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We Have Cruelty-Free Cosmetics.
Why Not Cruelty-Free Medicines, Too?
Our drug development system has been broken for decades. It’s time for reform in developing and screening drugs, sans animal testing.
By Wayne Pacelle, Tamara Drake, and Dr. Zaher Nahle
Walk down the aisles of any American pharmacy in the United States or Europe today and take a close look at the labeling.
Shampoos, lotions, cosmetics, soaps, deodorants, and household products increasingly carry labels assuring consumers they are “cruelty free” or “not tested on animals.” Some companies, such as Paul Mitchell, Burt’s Bees, and Urban Decay, have built their brands around that promise.
Animal protection campaigns and company executives, engaging consumers and customers, drove that change – a signature advance, though still a work in progress, of the 20th-century animal protection movement. Cosmetics and household product companies that once viewed animal testing as an unavoidable part of doing business discovered a more humane pathway.
Now keep walking through the pharmacy.
Pick up a bottle of pain reliever. Reach for an allergy medication or a heartburn remedy. Fill a prescription at the pharmacy counter.
Where are the cruelty-free medicines?
Just about nowhere to be found.
That’s got to change.
The Center for a Humane Economy is preparing a major new campaign to bring cruelty-free medicines into focus. We aim to transform the entire drug development ecosystem – from animal breeders and suppliers to contract testing laboratories, from biopharma R&D programs to pharmaceutical sales teams and pharmacy shelves.
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We Changed the Law. Now We Must Change the Industry
For generations, the development of new medicines relied on animal testing during the early and middle stages of bringing a product to market. Before any new therapy could advance to human clinical trials, federal law and regulations required drug developers to conduct studies in other species, such as mice, rats, rabbits, dogs, and primates.
Despite this decades-old federal mandate, in recent years innovative scientists have developed increasingly sophisticated human-relevant methods that allow researchers to study human biology directly, providing more relevant tools for understanding how medicines will behave in people and offering a pathway to replace traditional animal testing.
Yet even as science advanced, the regulatory framework was rigid and had animal testing at its core.
It was only at the end of 2022 that Congress, at our urging, passed the FDA Modernization Act 2.0. That landmark reform eliminated the statutory mandate for animal testing, giving drug developers the option — for the first time — to use modern animal-free approaches such as cell-based assays, microphysiological systems, and advanced computational models.
That was an important milestone, but the FDA has been slow-walking the inevitable transition to animal-free testing strategies. And pharmaceutical companies, long burdened by this onerous government requirement, have been maddeningly compliant with FDA’s archaic approaches and reluctant to demand that the agency certify more humane, human-biology-based drug screening methods.
Recognizing this bureaucratic and business torpor, we championed the FDA Modernization Act 3.0, which directs the Food and Drug Administration to update its regulations to conform them to the plain language of the new law.
In December, the U.S. Senate passed S. 355, the FDA Modernization Act 3.0, led by Cory Booker, D-N.J., Eric Schmitt, R-Mo., and Rand Paul, R-Ky. After an inordinately long delay, the U.S. House passed the companion bill, H.R. 2821, led by Reps. Buddy Carter, R-Ga., Nanette Barragán, D-Calif., Diana Harshbarger, R-Tenn., Rosa DeLauro, D-Conn., Vern Buchanan, R-Fla., and Troy Carter, D-La., bringing the nation one step closer to a more humane and reliable drug development system.
These back-to-back reforms will now put the ball squarely in the laps of FDA, pharmaceutical companies, biotechnology innovators, and the contract research organizations. Congress has opened the door. The next step is for industry and public health agencies to walk through it.
Animals Aren’t Furry Humans
For decades, scientists have relied on animals to help answer important questions about the safety and effectiveness of new medicines. Those studies have contributed to medical progress. But they have also revealed an unavoidable limitation: animals are not people.
Medicine can be absorbed, metabolized, and processed very differently in a mouse, rat, dog, monkey, or human being. Animal studies simply cannot reliably predict how drugs will affect human systems.
The history of medicine offers sobering reminders of that reality.
Some drugs that appeared promising in animal tests proved injurious or even deadly in humans. Vioxx, one of the world’s best-selling pain medications, underwent the conventional battery of preclinical animal studies before receiving FDA approval in 1999. Yet those tests did not predict the magnitude of the cardiovascular danger that subsequently emerged in people. Millions of Americans took Vioxx before evidence showed an increased risk of heart attack and other serious cardiovascular events. An FDA drug-safety scientist estimated that the drug may have caused tens of thousands of heart attacks and sudden cardiac deaths in the United States. Merck withdrew Vioxx from the worldwide market in 2004.
Rezulin, a diabetes drug, caused severe liver injury that animal studies had failed to anticipate. In another widely cited case, the experimental immune therapy TGN1412 triggered life-threatening reactions in healthy volunteers despite extensive preclinical testing, including studies in nonhuman primates. Subsequent research showed that appropriately designed tests using human cells could have identified the dangerous immune response.
We now have more reliable predictors of the human reaction to drugs, with new technologies that previous generations could scarcely have imagined. Human cells and tissues, organoids, organs-on-chips, sophisticated computational models, and artificial intelligence are transforming how scientists study disease and evaluate new medicines. Collectively known as New Approach Methodologies (NAMs), these tools offer an increasingly powerful way to understand how medicines are likely to perform in the people they intend to help.
When it comes to evaluating medicines designed for humans, human biology should be the starting point — not the final hurdle in a lengthy, expensive, and unreliable process.
A Moral Imperative for Animal and Human Health
The cosmetics industry offers a powerful lesson about how meaningful change happens.
For years, consumers were told that animal testing was the price we had to pay to ensure we got safe products onto the market. Many accepted that explanation, because even if they saw animal testing as evil, it seemed a necessary evil. But science advanced, public expectations evolved, and companies responded. Today, cruelty-free products are no longer a niche market; they are widespread, although not an industry standard yet. More and more, though, cosmetic testing on animals has become a relic of a less humane world, and a symbol of corporate moral malfeasance.
Why should we expect less from the pharmaceutical industry?
According to the CDC’s National Center for Health Statistics, roughly half [[link removed]] of all Americans have taken at least one prescription medicine in the last 30 days. Countless more have reached for the medicine cabinet when they had heartburn, got a headache, or caught a cold. Medicines can improve not only our physical health, but also our psychological health, our memory, and our ability to work, socialize, and enjoy life. The pharmaceutical industry has both an opportunity, through experimentation and investment in NAMs, and a responsibility to lead the transition toward a modernized drug-screening era.
Congress has begun wiping away archaic government mandates. The FDA is increasingly recognizing human-relevant approaches. Pharmaceutical companies are squandering immense resources on animal-based R&D programs that they know are unreliable, even as the science of drug discovery continues to advance at an extraordinary pace.
Now it is time for industry to seize the new tools, work with the regulatory agencies to demand their acceptance, and shed a system of drug development that is badly broken.
Ridglan Was an Important but Small Step Forward
Our successful campaign to rescue the Ridglan Farms beagles and to end Ridglan’s participation in the laboratory animal pipeline demonstrated what strategic, determined, and collaborative advocacy can accomplish.
Facilities like Ridglan exist because there is a continuing demand for animals in research and drug development. If that demand remains unchanged, closing one breeding facility simply shifts the problem elsewhere.
The lasting solution is to convince the pharmaceutical companies, now that the regulatory burdens are being dismantled, to alter their drug discovery paradigm centered on animal testing, stop buying and using dogs and other animals altogether, and fully embrace — if not lead — the shift to human-relevant preclinical discovery programs. Many have already invested in this new path.
That is the vision behind the Cruelty-Free Medicines campaign.
We want the public health agencies and pharmaceutical companies to embrace modern, human-relevant science and systematically replace animal-based testing.
We understand hurdles remain. But we feel the fierce urgency of now. Rapid change is required because of the moral imperative to stop the abuse of animals and to find effective palliative treatments and cures for people suffering from illnesses that degrade the quality of life and take people away from their friends and families.
The cruelty-free revolution must extend beyond the cosmetics and household products aisles. It must reach the pharmacy counter and the medicines on store shelves.
It is time for cruelty-free medicines.
Wayne Pacelle, president of Animal Wellness Action [[link removed]] and the Center for a Humane Economy [[link removed]] , is the author of two New York Times bestselling books, “ The Bond [[link removed]] ” and “ The Humane Economy [[link removed]] .” Tamara Drake is the director of research and regulatory policy at the Center for a Humane Economy. Zaher Nahle, Ph.D., MPA, is the Center’s senior scientific advisor.
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