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.
662 - Hi Patrick, I have the following question: When using the terms "proven efficacy" in a headline in the context of what the product is indicated for, why do we need high level fair balance? For example, "Product X has proven efficacy in the treatment of Arthritis." If the product has received an indication for the treatment of arthritis, it has been shown to be effective - otherwise it would not have received such an indication. So, this headline is simply a factual statement, as opposed to a clinical claim. Thanks in advance for your clarification.
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Although the indication is the evidentiary basis for a claim such as “Proven efficacy”, the statements, “Indicated in condition X” and “Proven efficacy in condition X”, are not equivalent. The message “Indicated in condition X” is a legal statement setting the parameters around marketing and clinical use. As such, lowest level fair balance is sufficient. The statement “Proven efficacy in condition X” is not a simple legal statement; it is a therapeutic claim. In HCP advertising, APS containing therapeutic claims (e.g. efficacy, effectiveness, safety, tolerability) are required to disclose the highest level of fair balance.
