Looking a Gift Horse in the Mouth

Ethics in practice is an issue that continues to spur debate among all healthcare practitioners, but over the last couple of years the debate seems to have reached a new level. Gift giving by pharmaceutical manufacturers to physicians has been held particularly closely under the microscope, and it has led to the creation of two camps of thought. Physicians in the first camp see gift giving by pharmaceutical companies as a practice that is, or has the potential to be, too influential and must be stopped. They see the gift giving as a practice that can’t help but have an influence at some level on the doctors who perform research funded by the very pharmaceutical companies doing the gift giving. While this seems like a logical — yet difficult to prove — argument, there’s another side to the equation. Physicians in the other camp fear that research funding will dry up if pharmaceutical companies are forced to temper how they allocate research dollars. New Regulations Take Route Recently, the debate has come to a head with the issuance of new guidelines from the U.S. Office of the Inspector General (OIG). The new Compliance Program Guidelines for pharmaceutical manufactures were released at the end of April as what the OIG is calling a voluntary program. According to a statement in the draft, this program “...is a set of guidelines that pharmaceutical manufacturers should consider when developing and implementing a compliance program or evaluating an existing one. For those manufacturers with an existing compliance program, this guidance may serve as a benchmark or comparison against which to measure ongoing efforts.” The program consists of seven recommended components that pharmaceutical manufacturers need in order to have an effective compliance program in place: • written policies and procedures • a designated compliance officer and committee • effective training and education programs • internal monitoring and auditing • disciplinary guidelines for when standards aren’t followed • prompt detection and response so problems are corrected. Within these steps, the OIG has some specific recommendations, such as stating that pharmaceutical companies can still fund continuing medical education if they separate the department handling grant-funding from the sales and marketing departments. In terms of research funding, the OIG recommends that payments for research be “fair market value for legitimate, reasonable, and necessary services.” The guidelines go on to say that the research should be scrutinized after the fact to make sure that it’s legitimate and not just a way to persuade doctors to prescribe a manufacturer’s specific drug. What This Means For Dermatologists What effect these voluntary guidelines will have is yet unknown. No one from the American Academy of Dermatology was able to comment about the matter, as there’s no official policy. The guidelines make it clear that funding for educational activities, meetings and research are important and valuable to the industry. But will the scrutiny given to funding from pharmaceutical companies mean less money for research and CME activities or will the funding continue with the industry being more mindful of the spending by pharmaceutical companies and the influence it may have? Learning More About the Guidelines For more information or to download a copy of the compliance program guidelines, visit https://oig.hhs.gov/fraud/complianceguidance.html.