FDA Proposes Long-Awaited Drug Testing Update as the Modernization Act 3.0 Nears Passage: Your Comments Could Make the Difference
Since 2025, Congress has been working to pass the FDA Modernization Act 3.0 in response to the U.S. Food and Drug Administration's (FDA) failure to take timely action on animal testing reforms that Congress passed in 2022. The landmark FDA Modernization Act 2.0, championed in the Senate by Cory Booker (D-N.J.) and Rand Paul, M.D. (R-Ky.), ended a federal mandate that experimental drugs must be tested on animals before they are used on humans in clinical trials, a requirement that had been in effect since 1938. Unfortunately, for years after that important legislation was passed, the FDA kept the same language in its drug trial regulations, which continued to require scientists to conduct animal tests. In response, Senators Booker and Paul joined a bipartisan group of colleagues in pushing forward the FDA Modernization Act 3.0, which would force the FDA to finally update its regulations and end mandatory drug testing on animals once and for all.
The bill, a direct rebuke of the agency's years of inaction, helped push the FDA to finally start aligning its rules with the FDA Modernization Act 2.0. The agency began a process of incremental changes, first with the release of a “Roadmap to Reducing Animal Testing in Preclinical Safety Studies” in April 2025, followed by draft guidance in December 2025 outlining when long-term testing on monkeys could be reduced or eliminated for certain antibody-based drugs, which are often used to treat cancer and autoimmune diseases. Then in March of this year, the FDA released broader draft guidance explaining how new non-animal testing methods, known as new approach methodologies (NAMs), can be shown to be reliable enough for the agency to accept them in drug development. The agency has also begun reducing or eliminating certain animal studies in other areas by looking at the full body of scientific evidence rather than automatically requiring animal tests.
During this period, Congress also made significant progress toward passing the FDA Modernization Act 3.0, which would turn the pressure lawmakers had been putting on the FDA into a legal requirement. In December 2025, the Senate passed the bill by unanimous consent, and in July 2026, the House of Representatives passed its own version of the bill, H.R. 2821. Because the two chambers passed separate bills, the Senate must now pass the House version so that both have approved the exact same text before it can be sent to the president to be signed into law. We are so thankful to every member of this community who used our petition form to send letters to their senators and representatives and helped drive the passage of this important legislation in both chambers. We have updated our petition to once again target the Senate, so our lawmakers know we appreciate their past action on the bill and want to see it swiftly cross the finish line.
Now, as the FDA Modernization Act 3.0 is closer than ever to becoming law, the FDA has taken its most significant step yet. On September 21, following years of pressure from Congress, animal advocates, and organizations like Species Unite, the FDA issued a new rule that would replace references to “animal” tests throughout key sections of its drug regulations with the broader term “nonclinical” tests, which includes modern, animal-free methods such as human cell-based testing, organs-on-chips, and computer modeling. If it takes effect as planned, this change would at long last bring the FDA's regulations in line with the FDA Modernization Act 2.0, which Congress passed nearly four years ago.
The FDA issued this change as a “direct final rule” and has opened a public comment period for the proposal, which runs through December 7, 2026. As long as the agency does not receive serious objections during that time, the rule is set to take effect on February 4, 2027. If the agency receives significant pushback, the FDA could withdraw the rule and restart a much slower rulemaking process. Showing the FDA that the public strongly supports this change is one of the most powerful things we can do right now, and every supportive comment will be considered as the agency moves forward. Submitting a comment only takes a few minutes:
Go to regulations.gov and search for Docket No. FDA-2026-N-5347, “Nonclinical Testing Terminology.”
Open the direct final rule and click “Comment.”
Write or paste your comment, fill in the required fields, and click “Submit” before 11:59 p.m. Eastern Time on December 7, 2026.
You can write something as simple as:
I strongly support the FDA's decision to update its drug testing regulations to recognize modern, non-animal testing methods, in line with the FDA Modernization Act 2.0. This change is long overdue, and I urge the FDA to finalize this rule as written.
Please keep your comment supportive of the rule, and try adding a few words of your own, since personalized comments carry more weight than identical ones. All comments are posted publicly, so avoid including personal information like your address or phone number in the body of your comment.
Although the FDA finally taking action is great news and a major victory for animals, passing the FDA Modernization Act 3.0 would ensure these long-overdue changes are fully completed regardless of what happens during the comment period, including updates to over-the-counter drug regulations that the new rule leaves out. Passing this bill would also send a clear message that moving away from animal testing is a priority Congress will continue to champion. If you haven't already, please use our petition form to write to your senators and urge them to do everything they can to support the swift passage of the House version of the FDA Modernization Act 3.0.