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Compounding pharmacies SUE the FDA for restricting off-label Tirzepatide production and favoring Eli Lilly

14 days ago -

The Outsourcing Facilities Association (OFA) has filed a lawsuit against the Food and Drug Administration (FDA) following the agency's recent decision to remove Eli Lilly's tirzepatide from its drug shortage list. The removal grants Eli Lilly exclusive rights to sell the drug, while compounding pharmacies are barred from producing it. This move has serious implications for the compounding pharmacy industry, which has been thriving on the production of compounded versions ...

Former New York COVID Czar admits to manipulating the public and defrauding the FDA while participating in perverted romps

a month ago -

COVID Czar-turned pharmaceutical tycoon admits to using media spin to defraud the public and the FDA

Currently the executive vice president and chief medical officer at the pharmaceutical company SIGA Technologies, Dr. Jay Varma has disclosed exactly how pharmaceutical companies manipulate the public so they can defraud the FDA and boost their stock prices.

“We want the Food and Drug Administration, the FDA, to approve our drug specifically for Monkeypox ...

FDA approves monkeypox vaccine despite acknowledging that it is DANGEROUS

a month ago -

The regulator approved the ACAM2000 vaccine on Aug. 29. The Defender's Suzanne Burdick said in a report that the vaccine was made by Emergent BioSolutions, a company specializing in vaccines for biochemical warfare threats such as anthrax and smallpox. While ACAM2000 was initially approved for smallpox in 2007, the FDA's recent expanded supplemental approval allows it to be injected into those at "high risk" for monkeypox, such as members of the LGBT community.

According ...

FDA-approved monkeypox vaccine causes DEATH in the vaccinated and can spread to UNVACCINATED people and kill them too

a month ago -

Yes, the ACAM2000 is a live replicating vaccinia virus vaccine that, per the adverse reactions listed on the warnings insert, can cause severe disability, inflammation of the brain and spinal cord, permanent neurological sequelae (long term infection), death of the vaccinated individual, and … wait for it… “death of unvaccinated individuals who have contact with vaccinated individuals.” You cannot make this stuff up.Monkeypox vaccine can kill the vaccinated person, the fetus, ...

FDA is still using emergency use authorization to release COVID-19 shots without meeting safety standards

a month ago -

How did they get away with it this time around? Much like the first COVID-19 vaccines, they took advantage of the “emergency use authorization” power that enables them to use a lower level of evidence than the traditional threshold for proving effectiveness in FDA product approvals. It essentially means that proving that they “may be effective” is justification enough to flood the market with these untested jabs.

Although the reasoning for granting emergency use ...

FDA authorizes yet another COVID “vaccine” – and once again WITHOUT clinical data to back it

2 months ago -

This latest jab is protein-based and targets the so-called JN.1 variant of the Chinese virus. Like the many others before it, Novavax's JN.1 injection was granted emergency use authorization (EUA) from the FDA.

Though there is not a single human clinical trial to back the shot, the FDA says it must be allowed to hit the market immediately based on animal testing data that supposedly supports its use.

"Today's authorization provides an additional ...

FDA grants emergency use authorization for updated Novavax COVID-19 vaccine even without clinical trial data

2 months ago -

According to the FDA, the updated and protein-based Novavax COVID-19 vaccine is specifically designed to target the omicron variant JN.1 strain of SARS-CoV-2. The updated vaccine is produced using a similar process to earlier Novavax formulas and individuals receiving it may experience side effects similar to those reported with previous versions.

This EUA applies to individuals aged 12 and older, with the updated vaccine featuring a monovalent component that aligns ...

FDA instructs outgoing staff how to influence agency “behind the scenes” after their departure

July 12, 2024 -

It is routine practice for high-level officials at the FDA to leave the agency and take lucrative positions within Big Pharma, explains a new investigatory report published in the British Medical Journal (BMJ).

The conflicts of interest with such an arrangement are endless, but they have never stopped this revolving door from spinning. Internal emails clearly show that FDA staff leave the agency to work at Big Pharma – and on their way out the door, they ...

FDA is a front organization: There are no technicians in the buildings, no equipment and no sample testing occurs

June 14, 2024 - One of the questions the reader is trying to answer has to do with whether biological regulation authority was ever statutorily established by [the US] Congress, for NIH and its precursor organisations, going back to the late 1800s.

(Article by Rhoda Wilson republished from Expose-News.com)

Modern-day NIH and FDA officials present historical accounts of how the biological product and vaccine manufacturing regulatory systems began and developed.

But from her research ...

FDA proposes ban of popular food additive linked to negative side effects

June 10, 2024 -

Brominated vegetable oil (BVO) is a food additive that is used to help emulsify citrus-flavored soft drinks and prevent the flavoring ingredients from separating during distribution.

BVO contains bromine atoms which are bonded to the triglycerides that are derived from vegetable oil.

The concern with BVO is due to the presence of bromine, an element also found in brominated flame retardants. Some research has suggested that excessive consumption of BVO can lead to ...

FDA detects surge in seizures and heart failure in children who were subjected to COVID-19 jabs

May 02, 2024 -

In a large cohort study involving over 4 million inoculated children, the FDA detected a surge in seizures for children ages 2 to 5. The agency also found a surge in myocarditis and pericarditis in children ages 12 to 17.

“Statistical signals were detected for myocarditis or pericarditis after BNT162b2 vaccination in children aged 12 to 17 years and seizure after vaccination with BNT162b2 and mRNA-1273 in children aged 2 to 4 or 5 years,” the study authors wrote....

FDA just lost a historic ivermectin lawsuit — so when will FDA officials be arrested and charged with manslaughter for denying lifesaving treatments to Americans?

March 29, 2024 -

Texas court cracks down on FDA and HHS officials

In a historic case, the U.S. District Court for the Southern District of Texas, Galveston Division ruled against the FDA and struck down their war against ivermectin. As part of the settlement, the FDA agrees to take down website and social media posts that warn people not to use ivermectin to treat COVID-19. The defendants in the suit include U.S. Department of Health and Human Services (HHS), HHS Secretary ...

FDA warns of HIGH SEIZURE RISK for children during first few days after receiving Covid-19 jabs by Moderna and Pfizer-BioNTech

March 27, 2024 -

Pfizer-BioNTech and Moderna mRNA stabs both pose elevated febrile seizure risk for children immediately following injection

During a febrile seizure, a child is prone to serious injury (and possible death) due to loss of consciousness and uncontrollable movements. During the seizure, if the child falls from a height, or happens to be swimming, the seizure could result in horrible health consequences. There's also a risk of suffocation during seizures, especially for toddlers during ...

FDA settles ivermectin lawsuit, agrees to delete posts discouraging its use against COVID-19

March 26, 2024 -

The FDA, which denied any wrongdoing, said it will remove content warning people not to use ivermectin to treat COVID-19 within 21 days. The move came as a condition of a settlement dated March 21, according to the Epoch Times. In exchange, doctors who sued the regulator will no longer pursue further legal action and will dismiss their claims.

Among the posts the agency will remove as part of the settlement include a March 5, 2021 consumer update titled "Why You ...

FDA refuses to disclose how it spends industry “user fees” – are funds being secretly used on LOBBYING?

March 20, 2024 -

A new investigation speculates that the FDA might just be spending that user fee cash on something other than what the law stipulates, seeing as how the agency refuses to answer questions about the matter.

Last summer, a Freedom of Information Act (FOIA) request was filed seeking basic information about the agency's user fee spending habits. When the FDA refused to honor the request, the group Protect the Public's Trust (PPT) was forced to take the agency ...

FDA warns consumers to throw away cheap cinnamon products that are heavily contaminated with LEAD

March 14, 2024 -

Multiple brands of cinnamon test high for LEAD

The lead levels are significant across multiple cinnamon brands, including: the La Fiesta brand sold by La Superior and SuperMercados; Marcum brand sold by Save A Lot stores; MK brands sold by SF Supermarket; Swad brand sold by Patel Brothers; El Chilar brand sold by La Joya Morelense; and Supreme Tradition brand sold by Dollar Tree and Family Dollar stores. The lead levels ranged from 2.03 to 3.4 parts per million, which is more ...

FDA places informed consent on a slippery slope

February 19, 2024 -

In late December 2023, a rule was issued by the FDA allowing certain clinical trials to operate without obtaining informed consent from participants. The rule officially went into effect on January 22, 2024. According to Dr. Robert M. Califf, serving commissioner of Food and Drugs for the FDA, the rule was passed to encourage the discovery of more treatment and diagnostic options in the medical field by reducing administrative burdens. “We anticipate this ...

FDA says RECALLED sleep apnea machines are linked to 561 deaths since 2021

February 07, 2024 -

The regulator made this revelation in a Jan. 31 notice, saying that there have been more than 116,000 medical device reports – including 561 deaths – over the now-recalled devices. The reports stemmed from foam breaking down in certain Philips Respironics ventilators, bi-level positive airway pressure (BiPAP) sleep therapy devices, and continuous positive airway pressure (CPAP) machines that were included in a major recall announced in June 2021. (Related: A majority of Americans ...

FDA fighting to dismiss federal lawsuit challenging its illegal ivermectin warnings that sought to INCREASE deaths from COVID

January 19, 2024 -

The FDA wants the court to dismiss the suit, which was filed in 2023 by three doctors who outed the FDA for providing illegal warnings against ivermectin, which the FDA itself approved for human use back in 1996.

The reason the motion was sealed, according to a government brief, is because it allegedly contains "confidential information" from a separate legal proceeding. There were supposed to be redacted versions of the motion released for ...

FDA commissioner pushing off-label pharmaceutical use in illegal Big Pharma marketing scheme

January 18, 2024 -

It was after his first appointment to the FDA role under Barack Obama that Califf proposed that drug companies be allowed to advertise their products for off-label uses. Though illegal, Califf's proposal would have opened up the floodgates for new Big Pharma profit streams, which for many drugs dries up once the market has become saturated for their approved uses.

At the time, Sen. Ed Markey (D-Mass.) wrote a scathing letter to Califf, explaining to him that ...