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Animal welfare groups find themselves in a real-life version of Napoleon Dynamite, as federal agency leaders appointed by the Republican version
of the cult film's Pedro Sánchez enact sweeping changes they've been
seeking for decades.

"It's hard to contain my enthusiasm" for Commissioner Marty Makary's announcement last week that the Food and Drug Administration is phasing
out animal testing in the development of monoclonal antibody therapies,
Animal Wellness Action and Center for a Humane Economy president Wayne
Pacelle said in a press call Tuesday.

The Biden administration's FDA "seemed to be inert" on the issue, and
even "obstructionist," after Pacelle's groups helped Congress remove
mandatory animal testing through the FDA Modernization 2.0 Act in 2022,
he said. "We liberated" Makary to act.

The FDA released its Roadmap to Reducing Animal Testing in Preclinical
Safety Studies the same day, explaining how it will ramp up
"scientifically validated new approach methodologies" such as
"organ-on-a-chip systems, computational modeling, and advanced in vitro assays."

Administrator Lee Zeldin is reinstating the Environmental Protection
Agency's phaseout of animal testing from the first Trump administration
after the Biden administration lifted its compliance deadlines to reduce
mammal testing by 30% by 2025 and eliminate it by 2035, spokesperson
Molly Vaseliou told The Washington Times.

Rep. Nicole Malliotakis, R-N.Y., said she was working behind the scenes
to revive the Trump plan, which "will save tens of millions of taxpayer
dollars and spare countless dogs, rabbits and other animals from painful
and unnecessary experiments" that are outdated and inefficient compared
to "modern alternatives."

Cheering its longtime ally Zeldin, who previously secured the end of dog testing at the Department of Veterans Affairs, the White Coat Waste
Project noted it exposed Biden's actions more than a year ago as
"establishment animal rights groups stayed silent."

The EPA spent millions "to make animals obese, electroshock them, and
force them to inhale wildfire smoke and emissions from rifles and
handguns in the name of 'environmental justice' and compelled companies
to poison puppies with pesticides," said WCW Senior Vice President
Justin Goodman, who testified at a congressional hearing on woke-derived
animal cruelty.

WCW said it has also lined up GOP and Democratic sponsors for
reintroduced legislation to ban National Institutes of Health funding
for animal testing in the labs of "adversarial nations" including China, Russia, Iran and North Korea.

While the Department of Government Efficiency prompted NIH to cancel
funding for Chinese malaria experiments exposed by WCW, the
animal-cruelty watchdog said over 20 other Chinese labs are still
eligible, including a beagle operation exposed by WCW.

While it secured the same House sponsors from the previous session,
Reps. Lisa McClain, R-Mich., and Don Davis, D-N.C., Goodman told Just
the News that WCW is still looking for a Democratic Senate sponsor to
join Iowa Republican Sen. Joni Ernst.

"We approached several moderate Democrats about helping introduce" the Accountability in Foreign Animal Research Act, "and this morning we
asked every Senate Dem office to cosponsor the bill," he wrote in an
email Tuesday.

"Whether creating zombie cats in Russia or supporting risky research in
Wuhan, funding sketchy experiments on animals in foreign labs, I am
cutting off the money for this … crazy pseudoscience overseas," Ernst
said in WCW's release.

Biden FDA the 'very definition of a bureaucracy on autopilot'

The FDA's April 10 announcement said animal testing will be "reduced,
refined, or potentially replaced" using approaches including "AI-based computational models of toxicity and cell lines and organoid toxicity
testing in a laboratory setting," and the new regimen will be
implemented "immediately" for investigational new drug applications.

The agency will start using "pre-existing, real-world safety data from
other countries, with comparable regulatory standards, where the drug
has already been studied in humans."

Makary said the changes will mean "a more efficient pipeline for novel treatments" for patients, better safety because "human-based test
systems may better predict real-world outcome," and sparing thousands of
dogs and primates from testing.

The roadmap document says it's starting with monoclonal antibody, or
mAb, testing because "animal immunogenicity is not predictive of human immunogenicity," the "stress of laboratory life" can affect their immune function and "some safety risks may go undetected in animals," such as
"a life-threatening cytokine release syndrome in human volunteers."

Animal mAb testing can cost a quarter of a billion dollars, take nearly
a decade and require more than 100 "non-human primates" costing up to
$50,000 each, only for most drug development trials to fail for "lack of efficacy or unexpected safety issues that were not evident in animal
tests," the roadmap says.

"This is a fantastic, revolutionary announcement," Pacelle, long known
as the head of the Humane Society before founding new groups, said on
the press call.

Zaher Nahle, chief scientific adviser for the Center for a Humane
Economy, said using mAb therapy "as a beachhead makes a lot of sense"
and Makary is thinking "systematically."

He said the first problem in drug development, the vast majority of
animal testing, is liver toxicity. The call featured CEO Jim Corbett of Emulate, which makes a "liver-chip."

Tamara Drake, Center for a Humane Economy director of research and
regulatory affairs, said people are still dying from "taking drugs as prescribed" based on animal testing, while some drugs fail in animals
that might work in humans.

But Pacelle warned the roadmap will face challenges, given that this is
an "almost universally accepted framework" across the pharmaceutical
industry, agencies and academic institutions – then-NIH chief Elias
Zerhouni flatly said in 2013 animal testing doesn't work – yet President Biden's FDA didn't revise its regulations to conform to the 2022 law.

The Biden administration exhibited the "very definition of a bureaucracy
on autopilot," and Pacelle suspects Makary will face internal resistance
due to that "muscle memory."

Their coalition succeeded in the Senate's unanimous approval of the FDA Modernization 3.0 Act in December, led by Sens. Rand Paul, R-Ky., and
Cory Booker, D-N.J., in the face of the Biden FDA's intransigence, but
it didn't get scheduled in the House, he said.

But the speakers eased up on the last administration when Just the News
asked why it was so resistant to changes. Both Democratic and GOP administrations have been beholden to animal testing, just as the
agribusiness lobby held sway at the FDA, Pacelle said.

"I found it was a culture of timidness that they had been doing
something so long they were afraid to change" and would be blamed if it
went wrong, yet those officials were willing to approve drugs with a
host of known side effects, Pacelle said.

Drake said the "shock" to her was Biden's FDA Commissioner Robert Califf claiming the science on non-animal testing wasn't there yet, which was
"really disappointing" in light of the strides made by companies such as Emulate.

https://justthenews.com/government/federal-agencies/animal-welfare-groups-thrilled-trump-administration-strides-biden

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