, see them at conferences. And you guys are in for a treat because this is a power duo of medical affairs info that's gonna knock your socks off. So I am so excited. Thank you guys for coming. Thank you for asking. Yeah. Thanks for the invite.
Cool. Cool. So let's start with intros. Love to have you guys, you know, tell everybody, you know, who you are, what you're all about, and what you're up to these days, that kind of thing. Sure. So this is Jessica McClinn, and, Melody and I have been told that our voices are very similar. So I'll try to sound as different as I can, but if you hear a slight Texas twang, that is Melody. Otherwise There's no need to start it this on this side of the foot. I don't know how to There it is.
So, I have a PhD in neuroscience, and I had not ever planned to stay in academia. I always kinda thought I'd come over to the pharmaceutical industry, and I've had a wide, you know, variety of positions. I started in pharma in 2005 as a preclinical researcher because I was one of the few grad students who really actually enjoyed animal work.
And then just kind of for variety, I became a medical writer and editor, and I rose through the ranks of that agency, BGB New York, to become a medical director. That was an agency very similar to the agency that Melody and I have today, except that that was focused on commercial support, whereas Melody and I are medical affairs. And then I moved on to be an MSL and, you know, rose up there and and became an MSL manager, managed a few teams.
And my last position, as a, you know, employed salaried person was, as a medical affairs trainer. And after that, Melody and I took the leap into entrepreneurship and and started our company. Got you. And so Texas twang here, Melody. So I also had a weird journey. I think that that's pretty common for people both in medical affairs and in training. So I worked my way through 2 undergrad degrees, so I was a little late to the grad school party. I worked at a district clerk's office.
I did check fraud kiting schemes in a district attorney's office. I worked in an emergency room business office, which definitely hones your customer service skills, and finally, ended up in grad school, got a PhD in microbiology and immunology, and I became an MSL back in 2,006. Serendipitously, it was my first MSL interview, which I know is very unusual, but I just happened to be in the right place at the right time. So that's what I would tell any MSL who's trying to, get that first job.
And I rose through the ranks as an MSL and really enjoyed teaching my teams and making sure that they knew the newest information. And so that resulted in creating a position for an MSL trainer back in 2013 and continued that, increased the range of responsibility in that role until I joined Jessica in this venture with Versant Learning Solutions. And so, as Jessica mentioned, we focused on medical affairs because it was a gap that we found ourselves when we were working in house.
We couldn't find vendors who had been MSLs, who understood medical affairs inside and out, and so we felt like there was a an opportunity there to really give back to the community. Got you. So okay. So in a nutshell, you guys both came through the MSL route. Both became medical affairs or MSL trainers, and then partnered up and joined and created this company, Versant Learning Solutions. And now you provide training programs and solutions for companies, to suit their medical affairs needs.
Correct? Yeah. Exactly. Awesome. Yeah. In the beginning, it really was a focus on the training piece, but I will say that we've sort of expanded more into the medical writing and medical communication areas. And Got you. If you look at the 2 of us, I'm focused more on the workshops and the online training courses and Mhmm. Training in general, and then Jessica focuses more on the medical writing and the data visualization projects. Got you. Awesome.
So we are going to talk about compliance, which we have not talked about on this podcast yet. But a lot of people ask me about it, you know, to do, like, a primer on compliance or, really discuss and kind of vet out those those gray areas. So let's jump right into it. I'm not exactly sure what to start, where to start, but I just figure, let's talk about compliance. And, specifically, let's get into, you know, what people need to know, what some of the gray areas are.
So I'm gonna leave it I'm gonna go back to either one of you to kinda jump in and say, hey. Where do we start? Like, when we talk about compliance, what what's what's the first thing we need to think about? Okay. Yeah. I I think I'll try to kinda cover the big areas to keep in mind, and then maybe Melody can get into some of the fun gray areas that all MSLs have to deal with.
I think the first thing to always keep in mind when you're in medical affairs is that the FDA holds medical affairs departments to the same standards as it does sales teams. I think that some people feel that because commercial and r and d are 2 separate business units within an organization, that there are some, you know, rules that apply to each differently, and that is just not the case. The FDA views any commercial for profit organization as a single entity.
So, you know, there's there's really no special, protected safe harbor for medical affairs. And it can be really hard to keep those separate. And people think, well, no. No. No. It's really straightforward. You know, I I don't do commercial things. I don't interact with them. There's firewalls. But I wanted to give you a real life example, something that seems really straightforward. But the answer is is not clear, and this is one of the most common gray areas that MSLs face.
So the example is you're a new MSL. Maybe you're new to your company or you're new to this product, this indication, or you're new to this territory, and, a sales rep in your territory or the sales manager, regional manager, says, hey. I can introduce you to this person. I have a great relationship with this customer, and it is one of your top KOLs. You absolutely need to meet that person, and this this sales rep is offering you a way to do that. Can you do that? That's the question.
Should you do that? And, unfortunately, for you as an MSL, the answer is not yes, and it is not no. It is it depends. And, you know, Melody will go a little bit more into that as as we go on into these gray areas. The second thing I would stress to MSLs is that always in the course of your day, you should be asking yourself, is what I'm doing right now, would that pass the red face test? Meaning, would I be embarrassed to tell somebody about what I did at my job today?
Does does it feel, you know, ethical to me that what I'm doing? And it's even a little bit more complicated than that because often compliance violations don't come up right away. They come up after, it's been going on for a long time and it's become endemic within an organization. And so you may be, called to court to come testify for something that happened 10 years ago. How are you gonna remember who you met with on that day and what you said to them?
And, you know, CRMs, like Veeva, where you're supposed to record your interactions, they limit what you can write in them and for for exactly this reason, for compliance reasons. But if you write it all in a personal notebook so that you have every detail of every meeting you ever had, that is all discoverable as well. So there's really no great way to document what you do on a daily basis. So you have to keep in mind, am I doing the right thing today?
So finally, the the last piece of advice kinda general I would give is that you should know your company's SOPs. Not knowing them is not protection from the law. Medical affairs company or departments should have their own compliance SOPs. They should not rely on commercial SOPs. I was reading an article in preparation for this, and I saw that Bayer in 2018, they had 60 SOPs that were just for MSLs. That makes my brain hurt. I would not wanna be on the training side for that poor MSL.
But, you know, that guarantees that those MSLs are pretty well protected in terms of what they're doing on a day to day basis. And, a lot of these SOPs that you're gonna see, I mean, I remember these when I was being trained, They're read and acknowledge. And what that meant to me was scroll all the way down as fast as my mouse can take me there and click, yes, I acknowledge. Really? But I yeah.
I mean, because you're busy, and it's just a read and acknowledge, and who cares what it you know, it's in legalese, and it's hard to understand to begin with. So it's not like something that you're gonna take anything from if if Well, you should. You should. You should know this stuff. Right? Exactly. You absolutely need to know what your company's policy is on joint meetings, on how to interact at conferences.
Like, they've they've thought all this through, and it's up to you to to read the fine print. But, we are seeing in the training world that there's been a lot more innovation in training for compliance. You know, it's not these read and acknowledge anymore. They're starting to do, you know, these real world scenarios where you have this fun kind of 5 minute cartoon. You're you're an MSL. You're walking into the KOL's office, and this happens. What do you do?
So those are very good innovations, and I think they're much more helpful. Yeah. So those were kind of the 3 that that I would Alright. So that's a good foundation. And we're gonna get I have some questions that I wanna get back to. But I want to go to Melody because I know that there's so, you know, that was a great general overview, but I know that there's these pitfalls, and there's these gray areas.
And that's what I'm really kinda interested in learning about and, for my own knowledge, but, obviously, for everybody that's listening, to really talk about and have an understanding of, examples of the gray areas that exist, compliance pitfalls for for MSLs. Right. So being an MSL means being comfortable working in the gray. And if that's not an area that's comfortable for you, there are other roles in medical affairs that you might find more to your liking.
Because there's not a lot of definitive, cut and dried, this is how it will be at every company kind of things we can share. There are decisions that separate companies and even teams will make in terms of where their stance is with these gray areas. And it starts out I can give you 13 quickly, but just off the top of my head, these are just areas that everyone's gonna deal with. What's the definition of safe harbor or scientific exchange?
You see that talked about all the time as if there's one definition for that and there's there's not. If you weren't an MSL, you might think that these are talking about some sort of nautical term. But, in reality, as Jessica said, you're in a commercial organization and so there is this belief that anything that you're doing might have some sort of commercial nature to it. And so this idea of safe harbor just because you're an MSL or just because you're meeting with a KOL is really a gray area.
And it's a thin line between educating someone, even on certainly credible scientific information in an unbiased manner, and promoting the use of that device, that drug, that biologic. And the team has to be really careful about that. Unsolicited requests are the lifeblood of MSLs, and the FDA considers requests for off label information that is prompted in any way to be solicited. So, where is that line?
So, if you have a sales rep who is the person going out and seeing physicians routinely in their territory and you as an MSL are getting a series of unsolicited requests through the pathway that your company has designated that are all very, very similar, then is that a red flag that needs to be raised with your manager? It's something that you need to be aware of because of that unsolicited nature that has to happen.
And the FDA has provided guidance, it's very specific on what their thinking is at this point regarding an unsolicited request, then when and how you can respond to those. And so you really have to understand what that is and where that looks. I think every MSL should read through the guideline and understand at least what the FDA is saying. In 2011, UCB paid 1,000,000 of dollars for violations that included MSL activities regarding off label discussions.
So, it has happened and it does get discovered in the course of an investigation. The other piece that MSLs run afoul of is proactive versus reactive. And, where exactly is that line? People say, Oh, well, I'm a 100% reactive. Well, that limits the scope of the MSLKOL relationship and your job is to build a strong one. So, how is that gonna impact your ability to do your job, your ability to gain insights, other broader pieces to the medical affairs puzzle?
For some companies, you can be proactive if it's disease state information. It doesn't talk about your drug or any other competitors in the marketplace, but some companies, really take a more conservative stance and want you to be more reactive than proactive in your discussions. And, so, developing a relationship in that situation where you're trying to provide value can be full of pitfalls.
The 4th item I would point out is that MSLs strive the pinnacle of fair and balanced in all of their communications and all of their discussions. And, this can have real impact. There have been fines levied, Forest Labs for 1, where positive results were discussed and presented but not negative. And so you really do have to make sure that you're showing the totality of evidence, whether it's your drug or a competitor's drug.
And, even safety information that's beyond the package insert, newer guidances have come out suggesting that you need to be attuned to that. If things are coming out in Phase 4 studies or in newer clinical studies, you need to be aware of what the changing safety profile is of your therapy. The 5th thing that I would would say is, again, these stances that you take depending on what the actual therapeutic area is.
So I think we've all seen the opioid crisis and the communication in the field about that. Think about if you're a pain or opioid MSL, maybe not today, but 5, 10 years ago, and what the legal stance might have been for that team about what you could be proactive versus reactive on, for example, versus a dermatology MSL supporting an eczema drug. Maybe there'll be a little bit more fluidity in those 2 teams in terms of how conservative they feel like they need to be.
And, in our life today, there's a lot of market access discussion. And some MSL teams take on that role. Some companies have separate MSL teams that focus in the managed care realm. And, a lot of those discussions have various stakeholders.
They might have the MSL presenting the scientific information, but there is a budget impact model or a value prop deck that is also gonna talk about the field itself and how much utilization of medical services that costs and the bottom line for an insurance company, which is not something that MSLs have traditionally been involved in in the past.
So, finding the way to deal with what is sometimes a blurred firewall between commercial views and medical affairs views is really important in that area. But it's it's going to just keep growing in importance over time. And, there's also the the possibility of actually presenting to non healthcare provider groups. A lot of companies won't allow MSLs to do that, but it can be particularly helpful with this patient centricity model that so many companies are, thinking about and striving for.
So those are just a few things to start out with. I'll I'll ask you if you have any questions. Well, there's a lot to unpack there. And I think that as I as I listen to all of these different areas that people can get in trouble, I mean so, like, what kind of training takes place internally? How much of the onus is just on the MSL? How much is on the on the manager? And how much trouble can you get into? You mentioned $35,000,000.
Is that common that, you know, companies get slapped with those those kinds of fees? And, and that's I believe that's a corporate integrity agreement. Right? Isn't that the CIA? Is that I mean, I know I just asked you a lot of different things. I don't know where where you wanna start, but, yeah, there's a lot to unpack here. Right. So training is is super important, and I would say the first thing that comes to mind is the internal training that MSLs receive is very important.
They have to really undergo what training they have internally. They need to ask questions when they don't understand it. If that SOP has not been translated to English and it's still in legalese, if you don't understand that how this is really gonna impact you day to day on the job, then you need to ask those questions of your mentor or your manager, legal and compliance.
And you really do need to have a partnership with those other stakeholders in the company with legal and compliance, you know, the the red phone hotline to ask them questions when things come up that you're unclear about or were not listed in an SOP because they're not gonna be able to go through every potential situation. And having a discussion about what your day to day looks like with them so that they understand what it is to be an MSL and they're not making assumptions.
And you're also inviting them in to talk to the team and tell them what they're hearing and kind of what is changing in the field is really important to do. So I think having that really, careful internal non siloed discussion really helps bring it to light so that people are not doing things just because they don't know any other way to do it. Right. But there's also a lot of external places you can go to for assistance as well.
The FDA, like I mentioned before, has FDA guidance documents and it gives their thoughts on where they stand with that topic. It's not binding to them or the company, but it's a good place to start. And Pharma, the entity, created a code back in 2,009 and it was updated just in 2019 to give a code on interactions with healthcare professionals. So, knowing that and having read through that will also provide a perspective. And you were right on.
The corporate integrity agreements and knowing which ones of those have come forth can be a useful tool in figuring out where the enforcement actions are happening, and so that you can make sure that you're you're doing the compliant things that have come out from that. And you can also go to professional societies.
Many of them have a wealth of knowledge from years of being in the field about what you should and should not be looking out for in your day to day work and, you know, considering medical affairs as a department and having those interactions internally. What what is SICOM hearing? What is MedInfo talking about? What about the grant committee or the ITT team? And having those conversations can really help bring forth a lot of other issues and best practices for everyone. Got you.
So just to go back, when you say pharma, you mean pharma, p h r m a. Right? That's I do. Yeah. Okay. So you so let me go back. So you I'm assuming that, you know, when MSL is in a company, they go through some training. There's SOPs, which hopefully they'll read and they're not just checking the box. Right? And then they are going to obviously have a relationship with their manager that's gonna help guide them.
They're gonna probably do some, you know, some in house, whether it's ride alongs or something that's going to assist them in better understanding, the do's and don'ts, the rules of the road, the gray areas. And then from what you're saying, and, Jess, let me come back to you, because, Melanie, you mentioned external resources. So there's probably a lot of people listening that may work for smaller companies that don't have the infrastructure.
So do you think it's is that the advice is to really take try to take some matters into your own hands? Look for external resources like you just talked about, Melody, to really educate yourself so that you're aware of what you can and can't do? Yeah. That's absolutely what I would say for the small small companies where there's maybe just one MSL and their medical affairs department has just begun. You know, they don't have any SOPs.
But what you can often do is, if you have colleagues in the field, sometimes they will share their SOPs. You can also go to these external sites and see the pharma guidelines or code that Melody mentioned, is one of the best because the interactions code, it goes through every potential scenario. It's really detailed. And so, you know, you know, these aren't laws, but they are very helpful when you're trying to determine what your own policy should be. Got you.
Okay. What about, like, conferences and stuff like that? I mean, is that one of the ways that companies will help to train, their MSLs, or is that something that MSLs should be looking for themselves to see if maybe and nowadays, all the conferences are virtual. But is that a way that they can come up to speed quickly, or or do they even talk about this stuff in conferences? Yeah. There there are conferences devoted directly to this, but as an MSL, I was never sent to 1.
And I don't know that, any MSLs really are are actively involved in these types of things. Melody, what would you say? So it depends on if you're talking about a scientific conference, which really is the type of conference that most MSL teams are sending MSLs to actively.
And at those conferences, they're really focused on finding the content to bring back in for their internal stakeholders and also to share with physicians in the field who weren't able to attend or to discuss with their high level KOLs to understand their insights from that data. So there isn't, time at those conferences to take advantage of any kind of external training that might be there. But Mhmm. At most scientific conferences, they don't do a lot of professional education like that anyway.
So the other place that MSLs would find this, the other type of conference an MSL would find is that, is a professional conference. Whether that's something like DIA or other professional Yeah. Massey. That are out there. I was gonna say the Massey conferences. Big conferences that you see. Yes. Some of those. That would be where these things get discussed, But that's a discussion between the MSL and their manager, whether they can get the approval to go to that.
They would have to navigate that individually. So as you as you mentioned, management and leadership so what what is the role of leadership in enforcing and educating the compliance standards? Does it all fall on them, or is it typically a department? What what what are managers really responsible for, when it comes to compliance? So the managers are really discussing this at the leadership team themselves.
Okay. You'll have them come together and work through issues that the team might be experiencing, what is the plan moving forward. They will also have conversations continuously with legal and compliance to understand better where they are at and what is allowed and not allowed and what's the path forward. And so the managers then communicate that and re communicate that and communicate it again to their MSL teams and discuss it in 1 on 1 meetings.
That's really important that you have those strong bonds between the manager and the individual MSL contributor.
Most difficult MSL scenarios will come up where you haven't seen it before, it's new, it's gonna happen now with all of the digital and the the change over to digital excellence that we're seeing across teams, and the manager can best serve their team by doing that consultation with legal and compliance to make sure that everyone's on the same page, they're all speaking the same language.
And, you know, all the teams are auditable, and so managers should really have that in the back of their mind and be prepared for an audit, being able to show training records, being able to understand where records are kept and how those things happen internally. That's how they can best serve their teams. When you say audit, who's who's doing this audit?
Is there do the companies have internal audits, or you're saying that, like, the FDA comes in and does an audit, and that's how you get caught and that's how you have trouble? So teams can have internal audits, definitely. And when an FDA comes in to look at a clinical site or a manufacturing process, oftentimes those audits can become more broad than the original intent.
And so, there's always an issue where, as Jessica said, information can be discoverable and you would have to discuss why decisions were made, what was the context of those decisions. So, Jess, before you mentioned Veeva and, you know, CRM systems and how MSOs are recording their interactions and insights, So is talk to me a little bit about that. Is that like, is there a a standard way that you need to record this stuff so that you're not oversharing?
Or or or you're supposed to like, how like, what advice do you have for folks, that maybe are newer or even experienced MSLs that just want to be careful in how they, you know, document their interactions. Well, larger midsize and larger companies, they have their Veevas set up to already be pretty restrictive. So they have a bunch of menus and drop downs and very few free text fields Mhmm.
So that an MSL can't, you know, enter the details of an interaction, which is, you know, protective, but also limiting in terms of the understanding of of what that interaction was really about. Like, I checked the we talked about the product box. I checked the disease state box. You know, I I said it was 45 minutes long, and that's really all I got to say, when it might have been a much richer discussion.
So it's a it's a little bit limiting, but, when I was a manager, I was careful, especially for the new MSLs, but but I tried to read every single MSLs entry into Veeva, just to make sure that they understood what was important to report. You know, was this a true insight, or was this just something that you found interesting that was maybe an anecdotal patient story? And, also, were were they being compliant? Were they saying things that, you know, would would get them in trouble?
Those kinds of things. So I always had a lot of feedback for MSLs on their Veeva reporting beyond just, like, you know, you missed your deadline for the month or whatever. Yeah. It was kind of based on what I would see trends I would see in their reporting. But it's it's kind of a catch 22 because companies want insights. Right. They wanna know what took place in that interaction. What pearls are you bringing back to the organization?
What what can we learn from the in you know, that's why they call them insights. They want Yeah. You know, it's a real thing. And we have no I I have not yet worked with a company, client or as an employee where they did their insights in a way that really worked. You know, some of them have a box in Veeva that you check it if it's an insight. But if it doesn't go beyond the checkbox, then who cares?
There was no, in Veeva, there was no automatic forwarding of that when the box was checked to to somebody. And other other companies do it by spreadsheet or biweekly call with management. And I just I haven't seen that anybody has a great way to collect insights and distribute them where they need to go. There are newer platforms coming out that are trying to do this.
I think one of the compliance issues is that you take this insight, it's free text, because you need to be able to provide all the context and the information around it, but maybe it needs to be de identified, and maybe some companies de identify even the region that it's coming from. So that then has a downstream effect. You can't tell, well, regionally, we're seeing something in the northwest that we're not seeing in the southeast, and what does that mean?
You can't, make those finer graduations of insight building and knowledge building if you're stripping some of the metadata out. And so it, again, is a question for each team and each company about how far they want to go with that. Where where is their comfort level? Got you. So just to kinda wrap up the conversation, like, what's what would you say is the most important things if you had to create another little list?
Like, what's the most important things MSLs need to keep in mind to stay compliant? Yeah. So, you know, every company's SOPs are different, and some companies, like we were talking about that are very, very small, may not even have SOPs. But there are some rock solid compliance rules that apply wherever you work, whoever you work for, whether it's device or biologic or, you know, more traditional, product.
And and so we thought maybe it would be a good idea just to kinda quickly go through some of those so that as an MSL, if you're listening, you can be checking these off and, you know Yeah. Let's do it. Am I compliant? So the first one and probably the most important or at least the most litigated is do not talk about, a drug's off label uses unless asked. That has to be 100% reactive.
Similarly, do not talk about a unapproved drug, a pipeline drug, unless asked because that again is should be 100% reactive. Boosts, you know, at medical conferences, this has sort of changed a lot with the, pandemic, and there's really only virtual conferences happening right now. But conferences used to be one of the biggest danger zones for MSLs because physicians naturally wanna meet at the company's booth. That's the easiest for them to find.
There's no, wandering around, and so they wanna have a 10 o'clock discussion with you, and they'll see you at the booth. But as an MSL, you cannot be having conversations in the commercial booth. That so that's a big that's a big one to keep in mind. Paying for recreational activities, I think that's gone way down. When I first started, KOLs were being flown in helicopters to hunt polar bears in Alaska and all sorts of craziness. Those are the good old days. That was the wild. I know.
It's, like, so funny. Everybody, you know, refers to them that way. Custom ski boots. Yes. And now, you know, honestly, you can get in big trouble if you give them a pen, if you give them a mug Yeah. If you give them an article without discussing Sunshine Act. So now it's it's it's a pretty clear line. Just do not give them anything. Yeah. MSLs and sales reps should never be in a visit together.
And even if it's the regional sales director or somebody higher up in commercial, commercial and medical affairs should not be in a meeting together. The one exception that's usually acceptable is the introductory meeting. Pharma, the code we were talking about, they talk about that that's permissible and, but really, I mean, I think the majority of the time, never the 2 shall meet. And then finally, I think the one that MSL struggle a lot with is the Sunshine Act.
They are talking about a new pub with a with a KOL, and the KOL wants to see it. The MSL, that's a that's a value add that they can bring. They wanna provide it, but they have to tell the KOL that they're going to then report this to their company, and their company is going to have to report it as a transfer of value, $50, $60. And so a physician will show up on a list somewhere as having received x amount of dollars from this company.
And, you know, MSLs feel like that is a discussion that's really uncomfortable to have, and they'll just give them the pub and it'll be fine. But no. Unfortunately, probably offering the link is better. You know, most of these KOLs have access to journals. So just send them a link and and let them download it themselves. So those are if if you follow those kind of basic rules, you're you're gonna be fine. It's just, kind of a matter of keeping in mind every day, what am I doing?
Do I feel good about it? Is there anything that I'm doing that makes me feel uncomfortable? Good stuff. I love it. I just learned a lot. I'll be honest with you. This is great. So This is why we're in training. Yeah. You guys are great. Awesome. This was really good. I can't thank you enough because this was something that a lot of people were asking for, and I think that these are really, really practical tips. It's good sound advice. So, I wanna thank you both for coming on. You're awesome.
So much for having us. Yeah. Appreciate it. We're gonna have to do this again. So well, listen. Be well, and, and thank you for everything. Alright. Have a good rest of your week. K, guys. Thank you so much for listening to the show. And if you enjoyed it, please subscribe so that you don't miss an episode in the future, and feel free to leave a rating or a review or a comment. Thanks again, and we look forward to seeing you soon.