With an EUA declaration from HHS for whatever bird flu strains they've chosen, the FDA is now free to issue EUAs for any product whose benefits they believe exceed the risks, based on "available information."
If there's anything like IVM or HCQ that could work for bird flu, they'll have to suppress it, because there cannot be any other "adequate, approved and available" candidate product for doing what the EUA product is supposed to do.
I suspect HCQ will work like a charm..like it does for zcovid and many other influenza like conditions. Dr. Uso let that drop way back on 2020 or 2021.
And that is against the law. If there are therapies and medications already available then they cannot or allowed to create a maxxine, but they did and got away with it during the plandemic/scamdemic. 🤬
Question is, will there be people stupid enough to fall for it again?
Meryl, I don't know how you can read, absorb,and translate our Byzantine bureaucracy 's pronouncement and regulations into plain english..but I'm very very grateful you do.
The best way to control the public is to keep them living in a constant state of "emergency" (real or cooked up). We have been living in an "emergency" since 9/11. They love this stuff. I REFUSE their fear. We can be concerned about things, but we should not fear them. These monsters want a constant state of 03/2020 for generations. We must say NO. We must be the adults in the room. We must be the sane ones.
They already did this with the Pfizer - Cominarty - Children's vaccine (under 12) - issued on September 11, 2023 (ya, no media to report about it that day).
EUA issued with no national emergency, and certainly not a potential one for children.
And whatever is decided south of the border with Canada will be be what happens in Canada, and across the pond in the UK and around the other side of the planet in Australia and across the continent of Europe. Marvelous isn't it?!?
Well, I’m sure this move is driven by science of virology, which has been proven reliable at creating pandemics and has nothing to do with politics…
Let’s not forget: if governments have the authority to mandate treatments for symptoms of an infection, or no symptoms, because the so-called mRNA vaccines were not designed to prevent infection of anything, what else will they mandate in the future? Aspirin, because it is supposed to do the same thing? EUA for mRNA aspirin. Why? Because it’s good for you…
Yeah, for those who have not seen the cool timeline of when alternatives were available go to c19early.org to check it out.
By the end of 2020 there were 8 treatments that had shown promise and another 4 more before Remdesivir was available. Any one should have short circuited the EUA process.
Meryl - I believe the FDA actually does not have to consult with anyone if they don't want to, once the HHS Secretary makes the emergency declaration. Here's the wording from the FDA website:
"After the Secretary of HHS issues an EUA declaration based on one of these four determinations, and after consulting (to the extent feasible and appropriate given the applicable circumstances) with the Assistant Secretary for Preparedness and Response (ASPR), the Director of the National Institutes of Health (NIH), and the Director of CDC,17 the Commissioner may authorize the emergency use of an unapproved product or an unapproved use of an approved product, provided that other statutory criteria are met."
The key here is "to the extent feasible and appropriate given the applicable circumstances" - in other words, totally optional. Also, as it says, once the HHS Secretary makes the general declaration enabling EUAs for anything that addresses the emergency, it's up to the FDA Commissioner to apply EUA to specific products, based on the "statutory criteria" which are all non-specific and optional.
Debbie, I think I quoted the same paragraph. I have spent two days trying to disentangle this, because PAHPRA was enacted in 2013 (and subsequently reupped) and made some changes that I cannot figure out.
I believe it was possible for Becerra to make both declarations at once--that a potential emergency existed and that we have a vaccine to authorize for it. But he did not say the second part.
So he has still not given the FDA permission to issue an EUA. However, once he says we have a vaccine for this, FDA could issue the EUA in a heartbeat, as I am sure they have already done the paperwork, since we ordered 4.8 M doses from Sequirus of the H5N8 Holly Springs, MF59-adjuvanted trash...back in May?
"Based on any of these four determinations, [of a potential or emergency--nass] the Secretary of HHS may ALSO
declare that circumstances exist that justify an Emergency Use Authorization (EUA), at which point the FDA may issue an EUA authorizing (1) the emergency use of an unapproved drug, an unapproved or uncleared device, or an unlicensed biological product; or (2) an unapproved use of an approved drug, approved or cleared device, or licensed biological product, if the criteria for issuance of an authorization under section 564 of the FD&C Act are met."
All such "rules" are crafted to be vague, inconsistent and impossible for the average citizen to interpret. Any who dare to challenge them will face the costly and impenetrable maze of legal procedures designed to thwart such challenges.
Our Supreme Court just threw out the doctrine of Chevron deference, which assumed experts would always act expertly and regulate honestly.
The straw that broke the camel's back was a fisheries case, Loper Bright Enterprises v US.
In that appeal, the fisheries regulator wanted to give themselves pay raises and regulated a tax into operation to accomplish that. Loper Bright sued, claiming to a lower court that the fisheries regulator lacked the legal authority to create a new tax. The fisheries regulator said they had interpreted the law, found their actions legal, and under Chevron were entitled to change the tax law, and therefore sought dismissal. The trial court disagreed and held a bench trial. The regulator appealed seeking to moot the trial by forcing a dismissal and got an appeals court to go along with it. Plaintiffs appealed the dismissal. Justice AC Barrett who supervises that circuit, saw the case as an extreme example of a common problem. Regulatory agencies undergo corporate capture because corporations reward retired regulators with high paying lobbying jobs. Did the FAA regulator who allowed Boeing's door plugs to fit in any fuselage, pressurized or not, end up as a Boeing lobbyist? The thought wasn't on the mind of the passengers on the Alaska Airlines flight when the door plug blew out next to their seats...they probably had a screaming earache and worried if they'd survive. But that corporate revolving door was a major concern for many legal ethics writers, Justice Barrett had apparently seen Chevron deference used to defend allegations of malfeasance at other agencies where someone wrote a corporation-friendly reg and got a fat job offer shortly afterward, realized we'd created a recipe for corruption by allowing agencies to refuse to answer questions in court, and persuaded her brethren and two sisters to take the case. A Writ of Certiorari went out to the fishing regulator, the plainiff, and the courts below last year, and the case was taken up. Result: Just because a federal agency claims expertise does not prove them to have it. Trial courts should make their own g
Trial courts should hear evidence and decide if the claimed expertise existed. Being an expert on how fast fish multiply, is not the same thing as being an expert on what's legal under the tax code.
With an EUA declaration from HHS for whatever bird flu strains they've chosen, the FDA is now free to issue EUAs for any product whose benefits they believe exceed the risks, based on "available information."
If there's anything like IVM or HCQ that could work for bird flu, they'll have to suppress it, because there cannot be any other "adequate, approved and available" candidate product for doing what the EUA product is supposed to do.
As far as I can tell, they do whatever they want. We don't have the rule of law anymore.
I suspect HCQ will work like a charm..like it does for zcovid and many other influenza like conditions. Dr. Uso let that drop way back on 2020 or 2021.
Vitamin C in mega doses for regular bird flu (but nobody knows about this new-fangled junque!) doctoryourself.com
And that is against the law. If there are therapies and medications already available then they cannot or allowed to create a maxxine, but they did and got away with it during the plandemic/scamdemic. 🤬
Question is, will there be people stupid enough to fall for it again?
Yes, but rest assure they will not mandate aspirin because there is not money there to be made unless it is an mRNA aspirin lol
Meryl, I don't know how you can read, absorb,and translate our Byzantine bureaucracy 's pronouncement and regulations into plain english..but I'm very very grateful you do.
God sends prophets to those who will listen.
The best way to control the public is to keep them living in a constant state of "emergency" (real or cooked up). We have been living in an "emergency" since 9/11. They love this stuff. I REFUSE their fear. We can be concerned about things, but we should not fear them. These monsters want a constant state of 03/2020 for generations. We must say NO. We must be the adults in the room. We must be the sane ones.
🎯🎯🎯
They already did this with the Pfizer - Cominarty - Children's vaccine (under 12) - issued on September 11, 2023 (ya, no media to report about it that day).
EUA issued with no national emergency, and certainly not a potential one for children.
And whatever is decided south of the border with Canada will be be what happens in Canada, and across the pond in the UK and around the other side of the planet in Australia and across the continent of Europe. Marvelous isn't it?!?
Well, I’m sure this move is driven by science of virology, which has been proven reliable at creating pandemics and has nothing to do with politics…
Let’s not forget: if governments have the authority to mandate treatments for symptoms of an infection, or no symptoms, because the so-called mRNA vaccines were not designed to prevent infection of anything, what else will they mandate in the future? Aspirin, because it is supposed to do the same thing? EUA for mRNA aspirin. Why? Because it’s good for you…
Vicious and evil Javier Becerra is a demon-worker who, like Kamala, pushed abortion in California.
Both of them are extremely evil individuals.
That’s who’s pushing the poison on humanity.
All heathens at the end of the day
Yeah, for those who have not seen the cool timeline of when alternatives were available go to c19early.org to check it out.
By the end of 2020 there were 8 treatments that had shown promise and another 4 more before Remdesivir was available. Any one should have short circuited the EUA process.
Love you all - to see my art and connect, reach out to the links below!
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www.mikeloayza.com
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Dr. Nass, can you post this to your Twitter/X.
done
Meryl - I believe the FDA actually does not have to consult with anyone if they don't want to, once the HHS Secretary makes the emergency declaration. Here's the wording from the FDA website:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities#A1
"After the Secretary of HHS issues an EUA declaration based on one of these four determinations, and after consulting (to the extent feasible and appropriate given the applicable circumstances) with the Assistant Secretary for Preparedness and Response (ASPR), the Director of the National Institutes of Health (NIH), and the Director of CDC,17 the Commissioner may authorize the emergency use of an unapproved product or an unapproved use of an approved product, provided that other statutory criteria are met."
The key here is "to the extent feasible and appropriate given the applicable circumstances" - in other words, totally optional. Also, as it says, once the HHS Secretary makes the general declaration enabling EUAs for anything that addresses the emergency, it's up to the FDA Commissioner to apply EUA to specific products, based on the "statutory criteria" which are all non-specific and optional.
Here's a detailed explanation:
https://debbielerman.substack.com/p/what-is-emergency-use-authorization
Debbie, I think I quoted the same paragraph. I have spent two days trying to disentangle this, because PAHPRA was enacted in 2013 (and subsequently reupped) and made some changes that I cannot figure out.
I believe it was possible for Becerra to make both declarations at once--that a potential emergency existed and that we have a vaccine to authorize for it. But he did not say the second part.
So he has still not given the FDA permission to issue an EUA. However, once he says we have a vaccine for this, FDA could issue the EUA in a heartbeat, as I am sure they have already done the paperwork, since we ordered 4.8 M doses from Sequirus of the H5N8 Holly Springs, MF59-adjuvanted trash...back in May?
With OUR tax dollars
The unkind cuts just keep coming
"Based on any of these four determinations, [of a potential or emergency--nass] the Secretary of HHS may ALSO
declare that circumstances exist that justify an Emergency Use Authorization (EUA), at which point the FDA may issue an EUA authorizing (1) the emergency use of an unapproved drug, an unapproved or uncleared device, or an unlicensed biological product; or (2) an unapproved use of an approved drug, approved or cleared device, or licensed biological product, if the criteria for issuance of an authorization under section 564 of the FD&C Act are met."
All such "rules" are crafted to be vague, inconsistent and impossible for the average citizen to interpret. Any who dare to challenge them will face the costly and impenetrable maze of legal procedures designed to thwart such challenges.
How your country will deal with this corruption?
We won't. Ws will have to either be razed to the ground and reconstitute our constitution..or we will be fully absorbed into the blob.
I get it.
Our Supreme Court just threw out the doctrine of Chevron deference, which assumed experts would always act expertly and regulate honestly.
The straw that broke the camel's back was a fisheries case, Loper Bright Enterprises v US.
In that appeal, the fisheries regulator wanted to give themselves pay raises and regulated a tax into operation to accomplish that. Loper Bright sued, claiming to a lower court that the fisheries regulator lacked the legal authority to create a new tax. The fisheries regulator said they had interpreted the law, found their actions legal, and under Chevron were entitled to change the tax law, and therefore sought dismissal. The trial court disagreed and held a bench trial. The regulator appealed seeking to moot the trial by forcing a dismissal and got an appeals court to go along with it. Plaintiffs appealed the dismissal. Justice AC Barrett who supervises that circuit, saw the case as an extreme example of a common problem. Regulatory agencies undergo corporate capture because corporations reward retired regulators with high paying lobbying jobs. Did the FAA regulator who allowed Boeing's door plugs to fit in any fuselage, pressurized or not, end up as a Boeing lobbyist? The thought wasn't on the mind of the passengers on the Alaska Airlines flight when the door plug blew out next to their seats...they probably had a screaming earache and worried if they'd survive. But that corporate revolving door was a major concern for many legal ethics writers, Justice Barrett had apparently seen Chevron deference used to defend allegations of malfeasance at other agencies where someone wrote a corporation-friendly reg and got a fat job offer shortly afterward, realized we'd created a recipe for corruption by allowing agencies to refuse to answer questions in court, and persuaded her brethren and two sisters to take the case. A Writ of Certiorari went out to the fishing regulator, the plainiff, and the courts below last year, and the case was taken up. Result: Just because a federal agency claims expertise does not prove them to have it. Trial courts should make their own g
Trial courts should hear evidence and decide if the claimed expertise existed. Being an expert on how fast fish multiply, is not the same thing as being an expert on what's legal under the tax code.
Like, like, like !
I understand.
Merci, Luc
De rien !