Bowling Green Today

WASHINGTON, D.C. – U.S. Senator Rand Paul (R-KY) and a bipartisan group of nine senators have sent 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 The legislation, which was enacted last year, ended the outdated mandate that required investigational new drugs to be tested on animals in pre-clinical trials.

The letter, 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), emphasizes the need for the FDA to align its regulations with the new law. The legislation allows drug sponsors to use alternative methods to demonstrate the safety and effectiveness of drugs if they are suitable.

The senators highlight the importance of updating the FDA's regulations to reflect the shift towards human-based biology and the use of alternative methods in drug development. These methods include cell-based assays, organ chips and micro-physiological systems, computer modeling, bioprinting, and other New Approach Methodologies (NAMs).

In the letter, the senators point out inconsistencies between the amended statute and FDA regulations, such as requirements for animal toxicology studies in Investigational New Drug (IND) applications and the need for a summary of pharmacological and toxicological effects in animals. The senators request information on the specific steps the FDA is taking to update its animal testing regulations and the timeline for 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 aims to address the limitations of animal testing and promote the use of more reliable and humane methods in drug development. Science and data have shown that animal testing is often an inconsistent predictor of toxic responses in humans.

Dr. Paul and Sen. Cory Booker have been advocating for the modernization of FDA regulations for some time. They previously introduced the first FDA Modernization Act in 2021 and hosted a Puppy Press Conference to raise awareness about the need for change.

The senators are committed to ensuring that the FDA's regulations align with the FDA Modernization Act 2.0 and promote the use of innovative and ethical approaches in drug development. They are awaiting a response from the FDA regarding the specific steps and timeline for updating the animal testing regulations.

This bipartisan effort reflects the growing consensus among lawmakers and scientists that animal testing should no longer be the default method for evaluating the safety and effectiveness of new drugs. The FDA's update to its animal testing guidance in accordance with the FDA Modernization Act 2.0 will provide drug sponsors with more flexibility and encourage the use of advanced technologies that can yield more accurate and reliable results.

Click this link to access more information: https://www.paul.senate.gov/dr-rand-paul-urges-fda-to-update-animal-testing-guidance-in-accordance-with-the-fda-modernization-act-2-0/