The Federal Sunshine Act for Pharmaceutical Companies

The new Federal Sunshine Act requires manufacturers of pharmaceuticals, medical devices, and biologics to disclose gifts, honoraria, travel and other types of payments provided to physicians. Currently, there are six states that require this type of spend activity to be reported to the states. These state based activities will continue in addition to the Sunshine Act.

In its current form, the Sunshine Act would cover both medical device and pharmaceutical companies and includes penalties for non-compliance that would be higher than current state penalties.

The Sunshine Act differentiates itself from current state laws by including penalties that can quickly add up to substantial payments because the penalties are based on the failure to report each payment to the Federal Government.

The Sunshine Act will go into effect within the next few months and it will require medical device and pharmaceutical companies to begin reporting spend activity, as stated above, for activity incurred beginning in 2010. This will require companies to have the ability to collect spend activity beginning January 1, 2010 and begin reporting on this data in 2011.

It is critical that companies begin gathering requirements and developing systems to comply with the new Sunshine Act.

MGD Services has been working with legislative reporting for the past two years and has a skilled staff to work on delivering systems that will comply with the regulations outlined in the Sunshine Act.

Mark Gunn has 25 years experience in the Quality Assurance and FDA validation fields. If you have any questions about these topics, please email Mark at Mark@mgdservices.com