ALMOST 15 YEARS have elapsed since the FDA caught the attention of the CME world with its proposed draft guidance on regulation of commercially supported educational activities. The fear of government involvement became a rallying point for many who believed that CME would be best served with a self-regulation model based on cooperation, communication, and collaboration. If accepted and effective, there would be little need for government intervention.
And so it was. The Accreditation Council for CME strengthened its requirements of providers and commercial supporters, the American Medical Association and other professional associations addressed the ethics of gifts to physicians, the pharmaceutical industry set policy and then issued its code, the FDA presented its final educational guidance but deferred to ACCME in most instances and, recently, the Office of Inspector General connected education and compliance.
While not everyone agrees on the need for and extent of the current CME ordinances, communication and collaboration have served CME reasonably well. The National CME Provider/Industry Collaboration Task Force is a direct outgrowth of the initial FDA foray into CME and is a fine example of how people from diverse backgrounds, experiences, and agendas can discuss and debate issues for the good of CME as a whole. Much time and effort has been given to using communication as a tool for improvement in CME. But now it seems the very process that has served us so well is being questioned and in some quarters discouraged.
In response primarily to the OIG Guidance but with the other regulations fresh in mind, some educational professionals in the pharmaceutical industry have been told that they cannot communicate directly with CME providers, whether commercial or academic, to propose or develop educational programs. It seems that industry will have to engage a nonaccredited, intermediary organization to initiate development discussions with CME providers, a short-sighted approach that is certain to cause more problems. ACCME, PhRMA, and other policies have allowed, if not encouraged, communication among all CME stakeholders with the proviso that final decisions and control rest with the accredited provider.
Direct conversation with providers to establish need, direction, and understanding is less of a risk for inappropriate influence than is working through a third party. In this setting, third-party involvement could complicate the process unnecessarily.
As CME guidelines mount up, it feels as if we may have lost our way. In most quarters, communication is considered desirable. Why is communication in CME not just as important as it is in business and social settings? Have we regulated ourselves out of a process that could bring us together, solve problems, foster understanding, agreement, and compliance, and ultimately deliver an acceptable product? Firewalls to prevent the blending of education and promotion serve a valuable purpose. But who says that the best way to improve CME is to prohibit communication among contributors? When we communicate, we understand each other. When we fail to communicate, solutions are few, and outcomes are random. Let's rethink this one.
Robert F. Orsetti is assistant vice president, continuing education, University of Medicine & Dentistry of New Jersey in Newark. Orsetti, a 24-year CME veteran, is a member of the AMA's National Task Force on CME Provider/Industry Collaboration. Contact him at (973) 972-8377 or send e-mail to orsettrf@umdnj.edu. For more of his columns, visit mm.meetingsnet.com.