Tag: animal testing

FDA Says It Plans to Phase out Animal Testing for Drug Development

The Food and Drug Administration (FDA) on April 10 said it will be phasing out animal testing for monoclonal antibodies and other drugs.

FDA officials said that its animal testing requirement will be “reduced, refined, or potentially replaced” with other approaches, including advanced computer simulations utilizing artificial intelligence and lab-grown products that are designed to mimic human organs.

The agency will also start looking at preexisting, real-world safety data from other countries that have regulatory standards similar to those in the United States.

“For too long, drug manufacturers have performed additional animal testing of drugs that have data in broad human use internationally. This initiative marks a paradigm shift in drug evaluation and holds promise to accelerate cures and meaningful treatments for Americans while reducing animal use,” FDA Commissioner Dr. Marty Makary said in a statement.

He said that the move “represents a major step toward ending the use of laboratory animals in drug testing.”

Companies that submit what the agency described as strong safety data from non-animal testing could receive faster review, according to the FDA.

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No monkey business here! Tiny Georgia town in uproar at plans to build a huge $400 MILLION breeding farm for 30,000 long-tailed macaques that will be sold off for animal testing

A tiny Georgia town is in uproar amid plans for a huge $400million breeding farm for 30,000 monkeys who will be sold off for animal testing.

Safer Human Medicine sparked fury in Bainbridge, in the south west of the state, by proposing the sprawling site for the long-tailed macaques.

It filed plans earlier this month to erect huge sheds across a 200-acre estate near the town of 14,000 people, which will hold the doomed primates.

But it has been met with fierce resistance, with locals claiming it will smell and depreciate the value of their homes.

Others raised fears the monkeys could escape during a hurricane or tornado while animal rights activists attacked the firm for selling them for animal testing.

Environmental impact is also a concern with locals cherishing the Flint River, which flows into Lake Seminole and whose waters reach the Gulf of Mexico. 

Safer Human Medicine is led by executives who formerly worked for two other companies that provide animals for medical testing. 

One of those companies, Charles River Laboratories, came under investigation last year for obtaining wild monkeys that were smuggled from Cambodia. 

The monkeys were falsely labeled as bred in captivity, as is required by U.S. rules, federal prosecutors have alleged. The company suspended the shipments from Cambodia.

Charles River had proposed a similar facility in Brazoria County, Texas, south of Houston, but it has been stalled by local opposition.

The Bainbridge facility would provide a domestic source of monkeys to offset imports, the company said. 

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Why Is the FDA Still Requiring Human or Animal Testing For New Drugs?

Congress unanimously passed the FDA Modernization Act 2.0 in December 2022. The law allows drug companies to find alternative methods of assessing their products, without testing them on animals or human beings.

The bill was sponsored by Sens. Rand Paul (R–Ky.) and Cory Booker (D–NH). Its goal was to speed up the drug approval process, and to let scientists experiment with approaches methods that are more humane than testing on live subjects. Reason‘s Elizabeth Nolan Brown aptly summarized the bill’s achievements, noting that “previously, all drugs in development were required to undergo animal studies before being tested in human trials. Now, drug companies will still have the option to start testing experimental drugs on animals, but they won’t have to.”

And yet the Food and Drug Administration (FDA) has not taken action to update the agency’s regulations.

“The FDA’s regulations related to animal testing no longer fully conform with applicable law,” writes Paul in a letter to FDA Commissioner Robert Califf.

Paul’s letter, obtained exclusively by Reason, was co-signed by Booker and several other senators from both parties. It notes that the FDA has previously spoken positively about moving away from animal testing. But companies currently submitting applications for drug approval still have to deal with FDA requirements that stipulate human or animal testing—at least on paper.

“These and other regulatory provisions no longer reflect the full scope of the governing statute and should therefore be updated as expeditiously as possible,” writes Paul.

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The Pentagon is funding experiments on animals to recreate ‘Havana Syndrome’

The Defense Department is funding experiments on animals to determine if radio frequency waves could be the source of the mysterious ailment referred to as “Havana Syndrome” that has afflicted hundreds of U.S. government personnel in recent years, according to public documents and three people familiar with the effort.

This news of the ongoing animal testing, which has not previously been reported, comes after the Office of the Director of National Intelligence determined last week that there is no credible evidence that a foreign adversary wielding a weapon caused the health incidents. Despite the assessment, the Pentagon is continuing to examine that possibility, as POLITICO reported.

The Army in September awarded Wayne State University in Michigan a $750,000 grant to study the effects of radio frequency waves on ferrets, which have brains similar to humans, according to information on the grant posted on USASpending.gov. The aim is to determine whether this exposure induces similar symptoms to those experienced by U.S. government personnel in Havana, Cuba, and China, the documents show.

Symptoms have been described as severe headaches, temporary loss of hearing, vertigo and other problems similar to traumatic brain injury.

DoD has also recently tested pulsed radio frequency sources on primates to try to determine whether their effects can be linked to what the government calls “anomalous health incidents,” according to one former intelligence official and a current U.S. official who were briefed on the effort. Both were granted anonymity to discuss sensitive work. It is not clear whether these studies, which were done internally, are ongoing.

DoD spokesperson Lt. Cmdr. Tim Gorman confirmed that the grant to Wayne State University, with collaborators from the University of Michigan, “will develop and test a novel laboratory animal model to mimic mild concussive head injury.”

“Behavioral, imaging, and histological studies will determine if the model is comparable to the abnormalities seen in humans following concussive head injury,” Gorman said, adding that: “The model may subsequently be used to test potential treatments to alleviate the deficits associated with traumatic brain injury.”

Gorman declined to comment on whether DoD has recently conducted these experiments on primates.

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NIH To Spend $2 Million in Taxpayer Funds on ‘Unnecessary’ Puppy Experiments

The National Institutes of Health division led by Dr. Anthony Fauci is slated to spend nearly $2 million to force feed puppies with experimental allergy drugs, according to a government watchdog group.

NIH’s National Institute of Allergy and Infectious Diseases (NIAID), which is helmed by Fauci, allocated $1,836,453 in taxpayer dollars for a contractor to test an experimental hay fever drug on mice, rats, and dogs, including puppies, according to the funding documents, which were obtained by the White Coat Waste Project and provided to the Washington Free Beacon. The most severe symptoms of hay fever, also known as seasonal allergies, are a runny nose and sneezing.

The documents, which were obtained through a Freedom of Information Act request and are highly redacted, show that the division requested at least five separate experiments on dogs that are likely to include force-feeding them experimental drugs for several months. While the contractor conducting the tests, Inimmune Corp., said guinea pigs could be used in place of dogs for some testing, purchasing “six-month old puppies” that would be exposed to allergens and then used for testing was also proposed.

NIH’s animal experiments have become a flashpoint in Congress after it emerged earlier this year that the government spent $2.5 million injecting beagle puppies with cocaine, sparking a bipartisan investigation, which was first reported by the Free Beacon. The NIH also funds labs in Russia, even as it invades Ukraine, including one lab that conducted “horrific and barbaric experiments on 18 cats.” The disclosure of the latest funding tranche is likely to build momentum for legislation called the Preventing Animal Abuse and Waste Act that would bar NIAID from conducting these types of dog experiments.

“Fauci’s white coats at NIAID have forced taxpayers to pay millions to de-bark and poison puppies, infest beagles with ticks and flies, and, now, needlessly torture puppies to test a new drug to treat a runny nose,” Devin Murphy, White Coat Waste Project’s public policy and communications manager, told the Free Beacon. “Even NIAID’s own contractor acknowledges that the dog testing demanded by Fauci’s agency is unnecessary because alternative animal models are available.”

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