The Senate Finance Committee report on CME, combined with extensive media coverage about the inappropriate relationships between doctors and the pharmaceutical industry, including The New England Journal of Medicine article “A National Survey of Physician-Industry Relationships,” (April 26, 2007), shows that the public has reached its limit on drugin the guise of education. There are certain trends we see coming.
The Senate report criticized the Food and Drug Administration for not properly overseeing that its rules against using CME as a veil for promotion are complied with. To us, this indicates that we will begin to see oversight by the FDA in the form of spot visits to CME activities as well as review of written materials. However, it should be noted that the FDA is both overworked and underfunded. It will take time for these funds to be authorized. The FDA's decision to allow discussions of off-label or unapproved uses of drugs and devices only in the context of accredited education may need to be re-evaluated. The Senate report also focused on this topic; the FDA may promulgate a new policy on acceptable discussions of unlabeled or off-labeled uses in CME.
The U.S. Department of Health and Human Services Office of Inspector General now targets only industry violators. As you know, the OIG is authorized to levy both criminal and civil penalties; to date only major fines have been levied. The Senate report may not only toughen OIG's focus on criminal penalties, but also extend its interest to CME providers as well. It should be pointed out that small pharma and medical device companies have existed “under the radar” now for years; we think that invisibility will end.
The Senate report is clearly calling for some type of prospective review of activities by the Accreditation Council for CME. But a prospective review of proposed CME (much like the one the American Academy of Family Physicians does) by the ACCME would be a daunting, if not impossible, task. However, there are some compromises that might satisfy the public interest.
- Create Content Validation Authorities
The ACCME might qualify and certify certain organizations that apply to it as Content Validation Authorities. All certified activities would have to be approved by a CVA in writing, and concerns on their part would have to be rectified before an activity could be executed.
- End the Gravy Train
Many clinics and managed care organizations, as well as groups like the National Institutes of Health, have put in place requirements to end the historic and lucrative relationships physicians have with industry if they wish to continue to participate in education. The ACCME may now focus on this subject by strengthening and defining what it means to “resolve conflicts of interest.”
The Political Picture
Almost all Democratic and some Republican candidates for the presidency are touting the development of a national health plan. Any such plan must deal with issues such as overutilization and costs of health care. The Senate report says that industry influence on CME has the potential to increase overutilization and escalate costs without increasing quality. As the campaign season picks up steam, we can expect this national conversation to influence changes described above.
In addition, we can expect industry to continue to lose clout with legislators in the new environment in Washington, D.C. This will affect the role and function of the FDA, the reach of the OIG, and the potential to fully or partially federalize CME.
Steven M. Passin is president of Steve Passin & Associates, LLC, a CME consulting company based in Newtown Square, Pa. He may be reached at email@example.com.