CME, educational material, Reprints, reports, textbooks, independently created content
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435 - 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?
• Jennifer Carroll -
421 - Can I pharmaceutical company support the development of an independent third-party publication covering the highlights of a conference in a therapeutic area where it does not yet have an approved product? The report and a summary slide presentation with the same content is developed by an independent faculty of medical experts, who have full control of the content, and coordinated by a third-party communication agency. The content is completely unbiased (less than 10% of the content is about trials on the company's future potential product), and there is no involvement of the company in the distribution of the content. The content is housed on a third-party independent website that is distributed by this third-party and/or to medical associations only. Does the site have to be gated? Does the content have to be PAAB-reviewed or accredited? Thank you in advance for your answer.
• Jennifer Carroll -
350 - Is sponsorship of an accredited CME event considered marketing on the part of a pharmaceutical company? Can the CME provider include therapeutics that are not (as yet?) approved for use in Canada for a specific indication? The product has been approved in Europe and the USA for that same indication. There is no off-label issue. Only the scientific evidence will be presented concerning the drug.
• Jennifer Carroll -
148 - Can you provide an opinion on the use of reprints with information containing both within indication information and information outside of indication. The example would be a review article that has both, yet the direction to the sales force would be to highlight and promote the medical issue and the information consistent with the product's use and indication.
• Jennifer Carroll -
135 - I am developing a web site to host presentations of specialists to family physicians. The website will be gated to only allow physicians and the presentations will be accredited by the College of Family Physicians and produced independently by the speaker. There will be space for physicians' comments as well discussion forums focussed around the the topics being presented. I will seek pharma sponsorship of the presentations and will declare the sponsorship on the pages where members access the presentations. Will the slides require PAAB approval and do you see any hurdles that I may face in this endeavour?
• Jennifer Carroll -
129 - Can sales representatives distribute Congress reports? The congress reports are commissioned by a pharma company to a third party ( ex medical communications company). Information is not focussed on company brands and is balanced and independently produced.Do these reports need to go to PAAB for reps to be able to distribute?
• Jennifer Carroll -
93 - As follow-up to question 91 and as referenced in question and answer 46, if the off-label content of the educational material (publication) is not the focus and will not be discussed by the rep, and that the reps are trained to use the material in a non-promotional manner, would this then comply to PAAB exemption?
• Jennifer Carroll -
91 - Can sales representatives distribute educational materials that have been commissioned by their pharma company. The content of the educational material is produced by an independant expert faculty in a given disease area and content is reviewed by an University for balance & scientific integrity and endorsed as being deemed appropriate for Mainpro 2 or Section 2 credits. For reps to be able to distribute the information do the materials need to be reviewed by PAAB even though they are not promotional but rather educational?
• Jennifer Carroll -
84 - Recently the FDA issued new guidance for the distribution of medical journal articles and medical or scientific reference publications by drugmakers that address off-label uses of approved compounds. Among the new recommendations, the FDA stated that the drug manufacturers will no longer have to submit medical journal articles on unapproved new uses of cleared products to the FDA before distributing the studies to physicians. What influence will this have on HEalth Canada policy and what influence will this have on PAAB's rules around distribution of these types of articles by drugmakers representatives.
• Jennifer Carroll