COVID-19 USA Daily Numbers, page-348

Thanks Snorks, We’ve read the announcement, hanging out for an EUA despite futility.

Been to three bars by 3pm- not a good look, however It’s better than doom and gloom fortune tellers.
Seriously peeps, we get it, the trial stopped recruiting because it would most likely not hit the primary endpoint. Yes, yes , yes - we know , thanks, got it, read it a few times. Cheers..
Personally I’m on board for an EUA from the 60 day data secondary endpoints. Overall mortality, time in hospital, time in ICU.

So Snorky and Co , how’s about find something positive to talk about.

Here’s some horses mouth stuff for the negative Nancy’s to consider.

Rem-l works, definitive patient population will be identified, zero safety issues.

EUA EUA
Have a drink
To the FDA

Reg

During the COVID-19 pandemic, the U.S. Food and Drug Administration has issued many emergency use authorizations—known as EUAs—for tests as well as treatments, including convalescent plasma. Now the agency faces the decision about whether to issue an emergency use authorization for one or more COVID-19 vaccines.

Joshua Sharfstein, MD, the former principal deputy commissioner of the U.S. Food and Drug Administration and now vice dean of Public Health Practice at the Johns Hopkins Bloomberg School of Public Health, breaks down EUAs in a Q&A drawn from his September 4 conversation with Stephanie Desmon on the Public Health On Call podcast.

What is an emergency use authorization (EUA)?

In an emergency, like a pandemic, it may not be possible to have all the evidence that the FDA would usually have before approving a drug, device, or a test.

When there is a declared emergency, the FDA can make a judgment that it's worth releasing something for use even without all the evidence that would fully establish its effectiveness and safety. If there’s evidence that strongly suggests that patients have benefited from a treatment or test, the agency can issue an EUA to make it available.

How long have EUAs been around?

Emergency use authorization is a relatively new tool for the FDA. In fact, when I was the acting commissioner at FDA in 2009, before I became the principal deputy, I signed the first emergency use authorization the agency had ever put forward for the civilian population.

What was authorized?

During the H1N1 pandemic, there was a question of using Tamiflu—which was a medication for flu which had dosing approved by the FDA—for very little babies. People were worried that H1N1 could affect them, but Tamiflu hadn’t been well studied for infants.

So, we brought together the best minds at the FDA to come up with a recommended dosing for young infants. We did an emergency use authorization to provide this official recommendation to clinicians.

Ordinarily, it might require special studies to come up with a dose for infants, but we didn't have time for that. We wanted to make sure that people had the benefit of the best evidence. And we thought this was a reasonable approach based on their expertise about how babies would metabolize the medication.

How often is EUA granted?

Outside of a declared emergency, never. The agency doesn’t have the power to issue an EUA without a declared emergency. The agency has issued EUAs for anthrax, ebola, enterovirus, H7N9 influenza, and Middle East respiratory syndrome.

Is there a minimum requirement for the FDA to consider issuing an EUA?

Yes. One of the minimum requirements is that the known and potential benefits outweigh the known potential risks.

That is the minimum requirement. It is not the standard for an authorization. You can have that requirement met and still not give the authorization. You still need a good reason to do the authorization—such as that the product meets reasonable thresholds for safety and effectiveness and people are in urgent need of care

Its a pandemic- shit happens- rules change

Reg