Hey @AmandaM The PAAB has not created a specific set of guidance on proximity as there are multiple factors which could weigh into the decision of proximity creating linkage. As a general principle, the sponsor should be able to make the argument that the pieces (branded and unbranded) are not linked in any way, including but not limited to temporal and physical proximity. With this in mind, when thinking about proximity, it would be hard to defend that emails sent sequentially within an hour are not linked. However, emails sent days apart would present less risk of being linked. The PAAB can provide an opinion on ‘standard practice rules’ set up by the sponsor.

@lilymcneil These questions may be acceptable if the content, context, and link aligns with the general guidance provided in our prior response. Of course, copy specific guidance would be provided as part of the review process. Questions and responses need to be assessed in the context of the entire piece and with assessment of the references.

@akar Great question. Note that any of the proposed content would require review under the PAAB code. This is occasionally a point of confusion in the generic space. If the generic product’s TMA refers to the innovator brand as the reference product, the generic manufacturer may convey this fact in the APS. For example, “… generic version of Drug X [the reference product]”. In the unlikely event that the reference product is no longer authorized for sale, this should be conveyed through a cross-reference to the claim above. However, a manufacturer should only discuss the availability status of its own products. For example, it would be unacceptable to comment on a competitor’s drug shortage issues. Any messages relating to switching will require support from the TMA or standard setting organizations.

Hey @rcolbear Yes, the entirety of the message delivered should meet the standards of code section 1.5E in order to not be subject to PAAB preclearance.

We’d need to assess the methodology through which the data was collected and analyzed through the third party research company. Ultimately, it's possible but unlikely since adherence is quite difficult to measure. It is important to distinguish between adherence and retention. Often when folks say the former, they are actually referring to the latter. PAAB interprets compliance/adherence as the extent to which patients administer the medication as instructed by the HCP. This is in contrast to persistence / retention which PAAB interprets simply as continued dispensing of the prescribed medication. It is inherently difficult to reliably measure patient adherence / compliance. We have yet to receive acceptable third party data that supports comparative adherence claims. However, PAAB regularly considers persistence / retention data from recognized or validated claims-based market data providers. The data may be comparative if it is less than 6 months old. Inferences (like “Drug X demonstrated higher retention rate vs drug Y”) may be made if supported by statistical significance.