Bowling Green Today

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 The legislation, which was passed last year, ended an outdated FDA mandate that required investigational new drugs to be tested on animals in pre-clinical trials.

The FDA Modernization Act 2.0 allows drug sponsors to use modern alternative methods to demonstrate a drug's safety and effectiveness, where suitable. Senator Paul, along with 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), sent a letter to Dr. Califf, the FDA Commissioner, urging the FDA to update its regulations to reflect the new law.

In the letter, the senators highlighted the need for the FDA's regulations to conform to Congress's statutory language and intent. They pointed out that certain regulations related to animal testing no longer fully align with the FDA Modernization Act 2.0. For example, current regulations require the submission of animal toxicology studies as part of Investigational New Drug (IND) applications, even though the new law allows alternative methods to establish a drug's safety and effectiveness.

The senators requested information on the specific steps the FDA is taking to update its animal testing regulations and asked for a timeline for implementing a revised regulatory framework. They emphasized the importance of expeditiously updating the regulations to ensure they align with the amended statute.

The FDA Modernization Act 2.0, introduced by Senator Paul and Senator Booker, was unanimously passed by the Senate and signed into law in 2022. This 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 that are more accurate and humane.

In a press release, Senator Paul stated, "Science and data have shown that in some products, animal testing is a highly inconsistent predictor of toxic responses in humans, all while animal testing on any single pharmaceutical product often requires killing hundreds of animal test subjects." He emphasized the need for the FDA to update its regulations to reflect advancements in scientific understanding and alternative testing methods.

The senators' efforts to update animal testing regulations align with the broader goal of the FDA Modernization Act 2.0 to promote a shift towards human-based biology and the use of innovative methods such as cell-based assays, organ chips, computer modeling, and bioprinting.

The call for updated regulations reflects a growing recognition of the limitations of animal testing and the importance of utilizing modern alternative methods that are more accurate, efficient, and humane. As Senator Paul and his colleagues seek answers from the FDA, they continue to advocate for the implementation of a revised regulatory framework that aligns with the FDA Modernization Act 2.0.

The FDA has been given a 30-day deadline to respond to the senators' letter. Their response will shed light on the specific steps the agency plans to take and the timeline for updating the animal testing regulations.

The push to update the FDA's animal testing guidance is a significant step towards promoting more ethical and scientifically advanced approaches to drug development. As Senator Paul and his bipartisan group of senators advocate for change, they aim to ensure that the FDA's regulations reflect the spirit and intent of the FDA Modernization Act 2.0.

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/