FDA Goes Completely Rogue by Developing Its Own EUAs


The FDA has gone completely rogue, reports Dr. Robert Malone on his substack. They’re now developing their own emergency use authorizations (EUAs) without bothering to deal with the president or Congress. [Just in time for 2024 and more mandates.]

The summary information below comes directly from Dr. Malone’s report; the details are available there.

Biden ended the COVID-19 emergency and public health emergency declarations on May 11th, and there is no COVID emergency now either. If there were, the boosters wouldn’t mean much anyway since they are mismatched. The researchers can’t keep up with the mutations of COVID-19. The illness is now considered an endemic threat to public health and can be managed through the normal authorities.

Yet, as of Monday, September 11, the FDA has provided its own emergency use authorization for the SARS-CoV-2 mRNA vaccine boosters. They didn’t go through Congress or the President.

The boosters that they have are for the Omicron variant called Kraken. It’s almost extinct. There are new variants like ERIS, and they have evolved to escape the antibody pressure from the leaky vaccines.

After the emergency was lifted on May 11, the FDA delayed. They said at the time it wasn’t law; it was just administrative guidance. That’s not the case, and they know it.

Now, they’re just making up their own rules.

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

  • Table 1 was those that would expire when the public health emergency (PHE) would expire.
  • Table 2 would be revised to continue in effect for 180 days after the PHE declaration expires, then will no longer be in effect on November 07, 2023 (Tuesday).
  • Table 3 shows those to be revised to continue in effect for 180 days after the PHE declaration expires, during which time the FDA plans to revise these guidances further – and then?
  • Table 4 lists COVID-19-related guidance documents whose intended duration is not tied to the COVID-19 PHE and will remain in effect when the COVID-19 PHE declaration expires. In other words, by administrative fiat, those guidances listed in Table 4 will remain in place for as long as the FDA administrators wish them to remain in place.
At the top of Table 3 (the ones that they will revise as they see fit and continue as long as they think necessary) are the following:

Did they actually revise FDA-2020-D-1137 between then and now? Did they do the work that they said they would do? In short, no. The guidance has remained unrevised since March 2022.

What congressional law and language determines when the FDA can issue EUAs?

The FDA’s own website regarding Emergency Use Authorization:

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives.

As you can see, the FDA administrative bureaucracy self-determined that they could continue to bypass their normal (already lax) procedures for evaluating vaccine purity, potency, safety, and efficacy for as long as their hearts desire, at least until November 07, 2023. They used the administrative basis to enable the September 11, 2023, “Emergency Use Authorization” for the SARS-CoV-2 mRNA vaccine boosters.

The congressional “gerontocracy,” as Dr. Malone calls them, sleeps, raises funds for the next election, and demonstrates their “literal mental incompetency (in a strict medical sense of the term.)

The data clearly demonstrates that there is no longer a COVID public health emergency, and no human data demonstrates the safety and effectiveness of these mismatched “vaccine booster” products.

Doctor Malone shared the graphs proving that. You can view them on his substack page. Here’s one:

Also, hospitalizations are up, but deaths are down. Most of the people in hospitals have received Moderna or Pfizer vaccinations. They keep you in the dark about that. If they worked, would all these people be hospitalized?

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The Prisoner
The Prisoner
5 months ago

The only way to stop this is to resist. The GOP is not going to help in DC. Some GOP governors have enough sense to resist.

The graph is not meaningful. The method to determine covid cases is a known fraud. The upsurge in illnesses is due to the accumulated effects of the jab. There never was a public health emergency for covid, and I think Malone agrees.

Fall is the time for the crooks to declare another emergency.