I am a voting member. I attended. Here are some of my impressions on the meeting process, which was different, in a good way.
To be clear - these are my views, not in anyway an official report of proceedings. The appropriate people will do that in due course.
What struck me is that the agency wants to engage patients. They worked hard to fit working with patients into their mandated process of public meetings. Maybe the most visible sign of that desire is the time commitment the director of the boss, Dr. Jeffrey E. Shuren gave to the meeting. He was the opening speaker and was there all day.
Less visible was the time that staff put into preparing for the meeting. They cleverly adapted existing meeting processes to patient engagement. One change was there were more opportunities for people in the audience to engage. Yes, there was the typical public comment period. Same as at other advisory committee hearings. But there were also calls from the Chairman for public comment throughout the day. That is good. What was different were roundtable discussions of questions asked of the audience.
All the people attending were invited to break up to randomly assigned tables to address questions pertinent to the day’s topic. The tables are moderated by agency staff who then summarised and reported out each tables conversations. While participation was voluntary the idea of having everyone in the audience join together and be part of the proceedings was pretty unique.
These breakout conversations were a bit of struggle to fit into the advisory meeting process. A process was in part designed to ensure that advisors on any given panel are kept separate from inappropriate influence. Like from industry or other parties. You know, no private meetings in the hallway.
That what we the panel saw and heard was through the open public process. Good meeting design - Particularly for meetings where the regulators seek advice on a device approval. The panel isn't meant to be talking privately with pharma sponsors or anyone else. In this case, since every comment at every table wasn’t publically reported out, as panel members, we couldn’t participate in those roundtable conversations.
To be clear - these are my views, not in anyway an official report of proceedings. The appropriate people will do that in due course.
What struck me is that the agency wants to engage patients. They worked hard to fit working with patients into their mandated process of public meetings. Maybe the most visible sign of that desire is the time commitment the director of the boss, Dr. Jeffrey E. Shuren gave to the meeting. He was the opening speaker and was there all day.
Less visible was the time that staff put into preparing for the meeting. They cleverly adapted existing meeting processes to patient engagement. One change was there were more opportunities for people in the audience to engage. Yes, there was the typical public comment period. Same as at other advisory committee hearings. But there were also calls from the Chairman for public comment throughout the day. That is good. What was different were roundtable discussions of questions asked of the audience.
All the people attending were invited to break up to randomly assigned tables to address questions pertinent to the day’s topic. The tables are moderated by agency staff who then summarised and reported out each tables conversations. While participation was voluntary the idea of having everyone in the audience join together and be part of the proceedings was pretty unique.
These breakout conversations were a bit of struggle to fit into the advisory meeting process. A process was in part designed to ensure that advisors on any given panel are kept separate from inappropriate influence. Like from industry or other parties. You know, no private meetings in the hallway.
That what we the panel saw and heard was through the open public process. Good meeting design - Particularly for meetings where the regulators seek advice on a device approval. The panel isn't meant to be talking privately with pharma sponsors or anyone else. In this case, since every comment at every table wasn’t publically reported out, as panel members, we couldn’t participate in those roundtable conversations.
I would have loved to hear those conversations. I respect that Center for Devices and Radiological Health found a way to have everyone engage and that the price of that was that committee members couldn't just jump in.
All voices = better.
Devices are critical in diabetes care. So I suggest that people with diabetes take the time to join in these meetings. You will be heard, even if I can't chat you up in the hallway.
* Two cents on acronyms. I'm finding them wearying, and I tried to edit them out.
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