Physician Payment Sunshine Act: Principal Investigators and Primary Care Physicians Largely Unaware of Regulation

Industry Standard Research (ISR) recently conducted a survey of various physicians and stakeholders affected by the Physician Payment Sunshine Act in light of the final regulations issued in February of this year.  In generally, out of 103 U.S. primary care physicians, 74% said they were not in favor of all financial physician-industry relationships being made available to the public.  Other findings include: 

• 71% of physicians said they expect to be notified by the pharmaceutical company of the value of a particular service or benefit prior to it being offered to you 

The report concluded that there is a general lack of awareness among both U.S. Primary Care Physicians (PCPs) and U.S.-based principal investigators regarding the Physician Sunshine Act (Sunshine Act).  Among PCPs 

• Only 14% are very familiar
• 49% are somewhat familiar
• 38% are not at all familiar 

Among 100 Principal Investigators: 

• Only 10% are familiar and have a complete understanding of the Act
• 33% have a basic understanding
• 34% have heard of the Sunshine Act but could not define it; and
• 23% have never heard of the Sunshine Act 

ISR then asked principal investigators: “Assuming the legislation continues as-is and any payments, including grants/ fees for recruiting patients into clinical trials, are made publically available via a national database, how would this change the likelihood your site would be an investigative site for clinical trials?” 

• 4% said it would make them much less likely to be an investigator site
• 10% said it would make them somewhat less likely be an investigator site
• 77% said no change in their likelihood of participating as an investigator site
• 3% more likely
• 6% much more likely 

ISR then asked: “In thinking about how this might affect your trial selection based on who the pharmaceutical sponsor of the research is, would you stop participating in some trials if you started to do “too many” trials for one sponsor?” 

• 18% said yes
• 82% said no 

When ISR probed a little further, we discovered that, on average, investigators start to get uncomfortable when the percent of trials they run with one pharmaceutical company reaches approximately 40%. In other words, if a site runs approximately 40% of their trials with one sponsor, then they might start to get uncomfortable and possibly throttle back the number of trials they conduct with that sponsor.  Similarly, ISR found that roughly one-in-eight investigators (13%) would stop participating in some trials if their site started to make “too much” money from clinical trials.