FDA Seeks to Phase Out Animal Testing for Certain Medical Drugs

On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced the agency will be taking a new approach to the development of monoclonal antibody therapies and other drugs that will consist of phasing out animal testing with “more effective, human-relevant methods.” As part of the FDA’s new plan, it states that the “animal testing requirement will be reduced, refined, or potentially replaced using a range of approaches.”

Animal testing is a cruel and gruesome industry where animals are subjected to horrifically painful experiments, too often without pain-relieving medication. There is little regulation or meaningful oversight of the labs in which animals are experimented on. For all that pain, experts say that the testing isn’t even effective.

Commenting on the new approach, FDA Commissioner Martin A. Makary explains, “It represents a major step toward ending the use of laboratory animals in drug testing. Thousands of animals, including dogs and primates, could eventually be spared each year as these new methods take root.”

There have been promising developments such as the FDA’s new reforms, but the fact that it is estimated there are over 100 million animals used for research in the U.S. annually — the vast majority of which are mice and rats who are offered no legal protections. Most experimentation on animals is conducted in the private sector and not by government agencies like the FDA. Both show how much more work is still needed.

The Animal Legal Defense Fund (ALDF) has a long history of taking action to protect animals used for research and those advocating on their behalf that continues to this day. For example, in July 2024, the U.S. Court of Appeals for the D.C. Circuit ruled that the National Institutes of Health (NIH)’s use of keyword blocking on its social media pages, which censors comments critical of animal testing, violates the First Amendment. The decision came in response to a lawsuit brought by animal activists represented by ALDF and the Knight First Amendment Institute at Columbia University, along with People for the Ethical Treatment of Animals (PETA).

In April 2022, ALDF and Rise for Animals (RISE) filed a lawsuit against the U.S. Department of Agriculture (USDA) challenging the agency’s secret policy of only conducting partial inspections of laboratories accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC International), a private organization dominated by the animal research industry. Under this secret policy, the USDA is failing in its duty to conduct thorough annual inspections of numerous animal research facilities regulated under the federal Animal Welfare Act (AWA) — the only federal law ensuring minimum standards of care for animals tested on by research facilities. ALDF and RISE are represented by the Harvard Law School’s Animal Law & Policy Clinic.

It is extremely rare for any animal to get out of a research lab alive. However, in July 2024, ALDF helped facilitate the legal release of six Gottingen pigs from an undisclosed research lab to three reputable sanctuaries and made a financial contribution to support the pigs’ care during and after the transition. Gottingen pigs are specifically bred for use in biomedical research, engineered to be small, compliant, docile pigs with good ear veins, that make them easier for researchers to experiment on.

ALDF continues to work throughout the legal system to secure better protections for animals used in research, and better enforcement of those protections.