“HOW MANY REGULATORY angels can dance on the head of the CME pin?” asked Michael Saxton, an independent CME consultant based in Glen Gardner, N.J. Speaking at the Center for Business Intelligence's second annual CME conference, he was referring to the recent spate of regulations affecting the CME industry. The conference, held June 12 to 13 at the Westin Philadelphia hotel, attracted about 80 pharma execs and CME professionals. Presenters discussed the ramifications for CME of the Office of Inspector General's Final Compliance Program Guidance for Pharmaceutical Manufacturers and the Accreditation Council for CME's proposed new Standards for Commercial Support.
Are all these new rules necessary? Saxton asked attendees: How much does industry's role in CME need to change? Ninety percent responded that major change is needed — but they are not necessarily happy about the way change is being instituted.
Standards Spark Controversy
It will come as no surprise to CME providers that the pharmaceutical industry is up in arms about the draft revision of the Standards for Commercial Support, especially the sections stating that disclosure of relationships with industry is no longer enough to protect CME's independence. The draft proposes that presenters or planners who have a conflict of interest with industry will be excluded from the CME process.
While complimenting thefor its open process and recognizing the complexity of the issues involved, keynote speaker Ursula B. Bartels, senior vice president, general counsel and secretary, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Conn., expressed reservations. “It's not clear that something is broken that needs to be fixed,” she said. “It's not clear that the line between disclosure and exclusion has been drawn in the appropriate place. This could have some very serious consequences for CME. Do you really want competing accrediting organizations developing? Do we want nonaccredited CME in the place of accredited CME? I don't think so. That's one of the possibilities we have to seriously consider.”
Asked how she would change the proposal if she were on the ACCME board, she answered: “I would say, ‘You know what? It took 11 years from drafting the Declaration of Independence until we finished drafting the Constitution of the United States. We've got a lot to consider. Get the whole team back together again and put some other members on there. Get some people from industry, from medical education companies. Get them all together in a room and see if you can hammer something out that includes everybody in the debate.’”
While it's important for the CME community to rework the ACCME Standards and understand and follow the new government regulations, it is also crucial to proactively assert the industry's contributions to healthcare. That was the message given by John F. Kamp, partner, Wiley Rein & Fielding LLP, Washington, D.C. In the face of government, press, and public scrutiny, Kamp, who represents pharma companies, offered the following advice: “We have to be aggressive in Washington. We have to start talking about the value of CME in the process of clinical education. We have to make sure that the policymakers don't throw the baby out with the bath water. This industry is everyday helping doctors do a better job treating our parents, our children, and us, and they're doing that because the CME programs are just wonderful. The system really works. Be proud.”
For an analysis of the OIG pharma guidance's impact on CME, see “No Turning Back,” page 20.