Compliance: Obey and Avoid

Advice from a corporate compliance officer can keep the prosecutors away.
Mar 01, 2005
By Pharmaceutical Executive Editors

These seven tips are designed for meetings that could have customers or prescribers present. The key is that you don't want the meeting alone to become an inducement to prescribe or purchase your products. You have to look at the context of the whole meeting. In other words, one of these tips may or may not cause problems on its own, but all these factors have to be looked at in their entirety and there's certainly some here that are more important than others. Take the first one—bona fide purpose. If you start down the path doing your meeting for all the wrong reasons, everything from there will probably evolve to be for all the wrong reasons. Other ones, like the appropriate size of the audience, won't be as much of an issue if you have a good purpose and it's in a modest location. Each one of these tips can't be looked at as a single isolated event; they all have to be looked at in context.

1. Bona fide purpose It's important that a meeting have a bona fide purpose, both in reality and documentation. In reality, the reason you should be having the meeting may be to discuss a new indication or a particular treatment regimen. That should be real; you shouldn't just make it up for the purpose of having a meeting. So for example, you wouldn't want to have a group sitting in a room somewhere, with the pharma company saying, "We need to develop a better relationship with the leading oncologists in the country, so let's have a really good meeting at a resort somewhere and then we can think of what they can all talk about." Nor should you be saying, "Let's try to get them all in a room so we can really take care of them and show them that they're important to us." That wouldn't result in a good discussion and documentation around it would be problematic. I think what you would prefer people to be saying is, "our particular treatment is being prescribed in a particular way and we need to get that message out because that would be the best thing for the prescribers, and ultimately, the patients." Then, plan the meeting from that perspective. It's an important distinction as you think about the brave new world that we live in, from regulatory enforcement and compliance perspectives.

2. Audience Sticking with the oncology example, let's say you're dealing with a very specific type of cancer. And there's a very limited number of oncologists who treat that type of cancer—say 200 doctors. You certainly would be surprised to see 500 oncologists show up to discuss that particular topic. Here's another way of looking at it: You're trying to get a sense from your key opinion leaders and you want to have a very robust, interactive discussion. So you invite 100 people, but it's very hard to have a discussion with 100 people. If your purpose is to have a very frank and open process, you would reasonably think that your group should be about 20 to 30 people. And again, there's no bright-line rules for these things, it's just common sense and good reason.

Fair Market Value
In terms of expertise, if you're going to be talking about an oncology product, unless you have other reasons to draw them there, it would be surprising to see very many primary care physicians there. It may sound like common sense, but it needs to be said.

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