Sunshine Act Impacts Drug Companies' Promotional Activities

Manufacturers Prepare to Meet 2012's New Reporting Requirements, but Companies Feel the Burden of Tracking Key Opinion Leaders' Activities, Finds Cutting Edge Information

RESEARCH TRIANGLE PARK, NC--(Marketwire - Jun 28, 2011) - Although the Sunshine Act requires disclosures for grants and other funding of medical research, the majority of payment categories are focused on promotional engagements. A new report from Cutting Edge Information finds that drug manufacturers are feeling the burden of tracking promotional engagements, such as dinner meetings, across their global operations.

"KOL Fair-Market Value and Aggregate Spend" comes out of recent research on establishing the fair-market value of key opinion leader compensation as well as understanding the impact of current market and regulatory changes.

"The difference between paying a thought leader for a promotional versus a clinical engagement is that the promotional activities come with greater disclosure requirements," said Elio Evangelista, director of research at Cutting Edge Information. "The burden of documenting and tracking all the promotional activities for all the thought leaders involved may put too much of a strain on drug companies and we may see a downward trend emerge for certain events."

For example, the biggest current challenge for one benchmark company is tracking various promotional groups' spending on key opinion leaders' services and other associated costs, such as meals and travel accommodations, in a system that is up-to-date, not overly complicated, and ensures full compliance with the Sunshine Act.

As physicians grow more concerned that their compensation for educational and scientific activities will become a matter of public record, attendance at dinner meetings as well as general access to physicians by the field force have begun to pose problems. Although the report did not find evidence of an immediate epidemic of physicians cutting ties with the drug and device industries, it is still a critical concern for many thought leader development executives.

"KOL Fair-Market Value and Aggregate Spend: Documentation, Tracking and the Sunshine Act" includes benchmark metrics for thought leader compensation and physician fee schedules. The report includes strategic recommendations to help medical affairs executives and other specialists:

  • Build a comprehensive thought leader management database.
  • Calculate fair-market value and develop physician fee schedules.
  • Build relationships with clinical and commercial key opinion leaders.
  • Segment and compensate thought leaders in a compliant system.

Contact Information:

Elio Evangelista
+1 919-403-6583