Unbranded HCP educational materials where sponsor occupies novel treatment space
-
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)?
-
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.
