FDA Wants to Drop “Animal” from Its Rules. Let’s Lock It In.
On September 21, 2026, the Food and Drug Administration (FDA) did something advocates have been awaiting for nearly four years: it issued a direct final rule that replaces terms like “animal tests” and “animal studies” with the terms “nonclinical tests” and “nonclinical studies” throughout key drug-safety regulations. This is the same umbrella language Congress wrote into law in December 2022, when it passed the FDA Modernization Act 2.0.
FDA’s Rule Is Real Progress, But It’s Not a Done Deal—and It’s Only a Starting Point
This is a concrete win, and it belongs to everyone who fought to make the FDA Modernization Act 2.0 law.
But our work isn’t finished, for at least four reasons:
- The rule isn’t final. It is open for public comment until December 7, 2026. If FDA receives “significant adverse comments,” it will withdraw the rule and proceed through the standard notice-and-comment process, instead.
- The rule can be reversed. Even after it takes effect, the rule could be undone by future agency action.
- Animal research remains just as permissible. FDA stressed that the rule “does not eliminate or prohibit animal studies,” and the agency will continue supporting animal studies when “appropriate.”
- Industry practice may not change. By FDA’s own account, the rule is not expected to change what drug developers are already doing.
That gap, between a regulatory milestone and its uncertain real-world effects, is why this moment calls for both celebration and vigilance.
It is also why we must keep fighting to pass the FDA Modernization Act 3.0.
FDA’s Regulations Have Lagged Behind the Law for Nearly Four Years
The FDA Modernization Act 2.0 changed the statute that governs drug development. It struck decades-old statutory language calling for preclinical “animal” tests and replaced it with the term “nonclinical tests,” a category that includes non-animal methods like computer modeling. But 2.0 did not order FDA to rewrite its own regulations. Those regulations are what drug sponsors and FDA reviewers actually work from, and they continued to reference animal studies, signaling that animal data remained the expected default. Nearly a year after 2.0 passed, we documented that FDA still hadn’t updated those regulations, even as members of Congress pressed the agency to explain the delay.
The FDA Modernization Act 3.0 Would Give this Change the Force of Law
The FDA Modernization Act 3.0 was introduced to close that gap by directing FDA to update its regulations to match the statutory changes Congress made in 2022. The U.S. Senate passed the bill in December 2025, and the House passed its version in July 2026.
Because the two chambers passed separate bills, they must still agree on a single bill before it can go to the President—and the House-passed bill is now before the Senate.
In the meantime, FDA has started doing on its own what the bill would require. But agency action does not carry the same weight as an act of Congress.
A rule adopted by FDA on its own can be reversed by later agency action or by a future administration, whereas a law passed by Congress would put the change on statutory footing—making it harder to undo.
The FDA Modernization Act 3.0 would also remove some remaining uncertainty hanging over FDA’s rule. The rule won’t take effect until—at the earliest—February 4, 2027, and only if it survives public comment. The FDA Modernization Act 3.0 would require FDA to make the change within a year of the bill’s enactment, regardless of how the comment period goes.
FDA’s Own Framing Still Treats Animal Tests as the Default
Whether the change comes through FDA’s rule or through the FDA Modernization Act 3.0 (or both), FDA will be the agency applying it. That makes the way FDA describes the change worth close attention—and, unfortunately, part of FDA’s announcement betrays how far the agency still has to go.
Acting FDA Commissioner Kyle Diamantas described the rule as foremost supporting efforts to “complement” animal studies with new methods—and to “replace” animal studies only “where appropriate.”
We have previously warned about the danger of this industry-pushed framing, which positions new approach methodologies (NAMs) as “complements” to, rather than replacements for, animal tests.
That same framing, showcased by Diamantas’ comments, also re-highlights a critical double standard: it pairs animal studies “when they remain appropriate” with “validated alternatives.” In other words, animal tests are presumed appropriate until shown otherwise, while NAMs, including non-animal methods, must earn their place through validation—a bar animal tests were never required to clear.
Congress Must Secure the Progress FDA Has Made So Far
Neither FDA’s rule nor the FDA Modernization Act 3.0 will undo this double standard on its own. Changing the words in regulations does not change the assumptions or intentions of the people who apply them, and that fight will continue at FDA and other federal agencies, in Congress, and in labs across the country. But the FDA Modernization Act 3.0 can make sure the progress FDA has made so far cannot quickly or quietly be rolled back.
By turning a discretionary agency action into a congressional mandate, the FDA Modernization Act 3.0 would back FDA’s language with the force of law.
FDA has taken a meaningful step, and we should say so without hesitation.
At the same time, we must recognize that a change in words is not a change in practice, and that a regulation is not a law—and, then, we must continue the fight.
Your Call to Action: If Senators pass the House-approved bill without amendment, the FDA Modernization Act 3.0 can go directly to the President for signature. Please take a moment to urge your Senators to do the right thing now.