Hello @dmauri
PAAB will generally consider alternate cut offs from the TMA if it does not appear to be minimizing the risks of the product. The alternate cut-offs should not remove pertinent ADRs/safety information that would otherwise be important to the product and within the therapeutic landscape. The TMA should also not have other safety considerations that would preclude the higher percentage cutoff.
We have seen older APSs that present AE rates (in copy or in the form of a table) using a higher incidence threshold than what is used in the PM. For example, the PM's AE table shows all AEs that occurred in >1% of patients, but in the APS, the table only includes the AEs that occurred in >5% of patients.
Does the PAAB allow this in newer APSs?
On one hand, we understand that this shortens the list of AEs, which could be contentious. On the other hand, the presentation is still accurate and clear if it discloses the threshold that is used (e.g., AEs that occurred in >5% of patients).
Good Morning @Jennifer_CM
Linking out to an unedited acceptable reprint would not render the email subject to highest level fair balance. The level of fair balance would be assessed based on the content of the email body in combination with the linked content. Therefore, it’s likely that the level of fair balance could be lowest level if the body copy does not prompt middle or highest itself as per the PAAB Guidance on Base Fair Balance Level Selection and Placement (HCP Advertising).
Hello! We would like to create a series of emails that link out to different e-reprints for relevant trial papers for sales reps to send to customers. If the email copy does not include any specific endpoints from the trial, what level of fair balance is required? Can we include low level or is a higher level required?
Hey @Supriya
This appears to be a specific question about a specific piece. Copy around “new product availability” is broadly open to interpretation. PAAB would also need to see the third-party program site to assess the combination of all messaging within the piece and the linked content. We suggest submitting for an opinion.
Hey @Pauvian
Advertising in a consumer space must meet the consumer regulations (i.e. does not exceed name, price, quantity for prescription (Rx) products or treatments for schedule A diseases). We would advise against including the DIN as this is a standard mechanism for gating patient information. Including the DIN would require assessment of all patient sites for the product to ensure this list is not promoting the password to the general public.
Note that the question is in response to a “list”. The website appears to contain additional elements (such as pictures) which may render the site in non-compliance. We’d recommend submitting for an opinion in order to fully assess the complexities of the proposed activity.
Hey @Supriya
This appears to be a specific question about a specific piece. The piece should be submitted for assessment. The forum is for general questions. As an example, a general question here might be “Is the inclusion of an indication statement required in materials directed exclusively to healthcare professionals, where no therapeutic or pharmacologic claims are presented”. The answer to this question would be, that the indication is not required when there are no marketing benefit or therapeutic claims (see Marketing benefit claims: What are they and what level of support do they require?).
