U.S. FDA Bids Adieu to Animal Testing

The U.S. Food and Drug Administration (FDA) re-examined its requirement for animal testing on products under its jurisdiction and slashed the need for testing on animals.

A story in Chemical & Engineering News, an independent news outlet of the American Chemical Society, explains that some alternative technologies that do not involve the use of animals could even improve the ability to predict human risk and efficacy for many drugs.

Animal Testing Methods for Some Chemicals Need Change, Don't Accurately Mimic Human Exposure
A new review suggests oral gavage, the most widely accepted method of dosing lab animals to test chemical toxicity, does not accurately mimic how humans are exposed to chemicals in everyday life.

‘The U.S. Food and Drug Administration (FDA) is no longer gonna test on animals and will consider alternative technologies for preclinical drug testing.’

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"Although animal models have been critical in bringing new therapies to market, this type of testing raises ethical concerns," says Senior Correspondent Britt E. Erickson.

Animal Testing: Is it Authentic?

In addition, animals aren’t identical to humans, and results from non-human studies can lead researchers astray. Different species absorb and metabolize drugs differently, so a drug could “fail” in mice or rats but work well in humans or vice versa.

Historically, FDA has only allowed alternatives to animal studies in a handful of cases, but the tide is turning.

In a meeting with its Science Board on June 14, 2022, FDA discussed nonanimal approaches that could replace, reduce and refine testing for regulatory purposes.

Scientists Find New Method to Reduce the Need for Animal Testing
Researchers must first test new medicines in animals, which is costly and time-consuming, as well as ethically challenging, to determine whether they are safe and effective for humans.

The agency’s new alternative methods (NAMs) group explained that new technologies, such as microphysiological systems in combination with cellular and computational methods, have the potential to provide better results and move products to the marketplace faster.

FDA is considering putting these technologies through their paces in a qualification process, which would mean that developers would not have to re-validate tools that have gone through this rigorous procedure.

New In Vitro Model Assesses Toxicological Risk Without Animal Testing
The newly developed Adverse Outcome Pathways (AOPs) have received an award from PETA for contributing to non-animal approaches to predict adverse health effects.

To fund these efforts, FDA is asking Congress for $5 million for its NAMs initiative in fiscal 2023. And language in bills to reauthorize FDA user fees would allow the agency to consider alternative technologies for preclinical drug testing, meaning it would no longer have to require animal studies.

Imitation of Blood-retinal Barrier to Reduce Animal Testing
An imitation of the human blood-retinal barrier has been developed on a microfluidic chip. This may reduce the use of animals for testing in research.

Source-Eurekalert