Tag: fda

The Case of the Damning FDA Memos

On July 21, 2025, the Informed Consent Action Network (ICAN) announced that it had secured the release of over 600,000 pages of Emergency Use Authorization (EUA) data used by the US Food and Drug Administration (FDA) to authorize and approve Pfizer-BioNTech’s COVID-19 vaccine (BNT162b2), following a successful lawsuit, culminating in a late 2024 court ruling.

These documents, now publicly available on ICAN’s website, are part of a broader release of over 1.6 million pages, including data from the vaccine’s licensure in August 2021 and the earlier EUA in December 2020.

This report builds on my prior investigative work analyzing thousands of FDA documents released following the Public Health and Medical Professionals for Transparency (PHMPT) lawsuit, which focused on the biological product file submitted by Pfizer for the full approval of its COVID-19 vaccine in August 2021.

I was one of the initial researchers to uncover and analyse the damning data hidden within Pfizer’s Pregnancy & Lactation Cumulative Review, Interim-Narrative-Sensitive document (3000+ pages), and Cumulative Analysis of Post-Authorization Adverse Event Reports document, among others.

Both ICAN and PHMPT’s lawsuits sought to make public the FDA’s data on the Pfizer-BioNTech’s COVID-19 shot, asserting that transparency is critical for public trust and independent analysis, given the global administration of billions of doses of this experimental gene-based product that was mandated in several countries.

My preliminary review of ICAN’s EUA data reveals several irregularities, outlined below with references to key documents and downloadable sources. This report focuses on four critical issues: manufacturing oversight gaps, missing Bell’s palsy data, clinical trial site deficiencies, and the exclusion of unconfirmed COVID-19 cases.

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FDA Warns About Potentially Radioactive Frozen Shrimp Sold at Walmart Stores

The U.S. Food and Drug Administration (FDA) on Tuesday issued a public warning against potentially radioactive frozen shrimp products sold at Walmart stores in several states.

The FDA alert urged the public not to consume, sell, or serve certain Great Value raw frozen shrimp due to possible contamination with Cesium-137, a radioactive isotope.

Impacted Shrimp Products

Walmart also shared the FDA’s warning on its website.

The impacted raw frozen shrimp products were sold under the Great Value brand at stores in Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Missouri, Mississippi, Ohio, Oklahoma, Pennsylvania, Texas, and West Virginia.

The impacted products have been stamped with lot codes 8005540-1, 8005538-1, and 8005539-1.

They also have Best by Dates of 3/15/2027.

What is Cesium-137?

Cesium-137, also referred to as Cs-137, is a radioactive isotope of cesium that is man-made through nuclear reactions, according to the FDA. The agency says because Cs-137 is “widespread worldwide,” trace amounts of the radioisotope can be found in soil, food, and the air.

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FDA Approves Therapy For Rare Disease Without Randomized Trial Data

The Food and Drug Administration on Aug. 14 approved a therapy for a rare disease called recurrent respiratory papillomatosis (RRP).

Regulators cleared Papzimeos, an immunotherapy made by Precigen, citing data from a single-arm, open-label trial that looked at how it performed in adults with RRP and who needed at least three surgeries a year.

Patients received four injections of the therapy over 12 weeks following surgical procedures.

About half of the participants needed no surgery in the year following treatment. The safety profile was also deemed favorable.

“Randomized trials are not always needed to approve medical products and this approval is proof of that philosophy,” Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

“The FDA will always demand the correct clinical study for the specific medical product and disease. Our requirements for products given to tens of millions of healthy people will be different than products given to at most hundreds or thousands of patients with unique diseases.”

The approval is the first announcement from Prasad after he rejoined the FDA following his July resignation.

Prasad had received criticism for not approving enough new drugs and therapies, including from the editorial board of the Wall Street Journal, which said that Prasad “has long criticized such single-arm studies that have no placebo groups.”

Replimune’s treatment for advanced melanoma is among the drugs the FDA has rejected since Prasad became its top vaccine and biologics official.

Prasad said in May that he favors randomized clinical trials but that for some rare diseases, it would be difficult or even impossible to complete such trials. He said that the FDA would have a “flexible regulatory standard” that takes into account “the context of a disease.”

In June, in an article co-authored by FDA Commissioner Dr. Marty Makary, he said that for some products targeting rare diseases, “premarket randomized trials may not be feasible.”

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THE BOMBSHELL THEY COULDN’T BURY— FDA ADMITS IT: mRNA COVID VACCINES CAUSE “EXTREMELY HIGH” RISK OF MYOCARDITIS AND PERMANENT HEART DAMAGE

The FDA has officially labeled mRNA COVID-19 vaccines as carrying an “extremely high” risk of myocarditis and irreversible heart damage — especially in young men.

This is a public admission that the Biden regime, Big Pharma, and the media knowingly hid the dangers. Millions were injected without informed consent.

The truth is now official. And accountability is coming.

THE BOMBSHELL THEY COULDN’T BURY: FDA FORCED TO ADMIT THE TRUTH UNDER TRUMP’S COMMAND

For years, the American people were gaslit, mocked, silenced, deplatformed, and destroyed for daring to speak a single forbidden sentence:

“These vaccines are dangerous.”

In July 2025, the U.S. Food and Drug Administration (FDA) — operating under the restored constitutional leadership of President Donald J. Trump — has formally updated the safety labeling on all mRNA COVID-19 vaccines to include the chilling truth:

“EXTREMELY HIGH RISK of myocarditis, particularly in young males, with a real potential for irreversible heart damage.”

Pfizer’s Comirnaty and Moderna’s Spikevax — the sacred cows of Big Pharma, promoted with religious intensity during the Biden regime — are now officially marked as potential death sentences for America’s youth. This isn’t conspiracy. It’s regulatory fact.

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SHOCKING: FDA Commissioner Dr. Makary Says NIH ‘Brewed Up a Virus That Killed 20 Million People Worldwide’

Newly appointed FDA Commissioner Dr. Marty Makary pulled no punches as he directly accused the National Institutes of Health (NIH) of funding the lab responsible for creating the virus that sparked the COVID-19 pandemic and claimed the lives of over 20 million people globally.

Speaking to NewsNation’s Connell McShane, Dr. Makary blasted the former NIH leadership for pouring taxpayer dollars into unaccountable pet projects, including the now-infamous lab that engineered the virus that triggered a global pandemic.

Dr. Makary:
The way it used to be. We’re planning to change our health agencies for a generation or longer. Look at the NIH. When J. Bhattacharya came in there, it was a mess. Fourteen percent of the grants were descriptive studies on health equity.

And the NIH had just funded a lab that brewed up a virus that killed 20 million people worldwide. So they’re getting back to studying root causes, a cure for cancer, debilitating neurodegenerative diseases, and they’re going to do good work.

Connell McShane:
Right, but you have to do it with fewer people. Is that a challenge with the cuts, or is that not really what it’s made out to be either?

Dr. Makary:
The FDA is strong, and it’s going to continue to be strong. The cuts were consolidations. There were no layoffs to scientific reviewers or inspectors at the FDA.

There was consolidation of the twelve travel offices at the FDA. And so we’re going to institute teamwork and break up the fiefdom culture within the agency. It’s an interesting conversation.

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FDA’s Mercury Cover-Up – – Poison In Our Teeth

 In a shocking betrayal of public trust, the U.S. Food and Drug Administration (FDA) has suppressed vital information about Mercury dental amalgam, misleadingly called “silver fillings,” which contain 50% mercury—one of the most toxic non-radioactive substances known.

The FDA refuses to mandate that dentists disclose this danger to patients, while dental boards, influenced by the American Dental Association (ADA)—a trade organization, not a public health authority—punish dentists who reject Mercury use and prioritize safe removal with rigorous informed consent, threatening their licenses. This double-standard is an outrage, leaving millions – – including South Florida’s families, military personnel and veterans – – unaware of the neurotoxin in their mouths.

A groundbreaking 2025 mini-review by Anita Vazquez Tibau, your author, and Blanche D. Grube, DMD, Will the US Food and Drug Administration (FDA) Follow the European Union’s Mercury Dental Amalgam Ban? A Mini-Review, exposes this scandal and demands reform. A new citizen petition calls for immediate action, and Floridians can join the fight by submitting comments at http://www.regulations.gov.

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Paul “Vaccine Puppet” Offit BUSTED exposing the absolute FRAUD of the FDA’s vaccine “licensure” protocol

The man who put a deadly pig virus in the Rotateq Rotavirus vaccine and made millions off it (pardon the pun with his name), just got busted exposing the ultimate dirty vaccine fraud and vaccine failure. The puppet of the vaccine industrial complex is a scam artist of the highest and most insidious magnitude, but he loves to run his mouth about it all. This is the same dirty vaccine pushing schmuck who admitted that vaccines are a violent act.

Many parents today are concerned about the number of vaccines their children are scheduled to receive under the Centers for Disease Control and Prevention (CDC) guidelines. As a more cautious approach, some parents seek antibody titer tests — blood tests that measure a child’s existing immunity to specific diseases — to potentially avoid unnecessary vaccinations.

  • Paul Offit Dismisses Antibody Testing, But Ignores Valid Parental Concerns: In a CHOP video, Dr. Paul Offit argues that antibody titer tests are unreliable indicators of immunity and urges parents to follow the CDC vaccine schedule instead. However, his argument fails to address legitimate safety concerns and presumes, without evidence, that the full schedule is safe.
  • Scientific Contradictions and Vaccine Licensing Exposed: Offit acknowledges that antibody levels don’t always correlate with immunity — yet this is the very measure the FDA uses to license vaccines. This contradiction reveals a major flaw in the FDA’s approval process and raises questions about the scientific validity of current vaccine policy.
  • Evidence of Vaccine Failure Undermines Offit’s Position: Offit cites past measles outbreaks to justify vaccination but omits that a significant portion of cases occurred in fully vaccinated individuals. Historical data show that vaccine failure — both primary and secondary — was a driving force behind adding a second measles dose to the schedule.
  • Undisclosed Conflicts of Interest Raise Ethical Red Flags: Offit’s financial ties to the pharmaceutical industry — including profits from a Merck rotavirus vaccine — go undisclosed in the CHOP video. This, combined with CHOP’s industry partnerships, casts doubt on the objectivity of their messaging and underscores concerns about propaganda replacing informed consent.

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Top FDA Official Resigns in Disgrace After Exposé by Investigative Journalist Laura Loomer

Dr. Vinay Prasad — a radical left-wing ideologue who wormed his way into one of the most powerful regulatory roles in the federal government — has officially resigned from the Food and Drug Administration following a explosive exposé led by investigative journalist Laura Loomer.

For weeks, Loomer publicly exposed Prasad’s shocking anti-Trump rhetoric, far-left allegiances, and dangerous abuse of regulatory power.

“We have a crisis at the FDA! A wolf in sheep’s clothing is sabotaging President Trump’s bold “Make America Healthy Again” (MAHA) agenda!” Loomer wrote on X.

Loomer continued, “This is no mere bureaucratic misstep. It’s a catastrophic vetting failure that threatens to derail the America First healthcare revolution. Prasad’s anti-Trump rhetoric, radical left-wing ideology, and deliberate actions to obstruct our President’s deregulatory mission prove he’s a dangerous misfit. The time to act is NOW—Prasad must be REMOVED before he destroys Trump’s vision for a healthier America!”

According to Loomer:

In 2021, Prasad described himself as a “political liberal, closest to Elizabeth Warren” and a “Sanders/Warren liberal,” proudly embracing a progressive identity. He voted for Bernie Sanders in the 2016 Democratic primary, and FEC records reveal he donated to Sanders’ campaign, signaling his support for radical left-wing policies.

In 2020, Prasad declared on X that he wanted “Biden to win more than anything” and confirmed he voted against Trump, solidifying his opposition to the President.

Prasad’s policy positions are a direct affront to the conservative principles underpinning Trump’s agenda. He advocates for universal basic income, student loan forgiveness, open borders, and Roe v. Wade abortion standards. He supports a 50% marginal tax rate for high earners, a wealth tax, single-payer healthcare, universally funded pre-K and community college, and expansive parental leave policies.

[..]

Prasad’s disdain for Trump is personal and vitriolic. He has called the President “perhaps the worst president in the history of the Republic.” Prasad has claimed that Trump disagreed with him “on probably 90% of issues.” He compared Trump’s family separation immigration policy to a “human rights violation” worthy of the International Criminal Court. Prasad mocked his election fraud claims as “laughable and pathetic,” and called January 6 “a terrible day.” Further, he even attacked Trump University as a “scam.” Prasad consistently refers to the President as “orange man.” This is a derogatory jab used by the radical Left to attack Trump over his tan skin. Prasad has a strong admiration for Dr. Anthony Fauci, whom he dubbed “St. Anthony of Fauci” with “profound reverence.” Thisfurther highlights his alignment with figures Trump has criticized, particularly over the COVID-19 response.

Since assuming control of CBER at the FDA, Prasad has amassed unprecedented power. He holds three key FDA roles: Chief Medical Officer, Chief Scientific Officer, and Director of CBER. Reports suggest he is under consideration to lead the Center for Drug Evaluation and Research (CDER). This could make him more influential than FDA Commissioner Marty Makary. Moreover, this consolidation of authority in the hands of a Trump antagonist and avowed Leftist is a recipe for disaster. Prasad’s actions further demonstrate a clear intent to undermine President Trump’s vision.

Read more here.

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FDA allows distribution of muscular dystrophy drug again after public criticism

After blocking a new muscular dystrophy therapy in order to investigate patient deaths, the Federal Drug Administration reversed course after criticism and restored hope to parents seeking a treatment to aid children affected by the debilitating disease. 

The FDA’s initial decision to freeze distribution of the therapy, marketed as Elevidys, following at least three patient deaths potentially connected to the therapy, stirred criticism from advocates for muscular dystrophy patients and from health policy experts. Added to the mix of criticism about the initial decision were the attacks and defenses of Dr. Vinay Prasad, the agency’s top biologics official, who supported progressive candidates and criticized several of President Trump’s key health policies in the past. 

The company that produced the therapy, Sarepta Therapeutics, initially resisted the freeze, but eventually paused shipments of its innovative product, opening its stocks up to a hammering that threatened to put the company’s future in serious jeopardy. According to financial analytics website companiesmarketcap.com, Sarepta’s market cap fell yesterday to $1.56 billion from $14 billion a year ago. Market capitalization, commonly called market cap, is the total market value of a publicly traded company’s outstanding shares — held by institutional investors and the public at large — and is commonly used to measure how much a company is worth.

The “Right-to-try”

The reversal of the pause aligns with President Donald Trump’s longtime advocacy for the right-to-try. During his first term, the president signed a new law giving terminally ill patients the opportunity to seek new or experimental treatments without obtaining the approval of the FDA, which had been required in the past. 

The FDA demanded on July 18 that Sarepta pull Elevidys from the market and halt all shipments to patients after reports of two deaths connected to the treatment. Elevidys is not an experimental drug, and was approved by the FDA under certain circumstances in 2024. It is a prescription gene therapy designed to treat patients with Duchenne Muscular Dystrophy, a genetic disorder that leads to the breakdown and decay of muscles over time and mostly impacts male children. 

Despite initially refusing to voluntarily pause shipments of the therapy, Sarepta eventually agreed to a “temporary pause” to allow “the necessary time to respond” to the FDA and to finish the “safety labeling supplement process.” 

The reaction was immediate. After the pause was announced, the Parent Project Muscular Dystrophy, a nonprofit organization dedicated to ending the disease by supporting research and advocating for care, criticized the decision. 

“These reports are profoundly upsetting and raise serious concerns for our entire community,” PPMD said in a statement. “Families who have fought tirelessly for access to this therapy, those who have already received it, and those who are in line to receive it are now left with more questions than answers.” 

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Antidepressants During Pregnancy Raise Risk of Birth Defects, Doctors Tell FDA

The U.S. Food and Drug Administration (FDA) needs to do a better job of warning pregnant women that taking SSRIs, a type of antidepressant, may harm them and their developing baby, doctors told the agency Monday.

The FDA hosted an expert panel of developmental biologists, psychiatrists, epidemiologists, obstetricians and mental health experts who discussed selective serotonin reuptake inhibitors (SSRIs) and pregnancy. The agency livestreamed the two-hour conversation on YouTube and X.

SSRIs have been “implicated in different studies to be involved in postpartum hemorrhage, pulmonary hypertension and cognitive downstream effects in the baby, as well as cardiac birth defects,” said FDA Commissioner Marty Makary, who opened the event.

Nearly 1 in 4 middle-aged women and up to 5% of pregnant women are on an antidepressant, Makary said.

“Antidepressants like SSRIs can be an effective treatment for depression, but we have to stop and also look at the big picture,” he said. “The more antidepressants we prescribe, the more depression there is. … We have to start talking about root causes.”

SSRIs in particular warrant scrutiny as serotonin “may play a crucial role in the development of organs of a baby in utero,” he said.

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