Follow me:
Follow me:

Off-Label Promotion Is Not Going Away

Play episode

Part 2 of my discussion with Dale Cook, MA, JD on OffLabel Promotion: Off-Label Promotion Is Not Going Away


Off-Label Promotion Is Not Going Away

December 26, 2019
[smart_track_player url=”″ title=”Off-Label Promotion Is Not Going Away” color=”#FF5722″ social_linkedin=”true” social_email=”true” tweet_text=”Listen to this @darshantalks podcast with @PhillyCooke on #OffLabel #Promotion!”] [learn_more caption=”Read Transcript” align=”right”] Darshan: Hello everyone. Welcome to another episode of Darshan Talks. We have Dale Cook with us, and Dale as many of you may know, is one of the experts when it comes to promotional compliance. And he’s joined us today. We’re going to be talking about off-label communications, off-label promotion, and why does the world think that off-label promotion is here to stay?

Speaker 3: 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

Dale: Thanks so much Darshan. Yeah, why is off-label promotion here to stay? Well, I mean as a concern for pharmaceutical companies, it’s never going to go away as long as the existing NDA system is in place, right? Because as we talked about in a previous podcast, the whole notion of bringing a product to market requires that the FDA evaluate a limited set of information for specific indications and specific uses.

Dale: And the FDA as recently as two days before the Obama administration ended, they published that memorandum on First Amendment and off-label concerns. I don’t want to parody or otherwise give short trips to a 63-page document, but I think it’s fair to say that a one-sentence summation could be “We’re right and y’all are wrong.” Off-label promotion is a bad thing and we’re right about that and everybody else who has come up with any other idea is just wrong and we are not going to back down.

Dale: At its core, the whole idea of off-label promotion potentially decimates the entire structure of the NDA system. I mean what would it be like if the FDA knew that when it was evaluating and reviewing a product prior to coming to market, if the FDA knew that you could then go out and market that product for absolutely anything without ever having to conduct any additional scientific research, what would you do? I mean what would the incentive structure be in that situation? The incentive structure would be bring the product to market with the absolute easiest possible thing to demonstrate.

Dale: The product will eliminate a headache, or will reduce nausea or whatever that easiest possible thing to demonstrate is, and then promote the product for whatever the most expensive, greatest demand is. You bring the product to market showing that it reduces nausea and then you promote it as a cure for cancer. Or you promote it as the way to prevent birth defects, or the way to extend your life forever. And you just have no obligation to actually demonstrate that it works and the FDA would know that.

Dale: So then the incentive structure on the FDA side becomes to not let the products on the market. Because they would be terrified that you’re bringing it to market having demonstrated X, but they know that X is not really what you’re going to promote it for. So then their incentive would be to make the review and approval process as difficult as possible to bring the products to market. So that world where off-label promotion is no longer viewed at all as being anything bad or at all being at all prohibited is from my perspective, terrifying. Because I don’t understand how the entire NDA process works anymore.

Darshan: So I’m going to challenge you on that Dale. And the reason I’m going to do that is because I read those cases differently. This is exactly why I love talking to someone like Dale because he can come back and go, you’ve missed this piece of it. Or here’s how I see it. So I love this opportunity to talk to someone really smart like him.

Darshan: Here’s how I read those cases. The cases came out and they basically said the information has to be truthful and not misleading. And to meet that standard as we know, the FDA requires either the substantial evidence standard of the car standard and that’s competent, reliable, scientific evidence. So the position you took that you would need to have information that is, that anyone can go out and you don’t need the studies, you wouldn’t meet that truthful, not misleading standard though. What was your take, how did you come to the position that maybe that may not be always necessary?

Dale: The truthful non-misleading standard as I understand it and as I think courts have applied it, is a much, much lower standard than the substantial evidence standard that FDA requires to actually get the product into the marketplace. And if all you ever had to do was to initially meet that substantial evidence for anything, and then henceforward and forevermore you only ever had to meet the much, much lower standard of truthful and non-misleading including for completely unapproved uses then that would, I believe, open up the door to a ton of inappropriate promotional activity by pharmaceutical companies.

Dale: By definition, prescription drugs are dangerous substances. If they were not dangerous substances, they would not be prescription drugs. I mean they would be food, or they would be something else. By definition, they have the harms associated with them and you want to make sure, and it’s hard to make sure. I mean, I don’t want to under-emphasize the fact that we’ve got situations right now, where products that have been on the market and have been used for 40, 50 years, we’re not sure that they actually work. And they’ve been used and they’re being used and they’re dangerous substances. So the people who are receiving them are actually suffering harm. And we’re not actually sure whether they work.

Dale: That’s not good. We want the incentive structure to be there, something similar to what we have today maybe not identical. I’m not claiming that what we have is perfect, but we want something similar to what we have today where the incentive structure is that we say to the sponsors of these products, yes, we will let you bring these dangerous substances into the marketplace, but you got to do the good science. You got to meet that rigorous standard to get the approval to bring it into the marketplace, because we know that some of the people are going to be harmed. We absolutely know that. And we’re willing to accept that some of the people are going to be harmed. So long as you convinced us via this rigorous good science and the evaluation of that research, that in fact the benefits outweigh those risks, those harms that are going to occur.

Darshan: So absolutely. So the benefits and the harm standards are, it’s that balance that’s absolutely critical. Now, one of the things we spoke about offline was this idea of how off-label promotional prosecution, we talked about has it been tapering off? And you were talking a little bit about some of the recent cases where that may not necessarily have come about. So talk to us a little bit more, I think you used a really interesting Mark Twain comment. You want to go from there?

Dale: Yeah, absolutely. So famously Mark Twain replied when then he was made aware of an obituary that had run in a newspaper and he wrote a letter saying the news of my demise has been greatly exaggerated. And I think some people have taken that same approach to off-label promotion. I have seen the headlines, not with a bang, but with a whimper, FDA gives up on enforcing the off-label prohibition. And comparable things in very reputable and solid publications. And that attitude and that approach I think is wrong. And I don’t think FDA has given up. I do think that its approach has changed.

Dale: Just recently I was at, as we record this, it was just last week the Food & Drug launched truth in advertising and promotion conference and attended a panel where some people from the government at HHS-OIG, and the Department of Justice were talking about off-label enforcement and where the government is. And they said from the stage, the government has not given up on off-label enforcement, but it has refined it. The core challenge that the FDA and the government have faced is that the entire understanding of the First Amendment and how it applies has changed radically since after the Food, Drug, and Cosmetic Act was passed in its current form.

Dale: So the understanding of the First Amendment and the ability of the government to restrict commercial speech when these changes in the Food, Drug, and Cosmetic Act were introduced back in the 1960s were very, very different from the understanding of the First Amendment today. And it has taken the FDA a long time and the rest of the government a long time to figure out how they can accommodate those changes and developments. I’m not sure, I don’t want to say, imply that FDA is currently 100% there where it needs to be or where it should be to have a perfect understanding of these issues, but where it is today is very different from where it was. And that, that is still going to be and going to involve enforcing off-label prohibitions.

Dale: And still seeing investigations just this summer. We saw a settlement with a medical device manufacturer that involved allegations of off-label promotion. And I thought an interesting one because it was a medical device, and the way in which it happened, the devices coming to market via 510(k) pathway submitted down to the FDA with proposed labeling. And the FDA responded back and said, and the sole, based upon public record and what’s in the allegations and the plea agreement, the FDA said in its response, your labeling is ambiguous here. We think there’s some concern that it’s unclear whether in fact your product is intended solely for external use or could also be used internally. We want to make absolutely clear that your product is only being cleared for the external use. If you actually want to use it internally, that wouldn’t be available to you via the 510(k) pathway. You’d have to go down the PMA pathway to bring your device to the marketplace.

Dale: And according to the allegations in the settlement, the company then went ahead and promoted the product for internal use, including having sales reps deliver case histories to the rest of the sales team demonstrating the internal use of the product. So very explicitly FDA said, we’re not approving you for this use and the company allegedly then went ahead and said, well we’re going to tell our sales force that, that’s a great way to increase sales.

Dale: So I mean that type of thing where, there were other issues as part of that settlement. And I don’t want to mislead the audience into thinking that the sole concern here was the off-label use. But the off-label use was absolutely part of the initial allegations and it was part of the settlement that the company agreed to, including, a CIA, a Corporate Integrity Agreement that the company has now had to put into place. As I’m sure you are well very familiar with, it’s a big deal coming under CIA.

Dale: As a consultant, your eyes light up because it’s like boy, am I going to be spending a whole lot of time helping this client. They got a lot of work to do. It’s not fun, right?

Darshan: So you point out this idea that there was a settlement. Have there been any recent convictions?

Dale: Yeah, back in 2016 there was a conviction up in Boston for off-label. And that was again taken to court. Now, there were a bunch of charges brought against individuals, former executives of the company and they were not convicted. They were found not guilty on the felony charges, but they were convicted of 10 misdemeanor counts, both of the two former executives of the company.

Dale: That’s something that, if you’re an individual executive and that was something that was mentioned at this FDLI panel, they are looking at the individuals. As the speaker from the Department of Justice said, we understand that corporations only act through individuals. So we are absolutely not just looking at corporate liability, we are looking to individual liability and we are willing to hold people accountable. That’s the type of thing that I certainly, I love my job, I’m not willing to go to jail for it.

Darshan: Right. Which really brings the question of, have you ever seen the Park Doctrine used in this context?

Dale: So in this particular case, I’m not sure whether the Park Doctrine was applicable. I’d have to go back and see whether it was solely a matter of the Park Doctrine. Of course, for your audience who are not familiar with it, is the idea that solely by virtue of having the position and responsibilities, the executives can be held accountable even if the individual executives have no knowledge, awareness or involvement in the actual wrongdoing. And I do not remember whether that was at play in this conviction from 2016. I’d have to go back and reread the documentation.

Darshan: Okay. I just didn’t know if you knew off the top of your head, that’s all. Great. This was amazing as always. Thank you again, Dale.

Darshan: Stay tuned. If we’re lucky, we might get a another talk from Dale pretty soon.

Speaker 3: 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[/learn_more]


More from this show


Make sure to subscribe to our newsletter and be the first to know the news.