FDA Archives - The Connecticut Star

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

March 24, 2024 Connecticut Star Staff

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.”

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

March 3, 2024 Just the News

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.

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

March 1, 2024 Just the News

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).

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

January 18, 2024 Just the News

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.

Supreme Court to Weigh Major Case on Abortion Pill Approval

December 14, 2023December 13, 2023 Connecticut Star Staff

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.

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

November 8, 2023November 8, 2023 Just the News

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.

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

September 12, 2023 Just the News

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.

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

August 14, 2023August 13, 2023 Just the News

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.

World Health Organization Labels Aspartame as a Possible Cancer Cause, FDA Disagrees

July 16, 2023 Just the News

A World Health Organization (WHO) committee has released a report that finds the well known sweetener aspartame is a possible cause of cancer.

The new classification is based on a review of “limited evidence.” The U.S. Food and Drug Administration (FDA), however, disagrees with the report released Thursday, according to NPR.

Lawmakers: FDA Delaying Investigation, Accountability over Baby Formula Shortage

July 7, 2023July 6, 2023 The Center Square

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.

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

July 6, 2023July 5, 2023 Just the News

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.

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

June 13, 2023 The Center Square

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.

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

June 2, 2023June 2, 2023 Admin

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.

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

April 19, 2023 Admin

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.

Federal Judge Suspends FDA Approval of Abortion Pill

April 9, 2023April 8, 2023 Just the News

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.

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

March 2, 2023 Admin

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.

FDA Approves New Drug for Early Treatment of Alzheimer’s

January 8, 2023January 7, 2023 Just the News

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.

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

November 15, 2022November 14, 2022 Admin

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.

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

October 14, 2022October 13, 2022 Susan Berry, PhD

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.”

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

September 16, 2022September 15, 2022 Susan Berry, PhD

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.

FDA Approves Most Expensive Drug in History

August 20, 2022August 19, 2022 Admin

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.

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

July 26, 2022July 25, 2022 RealClearWire

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).

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

June 28, 2022June 27, 2022 The Center Square

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.”

FDA Quickly Authorizes COVID Shots for Infants and Young Children

June 18, 2022June 17, 2022 Susan Berry, PhD

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.”

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

June 10, 2022June 9, 2022 Susan Berry, PhD

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.

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

May 29, 2022May 28, 2022 Admin

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.

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

May 19, 2022May 18, 2022 Admin

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.

Anatomy of the American Baby Formula Shortage

May 17, 2022May 16, 2022 Admin

At the outset of his presidency, Joe Biden promised competence by a bigger, better government. A few days ago, one of his loyal allies exposed a gross incompetence by federal officials on Biden’s watch that defied that promise and inflamed a baby formula shortage now panicking parents nationwide.

Rep. Rose DeLauro, D-Conn., a reliable liberal ally, unveiled documents showing the Biden Food and Drug Administration was alerted by a whistleblower last fall about potential contamination issues at the Abbott Nutrition baby formula factory in Michigan and failed for months to act aggressively.

Bird Flu Outbreak Spreads to 25 States

April 11, 2022April 10, 2022 The Center Square

The number of commercial and backyard flocks with confirmed avian flu increased by 36% in the past week, according to data on the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) website.

Three of the 57 new cases reported were in Missouri, bringing the state total to nine cases of Highly Pathogenic Avian Flu Influenza (HPAI) in seven counties—Bates, Dade, Gentry, Jasper, Lawrence, Ralls and Stoddard. Approximately 421,000 birds were in those flocks.

Commentary: Biden Needs to Decide If COVID Is Still a ‘National Emergency’

February 2, 2022February 1, 2022 RealClearWire

The omicron variant may be nearing its peak in some states, but across the country it’s produced a dizzying array of conflicting signals on whether the nation should remain under a COVID national emergency or move on to an endemic “new normal.”

Comedian Bill Maher’s “I don’t want to live in your mask-paranoid world anymore” monologue went viral last week, just days after the Atlantic, the standard-bearer journal for the liberal intelligentsia, ran a story headlined: “COVID Parenting Has Passed the Point of Absurdity.” Accompanying the article was a black-and-white photo of a woman frozen in a more desperate and primal state of panic than the subject of Edvard Munch’s “The Scream.”

Omicron, for most people without co-morbidities, produces much milder symptoms than do the coronavirus’s previous variants, but it’s far more infectious, racing through schools, shutting down classrooms and forcing parents to consult their district’s ever-shifting COVID “decision trees” on a seemingly daily basis.

FDA Pulls Authorization for Antibody Treatment, Refuses to Answer Questions

January 26, 2022January 25, 2022 Peter D'Abrosca

SAN DIEGO (Jan 26, 2020) Lt. Cmdr. Raben Talvo, Naval Medical Center San Diego's (NMCSD) Office of Clinical Quality department head, administers the hospital’s first monoclonal antibody (mAb) treatment to a COVID-19-positive patient Jan. 26. Bamlanivimab, the mAb treatment, is administered under emergency use authorization (EUA) guidance from the U.S. Food and Drug Administration (FDA) to treat mild to moderate COVID-19 symptoms in some adult and pediatric patients who are at high risk for progressing to severe COVID-19 symptoms. NMCSD's mission is to prepare service members to deploy in support of operational forces, deliver high quality healthcare services, and shape the future of military medicine through education, training, and research. NMCSD employs more than 6,000 active duty military personnel, civilians, and contractors in Southern California to provide patients withworld-class care anytime, anywhere. (U.S. Navy photo by Mass Communication Specialist 3rd Class Harley K. Sarmiento)

The U.S. Food and Drug Administration (FDA) Monday unexpectedly pulled its Emergency Use Authorization (EUA) for monoclonal antibody treatments for COVID-19, dealing a blow to states like Florida which have been using the treatment effectively for months.

“Without a shred of clinical data to support this action, Biden has forced trained medical professionals to choose between treating their patients or breaking the law,” Gov. Ron DeSantis (R) said in response to the FDA’s decree. “This indefensible edict takes treatment out of the hands of medical professionals and will cost some Americans their lives. There are real-world implications to Biden’s medical authoritarianism – Americans’ access to treatments is now subject to the whims of a failing president.”