Outdated indication
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Suppose a product has an outdated indication (15+ years old), where the name of the disease itself has been superseded by new terminology and more current medical practice.
Apart from going through a TMA update, is there any documentation or justification a Sponsor could provide to PAAB, in order to accept inclusion of new studies based on the newer disease terminology?
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This one is tough to answer in a general forum since there are a lot of considerations. First and foremost, the indication is the limitations for the Terms of Market Authorization and therefore sets the context of messaging within advertising. Code section 2.10 applies regardless of perception that terminology has changed. Next, this is a great opportunity for PAAB to remind clients that we do accept endpoints and terminology not listed in the TMA. What we look for is “consistency with the TMA”.
Let’s look at a few examples of where it would not be acceptable.
- If the “new terminology” appears to expand the scope of the indication into a broader population than what is outlined in the TMA.
- If the “current medical practices” contradict the TMA, such as “use first line” when the TMA states “after failure on class Y”.
- The studies based on “newer disease terminology” result in the patient populations or outcomes being broader than those outlined in the Product Monograph.
If a more specific assessment would provide more value, we invite you to submit for an opinion. You may also reach out to admin to set up a short billable consult meeting that would allow discussion of the specific example (more details to come about this service)
