The technocrats and scientists at the U.S. Food and Drug Administration seem apathetic about the suffering of beagles, primates, and other animals used in drug testing experiments. The FDA was created to protect the public from dangerous drugs getting onto pharmacy shelves, but its leadership today exhibits such ossified thinking that it’s undermining that mission and standing in the way of a more humane future.
At the end of 2022, we secured the most important advancement in our nation’s history on animal testing. Congress passed the FDA Modernization Act 2.0 to eliminate an animal-testing mandate that had been in place since the Great Depression of the 1930s.
With that new law — which you helped us pass with your letter-writing and financial support — we were poised to turn the page on the primitive era of inhumane animal experiments, along with the breeding and collecting of animals that precedes invasive procedures.
But the FDA, breeding labs, and too many 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 are firmly gripping their old instruments of pain.
The FDA is not implementing the new law as it should. The FDA has not lifted a finger to update regulations to allow for the use of 21st-century animal-free methods to screen new drugs that work better because they are based on humanbiology.
This bureaucratic foot-dragging doesn’t just mean suffering and death for animals. Because animal tests are so unreliable, clinging to them only delays the prospect of delivering safer, more effective drugs at a lower cost and a faster pace to patients.
Last week, with Animal Wellness Action and the Center for a Humane Economy working hand in hand with lawmakers and their teams, an extraordinarily diverse set of U.S. senators told FDA that it must get on with the task of implementing the law.
Here’s what U.S. senators from both parties had to say last week in introducing S. 5046.
“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 Senator 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.”
“The FDA Modernization Act 3.0 is aimed to do exactly what the bill is named to do — modernize our FDA and remove overbearing and often unnecessary animal testing requirements on new drugs,” noted Senator Eric Schmitt R-Mo., the Republican co-lead of S. 5046.
“In 2022 I was proud to lead the charge on the FDA Modernization Act 2.0, which was a critical step in reforming our drug approval process–getting life-saving treatments to patients faster, cutting costs, and embracing non-animal testing methods. Now, with FDA Modernization Act 3.0, it’s time to build on that success and ensure reforms can proceed expeditiously. Swift passage of this legislation will continue breaking down unnecessary barriers, so Americans can access safe, effective drugs without delays and at reduced costs,” said Dr. Rand Paul, R-Ky.
“The FDA Modernization Act was an important bill for protecting animals from drug testing. This bill is needed to get the FDA to update its regulations to follow the reforms put in place by our original legislation,” said Senator Mike Braun, R-Ind., who will leave the Senate and likely become the next governor of Indiana.
“The FDA Modernization Act 2.0 was designed to be a win for patients and animals alike, but it can only do so if the FDA makes the changes the law required,” said Senator Angus King, I-Me. “In the 21st century, access to cutting-edge technology allows drug developers the option to use modern animal-free testing methods in nonclinical tests where appropriate. However, it’s been nearly two years since this bill was signed into law and we have yet to see the updated regulations and reforms put in place.”
They were joined in introducing the legislation by Senators Ben Ray Luján, D-N.M., John Kennedy, R- La., Sheldon Whitehouse, D-R.I., and Richard Blumenthal, D-Conn.
And remember, this is a companion bill to H.R. 7248, led by Reps. Buddy Carter, R-Ga., Nanette Barragán, D-Calif., Diana Harshbarger, R-Tenn., and Rosa DeLauro, D-Conn. That bill has 20 Republican and 21 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.
Congress acted with clarity in 2022, and is now repeating itself on the need for action. Is FDA listening?
Beagles at Risk
We will never forget the plight of the beagles mistreated by Envigo.
It didn’t take an eagle eye or beagle nose to sniff out abuses at the Virginia-based dog-breeding facility. 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 had the task of caring for 5,000 dogs.
The U.S. Department of Justice shut it down in the end and worked with non-government organizations to adopt out the gentle, compliant, floppy-eared beagles.
But many other beagles, without proper action by the FDA, are still being used in labs by the thousands.
Trafficking and Mass Breeding of Primates to Supply Rudimentary Models of Drug Development
Primates are also 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 and as concerns rose about further spread of zoonotic disease.
Rather than embrace 21st-century animal-free strategies, U.S. laboratories panicked and declared “a national monkey shortage.” They decided to double down on primate use and start importing from other countries, too.
It didn’t start well for them. Charles River Laboratories, a big name in the field, decided to get monkeys from Cambodia. It turns out they were importing wild-caught, endangered primates from the southeast Asian nation.
A U.S. Department of Justice subpoena followed, highlighting illegal trafficking of endangered long- tailed cynomolgus macaques. The DOJ indicted eight Cambodians at the center of a separate smuggling ring.
The industry also turned to enhanced domestic production, 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.
Getting On with the Transition to Human-Biology-Based Testing
The current animal-centered paradigm of drug development–whether it’s primates, beagles, or other animals–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 ten drugs 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, congestive heart failure, stroke, pancreatic cancer, ALS (Lou Gehrig’s Disease), and psychiatric disorders like schizophrenia, depression, and more.
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.
The FDA Modernization Act 3.0
When enacted, the FDA Modernization Act 3.0, H.R. 7248 and S. 5046, will require the FDA to align its regulations with the new statute under the FDA Modernization Act 2.0.
The FDA’s lack of response to date is intolerable, as a matter of not only animal health but also human health and wellness. It’s indefensible to keep relying on animal models that do not translate to the human condition.