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FDA Policy Change Accidentally Exposes EUA Deception and Fraud

The FDA quietly changes their policy around what is allowed when promoting products under Emergency Use Authorization, exposing that the rules have been broken all along.
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Article by Scott Armstrong

Clip from The Daily Wrap-Up by Ryan Cristián: FDA Accidentally Exposes EUA Deception, Ukraine The Runaway Train & Massive Vaccine Risk Cover Up (12/14/2022)


The US Food and Drug Administration (FDA) has historically been looked at to provide rigorous health and safety standards that products must adhere to in order to be considered appropriate for public consumption. Prior to Covid, not many people gave much thought as to whether or not the FDA was operating with the public’s best interest in mind. Now that the FDA has been under an incredible amount of public scrutiny, it has become apparent that they have acted with a complete lack of integrity and clearly have motives beyond protecting the public.

In December of 2020, the Covid-19 “vaccine” was released to the public under Emergency Use Authorization (EUA). An EUA is different from an FDA Approval, in that it has not met the rigorous standards needed for “Approval” status. According to the FDA’s website:

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

There are certain criterion that need to be met in order to have a product (or in this case, an injection) qualify for use without FDA Approval. In a memorandum issued on October 27, 2022, that we will be discussing later, the FDA illustrates the criteria it requires in order for a medical intervention to be used without approval:

In issuing an Emergency Use Authorization (EUA), the FDA must determine that:

  • Based on the totality of scientific evidence available, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that:

    • the product may be effective in diagnosing, treating, or preventing a serious or life-threatening disease or condition caused by a chemical, biological, radiological, or nuclear agent; and

    • that the known and potential benefits of the product, when used to treat, diagnose or prevent such disease or condition, outweigh the known and potential risks for the product;

There are no adequate, approved, and available alternatives.

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An article from JD Supra entitled FDA Lightens Promotional Restrictions for Certain COVID-19 Drugs with Emergency Use Authorization analyzes this memorandum and points out that certain language must be excluded from any sort of promotional regarding products issued under EUA:

Because the evidentiary threshold for obtaining EUA is much lower than the evidentiary threshold for obtaining full FDA approval, the Agency places a number of conditions on authorization in order to protect the public from the potential dangers of a medical product that has not been fully evaluated.

One of these protections has historically been that the FDA has prohibited promotional material from including the phrase “safe and effective”. This is from the aforementioned memorandum from the FDA from October 2022:

To date, the Center for Drug Evaluation and Research (CDER) has included the following condition in the Letter of Authorization for COVID-19 therapeutics relating to “Printed Matter, Advertising, and Promotional Materials”:

  • No descriptive printed matter, advertising, or promotional materials relating to the use of Drug X under this authorization may represent or suggest that Drug X is safe or effective when used for <<authorized use>>.

Well now this is amazing. So you’re meaning to tell me that as a part of the EUA, they are prohibited from advertising their injections as safe and effective? I went to Pfizer’s twitter page and typed in “effective” to search their tweet history, and sure enough, they seem to not be purporting that these injections are “safe and effective” on Twitter. Back in 2020, they tweeted that they were “working hard on an effective vaccine”:

Here is a tweet from BioNTech and MSNBC that, again, talk about the safety and effectiveness of a future EUA injection:

Now it’s really interesting. Both of these tweets are in reference to EUAs that they are hoping to achieve in the future. It is hard to find a tweet from a media outlet or a vaccine manufacturer that has the phrase “safe and effective” in their tweet about a currently available EUA injection.

However, the CDC is a different story:

The article from JD Supra details that the FDA changed their policy to where they can now make comments on the safety and effectiveness of these EUA injections, as long as they are citing or referring back to actual data from clinical trials.

Once again, from the JD Supra Article:

However, CDER’s policy change with respect to these drugs is limited in scope – safety and efficacy claims made in print, advertising, and promotional materials must be tied to clinical trial data. Specifically, print, advertising, and promotional materials may only describe safety or efficacy results of clinical trials summarized in the drug’s authorized labeling, and such descriptions must include any limitations of clinical trial data described in the drug’s authorized labeling. Despite this slight relaxation of restrictions on drug promotion, the specified drugs are still bound by the rule that applies to all EUAs – in no event may the print, advertising, or promotional materials claim that the drug is “safe and effective” for its authorized use, as this language is deceptively similar to the standard for full FDA approval.

We are learning that the only time they can discuss the safety or effectiveness of an EUA product in promotional material is when they are referring back to clinical trial data. Before, they were not allowed to mention the safety or efficacy of an EUA injection at all.

Here is a press release from April of 2021 from Pfizer discussing the safety and effectiveness of their Covid-19 injection:

It appears that these companies and agencies are finding ways around the policy. Somehow it seems that they feel like it’s okay to break the law and promote their product fraudulently.

Now, even despite this new ruling, companies are STILL not allowed to use the term “safe and effective”. Once again, from the FDA memorandum:

Company A may not imply that DRUG X is FDA approved by making statements such as “DRUG X is safe and effective for <<authorized use>>.”

Even thought promotional materials are now allowed to describe the safety or effectiveness of an EUA product tied to its clinical data, they are still not allowed to use the term “safe and effective”, because it could give the wrong impression that the drug is actually FDA Approved. Analysis from the JD Supra article:

Despite this slight relaxation of restrictions on drug promotion, the specified drugs are still bound by the rule that applies to all EUAs – in no event may the print, advertising, or promotional materials claim that the drug is “safe and effective” for its authorized use, as this language is deceptively similar to the standard for full FDA approval.

It is very clear that anyone, this entire time, that has been promoting these injections as “safe and effective” has violated the law. This includes government agencies, politicians, media outlets and the manufacturers themselves. Will there be any accountability for the people who have violated this policy? We shall see.

You can do your part by sharing this article far and wide to help steer the public conscience to a point where they have no choice but to hold these frauds accountable.

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