The Sunshine Act: Physician Payment Sunshine Provisions

Clinical trials have become increasingly complex in trial execution with increasing stringent compliance regulations. Chief among these is the Physician Payment Sunshine Provision (Sunshine Act) of the Patient Protection and Affordable Care Act.

Passed in an effort to allay concerns about conflicts of interest between physicians and the pharmaceutical and medical device industries, the Sunshine Act requires manufacturers of drugs, devices, biologicals, and medical supplies to begin recording all physician payments—including payments made for clinical trial research—starting in January 2012 and to report them starting in March 2013.

Sponsors engage with multiple CROs during the course of their clinical trials, combined with the manual processes many organizations use to track this crucial information, makes it virtually impossible to collect and accurately report aggregate spend data in accordance with Sunshine Act requirements. Nevertheless, companies that do not comply with these regulations will face stiff penalties.