Physicians Committee Applauds FDA Commissioner Makary’s Leadership on Phasing Out Animal Testing in Favor of Human-Relevant Methods

WASHINGTON, D.C.—The Physicians Committee for Responsible Medicine, a nonprofit that advocates for nonanimal science, is applauding the new commissioner of the U.S. Food and Drug Administration, Marty Makary, MD, MPH, on the agency’s plan to phase out animal use in favor of human-relevant methods, such as computational methods, organ chips, and organoids, to test monoclonal antibody therapies and other drugs.

“This first action of Commissioner Makary begins a new era for drug testing—one that will advance safer, effective, more cost-effective drugs by accelerating use of advanced human-based methods that reduce and replace animal tests,” says Elizabeth Baker, Esq., director of research policy for the Physicians Committee for Responsible Medicine. “Nothing could be more exciting than this strong leadership from Commissioner Makary that will save both human and animal lives.”

The FDA, which regulates food, drugs, medical devices, tobacco, vaccines, cosmetics, and other products tested on animals, has long required that drugs be tested in animals, meaning that dogs, mice, rats, rabbits, pigs, and monkeys are used in painful and deadly experiments, even though it can currently take up to 15 years and cost an estimated $2.6 billion to develop a single drug, and more than 90% will fail in clinical trials, largely due to being unsafe or ineffective for humans.

Recently, the agency has engaged in activities related to nonanimal methods, including the 2017 Predictive Toxicology Roadmap, the 2019 Alternative Methods workgroup, the 2020 Innovative Science and Technology for Advancing New Drugs (ISTAND) pilot program, and the 2023 New Alternative Methods Program. Commissioner Makary’s announcement elevates this work with a comprehensive plan.

Physicians Committee experts have been working on this issue for more than a decade, pushing for changes to regulations and guidance that require and recommend animal tests, a clear pathway for acceptance of nonanimal methods, like the agency’s ISTAND, and training scientists and reviewers on nonanimal methods. Earlier this month, the Physicians Committee sent a letter to Commissioner Makary, asking him to commit to reducing and replacing animal testing with modern human-relevant methods; to change policies that currently require or recommend animal experiments; and to implement recent recommendations of the Science Board to the FDA to embrace modern approaches.

Phasing out animal testing at the FDA has bipartisan support in Congress, which, among other actions, has requested the agency update its regulations, establish a path for acceptance of nonanimal methods, and provided $5 million for the agency to reduce animal testing through nonanimal methods. The recently introduced FDA Modernization Act 3.0 seeks to change FDA regulations to ensure clarity that nonanimal methods are accepted.

The FDA’s announcement comes as a recent Physicians Committee/Morning Consult poll finds that 86% of Americans agree that “animal experimentation should be phased out in favor of more modern research methods.”