February 25, 2020

Darshan: So we have previously talked about promotional review committees. We've talked about what happened in 2019 that will change the landscape for promotional review committees in 2020. Well, let's actually look at 2020 and what those findings of what happened in 2019 actually means for companies, and how that changes how we engage.

Narrator: This is the DarshanTalks Podcast. Regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at darshantalks.com.

Darshan: What's interesting to me is, again, we talked about [LESE 00:00:36] summaries and this is actually outside what a lot of companies are looking at because they see that as something that's happening in clinical, it's not happening in promotional, so that's okay for them. However, I have actually had people with clinical push back at me and companies say, "You know what? We need to run this by our PRC." And how do you handle LESE summaries in the context of clinical trials?

Darshan: If you are a company that's engaged in global clinical studies, you may be subject to the EMA's clinical trial transparency requirements. You need to actually have been looking at the plain language summary requirement and how does that actually apply. I expect that if you are in one of those states or if you are in one of those countries and/or you are engaged in those studies, your promotional review committee needs to start coming up with a plan on what they will accept and what they will allow to be patient-centric and patient-facing. Unfortunately from the FDA I would be surprised if you see much guidance. They are saying that they want to be more patient-centric. However, this has not been a priority for them previously. But who knows, that might change. But at least at this moment I'm not expecting much to happen.

Darshan: As it relates to patient groups getting targeted, we've talked about Jazz Pharmaceuticals and we've talked about Lundbeck and talked about a couple of others all being targeted for illegally paying [inaudible 00:02:02] basically copays for their own products using patient groups. I would expect these patient groups will continue to be targeted under [EKL 00:02:10]. As we've talked about previously, there's been a decrease in enforcement under off-label marketing. However, that doesn't necessarily mean that DOJ and FDA have really just given up on the space. They have refocused there. First they are looking at some of these other issues, and I expect that patient groups need to be appropriately targeted. You need to have appropriate policies and procedures in place. If you are engaged in social media, I expect... Okay, you will be updating your policies but nothing crazy is going to change around social media. There was the Amerind decision that came up.

Darshan: Payments of doctors. I expect that to again continue to be an area of focus. There have been, as you know, in 2019, several lawsuits and settlements associated with for example, Insys, where there were settlements associated with payments to doctors. I expect that the DOJ and the FDA will continue to review and prosecute the types of engagements that are being had there.

Darshan: And then we previously talked about Outcome Health and we talked about how there was a $1 billion fraud scheme there. I expect that fraud will continue to be targeted, as we discussed before. But what I think is going to be interesting is that in 2020, promotional agencies are going to start realizing that they need to take ownership of fraud. And I expect that they would take this opportunity to reach out, to understand if they're engaging in ways that they misrepresent either what they do or the types of claims that they're making. And then they will develop their own fraud departments and own regulatory departments, avoid exactly what happened at Outcome Health.

Darshan: So stay tuned, listen in. If you disagree with me, reach out to me on at DarshanTalks on Twitter, or you can reach out to me via my website at darshantalks.com. Love to talk to you, love to discuss any of these issues and more. Do you think that pharma companies and marketing companies are going to engage differently in 2020 as opposed to in 2019? If so, what has changed? Leave a comment.

Narrator: This is the DarshanTalks Podcast. Regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at darshantalks.com.

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