No Laughing Matter

PhRMA, OIG, FDA. Their compliance guidelines have created some tension for the medical meetings industry, but one thing's certain—rules are not meant to be broken.
Sep 01, 2006
By Pharmaceutical Executive Editors

Jeannette Park
At Pharmaceutical Executive's annual marketing and sales summit in June, state sales and marketing regulations were a hot topic. At one session, Robert Freeman, US compliance officer at Serono, and Bert Johnson, Chiron compliance officer, broke down some of the biggest compliance challenges and drew lessons from recent enforcement efforts. They dissected the different—and sometimes conflicting—meeting requirements in states like California, Maine, and Vermont. And then the questions started. One marketer wanted to know, for instance, if a doctor practicing in West Virginia attends a CME program in Minnesota, which state code does the company follow?

As regulations governing medical meetings sharpen, and stakes get higher, these will not be idle questions. Pharma will need creative solutions to straddle guidelines from different states. This month's Pharm Exec supplement charts the current landscape of medical-education meetings and notes some of the trends that are reshaping the business.

Andy Bender and Nooshine Dayani of Polaris Management Partners explain some of the risks facing pharma companies as they interpret the OIG guidelines regulating medical education. OIG practically excludes sales and marketing teams from allocating grants, and imposes cost controls on educational events. Pharma is asking: Why invest in CME at all? Surviving in this changing regulatory environment requires pharma not simply to learn a set of rules, but to interpret them.

Emerging data suggest that racial and ethnic minorities are not benefiting from improvements in in the US healthcare system as much as Caucasian patients, says Ruben Gutierrez of Sudler & Hennessey. Doctors who treat this population segment need to understand how patients from different cultures process medical advice, and what conditions they might be predisposed to based on race, diet, and environment. In a Q&A with Pharm Exec, Gutierrez and Intramed's Annemarie Armani discuss how to help physicians break down barriers and improve communications with multicultural patients.

And speaking of cultural differences, CME support systems continue to progress overseas, so pharma companies are looking to set up programs in Europe and Asia. But to capitalize on this growing trend, providers have to be aware of local habits. Based on his experience, John Sheehan of M/C Communications explains how working with in-country expertise helps providers produce high-quality education programs that are tailored to individual nations.

As we dig into the confusing issues surrounding CME, one thing is certain. More questions—maybe new and stranger questions—are sure to arise. Like the one posed to Bert Johnson and Robert Freeman at the summit, about doctors from different states: "So if one state doesn't allow for gifts, including food, then what? You serve one doctor but not the other?"

Everyone laughed. Well, everyone except Freeman and Johnson. Compliance officers are not joking.

Jeannette Park is Pharmaceutical Executive's special projects editor. She can be reached at

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