The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB),
including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB
correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system.
Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly
prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.
131 - I have a question about the permissibility of the phrase "treatment-free" within the following context. If we are promoting a type of treatment with product X, where the patient takes product X for 2 weeks and then does not have to take the medication again until 50 weeks later (i.e. the following year), would we be allowed to say that the patient was treatment-free for those 50 weeks. Product X has a short half-life and is out of the patient's system within 24 hours so the patient would not be receiving treatment for those 50 weeks. Other treatments for the same disease are weekly or monthly, thus discussing the "treatment-free" portion of the treatment regimen is a point we would like to discuss with HCP and patients.
Claims & Support/References for Claims
1
Posts
1
Posters
290
Views
1
Watching
-
The product's TMA will need to be considered to answer this question. It would appear that the patient is still being "treated" even between dosing periods. Also note that some drugs are cleared from the blood quickly (i.e. short half-life) yet the treatment effect lasts a very long time (e.g. some drugs remain bound to the receptor at the active site for a long time). It appears that "dose-free period" may convey your desired message in an acceptable manner. Please call me at the PAAB office such that I can consider this specific case.
