Hasty pursuit of compliance

What it takes to support compliant CME hasn't changed, but the scramble among pharmaceutical firms to separate CME from promotional activities is unnecessarily turning to extremes, as reported in the March MM&M story,"Big Pharma Scrambles to Keep CME Separate." Some companies are attempting to cover

The Department of Health and Human Services' Office of the Inspector General's (OIG) "Compliance Program Guidance for Pharmaceutical Manufacturers," issued May 5,2003, covers a wide array of issues but says little about CME. What it does say about CME compliance is short and simple:

"Manufacturers should take steps to ensure that neither they, nor their representatives, are using these activities to channel improper remuneration to physicians or others in a position to generate business for the manufacturer or to influence or control the content of the program ... Codes of conduct promulgated by the CME industry may provide a useful starting point for manufacturers when reviewing CME arrangements."

The Accreditation Council for Continuing Medical Education (ACCME) sets the code of conduct for physicians' CME. Therefore, if a pharma company provides an educational grant to an ACCME-accredited company, they can rest assured that the programs they support are managed by compliance experts that prove their understanding of ACCME processes required to develop legitimate, effective CME programs on an ongoing basis. Ensuring that a CME provider is accredited prior to committing commercial support is the single most meaningful precaution that pharmaceutical firms can take in their pursuit of compliant CME programs.

The industry needs clear and effective firewalls between groups that manage the development of accredited and non-accredited content for promotional and educational purposes respectively. Beyond that, the industry needs to support the practice of non-accredited information that is educational in nature being developed and handled by an accredited medical education provider. News updates or articles that do not carry a CME credit, for example, may be delivered together with an accredited medical education piece, and therefore, pharmaceutical companies need to rest assured that both elements, if prepared by an accredited provider, are fair, balanced and compliant.

And what about university partnerships? Universities that offer medical education credits, like private CME providers, must also be ACCME-accredited. How, then, does this strategy of separating promotion and education affect relationships between universities and pharmaceutical firms, where pharmaceutical firms provide funding to universities for both CME and research? Presumably, pharmaceutical companies will protect their competitive advantages by continuing these valuable research relationships, but this stance is quite different than the extreme position being taken on the separation of promotion and education.

In pursuit of compliance, pharmaceutical firms needn't invoke such drastic measures as separation of vendors or independent delivery vehicles to carry promotional and educational content. They should choose and trust the best ACCME accredited CME providers to ensure compliance without shortchanging patients or clinicians on their educational experience.