FDA has Gone Rogue

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Paraphrasing Dr. Peter Marks: “We don’ need no public health emergency to emergency use authorize mismatched boosters”

President Biden to end COVID-19 emergencies on May 11

Associated Press, January 30, 2023

WASHINGTON (AP) — President Joe Biden informed Congress on Monday that he will end the twin national emergencies for addressing COVID-19 on May 11, as most of the world has returned closer to normalcy nearly three years after they were first declared.

The move to end the national emergency and public health emergency declarations would formally restructure the federal coronavirus response to treat the virus as an endemic threat to public health that can be managed through agencies’ normal authorities.

It comes as lawmakers have already ended elements of the emergencies that kept millions of Americans insured during the pandemic. Combined with the drawdown of most federal COVID-19 relief money, it would also shift the development of vaccines and treatments away from the direct management of the federal government.

Biden’s announcement comes in a statement opposing resolutions being brought to the floor this week by House Republicans to bring the emergency to an immediate end. House Republicans are also gearing up to launch investigations on the federal government’s response to COVID-19.


Many of us knew this day would come, and now here it is. As of Monday, September 11, 2023, the FDA has provided “Emergency Use Authorization” for the SARS-CoV-2 mRNA vaccine boosters. But there is no public health emergency at this time. And the “boosters” being “Emergency Use Authorized” are designed to provide protection against the Omicron variant called “Kraken”. Which is on its way to becoming extinct, outcompeted by newer variants like Eris which have evolved even further to escape the antibody pressure elicited by the globally deployed leaky “vaccines”.

Prior versions of which boosters, by the way, have been shown to have been adulterated with high levels of plasmid DNA incorporating SV40 virus promoter/enhancer sequences. Which adulteration the FDA continues to ignore.


“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”


But Biden, under congressional pressure, had decided and certified that the COVIDcrisis “national emergency” ended May 11, 2023, right? Sort of.

The administrative class at the FDA decided that they have the authority to interpret this in their own special way. Despite clear Congressional intent and the Presidential decision, the FDA responded with a series of delaying tactics. These are summarized in an “action notice” in the Federal Register titled “Guidance Documents Related to Coronavirus Disease 2019 (COVID-19), A Notice by the Food and Drug Administration on 03/13/2023”. At the time of the Presidential declaration, the FDA had 72 COVID-19-related guidance documents currently in effect. These are not law, they are administrative guidance, but often function and are enforced as if they are law. If you are seeking an example of administrative state overreach, this would be a good place to start. So, whats an agency to do? Issue an action notice in the federal register laying out new rules, functionally a guidance on guidances.

So here are the new rules, as unilaterally determined by FDA administrators. They took those 72 COVID-19 related guidances and divided them into four tables, and determined what they would mandate for the guidances in each table.

By Robert W. Malone MD, MS

Read Full Article on RWMaloneMD.substack.com

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