# The AARF Act of 2021: What It Actually Does

Right now, when pharmaceutical companies want to get a new drug approved by the FDA, they often have to test it on animals like dogs and other mammals to prove it's safe and effective. The AARF Act (Alternatives to Animals for Regulatory Fairness Act) would change this by allowing drug companies to use non-animal testing methods instead—like lab-grown human tissue, computer simulations, or other advanced techniques—as long as those methods meet the FDA's safety and effectiveness standards.

The bill's supporters argue that animal testing is expensive, time-consuming, and often doesn't work well anyway. According to the bill, about 30 percent of drugs that look promising in animal tests end up being toxic to humans, while 60 percent fail because they don't actually work. Meanwhile, pharmaceutical companies are already investing in newer testing methods that many experts believe are more accurate and faster. The FDA's own guidance documents actually encourage companies to explore these alternatives, but in practice, some drug makers say the agency hasn't always allowed them to use these newer methods to meet regulatory requirements.

What this bill would do is make it official policy that if a drug company develops a non-animal testing approach that meets all the legal requirements, the FDA must accept it. This could speed up drug development, potentially get new medications to patients faster, and reduce the number of animals used in pharmaceutical testing. For patients, this might mean access to new treatments sooner. For pharmaceutical companies, it could mean lower costs and faster approval timelines. The main catch is that the alternative testing methods still have to prove they're reliable and actually demonstrate that a drug is safe and effective—the bill doesn't lower safety standards, it just opens the door to different ways of proving those standards are met.

AARF Act of 2021

Boyle, Brendan F.

Animals for Regulatory Fairness Act of 2021 or the AARF Act of 2021 This bill requires the Food and Drug Administration to allow an applicant for approval to market a new drug to use a non-animal test to demonstrate the safety and effectiveness of the drug if the non-animal test satisfies all other applicable requirements.