FDA has Gone Rogue

5Mind. The Meme Platform
Who Is Robert Malone Substack Header

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) โ€” 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 agenciesโ€™ 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.

Bidenโ€™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 governmentโ€™s response to COVID-19.


Many of us knew this day would come, and now here it is. As of Monday, September 11, 2023, theย FDA has provided โ€œEmergency Use Authorizationโ€ for the SARS-CoV-2 mRNA vaccine boosters. But there is no public health emergency at this time. And the โ€œboostersโ€ being โ€œEmergency Use Authorizedโ€ are designed to provide protection against the Omicron variant called โ€œKrakenโ€. Which is on its way to becoming extinct, outcompeted by newer variants likeย Erisย which have evolved even further to escape the antibody pressure elicited by the globally deployed leaky โ€œvaccinesโ€.

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.


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


But Biden, under congressional pressure, had decided and certified that the COVIDcrisis โ€œnational emergencyโ€ 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 โ€œaction noticeโ€ in the Federal Register titled โ€œGuidance Documents Related to Coronavirus Disease 2019 (COVID-19), A Notice by the Food and Drug Administration on 03/13/2023โ€. 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

Contact Your Elected Officials
Substack
Substackhttps://substack.com/
Substack believes that great writers, bloggers, thinkers, and creatives of every background should be able generate income from their audiences on their own terms.
00:02:22

Young Washington: Movie Review

Sitting in the theater watching Young Washington, I found myself wondering why this story hadnโ€™t been made into a film sooner.
00:02:08

A Movie Thatโ€™ll Keep You Awake: A Great Awakening

So how does someone (me) who thinks theyโ€™ve just seen the greatest movie ever (A Great Awakening), persuade you to watch it?

Ring That Bell

If I could travel back in time to 1776,...

Thoughts On America 250

Before you, American reader, is the honor, blessing, and privilege of celebrating the 250th anniversary of our nation. A nation toward which God has been merciful, shining His great grace.
00:01:39

Citizen Vigilante Delivers the Warning Western Governments Desperately Need to Hear

Citizen Vigilante shows what happens when the state stops defending the native population and shields favored migrant groups while criminalizing native dissent.

Federal Judge Approves End of Temporary Protected Status for Nearly 4,000 Burmese Nationals

A federal judge permitted the DHS to end temporary protected status (TPS) for nearly 4,000 people from Burma.
00:02:00

Judge Denies Southern Poverty Law Centerโ€™s Bid to Dismiss DOJ Indictment

A federal judge rejected the SPLC bid to dismiss charges brought by the DOJ, saying the nonprofit failed to show that the prosecution against it was vindictive.
00:02:19

Older Homeowners Paying โ€˜Seniority Taxโ€™ When Refinancing Mortgages: Bankrate

Older U.S. homeowners are increasingly paying a hidden premium when they refinance their mortgages, which a new analysis calls the โ€œseniority tax.โ€

FBI Undergoing Sweeping Reforms, Fastest Transformation in Bureauโ€™s History: Director Patel

Director Kash Patelโ€™s first 14 months included a major overhaul of the agencyโ€™s operations, structure, and technology.
00:02:03

Senate Confirms Todd Blanche as Attorney General

President Trumpโ€™s nominee for AG, Todd Blanche, has been confirmed in the Senate after a few fellow Republicans reconsidered their opposition.

Senate Confirms 74 Trump Nominees, Including 4 US Attorneys

The Senate confirmed four U.S. attorneys, four U.S. marshals, and the inspector general for the DOJ in a package of 74 executive nominees.
00:02:07

Trump Signs Orders to Curb Birthright Citizenship, Target Birth Tourism

President Trump signed two EOs that will restrict automatic citizenship to โ€‹children born in the US because of commercial birth tourism and several other factors.
00:01:20

Blanche Nomination Advances to Senate Floor Vote

The Senate Judiciary Committee on Aug. 3 advanced the nomination of Todd Blanche as U.S. attorney general after he struck a deal with two GOP holdouts.
spot_img

Related Articles

Popular Categories

MAGA Business Central