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Dear friend,
As I studied the materials issued last week by the FDA and its newly confirmed Commissioner Marty Makary, I was dazzled by the roadmap provided by the agency to phase out animal testing in drug development.
This is one of the most consequential announcements to come from our federal government in the 150-year debate over the usefulness of animals in scientific experiments and the moral questions surrounding the use of beagles, primates, and other sentient animals in painful and often lethal tests.
On Thursday night, the Center for a Humane Economy is conducting a virtual town hall meeting to discuss the features of the announcement to phase out animal testing for new drug development and to talk about how we can support and guide the agency in its exciting new plan. Go here to register today. [[link removed]]

REGISTER TODAY [[link removed]]

The Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) required all drugs to be screened on animals in nonclinical tests. Since that time, there’s been no such thing as a “cruelty-free drug,” since all of them have gone through extensive animal trials.
What’s more, animal tests were always an imprecise tool.
Many drugs that successfully pass through animal tests ultimately don’t work in human patients, leading to an unbelievable 95% failure rate [[link removed]] for all developmental drugs. This enormous percentage of unsuccessful outcomes drives up the costs of drugs, and even those that make it to market come with a wide array of side effects for patients. In fact, adverse reactions to drugs are one of the leading causes of death in the United States.
Innovations in science offer better ways to predict how a drug will affect human patients than testing it on other species. That’s why in 2022, at the urging of the Center for a Humane Economy and Animal Wellness Action, Congress passed the FDA Modernization Act 2.0 to give drug developers the choice to use 21st-century animal-free methods like computer modeling, bioprinting, cell-based assays, and organ-on-a-chip technology.
Not only are these innovative non-animal alternatives more humane, they also offer significant cost savings for industry. An analysis by Moderna [[link removed]] using liver chips to screen 35 drug-delivery molecule candidates showed that the liver chips took only a year and a half at a cost of $325,000, whereas animal testing would have taken five years and cost more than $5 million.
It was an incredible thrill for me and all of the leaders and members of our organization to see Commissioner Makary say that the FDA will phase out the use of animals in favor of the new technologies.
I take away three key points from his announcement:
* Makary said that in a few short years, animal tests will be the exception and not the norm.
* The FDA will encourage and provide incentives to drug developers to use the non-animal testing methods.
* Once animals are replaced with 21st-century technologies grounded on human biology, we will see a drop in drug prices, more treatments and cures for more patients in crisis, and fewer side effects for the drugs.
The Center for a Humane Economy and Animal Wellness Action have been battling to change the ways of the FDA for the last four years, mainly by pushing Congress to change the statutes that guide the agency’s work and to tie annual funding of the FDA to reductions in animal testing.
It was in 2021 that we launched the FDA Modernization Act to eliminate the animal testing mandate for new drugs, to enable the transition toward newer, better, more reliable methods that Makary described.
When the agency delayed updating its regulations after we passed the law that eliminated the animal-testing mandate, we worked with our allies in Congress to introduce the FDA Modernization Act 3.0. That bill kept the pressure on the agency, and in Dr. Makary, we have found an informed and bold ally.
Millions of Animals, Millions of People at Risk from THE FDA Intransigence
The FDAMA 2.0 did not ban animal testing, but it offered drug sponsors the option to use 21st-century alternatives. More than 7,000 rare diseases affect between 25-35 million Americans — and 95% of those diseases have no cure. By shedding animal testing, drug developers can invest in treatments and cures for thousands of these maladies without breaking the bank.
Until last week’s announcement, we saw the FDA as an agency that had mastered stonewalling and embodied the very definition of “bureaucracy.” There was no fire in the belly, just a timid agency wedded to archaic strategies that contributed mightily to the pain, misery, and death of millions of animals annually.
But Commissioner Makary is rebooting a model developed during the Great Depression, in the second term of FDR. And the new Commissioner captured it so well in his statement: “ For patients , it means a more efficient pipeline for novel treatments. It also means an added margin of safety, since human-based test systems may better predict real-world outcomes. For animal welfare , it represents a major step toward ending the use of laboratory animals in drug testing. Thousands of animals, including dogs and primates, could eventually be spared each year as these new methods take root.” (Emphasis in the original.)
I hope you will support our life-saving, game-changing work. [[link removed]] Indeed, that announcement from Dr. Makary and the FDA came about because of our work in Congress to modernize testing.

DONATE NOW [[link removed]]

And I hope you’ll sign up right now to join the first-ever “town hall” on this dramatic change in animal testing and national health policy. Here again is the registration link. [[link removed]]

REGISTER NOW [[link removed]]

For all animals,
Wayne Pacelle [[link removed]] Wayne Pacelle
President
Center for a Humane Economy
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