In a special edition of the newscast, ASTHO President Dr. Nirav Shah, ASTHO President Elect Dr. Anne Zink, ASTHO CEO Mike Fraser, and Scott Becker, CEO of the Association of Public Health Laboratories, discuss the FDA’s Emergency Use Authorization...
In a special edition of the newscast, ASTHO President Dr. Nirav Shah, ASTHO President Elect Dr. Anne Zink, ASTHO CEO Mike Fraser, and Scott Becker, CEO of the Association of Public Health Laboratories, discuss the FDA’s Emergency Use Authorization (EUA) process during a workshop hosted Tuesday by The National Academies of Sciences, Engineering and Medicine.
The National Academies Webpage: FDA EUA Workshop
This is Public Health Review Morning Edition for Wednesday, October 6th, 2021. I'm Robert Johnson.
Here's today's news from the Association of State and Territorial Health Officials.
We're lucky we had it. Imagine what we'd be doing now if we didn't.
And I think that's, to me, kind of the take home at this point.
That's ASTHO CEO, Mike Fraser, on a panel talking about the FDA's emergency use authorization process to approve the use of vaccines and diagnostics during the pandemic.
Fraser, along with ASTHO president, Dr. Nirav Shah, and ASTHO president-elect, Dr. Anne Zink, joined others to discuss EUAs on Tuesday during a workshop hosted by the National Academies of Sciences, Engineering, and Medicine.
This is Dr. Zink from Alaska.
The EUA process, as a whole, allowed the FDA to move quickly in a time when we all could not move fast enough.
Dr. Shah of Maine says the pandemic has made the EUA a household term.
Since the EUA process is new—it's been around fewer than 20 years—and in prior settings and prior public health emergencies—Zika virus, Ebola—EUAs were largely limited, for example, to diagnostics.
But with COVID, as has already been referenced, the public has a much better understanding of the EUA process today than they did two years ago when that term "EUA" was barely even in the public lexicon.
The panel considered messaging associated with the EUA process.
Dr. Zink and ASTHO CEO Fraser weigh in.
The messaging, "We're in the process, we'll be back to you when we're done," is really hard to message to the public, particularly when they're seeing their friends and their loved ones dying and their hospitals overwhelmed like we're seeing right now in Alaska.
The majority of state health officials that we know and that we speak with on a routine basis trust the process.
I don't think it was a question of something bad happening. I think it was more trying to explain some of either the limitations or what happens next kind of conversations that get more complicated.
"When do the emergency use authorizations go through the normal process? Do they go through the normal process?" You know, those are the kinds of questions we get and need to explain.
Another member of the panel, Scott Becker, CEO of the Association of Public Health Laboratories, says the EUA process for diagnostics had to evolve to keep up with the virus.
You know, the FDA very quickly established pathways for laboratories than others. Now, it took, frankly, those first three weeks, four weeks were really tough, but they did that.
And then, moving forward, what I appreciate the FDA has done—and this is real transparency—they set up routine calls with test developers to answer all questions. That continues to this day.
And Becker's hope for the future.
So, what I'm hoping to see is that there continue to be essentially a community of practice.
Now, the regulators have their role; test developers, laboratories, and users have their role. But I do think there needs to be more information sharing along those lines so we can learn together as a community.
Dr. Zink appreciates the work companies have done to develop the vaccines and diagnostics, but she says:
This is a public health need and a public health emergency; and if we're using the emergency use authorization, I think that we should put kind of guardrails on that process that focus on the public’s health and not on the individual company's process.
The workshop continues today. Dr. Shah is part of a closing panel.
We'll monitor that discussion and bring it to you on Thursday.
That's it for this special edition of the newscast.
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I'm Robert Johnson. You're listening to Public Health Review Morning Edition.