FDA: EUAS, COIs and more

Oh My!

The Substack today is a compilation of news stories regarding the Food and Drug Administration.

On Friday, the FDA published a news release (below), and even more interesting news that we have unearthed is published following the PR text:

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FDA NEWS RELEASE

FDA Roundup: March 10, 2023

For Immediate Release:

March 10, 2023

• Today, the FDA issued a notice addressing the agency’s COVID-19-related guidance documents, including which of those guidance documents will no longer be in effect after the expiration of the COVID-19 public health emergency (PHE) declared under the Public Health Service (PHS) Act, and which of those guidance documents the FDA is revising to temporarily continue in effect.

• This notice follows an announcement from the U.S. Department of Health and Human Services that, based on current COVID-19 trends, the Department is planning for the COVID-19 PHE declared under the PHS Act to expire on May 11, 2023.

• Since the start of the COVID-19 PHE declared under the PHS Act, the FDA has been committed to providing timely recommendations and regulatory information to support response efforts. 

• During the COVID-19 PHE declared under the PHS Act, the FDA has provided important tools and flexibilities to manufacturers, health care facilities, providers, patients, and other stakeholders. 

• Importantly, the ending of the PHE declared under the PHS Act will not impact the FDA’s ability to authorize devices (including tests), treatments or vaccines for emergency use. Existing emergency use authorizations (EUAs) for products will remain in effect and the agency may continue to issue new EUAs going forward when criteria for issuance are met.

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Public Health Service Act (PHS Act) is expected to expire at the end of the day on May 11, 2023.

The FDA notice addressing the agency’s COVID-19-related guidance documents, includes those guidance documents that the FDA is continuing past the expiration date. Table 3 lists the guidances and EUAs that will, for all intents and purposes, be continuing past the May 11 expiration date. Table 3 is quite extensive, but below is an image of the section mostly related to vaccines and biologics:

Note that the EUA for the vaccines, convalescent plasma, development and licensure of vaccines to prevent COVID-19, and development of drugs and biological products for treatment or prevention of COVID-19 will continue on until the start of next winter (at a minimum).

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The revolving door of the FDA and Pfizer

Patrizia Cavazzoni, MD, is the director of the US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER). CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs, this includes evaluating new drugs through the clinical trials process.

Trained as a psychiatrist, Dr. Cavazzoni worked at Pfizer for thirteen years prior to joining the the FDA in 2018. Once at the FDA, she was rapidly promoted, becoming director at CDER in 2021. Her positions at Pfizer included the following:

• Senior Vice President Clinical Sciences and Operations at Pfizer

• Senior Vice President Development Operations at Pfizer

• Senior Vice President Safety and Regulatory at Pfizer

• Senior Vice President Worldwide Safety at Pfizer

According to the FDA website,

“A conflict of interest is of a financial nature.

The issue is that conflicts of interest also can be of a professional nature.

As an example, remember the curious case of Dr. Gottlieb:

Cue the 'revolving door' criticism: Former FDA commissioner Gottlieb joins Pfizer's board

When former FDA commissioner Scott Gottlieb, M.D., resigned back in March, he said he wanted to spend more time with his family.

Since then, Gottlieb has nabbed a partnership at a VC firm and a think tank fellowship. And now, less than three months since his last day regulating pharma, Gottlieb has joined Pfizer, one of the biggest companies in the business.

Gottlieb snagged a spot on Pfizer's board of directors, the drug giant said Thursday. He'll also serve on the board's regulatory and compliance committee and its science and technology committee.

The announcement comes 85 days after Gottlieb left the FDA on April 5 to spend more time with his family. In his resignation letter to colleagues, Gottlieb wrote that “there’s nothing that could pull me away from this role other than the challenge of being apart from my family for these past two years and missing my wife and two young children."

The revolving door at the FDA has to stop. There are many tried and true ways for this to happen but the FDA and HHS seem unable to police themselves.

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More reasons to get off Google.

The FDA is scaling up its war on misinformation by spreading disinformation. Currently, in the USA - people dying of or WITH COVID-19 are less than 150 people a day (world meter data) and as we all know, the CDC freely admits that many of the deaths list COVID-19 as a contributing factor, not the main cause of death.

In 2022, the FDA Commissioner Dr. Robert Califf made this statement (from the AP, 2023):

FDA Commissioner Dr. Robert Califf has spent the last year warning that growing “distortions and half-truths” surrounding vaccines and other medical products are now “a leading cause of death in America.”

“Almost no one should be dying of COVID in the U.S. today,” Califf told The Associated Press, noting the government’s distribution of free vaccines and antiviral medications. “People who are denying themselves that opportunity are dying because they’re misinformed.”…

“We’re now in a 24/7 sea of information without a user guide for people out there in society,” Califf said. “So this requires us to change the way we communicate.”

So, the FDA is stating that “a leading cause of death in America” is “distortions and half-truths” about “vaccines and other medical products.”

Who knew? And who is actually responsible for the majority of those distortions and half-truths?

All kidding aside, where is the peer-reviewed papers or data showing that misinformation is a leading cause of death in the USA?

Then the FDA used the above statement by the commissioner to justify the FDA’s new misinformation policy and procedures.

An FDA page dubbed “Rumor Control” debunks a long list of false claims about vaccines, such as that they contain pesticides. A Google search for “vaccines” and “pesticides” brings up the FDA’s response as a top result, because the search engine prioritizes credible websites.

“Because the FDA puts that information on its website, it will actually crowd out the misinformation from the top 10 or 20 Google results,” said David Lazer, a political and computer scientist at Northeastern University. (AP)

Another fifth-gen warfare tactic. In the example above, the FDA is using their ability to eliminate other media sources off of the front page of Google searches.

Note how the biased AP uses an outlandish example (pesticides found in the vaccines) to smear all of those who are hesitant and have very real concerns about the vaccine. This tactic of linking people on “the other side” or movements to an extreme organization or prejudice is used repeatedly in main-stream media now. Another variation on the widespread gaslighting which has become the new norm.

The FDA is also rapidly expanding its misinformation monitoring capabilities.

Perhaps the most promising approach to fighting misinformation is also the toughest to execute: introduce people to emerging misinformation and explain why it’s false before they encounter it elsewhere.

That technique, called “pre-bunking,” presents challenges for large government agencies.

“Is the FDA nimble enough to have a detection system for misinformation and then quickly put out pre-bunking information within hours or days?” Lazer asked.

Califf said the FDA tracks new misinformation trends online and quickly decides whether — and when — to intervene. (AP)

The question is, how else is the FDA intervening?

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