From Wayne Pacelle <[email protected]>
Subject FDA defying Congress on FDA Modernization Act. We won’t stand for it
Date January 31, 2024 2:30 PM
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͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌ ͏‌To prevent cruelty to animals, we promote enacting and enforcing good public policies. To enact good laws, we must elect good lawmakers, and that’s why we remind voters which candidates care about our issues and which ones don’t. If you’d like to unsubscribe, click here. [[link removed]]

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The Fight Against Animal Testing Continues
Dear friend,
Just more than a year ago, I passed on remarkably exciting news. Thrilling news for those of us who care about the welfare of animals and people.
After a campaign launched in early 2021 by Animal Wellness Action, Congress passed the FDA Modernization Act 2.0!
President Biden signed the measure—led by Senators Rand Paul, R-Ky., Cory Booker, D-N.J., and Rep. Vern Buchanan, R-Fla.—into law in December 2022.
It was, without question, the most important policy in the nation’s history addressing animal testing. The bill eliminated an 84-year-old animal-testing mandate for every new drug in development, whether a drug for cancer, pain, Alzheimer’s, or any other affliction of the human body.
So many of you told your lawmakers you 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.
This new law promised a reboot of our national policies on drug development, sparing the lives of millions of animals a year, saving drug developers billions because they could now use more reliable and less expensive screening methods, and delivering better life-saving and life-enhancing treatments and cures for tens of millions of patients in need.
The FDA Modernization Act 2.0 promised to usher in a new era of drug development in the United States and in other nations throughout the world who pay attention to our policymaking. Indeed, lawmakers from the United Kingdom to India to South Korea saw what we did and initiated efforts to adopt similar policies in their nations.
But There’s a Big Hiccup—the FDA Bureaucracy
There has been so much excitement within the biotech and pharmaceutical sectors, and others involved in drug development, since the passage just more than a year ago of the FDA Modernization Act 2.0.
But the U.S. Food and Drug Administration, which is charged with implementing the law, has been stonewalling.
The agency is, 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 animal tests.
In holding onto these archaic regulations, the FDA is defying Congress and the will of the people.
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.
It’s nothing new, but it’s infuriating. That’s why Animal Wellness Action is built not just around passing laws but seeing they are implemented and enforced. In this case, the obstructionism is especially infuriating, given the excitement from so many key stakeholders in the realms of human health and wellness over the prospect of using 21st-century scientific methods to screen drugs for safety and effectiveness.
Just days ago, we hosted a webinar [[link removed]] that featured Senators Rand Paul and Cory Booker speaking about the legislative change they led and, in the wake of that legislative work, the obstinate response of the leaders at the FDA.
[link removed] [[link removed]]To underscore the urgency we bring to this situation, we are working with allies in Congress to launch new legislation—the FDA Modernization Act 3.0—to compel the FDA to act with urgency and to direct changes within the FDA structure to qualify new screening methods for drugs.
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
Seldom does everything fall into place when a landmark law is passed. The sponsors of that law—that’s you and I and the lawmakers who shepherded it to passage—need to keep on the task. We need to hold agencies and all key stakeholders accountable.
That’s what we are doing right now.
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 FDA understands Congress means business. [[link removed]]
CONTACT YOUR LAWMAKERS [[link removed]]
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. [[link removed]]
DONATE NOW [[link removed]]
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 [[link removed]] Wayne Pacelle
President
Animal Wellness Action
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