Over the course of more than 20 years at Johnson & Johnson, Michael Varlotta maintained a critical, delicate balancing act.
As a senior director tasked with regulatory compliance, he harmonized company policy and procedures for physician interactions, including fee schedules, key opinion leader tiering, and standard operating procedures for travel and food and beverage. At the same time, he had to sell those changes to the sales and marketing teams that thrive on physician interactions at company-run meetings and industry shows.
In 2021, Varlotta took on an even more complex challenge. He left J&J to form MLVII Associates, where he helps implement change across compliance programs at various life-science firms—each with its own culture that he must deftly navigate to deliver results. “As an individual proprietor, I have to embrace change perhaps more than others in this field,” he says. “I definitely have to adjust to each client; company A wants to do something one way, but company B and company C have other ideas about how they want to do it.”
Among his biggest day-to-day challenges: “I'm on a call with one firm and I’m in their cultural mindset, but five minutes later I’m on a call with another client and have to engage them in their own way.”
Varlotta has also been a trainer for the Healthcare Meetings Compliance Certificate for the past nine years, and is always eager to speak to life-science planners so that their physician-focused meetings reach their objectives while remaining compliant.
Selling Change to Stakeholders
“You have to tell people why the change needs to happen. In life sciences, we can either change willingly and do it the way that works best for us in the long run, or we find ourselves being forced into change by new regulations or lawsuits. And when that happens, the outcomes are rarely as good for the company as when you proactively make changes to get ahead of an issue.”
Advice for Implementing Change
“Listen to how people feel, because feelings are facts. Especially when it affects multiple departments and you need their buy-in, you can help each of them understand the change only after you hear what they think it will mean for them. This way, you don’t ever have to tell them ‘no.’ Instead, you’re able to explain how, even with this change, they will still be able to achieve what they need to.”
The Next Change for Medical Meetings
“This industry has faced a lot of change over the past few years. When serving alcohol [at dinner meetings with healthcare providers] was taken away from us, some firms moved to allowing physicians to buy alcohol at the bar. Many firms use modest restaurants for meal events and keep the seafood tower and filets off the menu. You just have to engage in risk mitigation when dealing with regulations.”
“Now, the federal government is saying that because we know how to do virtual programs, we don't need [as many] in-person programs. Some companies have found their footing in this area, but I'm dealing with one right now regarding their in-person and virtual scenarios. What I teach is that, no matter how you do it, there is risk. But what you need to do as a planner with an eye on compliance is act to minimize those risks” and get everyone on board with those actions.
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