Accelerated approvals can be complex animals but can be done with carefully executed plans that are very cross-functional in nature. I'll provide some initial advice, but cannot cover all of it here. Several things have to be considered:
You must have good internal communications between the Regulatory team that is driving the NDA/BLA toward approval, the labeling team who will be negotiating with FDA on the draft labeling and FDA comments during finalization, marketing who is trying to craft all promotional content to align to the expected labeling, clinical development who knows the data and the studies supporting the approval, sales teams to understand their plans for launch and to partner with to educate them on the limitations that accelerated approvals place upon the commercial execution, as well as other functions depending upon your organizational structure.
At a high level, you cannot submit your draft promotional materials prior to product approval until FDA is ready to accept them. It is wise to initiate a dialogue with OPDP or APLB at FDA to ensure you have a good line of communication and working relationship. They will almost always tell you that they will not want to see any draft materials until the label is in a near final state - reason being: why should they expend limited resources reviewing content that is likely to change as the label evolves toward finalization. What constitutes a "near final label"? Often that is the point where 80-90% of of the FDA redlines have been resolved and things are progressing toward approval.
As part of your planning efforts, a promotional regulatory person must be working closely with sales/marketing and importantly, your medical affairs team to plan out the timelines and sequencing of promotional and educational materials - not everything can be done first and not everything is needed on the day of approval. Break out the proposed materials into buckets: 1) items needed to be used in the first 120 days post-approval, 2) items needed after the first 120 days post-approval.
Those items in bucket 1 MUST be submitted to FDA prior to approval. Those in bucket 2, must be submitted at least 30 days before date of intended use. The later 30 day pre-submission timeline will need to be accounted for as an ongoing process or until the product converts from accelerated to full-approval.
This separation of materials into these 2 buckets helps you narrow down the work needed to be accomplished in the pre-approval period.
There is so much more that you have to plan and account for in this setting. I recommend finding a good ad/promo person to hire or an experienced consultant who has executed such launches. They will have a wealth of knowledge that will help navigate this complex situation.
It is a challenging, but rewarding experience to accomplish an accelerated approval launch. It is also fast-paced and loaded with pitfalls, so don't get discouraged. Good Luck!
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Glenn Byrd, MBA
Chair, RAPS Board of Directors
United States
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Original Message:
Sent: 28-Sep-2022 08:50
From: Anonymous Member
Subject: Pre-launch Promotional Materials for Accelerated Approvals
This message was posted by a user wishing to remain anonymous
Thank you for your insights.
Can you also provide your insights into the pre-approval timing of the submission of those promotional materials? The submission of launch promotional material is required "during the pre-approval period" per CFR, and I'm trying to learn from others' experience on the timing of this submission relative to key NDA review milestones (e.g., original submission, 120-day safety update, mid-cycle meeting, PDUFA date). Thank you!
Original Message:
Sent: 27-Sep-2022 13:20
From: Anonymous Member
Subject: Pre-launch Promotional Materials for Accelerated Approvals
This message was posted by a user wishing to remain anonymous
First 6 months since accelerated approval date no promotions are allowed!
Original Message:
Sent: 26-Sep-2022 16:53
From: Anonymous Member
Subject: Pre-launch Promotional Materials for Accelerated Approvals
This message was posted by a user wishing to remain anonymous
Dear Colleagues,
For an NDA based on accelerated approval, pre-approval submission of all promotional materials intended for launch is required per 21 CFR 314.550. The exact timing of the submission of these materials is vague per the regulations and the associated guidance, stating only that pre-submission should occur "during the preapproval review period". I assume that the submission would be most effective later in the NDA review cycle, once discussions with the FDA on the patient and PI labels has occurred.
Can anyone provide clear guidance on when the pre-launch materials should be submitted for a) priority review and b) regular review?
Also, is the timing of the pre-launch material submission agreed upon with the Agency at the pre-NDA meeting?
You insights are much appreciated!