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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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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FDA Inspections of Foreign Drug Facilities Plummeted Since Before COVID-19, Study Shows

The Food and Drug Administration (FDA) has inspected fewer pharmaceutical manufacturing facilities compared to before the COVID-19 pandemic, with foreign facilities, including those from China, seeing the largest decreases, according to a study released in December.

In 2022, the total number of inspections of drug manufacturing establishments by the FDA decreased by 79% for foreign and 35% for domestic facilities compared to 2019, before the COVID-19 pandemic, according to a study by Emily Cuddy, Yun Peng Lu and David B. Ridley using data acquired through Freedom of Information Act requests. Despite the drop in inspections, there was no corresponding decrease in imports or manufacturing, while resources allocated by the FDA toward inspections surged per inspection.

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More Restaurants, Bars Stock Up on Fentanyl, Opioid Overdose Reversal Drug as Deaths Soar

An increasing number of restaurants and bars across the country are keeping a stock of Naloxone, an antidote to fentanyl and opioid overdoses, according to The New York Times.

Local officials and nonprofit organizations are ramping up efforts to more bars and restaurants as overdoses become all too common in public spaces, according to the NYT. Between February 2022 and February 2023, there were more than 105,000 reported drug overdoses in the U.S., according to provisional data from the Centers for Disease Control and Prevention (CDC).

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

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.

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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.

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Supreme Court Maintains Broad Access to Abortion Pill, Pending Litigation

The Supreme Court on Friday opted to preserve access to mifepristone while a challenge to the Food and Drug Administration’s approval of the drug makes its way through the courts. The Biden administration and mifepristone manufacturer Danco Laboratories had appealed to the court for relief. The court did not decide on the merits of the case, which will continue through the court system, the Associated Press reported.

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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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Top Epidemiologist Wants Pandemic Emergency Powers Ended, Insurer Death Data Released

One of the nation’s leading epidemiologists is declaring there is no basis for President Joe Biden to extend his emergency pandemic powers and that it is essential for insurers to release data showing deaths and injuries to those who have received COVID-19 vaccines.

Dr. Harvey Risch, professor emeritus at the Yale University School of Public Health, told Just the News on Friday evening that federal agencies have epically mishandled the pandemic strategy by substituting theories and politics for science.

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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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Commentary: The Feds Pile Up Vaccine ‘Adverse Event’ Reports as They Decry Scaremongering Elsewhere

Since the Food and Drug Administration authorized the first vaccines for COVID-19 in late 2020, the government and much of the media have insisted that the medicines developed in record time are safe and effective. Those who raised questions about them have been routinely dismissed as conspiracy theorists.

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FDA Vaccine Panel Recommends COVID Shots for Babies and Toddlers

The Food and Drug Administration’s (FDA) vaccine advisory panel unanimously voted Wednesday to recommend the Moderna and Pfizer vaccines for infants and young children despite an abundance of calls from physicians, children’s health organizations, and members of Congress to refrain from approving the shots for a population that shows the least risk for serious disease from COVID.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted, 21-0, in favor of recommending Emergency Use Authorization (EUA) for the Moderna and Pfizer mRNA COVID vaccines for infants, toddlers, and preschool-age children.

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Doctor Crashes FDA Meeting and Shares the Whistleblower Story They Ignored

A doctor “crashed” a Food and Drug Administration’s meeting with outside vaccine experts earlier this week, to share a whistleblower’s story about the data integrity issues that plagued one of Pfizer’s clinical trials.

In September of 2020, a researcher from an organization testing Pfizer’s vaccine at several sites in Texas, emailed a complaint to the FDA, informing the agency of the company’s dangerously shoddy research practices. The FDA took no action on her email, and Pfizer continues to use the company.

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Pfizer CEO Calls for Another Booster Shot for All Americans

On Sunday, the chief executive officer of Pfizer said that Americans should be prepared to receive a second booster shot of the Coronavirus vaccine, which would mark the fourth overall shot that has been forced on the American public.

As reported by Politico, Albert Bourla made his remarks in an interview with CBS’ Margaret Brennan, where he said that his company was preparing to submit “a significant package of data about the need for a fourth dose” to the Food and Drug Administration (FDA).

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FDA Executive Says on Hidden Camera That Yearly COVID Shots Will Be Mandatory for All Americans – Including Toddlers

The Biden administration plans to make yearly COVID shots mandatory for all Americans, including young children, a Food and Drug Administration executive told a Project Veritas undercover journalist on hidden camera.

In the sting video released on Tuesday, Christopher Cole, Executive Officer of Countermeasures Initiative for the FDA, said: “Biden wants to inoculate as many people as possible.” According to Project Veritas president James O’Keefe, Cole has “over 20 years experience” at the FDA, and “claims to be directly involved in the approval process.”

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FDA Announces Postponement of Approval of COVID Vaccine for Babies and Young Children

Young girl with a blue shirt on getting a vaccine

Pfizer and the Food and Drug Administration (FDA) said Friday they are delaying their plan for Pfizer’s Emergency Use Authorization (EUA) for its coronavirus vaccine for children under five years old due to insufficient data on the efficacy of a third dose.

Pfizer announced February 1 FDA had asked the drug company, and its partner BioNTech, to submit data on a COVID vaccine series for babies as young as six months old and young children up until age five.

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Pfizer Plan for COVID Vaccine Series for Babies of 6 Months Draws Fierce Controversy

closeup of a baby

Pfizer announced last week the Food and Drug Administration (FDA) had asked the drug company, and its partner BioNTech, to submit data on a COVID vaccine series for babies as young as 6 months old.

Albert Bourla, chairman and CEO of Pfizer, said in the statement:

As hospitalizations of children under 5 due to COVID-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus. Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants. If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose.

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Governor Ron DeSantis Shreds Biden over Decision to Revoke Emergency Use Authorization for Monoclonal Antibody Treatments

Florida Governor Ron DeSantis shredded President Joe Biden’s administration over the decision to revoke the emergency use authorization for Regeneron and Eli Lilly monoclonal antibody treatments.

According to the Food and Drug Administration, the treatments are not effective against the Omicron variant. Because the variant accounts for most cases of the coronavirus across the country, leaders of the agency limited its use.

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Commentary: What Reverend Martin Luther King, Jr. Would Say About Biden’s New COVID-19 Policy

Given the Biden administration’s recent effort to prioritize COVID-19 treatments based on race, it is more important than ever that we remember – and practice – the teachings of Reverend Martin Luther King Jr.

Last week, the Food and Drug Administration released new guidance to medical professionals which listed “race or ethnicity” as high risk factors for doctors to consider when prescribing a new monoclonal antibody known as Sotrovimab. Other high-risk factors included obesity, pregnancy, and other health conditions which would make a person less able to fight the virus. The new guidance means a person’s race could qualify him or her for treatment ahead of others who need the drugs.

Biden administration officials have cited high rates of diabetes and other health issues which are prevalent in non-white and non-Hispanic communities as reasons to include the new criteria. Officials in New York and Minnesota have also prioritized treating non-white patients, but they have more overtly cited historic health care disparities as a justification.

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