U.S. Senate Passes FDA Modernization Act 3.0, Sends Urgent Measure to House for Final Action

By Wayne Pacelle and Tamara Drake

Today, the U.S. Senate passed the FDA Modernization Act 3.0, S. 5046, to compel the U.S. Food and Drug Administration to get on with the task of winding down the era of animal testing in drug development and boldly enter the era of screening drugs by methods grounded on human biology. The bill passed the Senate unanimously, and if the House takes it up next week before the close of the 118th Congress, it can be signed into law before the end of the year.

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 2.0, which Congress passed at our urging in December 2022. In the two years since then, the FDA did exactly nothing to put the law into practice. Now, the Senate has given the agency a finite timeline to finish the job.

The U.S. Food and Drug Administration is 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 appears 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 is an agency in need of an extraordinary reset. The Senate sees it, and it is telling the agency to re-imagine its work in drug development.

A New Era Dawns

Together with ethical concerns regarding animal testing, growing global investments and research grants for developing animal-free, human-relevant technologies have led to increased global interest and regulatory support for modern, state-of-the art, human-relevant test 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 for 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 two years since Congress passed that law, nearly 800 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 to the whole case of operators in the drug development sector.

The U.S. Senate said it’s had enough with FDA foot-dragging.

“The FDA Modernization Act 2.0 was a landmark achievement for both animals and public health, paving the way for 21st-century human-relevant science,” said Sen. Cory Booker, D-N.J., the lead author of the bill. “It’s time our country takes full advantage of technologies that can more accurately predict human responses and accelerate our nation’s drug development.”

Sen. Eric Schmitt, R-Mo., the Republican co-lead of S. 5046, said it’s time to “modernize our FDA and remove overbearing and often unnecessary animal testing requirements on new drugs.”

And Sen. Rand Paul, M.D., R-Ky., who led the charge to pass 2.0, said today’s action is a “critical step in reforming our drug approval process — getting life-saving treatments to patients faster, cutting costs, and embracing non-animal testing methods,” adding that “swift passage by the House will continue breaking down unnecessary barriers, so Americans can access safe, effective drugs without delays and at reduced costs.”

The House companion bill, H.R. 7248, is led by Reps. Buddy Carter, R-Ga., Nanette Barragán, D-Calif., Diana Harshbarger, R-Tenn., and Rosa DeLauro, D-Conn. That bill has 22 Republican and 23 Democratic cosponsors, 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 the experimental drugs. That means that when drugs pass muster in 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?

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 non-government organizations to adopt out the gentle, compliant, floppy-eared dogs.

But other beagles, without proper action by the FDA, are still being used in labs by the thousands.

Primates also are in use, but the lab-animal testing world has had a supply crisis. China cut off primate exports bound for U.S. labs after COVID-19 as concerns rose about further spread of zoonotic disease.

In response, domestic warehouses of research animals began expanding, seeking to set up massive new monkey-breeding colonies in Georgia and Texas. Thanks to citizen activism and unyielding opposition to these operations in local communities, these schemes have languished.

Rather than expanding the breeding of primates for cruel, costly, and morally questionable use, it’s time to turn to 21st-century science. 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 in the days ahead. Join us today by contacting your U.S. Representative and asking him or her to complete the job and to send the FDA Modernization Act 3.0 to President Biden for his signature.

Together, we can be catalysts for a necessary change in drug development in the United States and across the world.