PM comparisons of warnings & precautions
Our client would like to develop a tool that presents a text based side-by-side comparison from two product TMAs on instructions for use limitations (i.e. warnings & precautions). We understand that we have to make the comparisons representative of the section of the TMA that it is based on and not selective to which attributes are included, but a piece that presents the entire warnings & precautions section for each drug would be extremely long. We’re aiming to understand if we can make comparisons of just specific sub-sections of the W&P section (for example a sub-section under a “Cardiovascular” subheading, and then be complete about covering everything within that particular section for both products), versus having to include the entire W&P section?
We would, of course, ensure that a disclaimer is included that denotes that clinical significant is not implied, and that there is no heading that implies an overall comparison of safety.
Jennifer Carroll last edited by Jennifer Carroll
Side-by-side presentations of warning and precautions across two or more product monographs should be a complete presentation of the entire section so as not to be selective, unbalanced or incomplete. Focusing on a subset of the warnings is essentially a safety comparison and safety comparisons are not permitted across monographs. They require head-to-head RCTs per s5.7.
The way you make the presentation in question (warning and precautions across product monographs) something that can be considered, is by making it a complete comparison of the section of the PM.