Off-Label Promotion Is Not Going Away

    Off-Label Promotion Is Not Going Away December 26, 2019 [smart_track_player url="https://media.blubrry.com/darshantalks/content.blubrry.com/darshantalks/ep151-off-label-promotion-is-not-going-away.mp3" 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 darshantalks.com. 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....