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.
