The controlling statute for granting EUAs is section 564 of the Federal Food, Drug, and Cosmetic Act, codified in the US Code at 21 U.S. Code § 360bbb–3.
"mitigating symptoms" would fall within the treatment criteria for receiving an EUA.
HOWEVER, a key element of the standard that is to be applied is "...the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available,...."
The totality of scientific evidence for the inoculations and COVID-19 therapeutics, if properly considered, should be more than enough to disqualify all Big Pharma products pertaining to COVID-19 treatment and/or prevention. That the totality of scientific evidence is NOT being used in this fashion is yet another reason the FDA should be dissolved as a federal agency in its entirety.
I agree with your conclusions regarding the dissolution of the FDA. As it relates to the EUA, I think the more compelling evidence for this is the active propagandistic campaign against any early treatment (ivermectin and HCQ being the most visible).
The same federal regulation you referenced regarding EUA also lists as a requirement:
“that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition;” which goes a long way toward explaining why cheap, effective, safe, available treatments had to be vilified at all costs.
I would add the CDC to the list of organizations that should be disbanded. Too much money doing so much harm.
The demonization of Ivermectin and Hydroxychloroquine is yet another in the FDA’s lengthy list of failures to comply with its own mandates.
In a purely legalistic sense, however, the FDA has an out in the word "adequate". The same gray area that damns them on the body of evidence regarding the mRNA inoculations tends to exonerate them on Ivermectin--the simple defense is Ivermectin is not "adequate".
Still, regardless of the evidence for and against Ivermectin, without solid evidence of efficacy and safety for the inoculations, they should not receive EUA.
I agree with you on Ivermectin, but view that as an amplifying argument rather than a core argument.
Agree that their most egregious crimes are the promotion of ineffective and arguably harmful (albeit VERY profitable) treatments. Their obfuscation, suppression, and lies about safe alternative (less profitable)treatments supported and justified their primary offense. My reason for pointing it out was that the absence of alternative treatments is a prerequisite condition for EUA that many (including me) would argue was not met. Seems pretty important when you consider the lack of safety data for EUA drugs at the outset and the suppression of safety data as the “emergency” progressed.
The scary part of the emergency declaration statute (§319 of the Public Health Service Act, codified at 42 USC 247d) is that there are ZERO standards and ZERO criteria to be met. The public health emergency declaration is ENTIRELY upon the whimsy of the HHS Secretary.
If it doesn’t stop transmission. Then it doesn’t qualify for an EUA - right?
Definitely you can’t mandate something to “mitigate symptoms”...
Strictly speaking, when you look at the controlling statutes, the FDA CAN grant EUA for something that only mitigates symptoms.
https://newsletter.allfactsmatter.us/p/covid-19-the-endless-emergency
The controlling statute for granting EUAs is section 564 of the Federal Food, Drug, and Cosmetic Act, codified in the US Code at 21 U.S. Code § 360bbb–3.
https://www.law.cornell.edu/uscode/text/21/360bbb-3
"mitigating symptoms" would fall within the treatment criteria for receiving an EUA.
HOWEVER, a key element of the standard that is to be applied is "...the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available,...."
The totality of scientific evidence for the inoculations and COVID-19 therapeutics, if properly considered, should be more than enough to disqualify all Big Pharma products pertaining to COVID-19 treatment and/or prevention. That the totality of scientific evidence is NOT being used in this fashion is yet another reason the FDA should be dissolved as a federal agency in its entirety.
I agree with your conclusions regarding the dissolution of the FDA. As it relates to the EUA, I think the more compelling evidence for this is the active propagandistic campaign against any early treatment (ivermectin and HCQ being the most visible).
The same federal regulation you referenced regarding EUA also lists as a requirement:
“that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition;” which goes a long way toward explaining why cheap, effective, safe, available treatments had to be vilified at all costs.
I would add the CDC to the list of organizations that should be disbanded. Too much money doing so much harm.
The demonization of Ivermectin and Hydroxychloroquine is yet another in the FDA’s lengthy list of failures to comply with its own mandates.
In a purely legalistic sense, however, the FDA has an out in the word "adequate". The same gray area that damns them on the body of evidence regarding the mRNA inoculations tends to exonerate them on Ivermectin--the simple defense is Ivermectin is not "adequate".
Still, regardless of the evidence for and against Ivermectin, without solid evidence of efficacy and safety for the inoculations, they should not receive EUA.
I agree with you on Ivermectin, but view that as an amplifying argument rather than a core argument.
Agree that their most egregious crimes are the promotion of ineffective and arguably harmful (albeit VERY profitable) treatments. Their obfuscation, suppression, and lies about safe alternative (less profitable)treatments supported and justified their primary offense. My reason for pointing it out was that the absence of alternative treatments is a prerequisite condition for EUA that many (including me) would argue was not met. Seems pretty important when you consider the lack of safety data for EUA drugs at the outset and the suppression of safety data as the “emergency” progressed.
Plus it must be under a state of emergency. Another clause they have blatantly manipulated.
The scary part of the emergency declaration statute (§319 of the Public Health Service Act, codified at 42 USC 247d) is that there are ZERO standards and ZERO criteria to be met. The public health emergency declaration is ENTIRELY upon the whimsy of the HHS Secretary.
https://www.law.cornell.edu/uscode/text/42/247d
They don't have to manipulate it. They only have to use it.
And yet they DO mandate it.