FDA and Animal-Testing Industry Want to Keep Animal Testing Trade Brisk, No Matter the Costs to Animals and to Patients in Need

At the close of 2022, the Center for a Humane Economy and Animal Wellness Action engineered the most important advancement in our nation’s history on animal testing. Congress passed the FDA Modernization Act 2.0 to eliminate an animal-testing mandate that had been in place since the Great Depression of the 1930s.

With that new law, we were poised to turn the page on the primitive era of inhumane animal experiments, along with the breeding and collecting of animals that precedes invasive procedures.

But the FDA, breeding labs, and too many in the scientific establishment are still working from reflexive muscle memory when it comes to animal testing. Animal testing is what they know, and they are firmly gripping their old instruments of pain.

The FDA is not implementing the new law, as Congress demanded of it. The FDA has not, more to the point, lifted a finger to update its regulations that would allow for the use of 21st-century animal-free methods to screen new drugs.

There is widespread agreement among scientists and regulatory agencies that animal models are often poor predictors of the human response, with 90 to 95 percent of experimental drugs failing in humans. Drug developers are spending billions, we are generating few cures or treatments, and the lives of millions of animals, including primates and dogs, are being wasted.

We have innovative, human-relevant models that can and must be embraced to break this logjam. Introduced in the House and Senate this year, the bipartisan FDA Modernization Act 3.0, H.R. 7248 and S. 5046, will require the FDA to align its regulations with the new statute under the FDA Modernization Act 2.0.

The outdated and unsustainable abuse of primates and millions of other animals for testing fits into the definition of insanity — doing the same thing over and over and expecting a different result.

Primates Escape U.S. Breeding and Testing Facility for the Third Time

The companies that profit from selling animals to laboratories are desperately clinging to their lucrative business. Charles River Laboratories and Alpha Genesis, to name two companies in this space, want to keep selling animals to labs even if the work does little good for patients in need.

And their work creates its unique forms of chaos. Take a look at what’s happening right now in Yemassee, S.C. There, the county sheriff is telling residents to keep their doors and windows locked after 43 non-human primates escaped a facility run by Alpha Genesis (AGI) — the company that breeds thousands of primates for research and operates the infamous “Monkey Island,” also in South Carolina, for which it landed a $17 million federal contract last year.

“Residents are strongly advised to keep doors and windows secured to prevent these animals from entering homes,” Yemassee Sheriff’s Department said in a statement. “Anyone who finds a monkey should not interact with it but instead call 911.” It is unknown if the escaped primates carry disease, but it’s clear that authorities consider the escape a threat to public health.

This isn’t the first time primates have made a prison break at this facility.  In 2016, 19 primates escaped, but were found several hours later. In 2014, 26 monkeys escaped the facility.

The U.S. Department of Agriculture (USDA) fined Alpha Genesis $12,600 for incidents that occurred between December 2014 and February 2016. Some of the violations include improperly secured enclosures and dehydration caused by an accidentally closed water line and other violations.

AGI has shown a disregard for animal welfare laws while raking in the money. AGI received a USDA official warning in 2022 for three serious violations of the federal Animal Welfare Act, after four monkeys died and four others were seriously injured because of the negligence.

After a third successful escape attempt by monkeys, and numerous animal welfare violations, shouldn’t the authorities be asking whether AGI is fit to run a facility like this?

Charles River Laboratories Keeps Brisk Trade in Primates for Lab Use

Last year, the U.S. Justice Department hit Charles River Laboratories with a subpoena over imports of endangered long-tailed (cynomolgus or crab-eating) macaques who’d been living in the wild in Cambodia. The biggest-name brand in laboratory breeding had fraudulently passed off these wild-captured endangered animals as captive-bred before selling them to laboratories for invasive tests.

This was just a portion of a much larger trade in wild primates who go from tree canopies in Asia to testing labs in the United States. From 2000 to 2020, the research industry and its enablers imported approximately 482,000 primates, mostly for laboratory use.

The United States suspended all imports of primates from Cambodia last year, but Charles River engineered a work-around to funnel primates from Cambodia through Canada.

Last month, its lab was fined by Canadian authorities for improperly shipping long-tailed macaques into the country, and the trafficking of primates has now prompted a probe by officials who oversee an international treaty governing endangered species.

According to Science, the removal of cynomolgus macaques from the wild is not sustainable. And papers released by the CDC in July last year reveal that since 2019 the increase in imported primates has been accompanied by an increase in monkeys arriving with other zoonotic pathogens.

Dependence on Non-Human Primates Is a Threat to Public Health

A new era of animal-free drug development is dawning, but the laboratory-animal industry hasn’t gotten the memo.

Animal Wellness Action and Center for a Humane Economy’s senior scientific advisor, Dr. Zaher Nahle, wrote in Truthout last year:

“Despite being considered closer to humans than other species, NHPs [non-human primates] often do not reliably predict human disease responses. As an example, NHPs showed very mild clinical symptoms in response to SARS-CoV-2, rendering them unreliable as research models for COVID-19. No fatalities from disease burden were registered in SARS-CoV-2 infected NHPs, making them also inappropriate for modeling COVID-19-induced multisystem organ failure, a hallmark of COVID-19-related deaths. The lucrative primate research business must not cloud our judgment regarding their fitness for use. We must move towards future innovations and technologies — not backwards, recycling the same unreliable models used centuries ago.”  

When enacted, the FDA Modernization Act 3.0 will require the FDA to align its regulations with the new statute under the FDA Modernization Act 2.0.

Aligning the statute with regulations will eliminate confusion for drug sponsors, lead to more cures, cut drug development time, lower drug prices, and confirm the FDA’s stated commitment to reducing and replacing animals in drug development. That must be complemented by a clear, accountable, and transparent regulatory process, including the full and speedy implementation of the existing law. The FDA Modernization 3.0 is the only way we can accomplish this.

The author is the director of research and regulatory policy for the Center for a Humane Economy and Animal Wellness Action.