It starts with a knock on the front door of a low-level employee, usually around supper time. The visitor, an agent from the Office of Inspector General or the Federal Bureau of Investigation, is investigating alleged corporate misdeeds, maybe expensive gifts given to doctors at meetings or inordinately high speaker or consultant fees. The next thing you know, the company is subpoenaed and must turn over literally millions of pages of records--including documents related to meetings--to the courts.
That’s exactly the kind of scenario that attorneys Michael Manthei and Chris Myers, partners at international law firm Holland+Knight, help their clients avoid. But with government scrutiny of pharmaceutical meetings more intense than ever, and a growing belief that even small gifts and modest meals are a corrupting influence, it’s a real possibility these days, particularly for organizations that don’t enforce the rules or have compliance programs in place. In an August 2 webinar, Manthei and Myers outlined what meeting professionals need to know to keep the regulators away. The webinar, titled Staying Compliant in a Complex Environment, was sponsored by StarCite, a meetings industry supplier that works with 19 of the 20 largest pharmaceutical companies.
“There’s been a paradigm shift,” said Manthei. Now, federal regulators are looking at secondary markets and smaller pharmaceutical companies, not just ‘Big Pharma.” Also, individual states are instituting their own rules related to the marketing of pharmaceutical products. But the most significant change is that small gifts and relatively inexpensive meals may be considered a corrupting influence on physicians, said Myers. In recent subpoenas, the government has been asking for documentation on any gifts, meals, or expenditures over $22, despite the fact that the PhRMA Code says appropriate gifts should not exceed $100.