653 - Are there any limitations for using Phase II studies as support for therapeutic claims, apart from disclosing the Phase II nature?

[Jennifer Carroll]

Whether you are using a Phase II or a Phase III study to support therapeutic claims in advertising, the same standards apply:

• Clinical or therapeutic claims must be based on published, peer-reviewed, controlled and well-designed studies with clinical and statistical significance clearly indicated. The study (and the claim you wish to base on the study) must meet all relevant criteria listed in the PAAB code and the PAAB guidances.

• The study must be consistent with and within the limitations of the TMA The PAAB code does not specifically differentiate between phase II and phase III studies. Having said, keep in mind that phase III studies are much more likely to meet all the criteria listed in the PAAB code and PAAB guidances than phase II studies. If unsure of the acceptability of a study as the evidentiary basis for a particular claim, consider submitting a opinion request (see the fee schedule on our website).