Forum Update: Supporting Community-Led Discussion
The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.
Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:
- Correct any misunderstandings
- Provide guidance when questions remain unanswered after a few days
- Support discussions where official clarification is needed
Our goal is to foster a collaborative, trusted community where knowledge is shared and strengthened by everyone’s contributions.
Thank you for being part of the conversation.
Unbranded HCP educational materials where sponsor occupies novel treatment space
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If a sponsor occupies a novel treatment space (let's say they are the producers of the only marketed drug that targets geneX, indicated for treatment of diseaseA), could they make a completely unbranded (no drug or company branding) HCP educational piece discussing the roles of geneX in diseaseA (with no mention of treatment, medication issues, or any indication that it's a drug target)? Or does any focus on geneX automatically create a promotional link to their drug? If this would not be allowed, is there any way they could present this information in a compliant manner (e.g., discussing all genes involved)?
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If a sponsor occupies a novel treatment space (let's say they are the producers of the only marketed drug that targets geneX, indicated for treatment of diseaseA), could they make a completely unbranded (no drug or company branding) HCP educational piece discussing the roles of geneX in diseaseA (with no mention of treatment, medication issues, or any indication that it's a drug target)? Or does any focus on geneX automatically create a promotional link to their drug? If this would not be allowed, is there any way they could present this information in a compliant manner (e.g., discussing all genes involved)?
In general, unbranded disease information, without any mention of drug therapy or without mention of any potential effects of exogenous interventions within the pathophysiology, may be possible in APS even if there is only one drug product available. As noted in your question, the core issue is to ensure that there are no linkages to drug therapy for which the sponsors is the only one. This can render the APS to be branded instead of the intended unbranded message. Our opinion services may be helpful to determine if there is such a link.
