Tag: fda

Pfizer hires ex-FDA drug chief as top doctor

The former head of the Food and Drug Administration’s (FDA) drug division is joining Pfizer as its chief medical officer, the company announced Monday. 

Patrizia Cavazzoni was formerly director of the FDA’s Center for Drug Evaluation and Research (CDER) from 2020 until January, when she resigned just ahead of President Trump’s return to office. 

Cavazzoni previously worked at Pfizer prior to joining the FDA in 2018.  

The announcement spurred renewed criticisms about the common “revolving door” between the FDA and industry. Critics worry the close relationship leads to a quid pro quo and favoritism toward industry.

Robert Califf, who served as FDA commissioner under President Obama, left the agency to advise Google Health and its spinoff, Verily Life Sciences. The move garnered criticism and opposition from some Senate Democrats like Sen. Elizabeth Warren (D-Mass.) when President Biden nominated him for the same job.

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FDA Misled The Judiciary About Pfizer’s Vaccine Documents

On December 6, 2024, a federal judge ordered the US Food and Drug Administration (FDA) to release documents related to the emergency use authorisation of Pfizer’s Covid-19 vaccine. These documents had been hidden from public view.

The legal battle traces back to September 2021, when attorney Aaron Siri filed a lawsuit under the Freedom of Information Act (FOIA) on behalf of the Public Health and Medical Professionals for Transparency. The plaintiffs sought access to the vast trove of documents the FDA relied on to approve Pfizer’s vaccine.

Initially, the FDA proposed a slow release schedule. In November 2021, the agency stated it would release just 500 pages per month—a pace that would have stretched the full disclosure process to 75 years. 

However, in January 2022, District Judge Mark Pittman of Texas rejected the FDA’s proposal, ordering the agency to expedite its release to 55,000 pages per month, aiming to complete the disclosure of all 450,000 pages by August 2022.

As the documents trickled out, researchers began uncovering glaring gaps that prevented a systematic review of the data. These gaps fueled suspicions about what else the FDA might be withholding. 

It became evident that the FDA had withheld records directly tied to its emergency use authorisation of Pfizer’s vaccine, estimated to be over one million pages. 

These documents, which the FDA had full knowledge of, were excluded from earlier disclosures, effectively misleading the judiciary and undermining public trust.

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Emails reveal FDA refused to monitor select COVID-19 vaccine injuries from select vaccine manufacturers

In the first 18 months following the rollout of COVID-19 vaccines, the U.S. Food and Drug Administration (FDA) detected consistent safety alerts for the Janssen vaccine but largely overlooked similar risks for Pfizer and Moderna shots, according to newly released emails. These records, obtained through a Freedom of Information Act (FOIA) lawsuit by Children’s Health Defense (CHD), reveal a troubling pattern of oversight gaps in the federal government’s monitoring of vaccine injuries. Despite over 1.4 million adverse event reports in the Vaccine Adverse Event Reporting System (VAERS), the FDA’s data analysis failed to flag widely recognized risks like myocarditis and pericarditis for mRNA vaccines. The revelations raise critical questions about the adequacy of the government’s safety monitoring and its commitment to transparency during the pandemic.

The FDA emails, posted on the agency’s website, detail weekly data mining of VAERS reports from January 12, 2021, to July 5, 2022. The analysis, known as Empirical Bayesian (EB) data mining, showed consistent alerts for serious adverse events linked to the Janssen vaccine, including deep vein thrombosis and death. However, the same analysis yielded almost no alerts for Pfizer and Moderna vaccines, even for well-documented risks like myocarditis and pericarditis.

For example, the FDA noted an alert for “death” associated with the Janssen vaccine on March 8, 2022, and in every subsequent email. In contrast, the agency flagged only a handful of administration-related issues for Pfizer and Moderna shots, such as “mechanical urticaria” and “exposure via breast milk.” This discrepancy is striking, given that VAERS received over 15,000 myocarditis reports and 10,000 pericarditis reports for mRNA vaccines during the same period.

Ray Flores, senior outside counsel to CHD, criticized the FDA’s approach, stating, “The emails are further evidence of the federal government’s failure to make good on its promises to use VAERS as an ‘early warning system’ to detect and act on risks associated with the new vaccines.”

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The Compromised FDA Knows Exactly What It’s Doing

The sneaky bastards at the FDA did this a year ago, right under our noses. In January 2024, the FDA finalized a rule permitting Institutional Review Boards (IRBs) to waive or even alter informed consent requirements for clinical investigations deemed “minimal risk.” TTR guest author Jon Fleetwood, as always, brings us this news in his excellent reporting. Read his entire article here.

IRBs. Informed Consent. What does it all mean? If you don’t do research, you likely won’t know.

What is an IRB?

An Institutional Review Board (IRB) is a panel of individuals who review and oversee research studies that involve human participants. The IRB ensures that the studies are ethical and that they comply with all regulations. The IRB’s primary function is to protect the rights and welfare of the human research participants, making sure they are treated fairly, ethically and safely.

Anyone doing research must have an IRB, and that not only applies to direct human research (meaning the human is actually being given a drug or using a device), but also for indirect studies where the patient isn’t “touched” so to speak or actively involved. A direct example would be a clinical trial where a new drug is being tested. The human participants actually enroll in the trial and are given test doses of the medication. Even if a human participant is given a placebo, that research must be covered by an IRB to ensure the patients’ physical and psychological well-being. An example of an indirect study is one in which a company or other research entity is just using data from patients, with no direct patient interaction. In some cases an IRB is still needed to use data that may potentially identify who the subjects are.

The bottom line is that an IRB is needed for any drug, device assessment, survey or other study. And this is what makes the FDA’s ruling so unbelievable. Fleetwood says the implications are staggering, and he is absolutely right:

“Under this waiver, any person’s health data, biospecimens (such as blood or tissue samples), or medical records can be accessed and used for FDA-regulated research if it meets vague and highly subjective criteria.”

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Thiel-Linked HHS Nominee Threatens MAHA Ambitions with Biotech Stance

Late last November, President Donald Trump announced Jim O’Neill as his nominee for deputy secretary of Health and Human Services (HHS), where he would work under Robert F. Kennedy Jr., Trump’s pick for HHS secretary upon confirmation. As deputy secretary, O’Neill would essentially function as the Chief Operating Officer of the department, overseeing “the day-to-day operations of all sub-agencies” as well as leading “public health emergency preparedness,” i.e. the government’s policy responses to bio-terror events, pandemics, etc. In addition, O’Neill would “oversee the development and clearance of HHS regulations” and ostensibly be the main implementer of the “Make America Healthy Again” (MAHA) policy agenda.

Built on a promise to eliminate industry capture of public health regulatory agencies and curb the influence of Big Pharma and Big Food, Robert F. Kennedy Jr.’s MAHA movement played a crucial role in funneling would-be Kennedy voters into the Trump camp. MAHA, in essence, granted the Trump campaign a tinge of populist legitimacy among Covid era dissidents, which grew out of the shuttering of RFK Jr.’s independent presidential run.

However, O’Neill’s business connections, both past and present, as well as his previous statements on public health policy, strongly suggest that he is not only unlikely to implement the policies that MAHA-centric voters are expecting, but that he may in fact pursue an agenda that stands in direct conflict with the main tenets of the MAHA movement. Specifically, he advocates reforming the FDA to deregulate and accelerate the pathway from drug development to legalization. This would notably aid the biotech industry, which has long struggled to get its products approved outside of an “emergency”-based deregulatory paradigm.

When considering the investments and board positions that O’Neill himself has made and held in biotechnology companies, this would likely include mRNA products that Kennedy and other MAHA influencers have spent years criticizing since the Covid-19 pandemic — a clear contradiction between O’Neill’s views on public health, and those which the MAGA base were sold on the campaign trail.

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ICAN Acquires Critical FDA Safety Reports Concerning COVID-19 Vaccines After Years of Litigation

ICAN just got a 153 page document detailing COVID vaccine safety surveillance info collected by the FDA. Here’s the press release.

In a nutshell, the documents show that the FDA and CDC’s safety monitoring is inept. It generated no signals of adverse events of any significance. Not death, not myocarditis, not anything.

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J&J’s ketamine-derived nasal spray approved by FDA to treat depression

The Food and Drug Administration (FDA) approved Johnson & Johnson’s ketamine-derived nasal spray to help millions of U.S. patients suffering from severe depression.

Spravato, approved as a standalone treatment, is “the first and only monotherapy for adults living with major depressive disorder who have had an inadequate response to at least two oral antidepressants,” the pharmaceutical giant said Tuesday. 

An estimated 21 million adults in the U.S. are living with major depressive disorder, one of the most common psychiatric disorders, but one-third of them will not respond to oral antidepressants alone, hindering their quality of life, according to Johnson & Johnson. 

“Treatment-resistant depression can be very complicated, especially for patients who do not respond to oral antidepressants or cannot tolerate them. For too long, healthcare providers have had few options to offer patients much-needed symptom improvement,” Bill Martin, global therapeutic area head of Neuroscience at Johnson & Johnson Innovative Medicine, said in a statement. 

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The FDA Proposes a De Facto Cigarette Ban, Which Would Expand the Disastrous War on Drugs

On its way out the door, the Biden administration has proposed a rule that would effectively ban cigarettes by requiring a drastic reduction in nicotine content. The Food and Drug Administration (FDA), which unveiled the proposed rule on Wednesday, says the aim is to make cigarettes unappealing by eliminating their “psychoactive and reinforcing effects.”

In addition to cigarettes, the FDA’s proposed rule covers cigarette tobacco, pipe tobacco (except shisha for waterpipes), and cigars (except for “premium” cigars). All of those products would be limited to 0.7 milligrams of nicotine per gram of tobacco. That cap technically complies with a federal law that bars the FDA from banning tobacco products or “requiring the reduction of nicotine yields of a tobacco product to zero.” But the negligible amount of nicotine allowed under the rule would amount to both in practice.

The FDA, which first considered this policy under Scott Gottlieb during the first Trump administration, has abandoned the idea of gradually phasing in the nicotine reduction because that would initially result in “compensatory smoking.” That is, current smokers would be apt to inhale more deeply, take more or bigger puffs, or consume more cigarettes to get the nicotine dose to which they are accustomed, which would increase their exposure to the toxins and carcinogens in tobacco smoke. But avoiding that pitfall by mandating an immediate cut to a negligible nicotine level would magnify the black-market effects of de facto cigarette prohibition.

Given the disastrous results of the war on drugs, it is hard to fathom why a government agency in 2025 would think it is a good idea to expand that crusade to include products that are regularly consumed by nearly 30 million American adults. The proposed nicotine cap “would effectively outlaw almost all cigarettes currently being sold,” which would “benefit organized crime by igniting a robust illicit market for cigarettes and other tobacco products,” the Law Enforcement Action Partnership (LEAP) notes in an emailed press release.

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FDA Orders Pfizer to Add PARALYSIS WARNING to RSV Vaccine Labels

Last Wednesday, the FDA ordered Pfizer and GSK to add Guillain-Barre Syndrome (GBS) as a serious adverse event risk warning to both Pfizer’s Abrysvo and GSK’s Arexy Respiratory Syncytial Virus (RSV) vaccine labels.

RSV is the leading cause of respiratory infection in adults over the age of 60. Prior to 2023, the CDC has not published data on the incidence of RSV death in babies and children. In 2023, the CDC estimates that approximately 100 children under the age of 5 died from RSV. Despite these low numbers, the CDC recommends that pregnant women receive an RSV vaccine to ‘protect’ their baby from RSV.

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Full list of foods that have red dye 3 in them as FDA bans substance over cancer links

The FDA announced today it was banning the use of red 3 dye in foods in America, telling thousands of manufacturers to strip it from their products.

Food and drink makers have until January 2027 to reformulate their recipes or be forced out of the market.

The FDA agency said it was taking the action as a ‘matter of law’ because some studies have found that the dye caused cancer in lab rats. 

‘The FDA is taking action that will remove the authorization for the use of… Red No. 3 in food and ingested drugs,’ said Jim Jones, the FDA’s deputy commissioner for human foods. 

The dye has been used for decades to give candy, soda, and other foods and vibrant, cherry-red hue. It was banned from cosmetics by the FDA about three decades ago.  

There is no indication so far that food manufacturers will challenge the new rule, and they will have sufficient time to adjust their products to meet the new standards.

There is some concern that manufacturers may opt to use red 40, which, along with red 3, has been associated with various health concerns.

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