|
U.S. Senate, Again, Passes FDA Modernization Act 3.0, Sends Measure to House for Final Action
Critical vote strengthens momentum for human-relevant science and overdue regulatory reform
By Wayne Pacelle and Tamara Drake
Last night, the U.S. Senate passed the FDA Modernization Act 3.0, S. 355, signaling to the Food and Drug Administration that it must wind down the era of animal testing in drug development and boldly enter the era of screening drugs by methods grounded in human biology. We ask the House to take up the bill, which is being championed in that chamber by Reps. Buddy Carter, R-Ga., and Nanette Barragán, D-Calif., with all deliberate speed and send it to President Trump for his signature.
This is a bill that the Center for a Humane Economy and Animal Wellness Action should not have had to engineer. It’s a bill to direct the FDA to align its regulations with the plain language of the FDA Modernization Act 2.0, which Congress passed at our urging in December 2022. Finally, with the incredible leadership of FDA Commissioner Marty Makary, we are seeing action at FDA on animal testing. In April, he announced a “Roadmap to Reduce Animal Testing in Preclinical Safety Studies,” and he’s called animal testing “ineffective” and noted that “I don't believe God made these creatures on planet Earth for us to torture and abuse.”
Our work to pass the FDA Modernization Act 3.0 affirms the path he’s charted. Before Makary’s Senate confirmation in April, the FDA had been obstructionist and apathetic when it comes to the suffering of hundreds of thousands of beagles, primates, and other animals used in drug testing experiments—which constitute the biggest category of animal testing. But it appeared equally apathetic about the exorbitant drug costs borne by patients suffering from health crises; unreliable and onerous animal testing mandates not only swell the costs for new drugs, but also delay their delivery to patients. The animal testing and the drug development failures are as bound together as tightly as DNA strands.
The FDA was an agency in need of an extraordinary reset, and that reset is happening under Dr. Makary. The Senate’s action shows support for this work and reminds the entire FDA bureaucracy to charge ahead with its new roadmap.
A New Era Dawns
Growing ethical concerns about animal testing—combined with rising global investment and research funding for animal-free, human-relevant technologies—have fueled worldwide interest in, and regulatory support for, modern, state-of-the-art testing methods. Better screening methods, such as organ-on-a-chip systems and 3D tissue models, offer more accurate human physiological simulations, which will lead to faster drug development times, safer treatments for patients, and the reduction of unnecessary animal use, all while advancing scientific innovation.
The FDA Modernization Act 2.0 is cited as one of the main factors in increased global investment in 21st-century human-relevant science. The promise of that law was to accelerate the growth of alternatives to animal testing, especially concerning cell-based methods such as human-induced pluripotent stem cells (iPSCs) and organoids. In the three years since Congress passed that law, more than 1,000 papers have been published in scientific journals and elsewhere about its potential to spark a paradigm shift in drug development.
But the FDA, animal-breeding laboratories, and too many others in the scientific establishment are still working from reflexive muscle memory when it comes to animal testing. Animal testing is what they know, and they have been firmly gripping their old instruments of pain, even as Congress sent an unmistakable signal of change to the whole class of operators in the drug development sector.
The U.S. Senate said it’s had enough with foot-dragging by business and government. Let’s march into the new era, say Sens. Cory Booker, D-N.J., Eric Schmitt, R-Mo., and Rand Paul, R-Ky., in leading the FDA Modernization Act.
“It has been nearly three years since Congress eliminated the legal requirement that animal testing be conducted as part of the new drug development process, and since then the FDA has taken meaningful steps to modernize nonclinical drug evaluation,” said Sen. Booker, the lead author of the bill. “The FDA Modernization Act 3.0 will help lock in these reforms, ensuring that FDA regulations mirror current law and reflect the best available science, supporting the agency’s transition toward more predictive, humane research tools. This is how we improve public health and follow the science, all while reducing unnecessary animal suffering.”
Sen. Schmitt said, “I’m proud to see our bipartisan bill move past the Senate and get one step closer to becoming law. This legislation removes outdated and unnecessary animal testing requirements during the drug development process and allows drug developers to use modern methods that better promote public health.”
And Sen. Paul, who led the charge to pass 2.0, said yesterday’s action “sends a clear message: Americans deserve a regulatory system that embraces innovation, not one stuck in the past.”
The House companion bill, H.R. 2821, is led by Reps. Buddy Carter, R-Ga., Nanette Barragán, D-Calif., Diana Harshbarger, R-Tenn., and Troy Carter, D-La. That bill has fantastic bipartisan support, with both the House and Senate measures reflecting a bipartisan consensus in Congress that the FDA must turn toward drug development practices that trend away from animal use.
Absurdly Inefficient Testing Puts Beagles, Primates, Other Innocent Animals at Risk
The current animal-centered paradigm of drug development yields a crushing 90-95% failure in clinical trials of experimental drugs. That means that when drugs pass muster after years of animal tests, nine of 10 drugs will fail when they reach the human clinical trial phase.
In what kind of business do we accept that rate of failure?
After almost 100 years with a system that relies on animal models, we have no cures or meaningful treatments for major diseases such as Parkinson’s, multiple sclerosis, Alzheimer’s, pancreatic cancer, and ALS (Lou Gehrig’s disease), or psychiatric disorders such as schizophrenia, depression, and more.
The costs to animals are extraordinary, starting with the breeding facilities that supply animals to labs.
It didn’t take an eagle eye or beagle nose to sniff out abuses at a Virginia-based dog-breeding facility linked to Envigo, a company well known to breed and sell animals for testing. After a 2022 investigation by PETA into its practice of selling beagles for invasive experiments, Envigo was hit by the U.S. Department of Agriculture with more than 70 animal welfare violations.
Dead puppies, decomposed bodies, complete inattention to animals in varying states of illness. Just a single veterinarian assigned to monitor 5,000 dogs.
The U.S. Department of Justice ultimately shut down the facility and worked with nongovernmental organizations to adopt out the gentle, compliant, floppy-eared dogs.
The nation’s second-largest beagle breeding facility, Ridglan Farms in Dane County, Wisc., recently agreed to surrender its breeding license to avoid criminal animal cruelty charges.
But other beagles, without proper action by the FDA, are still being used in labs by the thousands.
We also must wind down the use of primates in invasive tests, focusing on regional primate centers that house and test on tens of thousands of these captive, tormented wild animals. China cut off primate exports bound for U.S. labs after COVID-19 as concerns rose about further spread of zoonotic disease, and that provides a perfect opening to shift to human-based biology within the United States. No more gambits to expand domestic breeding and to double down on a failed experimental pathway. Throwing more money at animal-breeding facilities makes little sense and won’t make us a global scientific leader.
It’s up to the House of Representatives to finish the job on the FDA Modernization Act 3.0 in the days ahead. Join us today by contacting your U.S. Representative and asking them to complete the job and to send the FDA Modernization Act 3.0 to President Trump for his signature.
|
