Bowling Green Today

U.S. Senator Rand Paul (R-KY) has led a bipartisan group of senators in sending a letter to the U.S. Food and Drug Administration (FDA), urging the agency to update its animal testing regulations in accordance with the FDA Modernization Act 2.0. The legislation, which was passed last year, ended the outdated FDA mandate that required investigational new drugs to be tested on animals in pre-clinical trials.

The letter, signed by nine senators including Cory Booker (D-NJ), Mike Braun (R-IN), and Angus King (I-ME), emphasizes the need for the FDA to align its regulations with the new law. The FDA Modernization Act 2.0 allows drug sponsors to use modern alternative methods to demonstrate a drug's safety and effectiveness, where suitable.

In the letter addressed to Dr. Califf, the senators highlight the inconsistencies between the amended statute and the FDA's current regulations. They call for the FDA to update its regulations promptly to reflect the full scope of the governing statute. The senators also inquire about the specific steps the FDA is taking to update its animal testing regulations and request a timeline for the implementation of a revised regulatory framework.

The FDA Modernization Act 2.0, introduced by Dr. Paul and Sen. Cory Booker, was unanimously passed by the Senate and signed into law in 2022. The legislation recognizes that animal testing is not always a reliable predictor of toxic responses in humans and aims to promote the use of alternative methods such as cell-based assays, organ chips, and computer modeling.

Dr. Paul has been a vocal advocate for modernizing the FDA's approach to drug development. He previously introduced the first FDA Modernization Act in 2021, and in line with the bill's spirit, he hosted a Puppy Press Conference with Sen. Mike Braun and Sen. John Kennedy.

The senators' letter to the FDA underscores the importance of updating animal testing regulations to align with scientific advancements and the goals of the FDA Modernization Act 2.0. It remains to be seen how the FDA will respond to the senators' request and what steps the agency will take to ensure compliance with the new law.

For additional details, please follow 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/