I have such vivid memories of big moments in animal protection.
I remember when I learned, after years of fighting the company, that Ringling Brothers Circus was ending its use of elephants and other wild animals in performances.
I remember when the United States halted its use of chimpanzees in invasive experiments after a long campaign to protect the species closest to humans.
I remember the votes that streamed in and added up to wins on ballot measures to ban cockfighting in Oklahoma, extreme confinement of farm animals in Massachusetts, and the use of body-gripping traps in Washington, to name just a few of the consequential measures backed by citizens.
Game-changing wins for our cause.
I felt that awe-inspiring rush yesterday when I read a Fox News story that the FDA, under its new commissioner, Marty Makary, M.D., announced a plan to phase out the use of animals in drug testing.
While I’m always cautious about believing grand promises from federal agencies, it was an incredible thrill to see those words uttered by a leader of the FDA.
The Center for a Humane Economy and Animal Wellness Action have been battling to change the ways of FDA for the last four years, mainly by pushing Congress to change the statutes that guide the agency’s work and to tie annual funding of the FDA to reductions in animal testing.
Here are just a few toplines of that work, done in tandem with our many donors and supporters and other key partners and dedicated lawmakers.
- We launched the FDA Modernization Act in 2021 to eliminate the animal testing mandate for new drugs — by far the biggest category of animal testing.
- We made a thousand and one moves and worked with lawmakers in Congress to pass that legislation — renamed the FDA Modernization Act 2.0 — just 20 months after facilitating its bicameral, bipartisan introduction.
- We then pushed the FDA to change its regulations and to get on with the task of constructing a new drug development paradigm not built on the backs of beagles, primates, and other animals.
- When the agency delayed updating its regulations, we worked with our allies in Congress to introduce the FDA Modernization Act 3.0, which would force the agency to take action. Senators Cory Booker, D.-N.J., Rand Paul, R-Ky., Eric Schmitt, R-Mo., and Representatives Vern Buchanan, R-Fla., Buddy Carter, R-Ga., Nanette Barragán, D-Calif., Diana Harshbarger, R-Tenn., Troy Carter, D-La., and Rosa DeLauro, D-Conn., were just some of the lawmakers who carried the torch in Congress.
- In December, the U.S. Senate passed the FDA Modernization Act 3.0, sending a signal to the agency that it had better act because we’d never relent in our goal of winding down the era of animal testing in drug development.
Millions of Animals, Millions of People at Risk from FDA Intransigence
The FDA Modernization Act 2.0 was, without question, the most important policy change in the nation’s history to address animal testing. The bill eliminated an 84-year-old animal-testing mandate for every new drug in development, whether a drug for cancer, pain, Alzheimer’s, or any other affliction of the human body.
FDAMA 2.0 did not ban animal testing, but it offered drug sponsors the option to use 21st-century alternatives such as cell-based assays, organ chips, computer modeling, and bioprinting. The goal was not only to make drug testing more humane, but to speed drug development, since non-animal methods are typically superior predictors of human responses to drugs. An astonishing 90-95% of drugs that pass animal tests go on to fail in human clinical trials, driving up costs for drugs, harming millions of animals, and delivering too few tangible results for patients in life and death circumstances.
Over 7,000 rare diseases affect between 25-35 million Americans — and 95% of those diseases have no cure. By shedding the animal testing, drug developers can invest in treatments and cures for thousands of these maladies without breaking the bank.
The innovative 21st-century methods outlined in FDAMA 2.0 are among the most promising frontiers in understanding rare diseases: organ chips for Barth Syndrome, 3D models (organoids) of the midbrain for NGLY1 deficiency (a rare neurological disease), and artificial intelligence in developing treatments for Fragile-X syndrome.
As a 2022 article noted of Fragile-X, “[t]his is a disease for which there were no mouse models. A different approach was needed, and the patients-on-a-chip model, combined with AI, seemed to be the best solution.”
Importantly, 21st-century technologies — referred to as New Approach Methodologies — are the only relevant models in the growing therapeutic areas known as “biologics,” where therapies (e.g., immunotherapy, cell-therapy) are by design very human-specific. The use of animals in this category of drug development is acutely misleading and scientifically unjustified.
This new law promised a reboot of our national policies on drug development, offering the prospect of sparing millions of animals a year, saving drug developers billions because they could now use more reliable and less expensive screening methods, and delivering better life-saving and life-enhancing treatments and cures for tens of millions of patients in need.
Dealing with FDA’s Bureaucratic Deflections and Delays
Until yesterday’s announcement, we saw the FDA as an agency that had mastered stonewalling and embodied the very definition of “bureaucracy.” There was no fire in the belly, just a timid agency wedded to archaic strategies that contributed mightily to the pain, misery, and death of millions of animals annually.
But while we felt immense frustration with the FDA, we did not relent in pressing it to change. In fact, just yesterday, we worked with Republican and Democratic allies in the House to introduce companion legislation to set a date-certain timeline for the FDA to act on reducing the use of animal tests.
Finally, late this week, the breakthrough came. Thanks to announcements from RFK Jr. and Dr. Makary, there is hope for a new, humane paradigm in drug development.
The days of tormenting millions of animals for ineffective drug screening may wind down in the years ahead.
Commissioner Makary captured it so well in his statement: “For patients, it means a more efficient pipeline for novel treatments. It also means an added margin of safety, since human-based test systems may better predict real-world outcomes. For animal welfare, it represents a major step toward ending the use of laboratory animals in drug testing. Thousands of animals, including dogs and primates, could eventually be spared each year as these new methods take root.” (Emphasis in the original.)
Thank you for sticking with us in this fight. It may turn out to be one of the great gains for our cause this century. But you can be sure we’ll keep at it to make sure these good words translate into good deeds.
And I hope you know that we bring the same combination of relentlessness and strategy to the other big fights for animals — whether factory farming; animal fighting; horse slaughter; commercial killing of kangaroos, bears, and other wildlife; and a range of other large-scale forms of exploitation.
That’s why your support of our work is itself life-affirming. By allowing us to take on fights, you assure that we’ll see more gains will come. It’s you who puts the wind at our backs.