Republican, Democrat Lawmakers Demand that FDA Implement the FDA Modernization Act 2.0 with Moral and Scientific Urgency

Dear John,

I celebrated with you when Congress passed the FDA Modernization Act 2.0 in 2022.

It was the most important federal law ever to provide a pathway to reduce animal testing. The measure—led by Senators Rand Paul, R-Ky., Cory Booker, D-N.J., and Rep. Vern Buchanan, R-Fla.—eliminated an 84-year-old animal-testing mandate for every new drug in development, whether for cancer, pain, Alzheimer’s, or any other affliction of the human body.

But the FDA has been stonewalling and not implementing it.

This week we struck back. A strong group of Republicans and Democrats in the U.S. House of Representatives introduced legislation to compel the FDA to act and to prescribe internal changes within the bureaucracy so that it will qualify and apply non-animal-testing methods—methods that not only will spare animals but deliver safer, more effective drugs to patients in a timely manner.

Since we launched our Modernize Testing campaign in 2021 and called on you to act, thousands of you told your lawmakers you had had enough of archaic government policies that required animal testing for new drug development protocols when morally and scientifically superior test methods were available instead.

Animal testing for drug development is the largest category of animal testing, with pharma companies, contract labs, government agencies, and academic institutions putting beagles, primates, and countless other animals through torment even though testing on animals does not typically forecast the human reaction to drugs.

The FDA Modernization Act 2.0 promised a reboot of our national policies on drug development and a new era of drug development in the United States and even abroad. But the gatekeeper of drug development—the U.S. Food and Drug Administration—must cooperate to allow this modernizing of testing to occur.

The agency has been, to say the least, dragging its feet when it comes to revising its regulations that still bind drug developers to use primates, beagles, and other animals in tests.

We’ve seen this playbook before. The USDA is not enforcing laws and regulations on puppy mills. It’s deficient in the enforcement of our laws against animal fighting. Other anti-cruelty laws are not robustly exercised when cases come to light.

The new legislation, named the FDA Modernization Act 3.0, requires the FDA to publish a final rule to implement the FDA Modernization Act 2.0 and establish clear guidelines for non-animal test methods that can better predict drug safety and efficacy, and speed the time to market for new treatments and cures.

U.S. Representatives Buddy Carter, R-Ga., Nanette Barragán, D-Cal., Diana Harshbarger, R-Tenn., and Rosa DeLauro, D-Conn. are the lead authors of the FDA Modernization Act 3.0. They are joined by Vern Buchanan, R-Fla., the House lead author of the original FDA Modernization Act; Michael Waltz, R-Fla.; Troy Carter, D-La.; Brian Fitzpatrick, R-Pa.; Troy Nehls, R-Texas; Lance Gooden, R-Texas; and Dan Crenshaw, R-Texas, as original cosponsors of the new proposal. We expect a Senate bill to follow soon.

The days of tormenting millions of animals for ineffective drug screening are winding down. But that practice is still with us, and we need to accelerate the transition to a post-animal-testing world when it comes to drug development.

With So Many Animals at Risk, and Patients in Need, It’s No Time to Relent

Let your lawmakers know that the agency’s delays in implementing the FDA Modernization Act 2.0 are not acceptable. And let them know you want to see the FDA Modernization Act 3.0 passed, so that the FDA understands Congress means business.

And please donate today to allow us to conduct the kind of comprehensive campaign that we put to work to enact the FDA Modernization Act 2.0 in the first place.

There’s so much at stake for our country. Our entire health system in the United States is built on developing new drugs, and that system of delivering safe and effective treatments and cures for patients has been broken for decades.

Let’s act and finish the job.

For the animals,

Wayne Pacelle President Animal Wellness Action