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FDA Says Telling People Not to Take Ivermectin for COVID-19 Was Just a Recommendation

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The U.S. Food and Drug Administration (FDA) telling people to “stop” taking ivermectin for COVID-19 was informal and just a recommendation, government lawyers argued during a recent hearing.

“The cited statements were not directives. They were not mandatory. They were recommendations. They said what parties should do. They said, for example, why you should not take ivermectin to treat COVID-19. They did not say you may not do it, you must not do it. They did not say it’s prohibited or it’s unlawful. They also did not say that doctors may not prescribe ivermectin,” Isaac Belfer, one of the lawyers, told the court during the Nov. 1 hearing in federal court in Texas.

“They use informal language, that is true,” he also said, adding that, “it’s conversational but not mandatory.”

The hearing was held in a case brought by three doctors who say the FDA illegally interfered with their ability to prescribe medicine to their patients when it issued statements on ivermectin, an anti-parasitic that has shown positive results in some trials against COVID-19.

Ivermectin is approved by the FDA but not for COVID-19. Drugs are commonly used for non-approved purposes in the United States; the practice is known as off-label treatment. (Read more from “FDA Says Telling People Not to Take Ivermectin for COVID-19 Was Just a Recommendation” HERE)

Photo credit: Flickr

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‘Pregnancy Is Not an Illness’: Doctors Sue FDA Over Approval of ‘Dangerous’ Abortion Pill

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Four national medical associations and four doctors are suing the Federal Drug Administration (FDA) for “illegally” approving abortion drugs that they claim harm women, according to a federal lawsuit filed Friday.

The groups, represented by Alliance Defending Freedom, are claiming that, “the FDA failed America’s women and girls when it chose politics over science and approved chemical abortion drugs for use in the United States.”

The lawsuit alleges that the FDA had to designate pregnancy as an “illness” and the abortion drugs as providing a “meaningful therapeutic benefit” in order to get them approved so rapidly.

“Pregnancy is not an illness, and chemical abortion drugs don’t provide a therapeutic benefit—they end a baby’s life and they pose serious and life-threatening complications to the mother,” ADF Senior Counsel Julie Marie Blake said in a press release. (Read more from “‘Pregnancy Is Not an Illness’: Doctors Sue FDA Over Approval of ‘Dangerous’ Abortion Pill” HERE)

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New COVID-19 Boosters To Be Authorized Without Human Trials Completed

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New variant-specific COVID-19 vaccine booster doses are set to be authorized by the Food and Drug Administration (FDA) before human testing is complete.

FDA Commissioner Robert Califf tweeted last week that the agency will not hold a meeting of its expert vaccine advisers to discuss the new boosters and that it will rely on existing clinical trial data and real-world results in its determination about Emergency Use Authorizations (EUAs) for Omicron-targeting booster shots. The Centers for Disease Control and Prevention (CDC) based its fall booster rollout plan on the assumption that the new vaccines would receive EUAs by Sept. 1. . .

The typical process for granting an EUA to a new vaccine involves a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), the FDA’s group of outside experts that examines research and evidence pertaining to the vaccine’s safety and efficacy. The panel votes on whether to grant the EUA, and under what circumstances to grant it, and passes that recommendation onto the FDA commissioner for a final ruling. (Read more from “New COVID-19 Boosters to Be Authorized Without Human Trials Completed” HERE)

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Pfizer Asks FDA to Clear COVID Shots for Babies

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Children statistically have virtually no chance of death or serious illness from COVID-19, but, in any case, the experimental vaccines rushed to market under emergency use authorization have proven to be ineffective against the current SARS-CoV-2 variants while posing the risk of severe harm or death in proportions far higher than any vaccine in history.

Children also, according to studies, are at low risk of spreading COVID-19. Further, the CDC recently reported higher COVID-19 case rates have been recorded among fully vaccinated children than unvaccinated in the age group 5-11 since February 2022. And the U.K.’s Office for National Statistics found children are up to 52 times more likely to die following the COVID-19 injection than children who have not received it.

Nevertheless, Pfizer has submitted a request to the FDA – which tried to hide Pfizer’s clinical trial data for 75 years – to grant emergency use authorization to administer its COVID-19 vaccine to children from six months to 5 years of age.

The pharmaceutical giant declared in May that a three-shot regimen of its Pfizer-BioNTech vaccine was 80.3% effective in preventing COVID infections among children under 5, based on early results of its trial for that cohort. (Read more from “Pfizer Asks FDA to Clear COVID Shots for Babies” HERE)

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Strawberries Linked to Hepatitis A Outbreak

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The Food and Drug Administration, along with the Centers for Disease Control and Prevention and other agencies, are investigating an outbreak of hepatitis A that could be linked to fresh, organic strawberries sold in the United States and Canada.

Consumers should not eat strawberries from the brands FreshKampo or HEB that were sold between March 5, 2022, and April 25, 2022, the FDA said in an announcement. Health officials also warned that retailers and restaurants should not use or sell the berries.

The strawberries in question are no longer in stores. However, some buyers may have stored or frozen them for later consumption, which the FDA warns against.

The berries were sold at Aldi, HEB, Kroger, Safeway, Sprouts Farmers Market, Trader Joe’s, Walmart, Weis Markets, and WinCo Foods, among others. (Read more from “Strawberries Linked to Hepatitis A Outbreak” HERE)

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Shock Claim: Tester Says He ‘Pushed FDA Commissioner Months Ago’ on Baby Formula; FDA Has Known About Formula Shortage Since February

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By Breitbart. On Friday’s broadcast of CNN’s “New Day,” Sen. Jon Tester (D-MT) said that he pressed the head of the Food and Drug Administration “months ago” on the baby formula issue and stated that right now the White House is “taking appropriate steps” to fix the issue and is “taking it seriously and I think they’re moving forward in the right direction.”

Co-host John Berman asked, “What are you hearing from Montanans about baby formula?”

Tester answered, “Big concern. And we need to do everything we can do to right this ship. It’s — literally is a life and death situation in many cases.” (Read more from “Shock Claim: Tester Says He ‘Pushed FDA Commissioner Months Ago’ on Baby Formula” HERE)

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Rep. Stefanik Blasts Biden Administration for Formula Shortage, Says FDA has Known About Threat Since February

By Breitbart. The Biden Administration has been aware of the threat of a national baby formula shortage for “months,” House Republican Conference Chair Elise Stefanik (R-NY) told Breitbart News – on the same day President Biden claimed only “mind readers” could have anticipated the crisis.

Asked Friday about whether his administration could have taken steps sooner to avoid the current supply crunch of baby formula, Biden replied, “If we’d been better mind-readers I guess we could have.” . . .

But Rep. Stefanik told Breitbart News in a wide-ranging interview on Friday that Biden has been “asleep at the switch,” and that the FDA has known about a pending baby formula shortage for over three months – at least since she reached out to warn them of it in February.

“They’ve known this has been an issue for months. I sounded the alarm and reached out to the FDA in February of this year, after the recall of the Sturgis, Michigan, [Abott Nutrition] manufacturing facility, and we got no substantive response from the FDA. There was absolutely no plan from this administration about how to address that supply chain issue, which has now created even more of a crisis,” Stefanik said. (Read more from “Rep. Stefanik Blasts Biden Administration for Formula Shortage, Says FDA has Known About Threat Since February” HERE)

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FDA, Biden ‘Dropped the Ball’ on Baby Formula Crisis, Experts Say

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The FDA “dropped the ball’’ on the country’s baby-formula crisis — shutting down a crucial plant on top of product recalls and then not warning parents of the ramifications, experts told The Post on Friday.

Desperate moms and dads have been trawling stores across the country in search of baby formula ever since mega-manufacturer Abbott issued a safety recall in February for products made at its plant in Sturgis, Mich., over contamination concerns.

The Food and Drug Administration later closed the plant after federal inspectors found Abbott failed to maintain sanitary conditions and procedures there — sparking a cascade of crippling effects on the supply chain.

“Somebody, whether it be Abbott or the FDA, should have realized, ‘We’re stopping production at one of a handful of plants that produces baby formula and what are the repercussions,’ ’’ said William Marler, a lawyer specializing in food-safety cases, to The Post.

“That’s where the FDA and Abbott dropped the ball. … They could have recalled the product without shutting the facility. They do recalls all the time without shutting the facility down.” (Read more from “FDA, Biden ‘Dropped the Ball’ on Baby Formula Crisis, Experts Say” HERE)

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Biden’s FDA Has Reportedly Not Proven Any Babies Died From Baby Formula

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President Joe Biden’s Food and Drug Administration (FDA) may have directly contributed to the ongoing nationwide baby formula shortage without proving any babies died from baby formula.

The FDA announced Feb. 17 that a major Abbott Nutrition plant in Michigan, responsible for producing massive quantities of baby formula, was under investigation for links to bacterial outbreaks, including salmonella. The agency helped Abbott initiate a recall of its baby formula. Yet neither the Centers for Disease Control and Prevention (CDC) nor the FDA have been able to prove that any babies got sick from Abbott’s formula, according to The Wall Street Journal.

There were two types of infections initially reported to the FDA, and linked back to the Abbott facility: Cronobacter sakazakii and salmonella. FDA inspectors found bacteria at the Abbott plant, but the company has strongly denied that it’s actually responsible for the reported infections, according to the outlet.

The company claims the evidence is on their side. The places at the facility where FDA inspectors found bacteria were not in contact with formula products, and genetic tests performed by the CDC determined that the cronobacter strains in the facility did not match those which caused the infections, according to The WSJ, citing Abbott. (Read more from “Biden’s FDA Has Reportedly Not Proven Any Babies Died From Baby Formula” HERE)

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FDA Drastically Reduces Use of This COVID Vaccine Over Blood Clots

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The Food and Drug Administration (FDA) announced Thursday it is significantly limiting use of Johnson & Johnson’s COVID-19 vaccine due to a risk of rare but severe blood clots.

The agency announced it is limiting the single-shot vaccine’s authorization to individuals who are either unable to get one of the available mRNA vaccines from Pfizer and Moderna, either due to a lack of access or a medical issue, or to individuals who will not otherwise get vaccinated unless it is by the Johnson & Johnson shot.

The FDA briefly paused the use of Johnson & Johnson’s shot last year, due to reports that some recipients were developing thrombosis with thrombocytopenia syndrome (TTS). The pause was lifted within weeks, as it was determined only 15 individuals out of eight million vaccine recipients developed the syndrome. (Read more from “FDA Drastically Reduces Use of This COVID Vaccine Over Blood Clots” HERE)

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FDA Authorizes Second COVID-19 Booster Shots for Adults 50 and Up

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The Food and Drug Administration on Tuesday signed off on a second booster shot for older Americans and people who are immunocompromised.

The second dose of the Pfizer-BioNTech or Moderna booster shots was authorized by the federal agency for people ages 50 and up and those with severely weakened immune systems at least four months following their first booster.

The FDA had previously only cleared the fourth doses of the Pfizer or Moderna vaccines for people ages 12 and older who were immunocompromised. That group can now get a fifth shot — three doses and two boosters — with Tuesday’s FDA authorization.

“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals,” the FDA’s vaccine chief, Dr. Peter Marks, said in a statement.

Data shows an initial booster dose is critical to protect all adults from “potentially severe outcomes” of COVID-19, Marks said. (Read more from “FDA Authorizes Second COVID-19 Booster Shots for Adults 50 and Up” HERE)

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