Tag: fda

FDA warns seniors to avoid this vaccine after deadly complications

Older adults are being warned against receiving the chikungunya vaccine before traveling.

The Ixchiq vaccination, developed by Valneva to prevent the mosquito-borne chikungunya virus, was approved by the Food and Drug Administration (FDA) in November 2023 as the first of its kind.

The approval applies to anyone aged 18 and older who has a risk of being exposed to the virus.

But the FDA and the Centers for Disease Control and Prevention (CDC) released a safety notice on May 9 recommending that adults over 60 years old pause use of the vaccine due to fatal complications.

“FDA and CDC will continue the evaluation of post-marketing safety reports for Ixchiq,” the release reads.

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FDA To Deploy Artificial Intelligence Across Agency

The Food and Drug Administration (FDA) is planning to roll out artificial intelligence across the agency following a successful pilot program.

FDA Commissioner Dr. Marty Makary has directed all FDA centers to immediately start using artificial intelligence (AI) and fully integrate it by the end of June, the FDA said in a May 8 statement.

By June 30, all centers will use what the agency described as a “common, secure generative AI system integrated with FDA’s internal data platforms.”

“I was blown away by the success of our first AI-assisted scientific review pilot,“ Makary said in a statement. ”We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process. The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies.”

AI refers to computer systems that can carry out complex tasks typically performed by humans.

“AI can be generally described as a branch of computer science, statistics, and engineering that uses algorithms or models to perform tasks and exhibit behaviors such as learning, making decisions, and making predictions,” FDA officials said in 2023.

Makary said on Thursday that past years have featured discussions on utilizing AI and that it’s time to start using it to save time, with some tasks that once took days now taking mere minutes.

“We at the FDA now have to ask big questions that we’ve never asked before. Why does it take over 10 years for a new drug to come to market? Why are we not modernized with AI and other things? We’ve just completed our first AI-assisted scientific review for a product and that’s just the beginning,” he said earlier in the week on social media platform X.

The rollout across the FDA is being coordinated by Jeremy Walsh, Booz Allen Hamilton’s former chief technologist, who was recently appointed as the agency’s chief AI officer, and Sridhar Mantha, who previously led the Office of Business Informatics at the FDA’s Center for Drug Evaluation and Research.

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RFK Jr. just made his best hire yet (and that’s saying something)

Yesterday, the Food and Drug Administration named Dr. Vinay Prasad, a San Francisco oncologist, as its top regulator for vaccines and other complex drugs called biologics.

This is a YUGE move.

I know Prasad. He is deeply thoughtful about the value and cost of new medicines. He understands the games Big Pharma plays to win approvals for expensive new drugs that all-too-often have little benefit — and hidden risks.

Those games often rely around the design of clinical trials: keeping them short for a drug that may be used for years; including only the healthiest possible patients (for example, the Covid-19 mRNA vaccine trials included few people over 80, who should have been the focus of the trials); comparing them to other drugs that have serious side effects and are not the true “standard-of-care.”

They also include pressure campaigns to push regulators to quickly approve drugs for serious conditions like cancer on the basis of “surrogate endpoints.” Drug companies, and the desperate patients they work with and fund, argue any treatment is better than no treatment.

They’re wrong.

Even for people who are dying, they’re wrong — at least on the institutional level.

The human body is incredibly complex. Efforts to modify disease and healing processes are even more complex. Medicine is rife with stories of treatments, from bloodletting to lobotomies, that did more than harm than good but that became accepted cures for decades or centuries.

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Secret recordings with ousted FDA vaccines chief suggest disinterest in documenting vax injury

The Food and Drug Administration’s top vaccine official until late-March met online several times with a COVID-19 vaccine injury group’s leader, who, opposing the vaccines in part, begged him to no avail to take severe adverse events such as paresthesia as a precursor to neuropathy seriously and to urge doctors to treat them as such rather than write them off as “anxiety,” secret recordings suggest.

The Informed Consent Action Network (ICAN) released the videos, compiled on “The Real Peter Marks“ website, with other documentary evidence from Marks’ leadership of the COVID response starting with Operation Warp Speed, at the National Press Club in Washington on Tuesday.

They also include a virtual meeting between San Francisco intensive care unit doctor Patricia Lee, Marks and other FDA officials, who asked no questions after Lee said a patient’s severe complications from vaccination at 22 weeks’ pregnancy and related death prompted a “nervous breakdown” among nurses on her shift, requiring a psychiatrist’s overnight visit.

ICAN CEO Del Bigtree shared pieces of Lee’s Oct. 22, 2021, conversation with FDA officials, who allegedly ignored her pleas for vaccine-injured patients until she brought “legal pressure,” on his show two weeks earlier with ICAN lawyer Aaron Siri and REACT19 founder Brianne Dressen, whose neurological injuries from the AstraZeneca vaccine trial were confirmed by the NIH. 

Organized as an animated vertical timeline that loads as it scrolls, the Marks website loaded slowly during Just the News’ review Wednesday. “They are receiving a ton of traffic and working on it,” a spokesperson said in the early afternoon.

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Not so fast on the FDA’s food dye ban — the Supreme Court has changed the rules 

Last week, the Food and Drug Administration announced long-awaited bans on certain food dyes and added new warnings about sugar in processed foods. Public health advocates cheered. Parents breathed a sigh of relief. But as someone who has spent years reporting on the intersection of federal science, health and regulation, I have a warning: In today’s legal climate, we are celebrating too soon. 

The Supreme Court’s recent reversal of the Chevron doctrine means every new regulation is now living on borrowed time — and the FDA’s food dye ban may be its first casualty. 

For 40 years, the “Chevron deference” gave federal agencies the benefit of the doubt in their interpretations of ambiguous laws within their areas of expertise. So when Congress writes broad rules, courts are to give agencies like the FDA, EPA and NOAA wide latitude to fill in the scientific and technical details.

But last year, in a move cheered by conservative legal activists, the Supreme Court struck down Chevron. Now, federal judges need not give such great deference to agencies as to what the law means, even on issues where the judges have no practical experience, such as food additives and clean air.

This is a landmark shift with potentially far-reaching consequences. While a regulation-friendly administration like Joe Biden’s can’t guarantee that new public health protections will survive the courts, Robert F. Kennedy Jr.’s FDA under the Trump administration should prepare to encounter similar hurdles.

The Chevron ruling presented us with a fitting preview of what happens when judges — as opposed to subject-matter experts at relevant agencies — determine the best way to interpret applicable regulatory frameworks within the law.

Justice Neil Gorsuch, in a concurring opinion overturning Chevron, referenced “nitrous oxide” as a pollutant from coal plants. Nitrous oxide — the compound best known for providing the temporary euphoria you may experience while a dentist fills a cavity — has nothing to do with the “nitrogen oxides” that actually come out of smokestacks and threaten respiratory health.  

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MAHA Rising: HHS, FDA Announce Phase-Out Of All Artificial Food Dyes

Health and Human Services Secretary Robert F. Kennedy Jr’s quest to “Make America Healthy Again” grew far more substantial on Tuesday, with the announcement that the federal government will eliminate all petroleum-based synthetic food dyes by the end of 2026. The announcement came at a Washington DC news conference, with RFK Jr joined by Food and Drug Administration (FDA) Commissioner Marty Makary and National Institutes of Health Director Jay Bhattacharya. The podium was flanked by “MAHA Moms” and their children; the moms are a coalition of outspoken advocates of the Trump administration’s health agenda.  

Kennedy framed the move against artificial, petroleum-based dyes using forceful language: 

“For too long, some food producers have been feeding Americans petroleum-based chemicals without their knowledge or consent. These poisonous compounds offer no nutritional benefit and pose real, measurable dangers to our children’s health and development. That era is coming to an end. We’re restoring gold-standard science, applying common sense, and beginning to earn back the public’s trust. And we’re doing it by working with industry to get these toxic dyes out of the foods our families eat every day.”

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FDA Removing Pharmaceutical Representatives From Advisory Panels

The Food and Drug Administration (FDA) is removing pharmaceutical company representatives from advisory committees in a bid to limit industry influence.

Dr. Marty Makary, the FDA’s new commissioner, issued a directive that eliminates the role of pharmaceutical representative

“Industry employees are welcome to attend FDA advisory committee meetings, along with the rest of the American public, but having industry employees serve as official members of FDA advisory committee members represents a cozy relationship that is concerning to many Americans,” Makary said in a statement on April 17. “In fact, the FDA has a history of being influenced unduly by corporate interests.”

The FDA has 32 different advisory committees, including panels that advise the agency on vaccines, food, and medical devices. Members are primarily a mix of federal employees and experts who do not work for industries.

But each FDA committee has an industry representative and an alternate industry representative. The Vaccine and Related Biological Products Advisory Committee, for instance, had a Pfizer officer and a Dynavax officer listed on the roster for its most recent meeting.

The industry representatives do not vote on what advice to convey to the FDA, but “offer perspective of a pharmaceutical company,” Kim Witczak, who has served on several FDA advisory committees, told The Epoch Times in an email.

“Sometimes they will say something that could influence or sway the discussion. I always wondered why they were on the committee,” she said.

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Fired FDA Chief Is Now Out Trashing RFK Jr. and his Autism Study on the Fake News – Big Pharma Has Most to Lose

Dr. Peter Marks, the FDA’s top vaccine official and a key figure in the first Trump administration’s Operation Warp Speed, was ousted from his post earlier this month.

​Dr. Peter Marks is an American hematologist-oncologist who has served as the director of the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) since 2016.

As CBER director, Marks was responsible for reviewing and providing advice during product development, evaluating applications, and making approval decisions based on safety and effectiveness data.

He oversaw the FDA’s vaccine programs and played a pivotal part in the rapid development and approval of the experimental COVID-19 vaccines under Operation Warp Speed during President Donald Trump’s first term.

Sources close to the matter told the Wall Street Journal that Marks submitted his resignation on Friday after a blunt ultimatum from a Health and Human Services (HHS) official: step down voluntarily or face termination.

His exit, effective April 5, marks yet another victory for HHS Secretary Robert F. Kennedy Jr.’s aggressive push to purge the federal health apparatus of what he calls entrenched bureaucrats peddling “misinformation and lies.”

It was very telling that Big Pharma stocks plunged following his resignation.

Shares of vaccine makers Moderna and Novavax, along with several other biotech companies, plunged following his resignation.

Now, Marks is out hitting the Sunday shows and attacking Robert Kennedy Jr.  It makes you wonder who is behind this?

The Disgraced former FDA official is ALREADY defending Big Pharma from RFK Jr’s groundbreaking study on autism.

This is how committed the Big Money players are with keeping the vaccines flowing no matter how many Americans will be injured or killed.

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Arcturus Therapeutics Receives U.S. FDA Fast Track Designation for the STARR® mRNA Vaccine Candidate ARCT-2304 for Pandemic Influenza A Virus H5N1

Apr. 10, 2025– Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicine company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the self-amplifying mRNA (sa-mRNA) vaccine candidate, ARCT-2304, designed for active immunization to protect against disease caused by influenza A H5N1 subtype contained in the vaccine. This designation recognizes the potential of ARCT-2304 as an innovative approach to address unmet medical needs for the prevention of disease caused by pandemic influenza A virus H5N1, a significant global health risk. The Phase 1 clinical study initiated in November 2024.

Fast Track Designation from the FDA is granted to vaccines intended to prevent serious conditions caused by infectious disease. The designation is designed to expedite the development and review process, providing several benefits, including enhanced communication with the FDA and eligibility for priority review, and the possibility of a rolling review.

“We are pleased to receive Fast Track Designation from the FDA for ARCT-2304,” said Joseph Payne, President and CEO of Arcturus Therapeutics. “We remain steadfast in our commitment to the U.S. government to develop safe and effective STARR® next-generation mRNA vaccines to protect U.S. citizens from future pandemic threats. This designation from the FDA is an important step forward in our mission to provide protective solutions for global health crises.”

This project has been supported in whole with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50122C0007.

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As Kratom Consumers Face Global Market Disruption, It’s Time For FDA To Put Safety Over Stigma

For over a decade, the U.S. Food and Drug Administration (FDA) has quietly crippled the kratom supply chain. Now, Indonesia’s new export regulations—meant to raise kratom quality standards and appeal to U.S. regulators—may have just squeezed the most responsible products out of the market.

At the end of 2024, the Indonesian government enacted sweeping new trade regulations aimed at tightening the export market for kratom, a tree native to Southeast Asia with leaves containing psychoactive alkaloids that have long been used as an herbal remedy.

One provision of the policy strengthens quality control for kratom exports, which was notably absent in the past. Moving forward, all kratom shipments must be sterilized before leaving Indonesia, and only batches that meet minimum thresholds for the concentration of the primary active compound, mitragynine, will qualify for export. These steps are designed to limit contamination and prevent exporters from bulking up shipments with non-kratom plant material.

The second component of the regulations is a prohibition on the export of raw kratom leaf with a particle size over 0.6 millimeters, which includes crushed-leaf kratom. In the United States, crushed leaf is most often used to make extracts. By imposing particle size restrictions, Indonesia aims to ensure that the economic value of processing raw kratom into finished extract products stays within its own borders, rather than being captured by foreign companies.

These new standards represent a step forward for kratom quality control and international industry fairness. The intentions are worth celebrating and supporting.

However, the new regulations have also inadvertently disrupted the supply chain of safer, more traditional kratom products while failing to address the root cause of regulatory tension between the U.S. and Indonesia.

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