The Association of Clinical Research Organizations is taking another stab at derailing new rules that would require drug companies to outline the payments they make to physicians and teaching hospitals for the clinical trial work they do.
The new rules are part of a broad effort by the feds to bring some transparency to the industry's practice of paying physicians for various things--a controversial practice critics maintain has influenced the way doctors prescribe medicines. But ACRO insists that applying the rules to payments for trial efforts should be exempt, claiming there's no proof that such payments ever influence prescribing habits and warning that one in four doctors could be persuaded to drop their research work if they become subject to the reporting regulations. The rules are also burdensome and ripe for misinterpretation by the public, ACRO insists.
ACRO cited a survey dating back to 2010 showing that one in four physicians would consider washing their hands of R&D work if they're subjected to the sunshine rules. "Stated differently," the association writes in its letter to the Centers for Medicare and Medicaid Services, "the survey findings suggest that the U.S. is in danger of losing one-quarter of its clinical investigators, which will slow innovation and delay the delivery of needed treatments for patients."
"While ACRO has maintained, and will continue to argue, that bona fide research activities should be exempt from so-called sunshine reporting, we believe, at a minimum, that CMS should define 'research' to exclude any research payments related to drugs that have not yet been approved for sale by the FDA," said ACRO executive Doug Peddicord. "As proposed, the reporting requirements for 'research' would be so burdensome, and yield such confusing information, that the costs incurred would far exceed any public benefit that we can see."
ACRO is likely going to find it tough trying to sell a change in the rules at this point, however.
- here's the press release from ACRO
- and here's the full letter (.pdf)