FDA Agrees to Remove Anti-Ivermectin Posts Off the Internet in Lawsuit Settlement

Ivermectin

The Food and Drug Administration (FDA) has reportedly settled a lawsuit brought by three doctors who accused the health regulator of interfering with their ability to practice medicine and prescribe Ivermectin to treat COVID.

Dr. Mary Talley Bowden, Dr. Paul E. Marik and Dr. Robert L. Apter sued the FDA in June of 2022, asking the court to: “Hold unlawful and set aside any FDA actions directing or opining on whether ivermectin should be used for certain off-label purposes, including treatment of COVID-19.”

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FDA Threatens Endangered Species with Shoddy Abortion-Drug Reviews: Lance Armstrong Investigator

Federal public health officials created strange bedfellows among animal-welfare advocates, scientists and vaccine skeptics for allegedly cutting corners in viral and COVID-19 vaccine research and oversight, possibly engineering a pathogen, then a cure that’s worse for some.

The Food and Drug Administration may be creating another odd couple in a case at the Supreme Court: environmental and pro-life activists.

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Just the News Sues Biden Administration to Force Disclosure of COVID-19 Vaccine Safety Data

COVID Vaccines

Just the News on Thursday sued the Biden administration in federal court seeking to force the disclosure of COVID-19 safety data that is being kept outside the government’s normal adverse events reporting system

In the lawsuit filed in partnership with the America First Legal public interest law firm, Just the News asked the U.S. District Court in Washington, D.C., to order the Department of Health and Human Services to comply with two Freedom of Information Act requests to the Food and Drug Administration and the Centers for Disease Control and Prevention seeking COVID-19 reactions data kept in a back-end, nonpublic system to the nation’s Vaccine Adverse Event Reporting System (VAERS).

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Documents: FDA, CDC Could Soon Employ ‘Indigenous Knowledge’

Scientist in Lab

The Biden Administration’s Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) could soon employ the use of so-called “indigenous knowledge” in research efforts going forward, according to internal documents.

According to the Washington Free Beacon, the document in question is a planned revision of scientific integrity guidelines within the Department of Health and Human Services (HHS), which includes such agencies as the FDA, the CDC, and the National Institutes of Health (NIH). The document calls for all agencies to utilize “multiple forms of evidence, such as indigenous knowledge,” when conducting research.

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Feds Conceal Details About Anti-Ivermectin Campaign in Response to Doctors’ Reinstated Lawsuit

Ivermectin

The Food and Drug Administration wants to continue its selective promotion of off-label drug use: good for COVID-19 vaccines, bad for alternatives to those vaccines. It just doesn’t want the public to see its full reasoning for the latter.

The FDA and the Department of Health and Human Services filed a renewed motion to dismiss a lawsuit by doctors claiming  the agencies have a practice of demonizing ivermectin by conflating its human and animal doses and using “command” language, such as “stop it,” to discourage using the anti-parasite drug against COVID.

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Research Finds COVID mRNA Vaccine Makes ‘Pfrankenstein’ Proteins, but Feds Seem Unfazed

Three years after federal regulators granted emergency use authorization to COVID-19 mRNA vaccines for older teens and adults, mainstream scientific research is confirming suppressed warnings from two years ago that the novel technology has a problem with “translation fidelity.”

Translation: it tends to make a bunch of wacky “off-target” proteins whose effects and severity are unknown.

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Supreme Court to Weigh Major Case on Abortion Pill Approval

The Supreme Court announced Wednesday that it is taking on a case regarding the Food and Drug Administration’s approval of the chemical abortion pill mifepristone.

Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians and the Christian Medical & Dental Associations filed a lawsuit against the FDA in November 2022, claiming that the FDA had ignored safety protocols to approve the abortion pill mifepristone. The Supreme Court said this week that it would hear the case, one of the first major abortion cases taken up by the court since overturning Roe v. Wade in June 2022, according to an order list.

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Florida Surgeon General Joseph Ladapo Demands Answers from FDA, CDC on DNA Contamination in COVID Shots

Florida Surgeon General Joseph Ladapo has formally asked the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) to address recent scientific studies showing that the mRNA COVID shots are contaminated with DNA fragments.

Back in June, Microbiologist Kevin McKernan, a former researcher for the Massachusetts Institute of Technology Human Genome Project, announced that he had discovered simian virus 40 (SV40), a virus found in monkeys and humans, in the mRNA COVID-19 vaccines. SV40 has been linked to cancer in humans, including mesotheliomas, lymphomas and cancers of the brain and bone.

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FDA Downplays COVID Vax Overdosing as Hydroxychloroquine Shows More Promise in European Research

The FDA repeatedly told the public that an antiviral with a sterling safety record, ivermectin, should not be used to treat COVID-19 because it was also prescribed, at higher dosages, to livestock.

The agency didn’t appear to show the same concern about correctly dosing the new single-shot mRNA COVID vaccines and is now scrambling to educate healthcare providers not to give children adult-strength jabs even while denying that overdosing is a safety risk.

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Voluntary Recall of Kroger Collard Greens Announced After Tennessee Department of Agriculture Investigation

A company from Georgia is voluntarily recalling collard greens sold in Kroger supermarkets in Tennessee after the Tennessee Department of Agriculture’s Consumer and Industry Services Division (CIS) found possible contaminants during a routine investigation. 

“Baker Farms of Norman Park, GA is voluntarily recalling a single production run of Kroger 16-ounce bagged Collard Greens, due to possible Listeria monocytogenes contamination,” according to the Food and Drug Administration (FDA). 

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Wisconsin U.S. Rep. Mike Gallagher’s Committee on the Chinese Communist Party Issues Subpoena in Chinese Lab Probe

The Select Committee on the Chinese Communist Party led by U.S. Rep. Mike Gallagher (R-WI-08) issued its first subpoena in the committee’s ongoing investigation into the clandestine Chinese laboratory that local authorities uncovered in Reedley, California.

“It is deeply disturbing that a Chinese company set up a clandestine facility in small-town America that contained, per the CDC, ‘at least 20 potentially infectious agents’ like HIV and the deadliest known form of malaria. We are grateful to the city of Reedley for their cooperation,” Gallagher said in a statement.

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Researchers Question One-Size-Fits-All COVID Booster Strategy as FDA Circumvents Advisors

Federal health officials face a growing hurdle in their quest to persuade Americans of all ages and risk profiles to get updated COVID-19 boosters: strong proponents of vaccination.

From New England to the Bay Area, researchers voiced concerns to mainstream science and health publications in recent days that the one-size-fits-all model may be backfiring.

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Appeals Court Says FDA Denunciations of Ivermectin Look Like ‘Command,’ not Advice

The Food and Drug Administration (FDA)  is claiming in federal court that it never told doctors not to prescribe ivermectin to treat COVID-19. Federal judges aren’t buying it, and state medical boards that rely heavily on FDA guidance continue to investigate doctors for such prescriptions.

Echoing a federal district judge nine months ago, a three-judge panel of the 5th U.S. Circuit Court of Appeals pressed a Justice Department lawyer to reconcile the FDA’s repeated public denunciations of ivermectin as an off-label COVID treatment with its insistence that the agency is not liable for resulting investigations of doctors who prescribe or promote it.

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Federal Audit Finds Florida Didn’t Document Prescriptions for Foster Care Kids

A report by the U.S. Department of Health and Human Services Office of the Inspector General says Florida failed to comply with state requirements for its foster care system regarding prescription drugs.

According to the report, Florida failed to comply with requirements for documenting psychotropic and opioid medications prescribed to children living in the Florida Safe Families Network (FSFN), which is also a federal requirement in order to receive funding.

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Lawmakers: FDA Delaying Investigation, Accountability over Baby Formula Shortage

U.S. House oversight lawmakers reviewing the FDA’s role in the baby formula shortage say the federal agency is dodging oversight and delaying providing answers.

Subcommittee on Health Care and Financial Services Chairwoman Lisa McClain, R-Mich., sent a letter to the U.S. Food and Drug Administration this week asking for interviews with FDA officials to get to the bottom of the baby formula crisis that rocked the U.S. last year.

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FDA Blasted for ‘Misleading’ mRNA COVID Vaccine Labels as ‘Sudden Death’ Research Mounts

Researchers around the world continue documenting potentially severe side effects from COVID-19 mRNA vaccines in certain demographics, but the Food and Drug Administration refuses to label them or even tell recipients the shots can’t stop transmission of an increasingly immune-evasive virus.

Autopsies and reviews of medical records revealed a much higher incidence of Pfizer and Moderna vaccine-associated heart deaths than officially categorized in South Korean, Japanese and Qatari government registries, particularly in younger people at lower risk from COVID. That echoes a German autopsy study of healthy people who died within 20 days of jabs.

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FDA Kicks Off Crackdown on ‘Dangerous’ Flavored Vapes Imported from China

Flavored, nicotine-packed vape products manufactured in China are becoming increasingly common among teenagers and raising health concerns.

The problem took off in February of 2020 after the U.S. Food and Drug Administration implemented a ban on the sale of many flavored vaping products, pushing compliant manufacturers out of the flavored market while some Chinese-based manufacturers continued to distribute and sell the now banned-products to American youth.

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Commentary: The FDA Must Partner with State AGs to Crack Down on Illegal Vapes and Keep Kids Safe

Millions of kids and teens in America are falling victim to an insidious campaign to get them hooked on illegal, disposable vapes that are made in China and intentionally marketed in youth-enticing flavors.

After years of inaction, the Food and Drug Administration (FDA) has finally said it will make compliance and enforcement against these products a priority. FDA’s decision to start taking action to stop the rising tide of illegal disposable vapes in youth-enticing flavors that are flooding our country from China is an important step forward but letters won’t be enough to get these products off our shelves.

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Pennsylvania State Senator Introduces Ban on Kratom Sales to Minors

A Pennsylvania state legislator is spearheading a bill to more stringently regulate the sale of the painkiller kratom.

The Kratom Consumer Protection Act, sponsored by state Senator Tracy Pennycuick (R-Red Hill), would ban the substance’s purveyance to anyone aged 21 or younger. The legislation would also limit the product’s potency, bar its combination with controlled chemicals and require its display of “adequate labeling directions for… safe and effective use….” 

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Commentary: After Decades of Outsourcing to China, the U.S. is Running Out of Children’s Antibiotics

Acute shortages of orally delivered amoxicillin, penicillin and other children’s antibiotics throughout the 2022 and 2023 cold and flu season have made it difficult for doctors to treat normal childhood illnesses like ear infections, bronchitis, strep throat and rarer cases of infections caused after suffering Respiratory Syncytial Virus (RSV), and also sickle cell disease—for months.

The Food and Drug Administration (FDA) issued a warning about the amoxicillin shortage in Oct. 2022 just at the start of the cold and flu season. But since then, no statement has been issued by President Joe Biden about what appears to be an underreported public health crisis.

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Federal Judge Suspends FDA Approval of Abortion Pill

A federal judge on Friday suspended the Food and Drug Administration’s approval of mifepristone, effectively stopping sale of the drug nationwide.

Mifepristone is one of two drugs necessary for a sort of abortion cocktail that allows recipients to terminate a pregnancy via pill. The second drug, misoprostol, is available through a traditional prescription. The FDA in January announced a regulatory change to permit major pharmacy chains to carry the drug in stores as opposed to mail-order pharmacies or select clinics.

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FDA Sued for Withholding Information About Children’s Use of Hormone Treatments

On Monday, the United States Food and Drug Administration (FDA) was sued for allegedly withholding records detailing the off-label use of hormone treatments, such as puberty blockers, by underaged children.

Fox News reports that the lawsuit was filed by Stephen Miller’s America First Legal (AFL) group, which had previously made a Freedom of Information Act (FOIA) request back in September regarding the use of such hormone drugs on children under the Biden Administration. After the FDA refused to respond to the request, AFL filed their lawsuit.

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Ohio Congressman Calls Out FDA for ‘Illegal’ Approval of Mail-Order Abortifacients

U.S. Representative Bob Latta (R-OH-5) is leading a charge by federal lawmakers against the Food and Drug Administration’s (FDA) relaxation of safety requirements for abortion drugs so consumers can access them by mail.

The Bowling Green-area lawmaker coauthored a letter with U.S. Senator Cindy Hyde-Smith (R-MS) and garnered signatures from 75 other members of Congress to insist that the FDA’s recent actions violate federal law. In particular, the legislators object to the agency’s approval of chemical abortion-inducing substances while no longer requiring in-person dispensing. 

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Susan B. Anthony List Applauds 22 Pro-Life Attorneys General, Including Tennessee’s Skrmetti, in Urging the FDA to Reverse New Policy on Abortion Drug

Susan B. Anthony Pro-Life America recently thanked a coalition of 22 attorneys general, including Tennessee Attorney General Jonathan Skrmetti, for sending a letter to the Food and Drug Administration (FDA) on the agency’s “illegal and dangerous” policy on mifepristone, a chemical abortion drug.

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Exclusive: Reps. Harshbarger and Hern Introduce Bill to Stop Mail-Order Chemical Abortion

Representatives Diana Harshbarger (R-TN-01) and Kevin Hern (R-OK-01) introduced a bill Tuesday in the U.S. House of Representatives to invalidate the FDA’s recently-updated Risk Evaluation and Mitigation Strategy (REMS) of mifepristone, a chemical abortion drug.

Mifepristone is a chemical drug treatment that works together with misoprostol to end a pregnancy through ten weeks gestation, according to the FDA.
Mifepristone is a chemical drug treatment that works together with misoprostol to end a pregnancy through ten weeks gestation, according to the FDA.

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FDA Approves New Drug for Early Treatment of Alzheimer’s

The U.S. Food and Drug Administration on Friday approved a new drug to treat Alzheimer’s disease, with testing reportedly showing considerable success in helping patients with the debilitating condition. 

The FDA said in a press release that it had approved the drug Leqembi for Alzheimer’s patients. The drug is “the second of a new category of medications approved for Alzheimer’s disease that target the fundamental pathophysiology of the disease,” the agency said. 

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FDA Social Media Posts on COVID Under Legal, Medical Scrutiny for Misleading Claims

The FDA’s Twitter habits are getting scrutiny in court and from medical professionals as the feds seesaw between walking back their once-confident COVID-19 assertions and making sweeping new claims without providing evidence.

Having long ago conceded that COVID vaccines can’t stop viral transmission and that assertions to the contrary by President Biden among others were based on “hope” rather than science, the feds are now downplaying the influence of their social media to escape liability for allegedly violating statutory limits by interfering in medical judgments.

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Growing Body of Evidence Disputes Claims That Puberty Blockers Are Safe, Reversible

Puberty blockers are widely touted by doctors and transgender activists as a safe and fully reversible way to pause puberty for children with gender identity issues, but a growing body of evidence is challenging those claims, according to The New York Times.

The drug prevents the surge in bone density that would normally occur during puberty, and patients can see lifelong bone issues that are never resolved, according to the Monday NYT article. Medical professionals are also challenging claims that the drug is reversible, arguing instead that blocking puberty permanently cements a child’s transgender identity and puts them on a path to lifelong biomedical intervention.

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Biden FDA Approves COVID Booster Shot for Children 5-11 Years Old Without Testing

Pfizer Inc. and BioNTech announced Wednesday the Biden Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for their “bivalent” mRNA COVID-19 booster shot for children aged 5-11 years without having completed clinical trials.

“As families across the country take part in fall festivities and plan for the upcoming holiday season, we aim to provide school-aged children with additional protection against the Omicron BA.4/BA.5 subvariants, which continue to account for more than 80% of cases in the U.S.,” said Pfizer CEO Albert Bourla. “Anticipating this need, we manufactured millions of booster doses, which will be made available, pending CDC recommendation, to help families stay up to date with COVID-19 vaccinations.”

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Sen. Rand Paul: ‘Dr. Fauci Continues to Lie, Cover-Up, and Deny the Science to Promote Himself’

Senator Rand Paul (R-KY) once again battled with White House chief medical advisor Dr. Anthony Fauci Wednesday about whether children with natural immunity from a prior COVID infection should be injected with the mRNA shots the government has referred to as “vaccines.”

“Dr. Fauci continues to lie, cover-up, and deny the science to promote himself,” tweeted Paul about his tense exchange with Fauci during a Senate committee hearing whose central focus was the federal response to monkeypox.

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Florida Sues FDA over Prescription Drug Program

The state of Florida is suing the U.S. Food and Drug Administration (FDA) over claims its review of the state’s Canadian Prescription Drug Importation Program has taken more than 630 days.

“Florida has been ready to deliver cheaper prescription drugs to those that need them for nearly two years,” Gov. Ron DeSantis said at a  Wednesday news conference announcing the lawsuit with Attorney General Ashley Moody. “The lack of transparency by the Biden administration during the approval process, and failure to provide records on the importation proposal, is costing Floridians who are facing rising prices across the board due to inflation. Florida is confident in our importation model, and we continue to look for more ways to lower drug costs for Floridians while the FDA delays approval of this importation proposal.”

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US Senator Ron Johnson Presses Feds for Source of Vaccine at Military Bases after Whistleblower Allegations

Sen. Ron Johnson (R-Wisc.) is pressing the Pentagon, Food and Drug Administration, and the Centers for Disease Control and Prevention for answers after multiple whistleblowers raised concerns about the provenance of a Comirnaty-labeled COVID-19 vaccine shipped to military bases.

On Monday, nine military officers from across all the branches sent a whistleblower report to Congress regarding a COVID vaccine appearing at Coast Guard medical clinics. Key GOP senator presses feds for source of vaccine at military bases after whistleblower allegations

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FDA Approves Most Expensive Drug in History

The U.S. Food and Drug Administration (FDA) on Wednesday approved a gene therapy for a rare blood disease which is set to reach the market at a record $2.8 million for a single dose, according to a press release by the therapy’s creator, Bluebird Bio.

Beta-thalassemia is an inherited blood disorder that causes a patient’s blood to fail to circulate oxygen through the body, according to the FDA press release concerning the approval. Bluebird’s new therapy, Zynteglo, infuses patients with cells that have a working copy of the gene responsible for the disorder, allowing the patient to produce blood that functions properly, according to a Bluebird press release.

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Commentary: Reducing Patient Access to New Medications Is Progressives’ Latest Medicare Price Fixing Scheme

pharmacy

As negotiations on their tax and spending bill continue, Senate Democrats are working on a legislative proposal to have the government fix the prices of Medicare prescription medications.  Though the details of the 190-page amendment differ in certain respects from earlier versions, the indisputable result would be the same: Reduced patient access to prescription drugs.

Like most giant regulatory schemes, the draft proposal is characteristically complex with numerous provisions, including detailed data collection, new mandates, tax penalties on drug manufacturers, free vaccines, and a cap on out-of-pocket costs. But the heart of the bill is the creation of a Drug Price Negotiation Program administered by the Secretary of the U.S. Department of Health and Human Services (HHS).

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Appeals Court Grants Temporary Stay in Juul Fight Against FDA Banning Its E-Cigarettes

A federal appeals court on Friday granted a request for a temporary stay to vape manufacturer Juul Labs Inc. in its fight against the U.S. Food and Drug Administration’s ban of its e-cigarettes from being sold in the U.S.

The FDA issued marketing denial orders (MDOs) Thursday and said JUUL’s current inventory being sold in the U.S. “must be removed, or risk enforcement action.”

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Tennessee House Leaders Ask Gov. Lee to Halt Vaccine Rollout for Children Under Five

Tennessee’s Republican House leaders this week penned a letter to Governor Bill Lee (R) asking him to halt the rollout of COVID-19 vaccines for children under the age of five.

“Governor, the COVID-19 emergency has long passed in Tennessee,” the letter, penned by State Rep. Jason Zachary (R-District 14), said. “Based on the data in the FDA’s own 66-page report, there is no concrete basis for amended emergency authorization to vaccinate small children.” 

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FDA Quickly Authorizes COVID Shots for Infants and Young Children

The Food and Drug Administration (FDA) quickly authorized the Moderna and Pfizer-BioNTech COVID vaccine shots for infants and young children Friday, paving the way for the Centers for Disease Control and Prevention (CDC) advisory committee to vote on authorization over the weekend to allow the youngest children to get the shots as early as next week.

Per the press announcement by the FDA, the Emergency Use Authorization (EUA) for the Moderna COVID vaccine for older children and adults has been “amended” to “include use of the vaccine in individuals 6 months through 17 years of age,” while the EUA for the Pfizer COVID shot will now include use of the vaccine for babies as young as “6 months through 4 years of age.”

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Republican Lawmakers Demand Answers from FDA on COVID Vaccines for Babies and Toddlers

A group of Republican lawmakers in the U.S. Senate and House are demanding answers from the Food and Drug Administration (FDA) and its vaccine panel regarding the Emergency Use Authorization (EUA) application for COVID vaccines in babies and young children under five years of age.

Though young children without other significant medical issues bear the least risk of serious illness from catching the COVID infection, White House COVID-19 Response Coordinator Dr. Ashish Jha is already planning for the distribution of COVID vaccines for babies and toddlers under five years of age as early as June 21 if the FDA and CDC approve.

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FDA Claims Whistleblower Report on Baby Formula Shortage Got Lost in Mailroom

An official with the Food and Drug Administration (FDA) claims that the reason the agency didn’t find a shocking whistleblower’s report on the baby formula shortage because the report was lost in the mailroom for at least four months.

The New York Post reports that the 34-page document had been sent to the FDA back in October, claiming that an Abbott Nutrition plant in Sturgis, Michigan was experiencing a shortage in product primarily due to increasingly unsanitary conditions. The FDA’s Frank Yiannas, Deputy Commissioner for Food Policy and Response, admits he didn’t actually see the report until February.

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Burchett Explains ‘No’ Vote on Baby Formula Shortage Bill

A U.S. Congressman from Tennessee explained Thursday why he voted against a bill that purports to help end the shortage of baby formula in the United States. 

“I wanted to talk a little bit about a bill that came through yesterday dealing with the formula and the shortage,” Rep. Tim Burchett R-TN-02) said in a video. “What it basically was, was $28 million in the bill, but like $23 million of it was for ‘administrative costs’ and ‘salaries.’ So basically, what the Democrat leadership did was use a bill, title it something that’s dealing with people who are genuinely hurting, and just use it as an instance to increase pay at the [U.S. Food and Drug Administration FDA)].”

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Dr. Robert Malone: ‘Rotten to the Core’ FDA Knew COVID Vaccines Could Spur Viral Reactivation, but Said Nothing

healthcare worker with a mask and hairnet on

The Food and Drug Administration (FDA) was aware early on that the COVID vaccines could spur viral reactivation of diseases like the varicella-zoster virus (shingles) in some people, but chose not to disclose it, according to renowned vaccinologist and physician Dr. Robert Malone.

“They knew about the viral reactivation,” Malone declared during a recent panel discussion hosted by Del Bigtree with fellow Global COVID Summit physicians Dr. Ryan Cole, and Dr. Richard Urso.

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