Is Off-Label Promotion Going Away?

    Is Off Label Promotion Going Away? December 24, 2019 [smart_track_player url="https://media.blubrry.com/darshantalks/content.blubrry.com/darshantalks/ep150-is-off-label-promotion-going-away.mp3" title="Is Off Label Promotion 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: Hey, everyone. Welcome to another episode of Darshan Talks. We have a very, very special guest for you. We've got Dale Cook and Dale Cook is the guy you talk to when it comes to promotional compliance. I do a bunch of work in it. He does a bunch of work in it. We talk a lot about this. He's the guy I've always reached out to and we have a camaraderie going. So I have this great opportunity for us to talk and learn more from him. Intro 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 @darshantalks.com. Darshan: Dale, do you want to introduce yourself a little bit? Dale: Sure. Thanks, Darshan for having me on. I've been following your podcast since you launched it. I'm really glad that we were able to work out some time to have this discussion, and I appreciate you opening up your audience. Dale: I am an FDA regulatory consultant. I started my independent practice five years ago. The tagline I use associated with my company is I help companies use 21st century technologies while communicating about FDA regulated products. And remaining compliant with regulations written in the 1960s. That core challenge of the Regs themselves have not changed and there are good aspects of that, right? We don't want the Regs constantly changing, but the world in which we live is very, very different from the world in which those Regs were written. And that is that mismatch between the world for which they were written and the world in which we actually wake up every day, I think presents one of the challenges for the companies that you and I both advise. Darshan: So that really brings us to the first question of, Regs changing and one of the areas that Regs are, well, not the Regs but the laws are changing, is in the area of compliance and in the area of off-label compliance specifically. Before we go down that path, the real question is what does, well, let's start with what is on-label, first of all? What does the word label mean? How is that different from labeling and why does any of this matter? Dale: Right. Yeah, so I mean the major significant radical change in the law in the 1960s going back to the Kefauver Harris hearings, was this notion that companies had to demonstrate that products were safe and effective prior to bringing the product to market as a new drug. And so if you create, invent, discover a new drug, you have to demonstrate to the FDA prior to introducing it to market that it's effective. The minute you do that, the minute you introduce that concept, you have to get the for what, right? Effective for what? Dale: And that introduces the idea of an indication. So your product doesn't get introduced to the market tout court, it's on the market you can do whatever you want with it. You may only introduce it into the marketplace for those specific indications where you have demonstrated to the FDA that the product is safe and effective. Dale: So that's the concept of an on-label use. An on-label use of a product is any use of the product where the company has, in fact, demonstrated that it is safe and effective and they have the labeling approved by the FDA for such use.