Congress Eliminates 1930’s Animal-Testing Requirement

FDA Modernization Act Promises to Usher in Era of “Cruelty-Free Drugs”
The FDA Modernization Act 2.0, signed into law by President Biden on Friday night, may be among the most important and consequential federal animal welfare laws passed in our nation’s history.

The legislation – bundling together the FDA Modernization Act and the Reducing Animal Testing Act — eliminates an 84-year-old animal testing mandate for experimental drugs and biosimilars.

Here’s why it’s so important: Animal testing for drug development runs through millions of animals but rarely delivers game-changing breakthroughs for millions of people in the throes of a health crisis.

Our drug development protocols are, without question, hindering the delivery of safe, affordable, and effective drugs, leaving millions of people in life-and-death circumstances without effective drugs to turn around their dire circumstances. Nearly all of us who have lost loved ones know the pain of doctors telling us there’s no more that can be done for them.

You can also tell so much about the legislation by the breadth of Congressional support it attracted, with libertarian-conservatives Rand Paul, R-Ky, and Mike Braun, R-Ind., and progressives Cory Booker, D-N.J., and Ben Ray Lujan, D-N.M. carrying the torch in the Senate and a similarly diverse group promoting the bill in the House.

The larger legislative vehicle also included $5 million in new money to support an FDA-wide New Alternative Methods Program to add even more alternative methods to the tool kit.

As with so many animal issues, when we help animals, we help people. That’s the case with this legislation, which my colleague Tamara Drake and the team at the Center for Responsible Science (CRS), along with Dr. Gary Michelson of the Michelson Center for Public Policy, presented to me two years ago.

At that point, the Center for a Humane Economy brought CRS and its amazing team into the fold, and we were off to the races in formulating this legislation. In the end, we built a coalition including PETA, SPCA International, and more than 200 animal welfare groups, patient advocacy organizations, and medical associations that got it over the finish line within the time boundaries of a single Congress. Two dear friends, Laurie McGrath and the late Robert “Skip” Trimble, made so much of this work possible and had faith in our ability to change our national policies on animal testing.

A New Era of Cruelty-Free Drugs?

We’re all familiar with the term “cruelty-free cosmetics” but there’s never been a workable formulation for “cruelty-free drug treatments.” The requirement in the Federal Food, Drug and Cosmetics Act made sure for eight decades that no drug or vaccine was ever delivered to market without extensive use of animals. Take that requirement and multiply it by the immense number of public and private institutions doing drug development and you can see how the numbers of animals stressed and alone, injured and tormented, and killed without ceremony climbed into the millions per year.

To be clear, the FDA Modernization Act does not end animal testing overnight. It only lifts the mandate. But if AWA and the Center and its partners within the animal welfare world and the domains of biotech and government do their jobs, we’re likely to see a massive shift toward alternative methods and a corresponding reduction in the use of animals.

Any fair-minded analysis shows that the current drug-development paradigm, built on the backs of animals, is archaic and counterproductive to our goals to allow Americans to live long, healthy lives. For example, despite billions in funding for animal research into Alzheimer’s disease and cancer over several decades, the failure rate in drug development remains 97 percent for cancer and 99 percent for Alzheimer’s. And consider these conclusions:

• More than 90 percent of drugs that pass muster in animal tests fail in human clinical trials
• The timeline with often useless animal testing is 10 to 15 years, and $1 billion to $6 billion in R&D capital costs, just to bring a single new drug to market.
• Adverse reactions to drugs are the fourth leading cause of death in the U.S.
• Most diseases have no cures, with 7,000 rare diseases getting little attention from major drug developers because the commercial returns could never equal or exceed the up-front R&D costs.

New studies grounded on human biology show that alternative methods are far more effective in gauging the safety and effectiveness of experimental drugs.

“The use of animal models for therapeutic development and target validation is time consuming, costly, and may not accurately predict efficacy in humans,” said Dr. Francis Collins, the long-time director of the National Institutes of Health, the largest research organization in the world. “With earlier and more rigorous target validation in human tissues, it may be justifiable to skip the animal model assessment of efficacy altogether.”

In a recent study, researchers assessed the performance of 780 human Liver-Chips across a set of 27 known hepatotoxic and non-toxic drugs, with the Emulate Liver-Chip correctly identifying 87 percent of the tested drugs that caused drug-induced liver injury in patients despite passing through animal testing.

Drug Testing: The Biggest Category of Animal Testing

Doctors prescribe all manner of drugs for people who get sick, whether pain medications or other palliatives, vaccines, or active treatments to deal with every kind of affliction from heart disease to the dozens of varieties of cancers, to cognitive disorders to 7,000 rare diseases. Pharma revenues worldwide totaled 1.42 trillion U.S. dollars in 2021, and the companies in the sector are just part of the medical-industrial complex that does drug development work, along with 18 federal agencies and academic institutions spending tens of billions a year on these projects.

It’s no surprise then that drug testing on animals dwarfs the use of animals in other categories of testing – perhaps accounting for three-quarters of all testing, with FDA regulations compounding the problem by requiring extensive, multi-species, multi-generational animal tests before drugs then go to human clinical trials.

Regulations and laws governing animal testing are so permissive and incomplete that the government doesn’t even tabulate numbers of animals used, specifically exempting research and testing institutions from reporting totals for mice and rats. We do know some of the data though, including that in 2021 there were 59,000 dogs, mostly beagles, tormented in labs. The number of non-human primates is even larger, with the U.S. leading the world in the number of primates it imports for medical research. Between 2017 and May 2022, more than 150,000 monkeys arrived in the U.S. for use in experiments, according to figures from the Centers for Disease Control and Prevention. Add in the captive breeding in our massive complex of contract breeding facilities and you get a sense of the scale of the exploitation.

A Moral and Scientific Duty to Use Alternatives Where They Exist

The FDA Modernization Act does not seek to settle the debate over animal testing, but to apply the widely accepted view that where alternative methods exist, they should be used. It’s not a controversial notion, and it’s enshrined in the broad acceptance of the “3Rs” approach – Reduction, Refinement, and Replacement — developed more than a half century ago.

In recent decades, almost all major research organizations, pharmaceutical companies, academic institutions, and even government agencies have embraced the principle. The FDA Modernization Act allows the government and pharmaceutical companies to act on their pledges.

Now that the animal-testing requirement has been lifted, it’s time for researchers to breathe life into it. There should be a vigorous and methodical approach to eliminating the use of animals in favor of alternative methods over time. The recent scandals about the mistreatment of beagles at a contract-breeding facility and the illegal capture of thousands of endangered primates in Cambodia are just two recent windows into the cruelty of the lab-animal trade. The running scandal is the enormous failure rate in drug development, the lack of cures for so many diseases, and the high prices for drugs that keep them out of reach for so many Americans.

This legislation, with proper oversight from Congress and the animal welfare community, will spare millions of animals over time and it will reward tens of millions of people seeking better treatments and life-saving cures.

I am so proud that AWA and the Center formulated this bill and got it signed into law. I’ve been fortunate to have developed and shepherded dozens of federal bills into law during a long run in animal protection, but in so many ways, I think this may be the most consequential one of all, when you tabulate the numbers of non-human animals and humans who will be spared suffering because of the changes we’ve scripted.

The process of eliminating this mandate should not have taken 84 years. But I am so glad this day is here. Finally. Mercifully.

Thank you for being with us in this fight,

Wayne Pacelle