Proposal for improving the format of FDA Advisory Committee meetings 1. Begin the day with the Open Public Hearing. This could serve as a grounding start, giving committee members and the public a clear sense of stakeholder perspectives before the more technical discussion begins. 2. After the Open Public Hearing, move directly into questions and clarifications, rather than the traditional live sponsor and FDA presentations. Instead, post the briefing materials and prerecorded FDA and sponsor presentations sufficiently in advance for members to review them before the meeting. Since members are already expected to review these materials in advance, starting with questions would help preserve more of the committee’s time and attention for the most substantive part of the meeting. 3. Require (or strongly encourage) members to submit their questions in advance so they can be routed to the appropriate party (FDA or the sponsor). This would give responders time to prepare complete, well-supported answers instead of relying on predicted backup slides or improvising on the spot. When an adequate answer isn’t immediately available, the committee is often forced to move on due to time constraints. 4. Allow members to share additional relevant analyses or papers they believe would inform the discussion. Currently these materials are frequently mentioned only as a citation during the meeting, without the rest of the committee having access to the actual content. Making them available ahead of time would let everyone review the substance rather than just hearing a reference. 5. Provide committee members with a brief orientation in advance of the meeting so everyone begins with the same foundation despite their different areas of expertise. This could include common regulatory concepts, statistical terminology, meeting procedures, and other recurring concepts relevant to the committee’s work. These changes would require adjusting the overall timeline so that members have sufficient time after the briefing materials and prerecorded presentations are released to thoroughly review them, submit questions, have those questions routed to the appropriate responders for preparation, and complete the orientation before the meeting. The overarching goal would be to shift advisory committee meetings away from serving primarily as a venue for presentations and toward serving primarily as a venue for scientific deliberation. This wouldn’t reduce transparency or the amount of information available to the public. The same briefing materials and FDA and sponsor presentations would still be publicly available. They would simply be shifted outside the live meeting so more of the meeting itself could be devoted to scientific deliberation. I have other thoughts on ways to improve FDA advisory committees, but I’ll leave it there for now.

Bad Blood, meet Shady Shit