Sharing DTC info with HCPs
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If a pharma company sponsors a third-party developed disease article to be published in print media for general public on disease awareness only (no mention of treatment by name/class/category) and has a help-seeking message, can reps share this article with HCPs in an unbranded communication? I would assume the article, and the unbranded HCP communication both, would not be considered advertising as per the 'Distinction between Advertising and other Activities' document and not need to undergo PAAB review?
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If a pharma company sponsors a third-party developed disease article to be published in print media for general public on disease awareness only (no mention of treatment by name/class/category) and has a help-seeking message, can reps share this article with HCPs in an unbranded communication? I would assume the article, and the unbranded HCP communication both, would not be considered advertising as per the 'Distinction between Advertising and other Activities' document and not need to undergo PAAB review?
An unbranded disease article, sponsored by a pharma company and distributed by company representatives to health care professionals, is generally subject to PAAB review as per PAAB code section 7.5, even if it was originally intended for the consumer audience. Messaging can take on additional meanings when distributed to a specialized audience like HCPs. Particularly as HCPs may generate additional associations between the article and other materials as they’ve been exposed to different auxiliary materials than consumers. Also note that the unbranded HCP piece used to distribute the article may impact whether the article is subject to advertising regulations. As the article and the linked unbranded communication are intended to now be targeted to HCPs, they should be submitted for PAAB assessment. As a courtesy, this assessment could potentially take place in an opinion submission during which we can confirm your position that the article and the unbranded communication linking to it are indeed exempt from PAAB preclearance when targeted to an HCP audience.
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An unbranded disease article, sponsored by a pharma company and distributed by company representatives to health care professionals, is generally subject to PAAB review as per PAAB code section 7.5, even if it was originally intended for the consumer audience. Messaging can take on additional meanings when distributed to a specialized audience like HCPs. Particularly as HCPs may generate additional associations between the article and other materials as they’ve been exposed to different auxiliary materials than consumers. Also note that the unbranded HCP piece used to distribute the article may impact whether the article is subject to advertising regulations. As the article and the linked unbranded communication are intended to now be targeted to HCPs, they should be submitted for PAAB assessment. As a courtesy, this assessment could potentially take place in an opinion submission during which we can confirm your position that the article and the unbranded communication linking to it are indeed exempt from PAAB preclearance when targeted to an HCP audience.
@jennifer-carroll Thank you for the response. I had understood the above to be true when there is a discussion on 'treatments' in the disease awareness article (as per section 7.5 on editorial advertising and discussion on treatment in a balanced way). Also, to your second point, the unbranded communication to inform HCPs of the article would be an email with a link to the article (no claims/additional information), and hence PAAB exempt?
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@jennifer-carroll Thank you for the response. I had understood the above to be true when there is a discussion on 'treatments' in the disease awareness article (as per section 7.5 on editorial advertising and discussion on treatment in a balanced way). Also, to your second point, the unbranded communication to inform HCPs of the article would be an email with a link to the article (no claims/additional information), and hence PAAB exempt?
The email communication is directed to HCP and generally reviewable. Given the described scenario, the review would entail ensuring that there are indeed, no claims or additional information that would render the article to be advertising. We would be unable to determine exemption status without actually assessing the content of the email communication. As noted previously, this assessment of the content could potentially take place in an opinion submission during which we can confirm your position that the article and the unbranded communication linking to it are exempt from PAAB preclearance when targeted to an HCP audience.
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The email communication is directed to HCP and generally reviewable. Given the described scenario, the review would entail ensuring that there are indeed, no claims or additional information that would render the article to be advertising. We would be unable to determine exemption status without actually assessing the content of the email communication. As noted previously, this assessment of the content could potentially take place in an opinion submission during which we can confirm your position that the article and the unbranded communication linking to it are exempt from PAAB preclearance when targeted to an HCP audience.
@jennifer-carroll said in Sharing DTC info with HCPs:
he unbranded communication linking to it are exempt from PAAB preclearance when targeted
Thank you. That really helps aid in understanding. Have a great weekend.
