Compliance: Obey and Avoid - Pharmaceutical Executive


Compliance: Obey and Avoid
Advice from a corporate compliance officer can keep the prosecutors away.

Pharma Meetings

6. Market value One of the other things prosecutors have been looking at is the ethics behind awarding speaker contracts to key prescribers. Sometimes there's a conflict between whether you are paying them for their time at the meeting and speaking, or paying them because they're good prescribers. A good way of determining this—and there are many databases and resources out there today—is to establish what is fair market value for the type of physician that you're asking to speak and the location that you're asking them to speak at. There are different rates in different parts of the country. It's a combination of what they get professionally, let's say for an hour of office time, in addition to what the industry is paying for speakers. It's a formula that's driven from a variety of different variables, with those two being the major ones. (See "Fair Market Value,". [Editor's note: graphic was provided by Polaris Management Partners, not Saunders.])

7. Off-label promotion If you're going to have a promotional meeting, or one at which you're going to be doing any marketing of your product, you want to make sure that any and all messaging has gone through the company's internal review process for promotional material and that it's fair, balanced and on-label.

In the following interview, Brenton Saunders, JD, MBA, senior vice president, global compliance and business practices for Schering-Plough, offers pharma executives and their third-party suppliers responsible for corporate meetings and events some practical advice for avoiding some of the common pitfalls that lead to increased scrutiny—and sometimes sanctions—from FDA regulators and federal and state prosecutors. His ideas were originally presented by Michael Swiatocha, vice president and compliance officer at Schering-Plough, at the Second Annual Pharmaceutical Meetings Invitational, co-hosted in October 2004 by Pharmaceutical Executive and Meetings&Conventions magazines.


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