DID YOU KNOW whistle-blowers who bring actions against pharmaceutical companies under the false claims act can be entitled to 25 to 30 percent of any settlement? Mary E. Riordan, senior counsel, Office of Inspector General, presented that startling information at her session about the OIG's pharma marketing compliance program during the Annual Conference of the National Task Force on CME Provider/Industry Collaboration, held in September. Whistle-blowers, she said, initiated the recent cases against TAP, Astra-Zeneca, Bayer, GlaxoSmithKline, and Pfizer. These are all multimillion-dollar cases — the TAP settlement was $875 million. Do the math. The potential financial windfalls are a huge incentive for whistle-blowers. Avoiding such calamities should be a huge incentive for pharma companies to put good compliance programs into place.
Many pharma companies are doing just that — changing their procedures to ensure that consultant meetings and other events for healthcare professionals are legitimate, and that funding of CME go toward truly independent activities. However, some medical company executives believe that if they outsource meetings and events to third parties such as medical education and communication companies or independent meeting planners, they are, in effect,the responsibility for compliance. They think that they won't be held liable for violating the rules if it's the vendor who crosses the line.
But that is a dangerous misconception, said the legal and compliance experts who served as panelists at the National Pharma Congress Audioconference, also held in September. In fact, the opposite may be true. “I have seen companies enmeshed in fraud and abuse situations because of their vendors,” said John Bentivoglio, partner, Arnold and Porter, Washington, D.C. “Perhaps I only get consulted on the bad situations, but I have not seen vendors really digesting the [OIG] guidance and changing their practices.” He and the other speakers agreed that vendors who do institute a rigorous compliance program will have a competitive advantage.
I think that advice holds true for all the players in the industry. The current regulatory environment offers many challenges, yes, but it's also an excellent opportunity not only for MECCs and independent meeting organizers, but also for CME providers, inhouse pharma education and meeting planners, and suppliers to demonstrate leadership. For example, the OIG guidelines do not suggest compliance training for hoteliers, but Ritz-Carlton has trained at least one convention services manager at each of its properties in the codes. With that training, CSMs can be better partners for their pharma meeting planner customers. A smart move. (See “The Party's Over,” page 26.)
The scrutiny of pharmaceutical companies — and all who do business with them — is only going to increase should Congress pass a Medicare prescription drug benefit bill, cautioned Riordan. Rather than figuring out creative ways to evade responsibility, let's put our creativity into developing education initiatives that will teach all parties how to better comply, and produce real and lasting change in relationships between physicians, pharma firms, and CME providers.