Bowling Green Today

Nov 20, 2023

Recently, U.S. Senator Rand Paul, along with a bipartisan group of senators, 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 This legislation, which was enacted last year, ended the outdated mandate that required investigational new drugs to be tested on animals in pre-clinical trials.

The FDA Modernization Act 2.0 does not ban animal testing, but it allows drug sponsors to use modern alternative methods to demonstrate a drug's safety and effectiveness. These alternative methods may include cell-based assays, organ chips and micro-physiological systems, computer modeling, bioprinting, and other New Approach Methodologies (NAMs). Senator Paul and his colleagues believe that these modern methods should be embraced to reduce the reliance on animal testing.

In their letter to Dr. Califf, the FDA Commissioner, the senators highlighted the inconsistencies between the FDA's current regulations and the requirements of the FDA Modernization Act 2.0. They pointed out that certain regulations still call for the results of animal toxicology studies or other human studies, which is no longer necessary under the new law. The senators requested 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 was introduced by Senator Paul and Senator Cory Booker last year and was unanimously passed by the Senate. It aims to modernize the drug approval process and reduce the reliance on animal testing. Over the years, scientific advancements have shown that animal testing is not always a reliable predictor of human responses to drugs. Additionally, animal testing often involves the sacrifice of hundreds of animal test subjects for a single pharmaceutical product. The FDA Modernization Act 2.0 seeks to address these concerns and encourage the use of alternative methods.

Senator Paul has been a strong advocate for updating the FDA's approach to animal testing. In 2021, he introduced the first FDA Modernization Act and even hosted a Puppy Press Conference to raise awareness about the need for change. The passage of the FDA Modernization Act 2.0 demonstrates the bipartisan support for updating animal testing regulations.

The senators' letter to the FDA is an important step in ensuring that the FDA aligns its regulations with the requirements of the FDA Modernization Act 2.0. By embracing alternative methods and reducing the reliance on animal testing, the FDA can improve the drug approval process and promote the use of more accurate and humane testing methods.

The FDA has yet to respond to the senators' letter, but they have been given a 30-day deadline to provide information on their plans to update the animal testing regulations. Senator Paul and his colleagues are hopeful that the FDA will take prompt action to bring their regulations in line with the FDA Modernization Act 2.0.

The push for updated animal testing guidance is an important step towards modernizing the drug approval process and promoting more humane and effective testing methods. With the support of Senator Rand Paul and his colleagues, there is optimism that the FDA will make the necessary changes to prioritize the use of modern alternatives to animal 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/