The FDA Roadmap will unleash 21st-century technology that will benefit patients desperate for cures, reduce time-to-market for new drugs, lower drug prices, and spare animals from needless experimentation
Washington, D.C. — Today, the Center for a Humane Economy and Animal Wellness Action urged Congress to pass the FDA Modernization Act 3.0 and to provide full-throated support for FDA Commissioner Marty Makary’s bold vision to reboot drug development in America. That work, the organizations said, will reverberate around the world, with pharmaceutical companies and analogue European and Asian regulatory agencies likely to follow U.S. leadership in this realm.
“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 only losers with this plan are the beagle and primate laboratory breeding facilities and others who profit from an archaic and erratic drug-screening system,” added Mr. Pacelle. 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 include:
- A 3-to-5-year goal to make animal studies the exception rather than the norm for pre-clinical 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 seen as truly optional, 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 for the 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.”
Dr. 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 of all new drug candidates. When Dr. Makary’s predecessor refused to implement that law, the groups spearheaded the FDA Modernization Act 3.0 to compel the agency to update its regulations and allow for non-animal test methods. That follow-up measure passed the U.S. Senate unanimously in December 2024.
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 just some of the lawmakers who were instrumental in driving policy change.
“The failure to act by the previous FDA administration for over two years since the enactment of FDAMA 2.0 is baffling, given the widespread support for it in the scientific community and among biotech companies and drug developers,” said Ms. Drake. More than 1,000 global publications, including news articles, commentaries, scientific reviews, and primary papers, have been published since enactment and noted the potential for a paradigmatic shift in 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,” noted Mr. Pacelle.
Mr. Pacelle predicted that biotech companies, including Emulate Bio, AxoSim, CN Bio, InSphero and countless others, will flourish because of their innovations in New Approach Methodologies (NAMs). On the other hand, laboratory breeding companies that supply primates and beagles to laboratories will have to adapt and change their business model if they wish to be involved in public health and drug screening work in the years ahead.
The Congress, the FDA, and the National Institutes of Health will also need to wind down the work of the seven regional primate research and breeding facilities. The average cost of a primate used in drug testing now costs $50,000 and does not deliver reliable information to the scientists involved in these protocols.
The Center for a Humane Economy and Animal Wellness Action launched the FDA Modernization Act in 2021 to eliminate the animal testing mandate for new drugs — by far the biggest category of animal testing — and worked with Republicans and Democrats to pass that legislation — renamed the FDA Modernization Act 2.0 — just 20 months later.
The groups then pushed the FDA to change its regulations to implement the new law, but when the agency delayed updating its regulations, we worked with our allies in Congress to introduce the FDA Modernization Act 3.0 to compel the agency to act within a set time frame. S. 355 was introduced in January and the House companion, H.R. 2821, was introduced on the same day that Dr. Makary made his announcement about a reboot of our drug development model.
In addition to Animal Wellness Action and the Center for a Humane Economy, key endorsers of the 2022 legislation were 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.
Participating in today’s press conference were Jim Corbett, CEO of Emulate Bio., and from the Center for a Humane Economy and Animal Wellness Action were Wayne Pacelle – president, Zaher Nahle – Senior Scientific Advisor, Tamara Drake – director of research and regulatory policy.
Note: Credentialed media may request a copy of the virtual press conference.