Tag: fda

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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FDA Says It Plans to Phase out Animal Testing for Drug Development

The Food and Drug Administration (FDA) on April 10 said it will be phasing out animal testing for monoclonal antibodies and other drugs.

FDA officials said that its animal testing requirement will be “reduced, refined, or potentially replaced” with other approaches, including advanced computer simulations utilizing artificial intelligence and lab-grown products that are designed to mimic human organs.

The agency will also start looking at preexisting, real-world safety data from other countries that have regulatory standards similar to those in the United States.

“For too long, drug manufacturers have performed additional animal testing of drugs that have data in broad human use internationally. This initiative marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments for Americans while reducing animal use,” FDA Commissioner Dr. Marty Makary said in a statement.

He said that the move “represents a major step toward ending the use of laboratory animals in drug testing.”

Companies that submit what the agency described as strong safety data from non-animal testing could receive faster review, according to the FDA.

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Why Did The FDA Hide Vaccine Injuries?

A frequent criticism of corporations (which I believe also applies to governmental bureaucracies) is that their organizational structure encourages sociopathic behavior. This is because members of these entities are shielded from legal or personal accountability for their actions, with any wrongdoings being attributed to the corporation as a whole. In contrast, the main form of accountability most members face is the pressure to advance the institution’s mission (e.g., make more money), leading to the proliferation of increasingly unethical methods to achieve that goal.

To illustrate, consider this quote from Peter Rost, a former executive at Pfizer and one of the few pharmaceutical leaders to speak out against the industry:

It is scary how many similarities there are between this industry and the mob. The mob makes obscene amounts of money, as does this industry. The side effects of organized crime are killings and deaths, and the side effects are the same in this industry. The mob bribes politicians and others, and so does the drug industry … The difference is, all these people in the drug industry look upon themselves – well, I’d say 99 percent, anyway – look upon themselves as law-abiding citizens, not as citizens who would ever rob a bank … However, when they get together as a group and manage these corporations, something seems to happen … to otherwise good citizens when they are part of a corporation. It’s almost like when you have war atrocities; people do things they don’t think they’re capable of. When you’re in a group, people can do things they otherwise wouldn’t, because the group can validate what you’re doing as okay.

In looking through what went awry with the COVID-19 response, while Fauci was commonly blamed for all that went amiss, I kept running into another less-known individual who, while hidden within the FDA bureaucracy, I believe was directly responsible for many of the mishaps that happened

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Who Needs Vaccine Data When You Have Vaccine Mandates?

FDA Gene-Editing mRNA Vaccine Chief – Peter Marks – has always been a strong proponent of vaccine mandates. Marks also has as a history of overruling large expert panels for FDA approval of gene therapies at the agency.

STAT News reported that “Marks was one of the architects of Operation Warp Speed, the $18 billion U.S. effort to speed development of Covid-19 vaccines. He regularly embraced regulatory flexibility. And he spoke not infrequently about the importance of accelerated approval for next-generation treatments, including with those whose potential benefits weren’t always crystal-clear in clinical trial data.”

“Vaccine Mandates Are Not Going to Get Us THERE. It’s Got to Be Compelling Evidence.” – Vaccine Chief Peter Marks

During a 4-hour Public Health Workshop hosted by Duke University on March 20, 2025, Marks alluded to having contentious disputes with the higher-ups of the new Health & Human Services (HHS) administration (aka – Secretary Kennedy) over ‘the need for vaccine efficacy and vaccine safety data’ when FDA-approved vaccines can just be mandated.

“How We Generate Evidence Going Forward”

Throughout the 4-hour workshop, Marks and his colleagues strategically avoided discussing retrospective data analyses (i.e. analyzing the adverse events of vaccines in the US government databases) and the specifics on how to measure safety data going forward.

“By Definition, Vaccines Are Very Safe Medical Products”

“By definition, when we are developing vaccines for broad use, one of their direct benefits has to be that they are very safe medical products. That just goes without saying, because that goes to getting acceptance for the individual’s direct benefit.”

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Congressional Committee Invites Hemp Industry Expert To Testify At Hearing On How FDA ‘Failed’ To Regulate Products

A congressional committee has scheduled a hearing for next week focused on the Food and Drug Administration (FDA), inviting a hemp industry representative to testify on how the agency “failed” to approve certain products such as CBD.

The House Oversight Committee hearing—titled “Restoring Trust in FDA: Rooting Out Illicit Products”—is set to take place on Wednesday.

FDA “failed to approve products and take necessary enforcement actions resulting in a flood of illicit and counterfeit products entering the country,” a memo on the hearing says.

The meeting won’t exclusively focus on cannabis issues. But among the four listed witnesses selected to testify is Jonathan Miller of the U.S. Hemp Roundtable, an organization that has long criticized FDA’s inaction on CBD and other cannabinoid regulations since the crop was federally legalized under the 2018 Farm Bill.

Miller told Marijuana Moment on Friday that he expects the hearing to be “wide-ranging,” but his testimony will concentrate on “all the challenges the hemp industry has been having by the FDA’s failure to regulate our products.”

He said that his testimony will serve as an “update” on issues he outlined during a 2023 hearing before a subcommittee of the full panel, where lawmakers raised concerns about FDA’s refusal to establish rules allowing for the marketing of federally legal hemp as a food item or dietary supplement.

In the two years since that initial meeting, the hemp market has faced repeated regulatory challenges—with a growing number of states moving to enact bans on certain hemp products due to the lack of regulations around intoxicating cannabinoids such as delta-8 THC that have become widely available.

“Nothing has happened at the FDA” to resolve the issue, Miller said. “And we think these ban efforts have a lot to do with the fact that we’re not regulated. So if we can get regulated, hopefully people will drop the efforts to ban our products.”

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Marjorie Taylor Greene Demands FDA Pull Approval of Dodgy COVID Vaccines ‘Causing Permanent Harm and Death’

Congresswoman Marjorie Taylor Greene is demanding the Food and Drug Administration (FDA) pull approval of the dodgy coronavirus vaccines.

The conservative firebrand pointed out in a post on the X platform that the vaccines are causing “permanent harm and deaths.”

She wrote:

FDA approval for COVID-19 vaccines needs to be pulled and they need taken off the childhood vaccine schedule ASAP.

COVID-19 vaccines are causing permanent harm and deaths.

I’ve been saying this ever since they were created and my personal Twitter account was permanently banned for my outspoken stance against the vaccines until Elon Musk bought Twitter, changed it to X, and restored my account along with thousands of people who were censored and silenced.

The truth remains the same. COVID-19 vaccines should have never received approval and they’ve known the entire time how bad the side effects are and deaths caused by them. It’s time to do the right thing. Stop the COVID-19 vaccines.

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RFK Jr. Seeks To End Rule Allowing Food Companies To Bypass FDA Ingredient Approval

The U.S. Department of Health and Human Services (HHS) said on March 10 that it is seeking to terminate a rule allowing food manufacturers to use additives without formal regulatory approval.

The Generally Recognized As Safe (GRAS) rule allows companies to self-approve the inclusion of additives in food items without requiring a review and the approval of the U.S. Food and Drug Administration (FDA). The rule enables manufacturers to add an ingredient even if the FDA has not determined its safety.

On Monday, HHS Secretary Robert F. Kennedy Jr. directed the acting FDA commissioner to explore the possibility of eliminating the “self-affirmed GRAS pathway” available to companies, the department said in a statement.

“This will enhance the FDA’s oversight of ingredients considered to be GRAS and bring transparency to American consumers,” HHS said.

As of now, manufacturers submit notices through the FDA’s GRAS notification program, which is not a mandatory process. The agency assesses 75 such submitted notices on average each year.

By eliminating the self-affirm pathway, companies would be required to publicly notify the FDA before introducing new ingredients to food items. The notification must include details such as underlying safety data and the intended use of the ingredients

A 2022 analysis conducted by the activist organization Environmental Working Group found that “nearly 99 percent of all food chemicals introduced since 2000 were greenlighted for use by the food and chemical industry” through the GRAS rule, without requiring FDA approval.

Out of the 766 new chemicals added to the food supply since 2000, only 10 involved companies petitioning the FDA to approve the ingredient.

Nine out of the 10 FDA petitions were filed before 2010. The only petition filed post-2010 was in 2018, EWG said.

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