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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DeSantis Won’t Order COVID Shots for Children

On Wednesday, reports came out that the State of Florida would be the only state in the country to not pre-order COVID shots for children five and under. Yesterday, Florida Gov. Ron DeSantis confirmed that Florida would not be recommending COVID shots for Florida’s youngest residents.

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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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Crom’s Crommentary: Is There a Connection Between Biden, the Baby Formula Shortage, and Hunter Biden’s Art?

Monday morning on The Tennessee Star Report, host Leahy welcomed original all-star panelist Crom Carmichael to the studio for another edition of Crom’s Crommentary.

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Anatomy of the American Baby Formula Shortage

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.

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Bird Flu Outbreak Spreads to 25 States

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.

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Tennessee Senate Passes Bill Allowing Over-the-Counter Sale of Ivermectin

A bill Thursday passed the Tennessee Senate that would allow patients to obtain a commonly-used drug over the counter. 

SB 2188 “authorizes ivermectin suitable for human use to be sold or purchased as an over-the-counter medication in this state without a prescription or consultation with a pharmacist or certain other healthcare professional.”

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Wisconsin Senator Ron Johnson and Dr. Robert Malone: ‘COVID Cartel’ Lied to Scapegoat Unvaccinated Americans in Effort to Divide Nation

Wisconsin. Senator Ron Johnson (R) and Dr. Robert Malone wrote in an op-ed at The Federalist Thursday the “COVID cartel” – federal health agencies, Big Pharma, establishment media, and Big Tech – lied in order to scapegoat unvaccinated Americans in a campaign to divide the nation.

Johnson, who has spearheaded efforts to break the silencing of physicians and scientists on the issue of early treatment for COVID-19, and Malone, a pioneer in the development of mRNA technology, wrote Americans have been deceived for the sake of covering up government fraud and incompetence, while likely thousands have died unnecessary deaths.

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

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.

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FDA Cites Non-Peer Reviewed Study to Revoke Monoclonal Antibody Authorization

As reported Tuesday by The Florida Capital Star, the U.S. Food and Drug Administration (FDA) revoked the Emergency Use Authorization (EUA) for monoclonal antibodies as a treatment for COVID-19, but did not provide the data is cited in making its decision. 

Without the help of the FDA, which did not return a follow up comment request Wednesday, The Star was able to locate what appears to be the data used in the decision-making process. It is on the website for the National Institute of Health (NIH), which is headed by Dr. Anthony Fauci. 

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FDA Pulls Authorization for Antibody Treatment, Refuses to Answer Questions

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.”

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Dole Announces Recall Due to Listeria Contamination

The Dole Company announced a recall last week on specific products due to possible listeria contamination. Many variations of Dole’s bagged salads that had been processed in Bessemer City, NC, and Yuma, AZ were found to have been contaminated with listeria.

In the statement from Dole, “all Dole-branded and private label packaged salads” that were processed at both locations were possibly contaminated. It added that both locations would temporarily suspend operations and undergo an extensive cleaning and sanitizing protocol. 

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Department of Defense Silent After Lawyer Told Judge it Had ‘Adequate Supply’ of Unavailable Pfizer Vaccine

The Department of Defense (DOD) declined to comment on whether it had any of Pfizer’s Food and Drug Administration (FDA) approved vaccine called Comirnaty, after one of its lawyers told a federal judge the department had Comirnaty on hand. 

“We don’t have anything for you on this,” a DOD spokesman told The Star News Network by email on Wednesday. 

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FDA Won’t Say Why Some Non-Approved Pfizer Vaccines Were Deemed ‘BLA-Compliant’

Through Ohio attorneys representing Miami University in a lawsuit against the school over its mandatory COVID-19 vaccine policy, The Ohio Star confirmed that at least none batches of Pfizer’s Emergency Use Authorization (EUA) vaccine were deemed Biologics License Application (BLA) compliant. 

BLA compliance is typically reserved for Food and Drug Administration (FDA) approved drugs. That is the licensing procedure for drugs seeking to become FDA approved. 

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Pfizer’s Comirnaty Available Abroad, Not in U.S.

New York-based Pfizer has sold and shipped hundreds of millions of doses of its Food and Drug Administration (FDA) approved COVID-19 vaccine Comirnaty to the European Union (EU) despite saying last week that it is not being shipped in the United States. 

“Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they will supply an additional 100 million doses of COMIRNATY®, the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states in 2021,” Pfizer said in an April press release. “This announcement is a result of the European Commission’s (EC) decision to exercise its option to purchase an additional 100 million doses under its expanded Advanced Purchase Agreement signed on February 17, 2021. This brings the total number of doses to be delivered to the EU to 600 million.”

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FDA Authorized First COVID-19 Antiviral Pill in U.S.

The FDA on Wednesday authorized the first COVID-19 antiviral pill in the U.S.

The Pfizer pill, Paxlovid, will be prescribed for use in adults and children 12 and older who have mild to moderate virus symptom and at risk for severe disease or hospitalization, according to a Food and Drug Administration statement obtained by NBC News.

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Version of Pfizer Vaccine that Predates FDA Approval Still Being Distributed in Pennsylvania

healthcare worker giving vaccination

Of the three companies producing COVID vaccines in the U.S., only one—Pfizer Inc.—has yet gained full FDA approval, and at least some Pfizer vaccines currently being administered in Pennsylvania come from inventory that predates that approval.

On Aug. 23, the U.S. Food and Drug Administration (FDA) approved a Pfizer shot to prevent severe COVID-19 cases. Like Johnson & Johnson and Moderna, Pfizer had been a manufacturing vaccine to fight the coronavirus under federal emergency-use authorization (EUA). The injection produced by Pfizer under EUA is known as Pfizer BioNTech and the company’s post-FDA approval vaccine is called Comirnaty (pronounced kuh-MUR-nit-ee).

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6th Circuit Ruling Restoring Employer Vaccine Mandate Falsely Claims ‘Options Available to Combat COVID-19 Changed Significantly’ When ‘FDA Granted Approval to One Vaccine on August 23, 2021’

The majority opinion released on Friday by the 6th Circuit Court of Appeals, which restored the Biden administration’s Occupational Safety and Health Administration (OSHA) Emergency Temporary Standard (ETS) requiring employers with more than 100 employees to mandate that all employees take a COVID-19 vaccinefalsely asserts that Pfizer’s Food and Drug Administration (FDA) fully approved vaccine is currently available and in use among the general public.”

“At the same time, the options available to combat COVID-19 changed significantly: the FDA granted approval to one vaccine on August 23, 2021, and testing became more readily available,” the majority opinion asserts on page 24 of the ruling.

The majority opinion was written by Obama-appointed Judge Jane Branstretter Stranch of the United States Court of Appeals for the Sixth Circuit.

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Georgia Department of Health Reveals Policy on Shipping in and Distributing FDA-Approved COVID-19 Vaccine Comirnaty

A Georgia Department of Public Health (DPH) official said Friday that her agency currently does not offer the Food and Drug Administration’s (FDA’s) fully approved COVID-19 vaccine, which the manufacturer, Pfizer, calls Comirnaty “Comirnaty has only recently become available, and DPH and its enrolled vaccine providers currently are using on-hand inventory of Pfizer COVID vaccine,” said DPH spokeswoman Nancy Nydam via email.

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FDA-Approved COVID-19 Vaccine Comirnaty’s Availability in Tennessee Unclear

A Tennessee Department of Health (TDOH) official did not say Friday whether his agency currently offers the Food and Drug Administration’s (FDA’s) fully approved COVID-19 vaccine, which the manufacturer, Pfizer, calls Comirnaty. TDOH officials did, however, comment on the matter in October.

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Exclusive: Large Ohio Hospital System Still Distributing Pfizer COVID-19 Vaccine Not Fully Approved by FDA

Ohio’s state universities have implemented vaccine mandates, despite HB 244, which bans vaccine mandates for any vaccine that is not fully authorized by the Food and Drug Administration (FDA). 

Ohio State University, Ohio University, and Wright State University all require students to be vaccinated against COVID-19. 

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FDA Claims It Needs 55 Years Before Revealing Data on Approval of Pfizer Vaccine

Doctor giving vaccination to patient

On Monday, the Food and Drug Administration (FDA) requested that the courts allow the agency to wait until the year 2076 to release all of the relevant documents regarding the approval of the vaccine developed by Pfizer and BioNTech, as reported by the Daily Caller.

The FDA made its request after a lawsuit was filed against the agency by the group Public Health Medical Professionals for Transparency (PHMPT). The PHMPT had previously made a Freedom of Information Act (FOIA) request on September 9th asking for the release of the vaccine approval documents; after the FDA denied the request, the group filed its lawsuit on September 16th.

The FDA concluded that there were roughly 329,000 pages in total that would qualify under this FOIA request. In its appeal to the courts, the agency said that, at most, employees would be able to “process and produce the non-exempt portions of responsive records at a rate of 500 pages per month.” Under this process, the FDA said that it would hand over prioritized documents to the plaintiff, and release non-exempt documents on a “rolling basis.”

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FDA Approves Moderna and Pfizer Boosters for Adults

The Food and Drug Administration (FDA) approved Moderna and Pfizer’s COVID-19 vaccines for booster shot use for adults in the U.S., the agency announced Friday,

The announcement was made just two months after the FDA first rejected the White House’s plan to administer booster shots to all adults the week of Sept. 20. FDA Acting Commissioner Janet Woodcock approved the booster without holding the usual public meeting to review the data, and the Centers for Disease Control and Prevention (CDC) will meet Friday afternoon to discuss the authorization, according to the FDA press release.

“Throughout the course of the COVID-19 pandemic, the FDA has worked to make timely public health decisions as the pandemic evolves. COVID-19 vaccines have proven to be the best and highly effective defense against COVID-19,” Woodcock said in the press release.

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Biden Announces Former Obama FDA Commissioner Robert Califf to Lead FDA Again

Robert Califf

President Joe Biden on Friday announced the nomination of Robert Califf to head up the Food and Drug Administration again, urging the Senate to quickly confirm him a second time.

Califf, who served in the same role near the end of then-President Barack Obama’s second term, is “one of the most experienced clinical trialists in the country, and has the experience and expertise to lead the Food and Drug Administration during a critical time in our nation’s fight to put an end to the coronavirus pandemic,” Biden said in a statement announcing the pick.

“I am confident Dr. Califf will ensure that the FDA continues its science and data driven decision-making,” the president added, pointing out that Califf enjoyed “strong bipartisan support in the Senate in 2016.”

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Minnesota Teachers Union Wants State Holiday to Vaccinate Kids

Education Minnesota, the state’s far-left teachers union, wants lawmakers in St. Paul to “consider a state holiday for vaccinating students.”

Denise Specht, president of the union, thinks all eligible children should be vaccinated unless they have a “rare and legitimate medical reason” for not getting the shot.

“State and local leaders must be bold in their efforts to make this vaccine available to every student, no matter where they live or how much money they have,” she said.

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Crom’s Commentary: Joe Biden’s Increasingly Strange COVID Policies and Vaccines for Children

Wednesday morning on the Tennessee Star Report, host Michael Patrick Leahy welcomed the original all-star panelist Crom Carmichael in studio for another profound edition of Crom’s Commentary.

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Commentary: Defense Department Pulls a Bait and Switch on Vaccines

On August 24, Secretary of Defense Lloyd Austin issued a memo to senior Pentagon leadership announcing that he was implementing a mandatory COVID-19 vaccination policy for all military service members. The day before, the FDA had issued full authorization to Pfizer for their Comirnaty COVID-19 vaccine product (the nomenclature of which is meant to be a mashup of the words “COVID”, “mRNA”, and “community”) . At first glance it would seem that the mandatory vaccination policy, while scientifically unsound and strategically foolish, was at least a policy being implemented according to both the letter of the directive and in accordance with the law. But a further examination of the facts and the manner in which this order is being implemented makes clear that the military’s implementation of this order is illegal and highly unethical.

In the memo, Secretary Austin issued a directive and a promise, that “Mandatory vaccination against COVID-19 will only use COVID-19 vaccines that receive full licensure from the Food and Drug Administration (FDA), in accordance with FDA-approved labeling and guidance.” The problem with this is that the Comirnaty vaccine product that was approved by the FDA is not available anywhere in the Military Health System. It is not even in production, according to the military’s TRICARE healthcare providers. If a soldier goes to a military hospital or a private provider to receive an approved Pfizer COVID vaccine, he will be administered the unapproved Pfizer-BioNTech vaccine which is a vaccine that is not approved but has been administered under an Emergency Use Authorization (EUA). We are told that this is but a brand name difference, that the formulation is the same, and they can be used interchangeably. But as the FDA was approving the Comirnaty product, they were renewing the authorization for the Pfizer-BioNTech product. If it’s just a matter of brand name, why issue an approval for one brand name and an EUA renewal for the other? This is because they are not actually the same. 

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Commentary: The FDA’s Power over Food and Drug Approval

Competition tends to bring about a better product or service, at a lower price, than does monopoly. This is a basic premise held by virtually all economists, disputed by pretty much no one in the profession. The entire antitrust edifice of the American system is built upon this foundational aspect of the dismal science.

And yet when push comes to shove, our society jettisons this insight, at least when it comes to assuring the quality of our food and drugs.

The Food and Drug Administration is a monopoly agency entrusted with this task. Its word is final concerning such matters. No competition is allowed. If a private agency set itself up as an alternative, it would first be subjected to raucous laughter, and then its creators jailed.

The FDA is a licensing agency. If it does not approve of a food or drug, it is illegal to offer it for sale. What is the non-monopolistic alternative to this sad state of affairs? This is called certification. How, pray tell, does this work? It is simple. Different firms set themselves up as evaluators of the quality of food and drugs, and each of them subjects these products to their examinations. They certify some as approved, and list others as not approved.

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Ohio Law Banning Mandatory Vaccination in Schools Now in Effect

An Ohio law banning schools from forcing students to take vaccinations that haven’t been fully approved by the U.S. Food and Drug Administration (FDA) took effect Wednesday. 

HB 244 says that primary and secondary schools, along with public universities, may not “Discriminate against an individual who has not received a [non-fully approved vaccine], including by requiring the individual to engage in or refrain from engaging in activities or precautions that differ from the activities or precautions of an individual who has received such a vaccine.” 

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Lawmakers Seek Federal Grand Jury Investigation for COVID-19 Statistical Manipulation

The CDC adopted a “double-standard exclusively for COVID-19 data collection” that inflated cases and deaths starting early in the pandemic, violating multiple federal laws and distorting mitigation policies, Oregon lawmakers told the feds’ top lawyer in the state.

Advised by “a large team of world-renowned doctors, epidemiologists, virologists, and attorneys,” state Senators Kim Thatcher and Dennis Linthicum petitioned U.S. Attorney Scott Asphaug to approve a grand jury investigation into how the pandemic is being measured.

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Commentary: New Ways to Diagnose Alzheimer’s Are Here, and Better Ones Are on the Way

In sharp contrast to every other top-ten cause of death, Alzheimer’s disease has long lacked affordable and accessible ways to diagnose it. While doctors have been able to tell patients with almost 100% certainty whether they have diabetes, heart disease or cancer, until recently, Alzheimer’s was a diagnosis of exclusion.

Doctors could look for signs of Alzheimer’s. They could test memory and other cognitive skills, judge a patient’s ability to perform routine tasks, and ask their friends and family about any behavior changes. MRIs could determine brain volume, which diminishes as Alzheimer’s progresses. But blood and other diagnostic tests were used only to rule out other possible causes of their symptoms, such as B12 deficiency or thyroid disorders.

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FDA Says It Does Not Buy Fetal Tissue – Any More

Baby covered in a blanket

The Food and Drug Administration assured the Daily Caller News Foundation Friday that it has not entered into any contracts “for the purchase of human fetal tissue” since 2018.

The agency’s response follows the release of documentation obtained by Judicial Watch showing that the FDA procured fetal organs, tissue, and heads for research that involved “humanized mice.” Previous documents uncovered by Judicial Watch found that the FDA requested “fresh and never frozen” fetal organs.

“I’ve been doing this for 23 years. These documents we’ve gotten from the FDA and our other lawsuit…they are the worst things I’ve ever seen,” Judicial Watch President Tom Fitton told the Daily Caller News Foundation Friday. “The most troubling documents I’ve ever seen.”

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Former FDA Head Says CDC Guidance Hurt Pandemic Response

Scott Gottlieb

The Centers for Disease Control and Prevention’s guidance ultimately hindered the U.S. response to the pandemic, former FDA Commissioner Scott Gottlieb wrote in his upcoming book “Uncontrolled Spread,” set to be released Sept. 21.

Gottlieb said in the book that U.S. intelligence agencies need to play a more active role in preparing for a pandemic, as opposed to leaving plans solely to health agencies like the CDC.

“We need to have human assets in the medical community so we understand when an outbreak emerges,” Gottlieb said, Axios reported. “We need to have the capability of monitoring typical streams of intelligence, like signals intelligence and maybe even satellite intelligence, looking for things that could be trip wires for an outbreak of disease.”

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Georgia Doctor Recommends COVID Vaccine, But Not Boosters

One Georgia doctor is taking a common sense approach to COVID-19 vaccine booster shots, which could be authorized by the Food and Drug Administration (FDA) in a matter of days. 

Dr. Cecil Bennett of Newnan Family Medicine in Newnan, Georgia, says he recommends that all of his patients take the COVID-19 vaccine. He will not, however, recommend booster shots for patients who have taken the vaccine and still have immunity from the virus, unless they are immunocompromised. 

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Report: Top Health Officials Tell White House to Pause Vaccine Booster Plan

Top U.S. health officials told the White House pandemic coordinator on Thursday to scale back the Biden administration’s plan to administer the coronavirus booster shots to individuals in September, The New York Times reported.

Dr. Janet Woodcock, the acting commissioner of the Food and Drug Administration (FDA), and Dr. Rochelle P. Walensky, the director of the Centers for Disease Control and Prevention (CDC), told White House Coronavirus Response Coordinator Jeffrey D. Zients that they need more time to collect and analyze the necessary data relating to the booster shots, The New York Times reported.

The doctors told Zients that their agencies might be able to determine whether to recommend boosters for recipients of the Pfizer-BioNTech vaccine in the coming weeks, according to the Times.

The two doctors presented their argument to Zients at a meeting on Thursday. It is unclear how Zients responded to the news.

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Commentary: The Clear Case for Joe Biden’s Impeachment

Alan Dershowitz says calls for the impeachment of Joe Biden are “wrong.” He claims in his most recent op-ed at the D.C. establishment’s favorite Republican rag, The Hill: “Whatever one may think of what Biden did or failed to do, it does not constitute an impeachable offense under the text of the Constitution.” With all due respect, Dershowitz is full of crap.

“The Framers,” Dershowitz writes, “insisted that a president could not be impeached unless he committed criminal-type conduct akin to treason and bribery.” If this is true, then why did President Thomas Jefferson call for the impeachment of a federal district judge on the grounds that he was “a man of loose morals and intemperate habits?” Jefferson was a prominent founder, who greatly influenced the framers of the Constitution.

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