Sunshine sheds little light on status of reprints
Jamie Kendall is senior director of CIS’ compliance, ethics & legal affairs dept.
Sunshine is coming. The Physician Payment Sunshine Act (Act), requires manufacturers to submit information regarding transfers of value (TOV) to physicians and teaching hospitals, beginning January 1. The Act casts a wide net in its definition of TOVs, sparking debate over what must be reported. An area where the government's apparent intent is murky is whether medical journal reprints (“reprints”) constitute TOVs.
The Act specifies “education” and “research” as descriptions of TOVs that must be reported. But while some items and services (such as supplying expensive textbooks) seem to clearly fall under these descriptions, conflicting messages make the reporting status of reprint distributions less definitive.
The act excludes “transfer[s] of anything the value of which is less than $10, unless the aggregate amount transferred…during the calendar year exceeds $100” from reporting. The question for reprints becomes whether their relevant value is in the information they contain, or in the cost of content delivery. If the relevant value is the cost of the delivery (i.e., printing, collating and copying), expenses may exceed $10 and, if not, the aggregate value of all reprints distributed to a physician in a calendar year may exceed $100. Manufacturers would seemingly have to report their reprint activities.
However, in 2009 the FDA recognized the important public health and policy justifications supporting dissemination of such reprints. Additionally, in the Washington Legal Foundation line of cases in the DC Circuit, courts recognized First Amendment protections inherent in providing non-biased, scientific information to physicians. In light of these official stances, it is counterintuitive to place a burden on the disbursement of non-promotional information, such as that found in reprints, which potentially adds substantial value to public health and safety. If manufacturers must track and report all costs associated with providing reprints, it could deter them from acting as an efficient conduit between academia and practitioners.This is not a logical outcome of a regulatory scheme and official guidance emphasizing transparency and comprehensive information. Congress should shine light on its own act and give manufacturers some clarity.