For those of you who were not able to watch this webcast, but are nonetheless interested, I jotted down a few takeaways.
1. FDA understands that there are stakeholders who want more transparency around the EUA process.
In the webcast, it seemed that this transparency would be addressed by issuing guidance, which most likely means the stakeholders he was referring to are in industry. As reported in the RAPS Focus, today Hahn also released a statement regarding the transparency of FDA's review of the vaccine data. It doesn't address any transparency on the process that FDA will follow to verify the integrity of those data, but..one tooth at a time, I guess.2.
Based solely on a statement or two in this one webcast, Hahn seemed to weigh benefit/risk from the perspective of a physician, probably because he is one. I don't think the FDA Commissioner is the nation's doctor, so it seems like there could be a disconnect there that might explain some things, especially given that Hahn seems to have been thrown into the deep end of the pool in the middle of a hurricane. He didn't seem to be weighing benefit/risk from the perspective of his patients, which is a lot closer to the perspective I personally would like from FDA. However, despite the rhetoric, the reality is that FDA is a public health agency, which means it is concerned with the public health, not with the health of individuals. There is a big difference, and over the course of this pandemic, I have come to realize how few Americans understand this. I'm not sure whether Hahn understands it either. If not, again, that might explain some things.3. FDA has 17,000 employees.
This seems to be very important to someone for reasons I haven't been able to figure out. This number was stated twice by the Senior FDA Career Civil Servants in their pinkie swear, and Hahn stated it at least twice in the webcast.4. FDA will be releasing a guidance for transitioning products from EUA to approved status, which is to say, from an emergency to not an emergency.
I think that's likely to get snarly. Or maybe it's that the Watchcat is likely to start snarling. Anyway, we'll see. At the very least, the current rhetoric seems to be backing off from Tim Stenzel's expectation that FDA expected this emergency to last for at least years. Unless maybe FDA will given manufacturers at least years to transition from EUA to approval.5. Hahn is hopeful that a national vaccine campaign will be kicking off soon.
Oh great, just when it looked like we might finally get some blessed relief from campaigns.6. The private sector has helped FDA so much.
I can only imagine.
7. Hahn was very pleased to report that FDA has issued hundreds of EUAs since the start of the pandemic.
Sigh.
8. FDA would like to strongly increase diversity among trial participants.
Hahn made a point of clarifying that he didn't just mean ethnic diversity, but diversity in patient populations, which I gather will pave the way for authorizing untold numbers of vaccines as well.
9. Based on my notes, he said something about "ten times all previous..." I think he said FDA was asking for ten times as much data in the vaccine trial as for all previous vaccine EUAs. The fact that I scribbled "nothing times nothing leaves nothing" after it would tend to confirm this, but I can't be sure.
That was as much as I got before he said "science," "trust," and "faith" in short order, and I had to switch off.I returned briefly to see if there was anything of interest at the end. I think it was at this point that one of the RAPS Board Members who was "moderating" the discussion announced that he thought he could safely speak for all 25,000-something RAPS members...and then my brain went to white hot noise, so what he said for all of us, I didn't catch. And now I have to email Hahn and make it clear that absolutely nobody speaks for me but me. Sigh.------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------