ACRO has told HHS the Physician Payments Sunshine Act is “highly problematic” for drug research and CROs in the US.
Provisions of the Sunshine Act enforce the reporting of payments made by biopharma to physicians. The stated aim of the Act is to increase transparency but ACRO (Association of Clinical Research Organizations) fears it will have a negative effect on drug research in the US.
John Lewis, vice president of public affairs at ACRO, told Outsourcing-Pharma that in its current form the research payments aspect of the Sunshine Act is “highly problematic” for US drug research and CROs (contract research organisations).
In an eight page letter to Kathleen Sebelius, secretary of the US Department of Health and Human Services (HHS), Douglas Peddicord, executive director at ACRO, outlined CROs’ concerns.
“Failing to exempt payments for legitimate research activities from the requirements of the proposed rule will have deleterious effects on the research enterprise in the US”, Peddicord wrote.
Peddicord quotes research that found one-quarter physicians would be less likely to take part in trials if revenues it generated were disclosed to the HHS. The reason, Peddicord thinks, is that physicians fear the “data will be highly susceptible to misinterpretation”.
Payments are made to support research activities, Peddicord wrote, and there is “no evidence” that such actions “bias prescribing or other practice behaviour”. ACRO has raised concerns in the past and Peddicord notes that the proposed rule attempts to fix some of the perceived problems.
“Regrettably, however, we are entirely confused by the methods the proposed rule suggests for reporting research payments”, Peddicord wrote. The concepts of ‘direct’ and ‘indirect’ payments were introduced but are “inconsistent, misleading and sometimes frankly contradictory”.