FDA Modernization Act 3.0: Why Every American Should Care & Speak Up

On December 29, 2022 President Biden signed the FDA Modernization Act 2.0 into law which removed the 1938 requirement to use dogs and other animals as part of the process to obtain a license for new human drugs. While this law does not ban the use of animals in scientific research, it allows researchers to employ Novel Approach Methods (NAMs)--human-biology-based technologies such as organs-on-chips--instead of animal testing. NAMs have been proven to be more effective in predicting human safety of new drugs than animals.

Sounds like a great deal, right? Problem solved? So…why in the world are we still fighting to get dogs and other animals out of labs when we have the superior technology to essentially replace them, and a federal law which states you don’t have to use animals anymore? Why is animal use in experimentation sadly on the rise according to the latest government statistics?

To answer these questions, we’re joined by two prominent experts on this issue: Wayne Pacelle, founder of Animal Wellness Action; and Tamara Drake, Director of Research and Regulatory Policy with the Center for a Humane Economy.  Together they were instrumental in the formulation and passage of the FDA Modernization Act 2.0. – which was, without question, the most important policy in U.S. history addressing animal testing.

However, now the FDA is stalling on their obligation to adhere to the provisions of FDA Modernization Act 2.0 law and are not advancing their regulatory policies to accept NAMs in human drug approval. This roadblock has led to the introduction of yet another bill, the FDA Modernization Act 3.0.

Get a genuine, inside look at industry, government, and politics surrounding animal testing, and why our voices are more important than ever in this inspiring episode of Dog Research Exposed.