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.

Louisiana Voters Reject Cassidy and His Costly Healthcare Policies

On Saturday, incumbent U.S. Senator Bill Cassidy (R-LA) finished in a distant third place in the Louisiana Republican primary with only 24% of the vote.

The Illusion of Ceasefire

Western diplomacy often views ceasefires as steps toward peace. Hybrid terrorist movements often use them to regroup, recover, reorganize, and strengthen for future conflict.

Mr. CIA COVID โ€˜Whistleblowerโ€™ Goes to Washington

The real question: How could an active CIA agent โ€œblow the whistleโ€ on the agency he works for all of his own volition?

South Korea Will Remain A Key Part Of The USโ€™ Chinese Containment Plans

Trump-Xi optimism dimmed after a quieter U.S.-South Korea defense meeting in Washington raised doubts about easing Sino-US tensions.

When Institutional Language Becomes Policy

Frequency, tone, repetition, thematic emphasis, and omission can now be studied across large bodies of text. Patterns once dismissed as anecdotal can be analyzed and tested.

LA Countyโ€™s Mental Health, Addiction Programs Could Provide a National Model, Says Kennedy

HHS Secretary RFK Jr. praised LA Countyโ€™s โ€œimpressiveโ€ response to its deeply intertwined mental health, addiction, and homelessness crisis.

Judge Allows Gun Found in Mangioneโ€™s Backpack to Be Used as Evidence

The judge in the United Healthcare CEO Brian Thompsonโ€™s fatal shooting case ruled that prosecutors are allowed to use the alleged gunmanโ€™s weapon in the upcoming trial.

US Issues Travel Advisories Over Ebola Outbreak in Congo

The CDC released an alert over an outbreak of a strain of the Ebola virus in the DRC as the UN health body declared it an international emergency.

Trump Drops $10 Billion Lawsuit Against IRS

President Trumpโ€™s attorneys filed a court notice voluntarily dismissing his $10 billion lawsuit against the IRS and the U.S. Treasury Department.

Senate Confirms 49 Trump Nominees, Including Key Energy Officials

The Senate has confirmed 49 nominees selected by President Trump, including officials tapped to oversee federal land management and energy policy.

Trump Heading to China for High-Stakes Summit With Xi

President Trump is set to depart Washington for China, where he will meet with Chinese leader Xi Jinping for a high-stakes summit.

Tech, Business Leaders Set to Accompany Trump on China Trip

President Trump is bringing a delegation of business executives when he travels to China for a summit with Chinese Communist Party leader Xi Jinping.

Trump Nominates FEMA Lead Fired From Role a Year Ago

The WH released a list of nominees for various positions across the federal government, including former Navy SEAL Cameron Hamilton to take over aa lead.
spot_img

Related Articles

Popular Categories

MAGA Business Central