We are developing an unbranded APS (Journal Ad). This APS would contain statistics and data pertaining to disease state. This APS would be disseminated directly to HCPs via print publications and perhaps some e-publications. The call-to-action on the APS would lead HCPs to register for an accredited e-CME on the disease state. Will PAAB require that the accredited CME be submitted for review?
No. But there is an important caution to consider as you mentioned that there will be a focus on discussion relating to the disease (rather than simply a corporate piece inviting HCPs to register). Accredited CME may be linked neither to branded advertising nor to unbranded advertising (aka editorial advertising). This is important because linkage of CME content to advertising of any sort risks rendering the CME content subject to the advertising regulations EVEN IF IT IS ACCREDITED. This would be problematic as the CME likely includes information which is off-label. You’ll therefore want to make sure that the journal ad does not fall in the realm of advertising. I suggest you submit the journal ad to PAAB for a written opinion to ensure that this is the case. Some obvious things to avoid include mentioning any medicinal product/class, and/or discussing a drug issue in the invite. As there are other more subtle ways to cause the invite content to fall in the advertising realm, particularly in the way the disease is discussed, I’ll reiterate the invitation (not requirement) to submit for a PAAB opinion.
IMPORTANT NOTE: Should the journal ad relate to pharmacologic class areas in which the manufacturer has a vested interest, PAAB review would be required under PAAB code section 7.5. Of course, the PAAB would not accept the link to accredited CME for the reason described above (i.e. editorial advertising linked to CME would cause the CME to be subject to the advertising regulations).