Bowling Green Today

Recently, a group of bipartisan senators led by U.S. Senator Rand Paul (R-KY) sent a letter to the U.S. Food and Drug Administration (FDA), urging them to update their animal testing regulations in accordance with the FDA Modernization Act 2.0. This legislation, which was enacted last year, eliminated the outdated FDA mandate that required investigational new drugs to be tested on animals in pre-clinical trials. The new law allows drug sponsors to use modern alternative methods to demonstrate the safety and effectiveness of drugs.

The letter was signed by Senators Cory Booker (D-NJ), Mike Braun (R-IN), Angus King (I-ME), Roger Marshall (R-KS), Tim Kaine (D-VA), John Kennedy (R-LA), Ben Ray Luján (D-NM), and Eric Schmitt (R-MO). In the letter, the senators emphasized the need for the FDA to update its regulations to align with the FDA Modernization Act 2.0.

The senators pointed out that the current FDA regulations related to animal testing no longer fully conform with the law. For example, regulations governing the submission of Investigational New Drug (IND) applications still require the results of animal toxicology studies, even though the new law allows for alternative methods. The senators urged the FDA to update its regulations promptly to reflect the full scope of the governing statute.

In their letter, the senators asked the FDA to provide specific steps it is taking to update its animal testing regulations and the timeline for implementing a revised regulatory framework. They requested a response from the FDA within 30 days.

The FDA Modernization Act 2.0, introduced by Dr. Paul and Senator Cory Booker (D-NJ), was unanimously passed by the Senate and signed into law in 2022. The legislation aims to modernize the FDA's approach to drug development and testing by shifting towards human-based biology and alternative methods. It acknowledges that animal testing is often an inconsistent predictor of toxic responses in humans and can result in the unnecessary killing of hundreds of animals for each pharmaceutical product.

This is not the first time Dr. Paul and Senator Booker have taken action to reform the FDA's approach to drug testing. They previously introduced the first FDA Modernization Act in 2021 and organized a Puppy Press Conference to raise awareness about the importance of updating animal testing regulations.

The senators' efforts reflect a growing recognition of the need for more humane and scientifically advanced methods in drug development. By urging the FDA to update its animal testing guidance, they are advocating for the use of modern alternative methods that can provide more accurate and reliable results while minimizing harm to animals.

It remains to be seen how the FDA will respond to the senators' request and what specific steps they will take to update their regulations. However, this bipartisan effort underscores the importance of aligning regulatory practices with scientific advancements and promoting more ethical and effective approaches to drug testing.

To find out more, go to this link: https://www.paul.senate.gov/dr-rand-paul-urges-fda-to-update-animal-testing-guidance-in-accordance-with-the-fda-modernization-act-2-0/