The FDA Roadmap and parallel efforts in Congress will unleash 21st-century technology to benefit patients desperate for cures and spare millions of animals from needless torment
Washington, D.C. — Today, the Center for a Humane Economy and Animal Wellness Action celebrate the 46th World Day for Animals in Laboratories, bolstered by the visionary pledge of Food and Drug Administration Commissioner Marty Makary to phase out the use of animals in drug development. The occasion is also marked by FDA actions to reduce animal testing requirements for certain classes of therapies as they progress through the agency’s regulatory process.
“God did not make these animals on planet earth for us to do cruel things to them and subjugate them,” said Makary in a recent interview on April 17. “It does not seem right. So, we are doing everything we can and we’re taking a lot of steps to reduce animal testing requirements and to stop unnecessary animal testing,” said the FDA commissioner.
On April 10, the FDA rolled out a comprehensive plan to phase out the use of animals in drug testing as a regulatory requirement. Makary noted that in a few short years, animal tests will be the exception and not the norm. This development is especially significant, as testing on animals for drug development accounts for about three-quarters of all animal testing.
Makary’s announcement follows years of advocacy and legislative action by the Center for a Humane Economy, Animal Wellness Action, and their coalition partners, who successfully fought to enact the FDA Modernization Act 2.0 in 2022, eliminating a Depression-era mandate that required animal testing for all new drug candidates.
Notably, Makary’s predecessor refused to implement that law, necessitating the development of the FDA Modernization Act 3.0 to compel the agency to update its regulations and enforce the policy mandates enacted by Congress. The FDA Modernization Act 3.0 (S. 355) was introduced in January, with the House companion, H.R. 2821, introduced on the same day Makary announced a reboot of the nation’s drug development model.
Senators Cory Booker, D-N.J.; Rand Paul, R-Ky.; Eric Schmitt, R-Mo.; and Representatives Buddy Carter, R-Ga.; Nanette Barragán, D-Calif.; Vern Buchanan, R-Fla.; Diana Harshbarger, R-Tenn.; Troy Carter, D-La.; and Rosa DeLauro, D-Conn., were among the lawmakers instrumental in driving policy change.
On this day dedicated to laboratory animals, we urge Congress to pass FDAMA 3.0 and provide full-throated support for FDA Commissioner Marty Makary’s bold vision to reboot drug development in America. Such actions will not only modernize the FDA domestically but also trigger similar shifts globally, with European and Asian regulatory agencies likely to follow suit.
“Dr. Makary’s announcement will bring seismic and beneficial changes to the treatment of animals, it will deliver a wider range of safe and effective drugs to patients in need, and it will lower drug costs for millions of Americans,” said Wayne Pacelle, president of Animal Wellness Action and the Center for a Humane Economy. “After four years of inaction and delay by Biden administration officials at FDA, Dr. Makary has, right out of the gate, charted a course that will deliver benefits for the American public and animal welfare.”
The organizations also expressed gratitude to Health and Human Services Secretary Robert F. Kennedy Jr. for the announcement.
“FDA Commissioner Marty Makary, M.D., has embraced human-relevant testing methods, including organ-on-chip technology, organoids, artificial intelligence, and advanced cell-based models to deliver safer and better drugs to patients on a faster timeline,” said Dr. Zaher Nahle, chief scientific advisor for the Center for a Humane Economy. “He has embraced better science and game-changing outcomes for patients in need.”
Some key points in the FDA Roadmap to Reducing Animal Testing in Preclinical Safety Studies:
- A three- to five-year goal to make animal studies the exception rather than the norm for preclinical safety and toxicity testing.
- Incentives to drug sponsors, such as fast-track reviews, for using animal-free New Approach Methodologies (NAMs). Over time, as animal testing becomes truly optional, the industry will adjust to these incentives.
- A promise that, once animal testing is replaced with 21st-century technologies grounded in human biology, we will see a drop in drug prices, more treatments and cures for patients in crisis, and fewer side effects from drugs.
“Our work with Congress to pass the FDA Modernization Act and subsequent efforts to push FDA to move toward 21st-century strategies triggered this extraordinary roadmap detailed by Dr. Makary,” said Tamara Drake, director of research and regulatory affairs for the Center for a Humane Economy. “But it took a visionary leader to pull all of this together and to see the consensus we forged in Congress on this issue. Kudos to Dr. Makary who didn’t waste a minute to get on with a consequential reset of drug development.”
“At long last, we may be at a pivot point where FDA is no longer obstructing the move away from animal testing and instead is acting as a catalyst for that change,” said Pacelle.
Biotech companies, including Emulate Bio, AxoSim, CN Bio, InSphero, and many others, will flourish because of their innovations in New Approach Methodologies. On the other hand, laboratory breeding companies that supply primates and beagles to laboratories will need to adapt and change their business models if they wish to continue participating in public health and drug screening in the years ahead.
Congress, the FDA, and the National Institutes of Health must also wind down the work of the seven regional primate research and breeding facilities. The average cost of a primate used in drug testing now exceeds $50,000 and fails to deliver reliable information to the scientists involved in these protocols.
In addition to Animal Wellness Action and the Center for a Humane Economy, key endorsers of the 2022 legislation included the Laurie C. McGrath Foundation, the Michelson Center for Public Policy, SPCA International, Teva Pharmaceuticals, PETA, the Rare and Undiagnosed Network, and the International Cancer Advocacy Network. More than 200 animal welfare organizations, patient advocacy groups, and biotech and pharmaceutical companies backed the legislation.