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648 - We have a product indicated for the treatment of 'drug-resistant Condition-X'. Since this disease inherently links to drug therapy, I do not see how we can produce PAAB-exempt disease education materials. Does this seem like a fundamental limitation of the Code (6.6vii)? Could we produce exempt materials describing 'resistant' or 'refractory' Condition-X instead?
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The interpretation that a piece describing a ‘resistant’ or ‘refractory’ condition is subject to PAAB review is correct. It would not be possible to create a disease information piece for this condition without alluding to drug therapy. The rationale for this however is more related to the PAAB scope of review then any specific preclearance exemption criteria. PAAB provides a preclearance review service related to promotional activities for healthcare products. Materials which are restricted to disease information (i.e. they do not allude to treatment in anyway) do not fall within the PAAB scope of review. Statements describing a condition as ‘resistant’ or ‘refractory’ suggest a prior treatment failure and as such would fall within the PAAB scope of review (as the disease material would not be required had treatment not occurred). This is necessary to ensure that discussion of drug therapy meets the PAAB code requirements.
