Bowling Green Today

U.S. Senator Rand Paul (R-KY) has called on the U.S. Food and Drug Administration (FDA) to update its animal testing regulations in line with the FDA Modernization Act 2.0. In a letter co-signed by a bipartisan group of nine senators, including Senators Cory Booker (D-NJ) and Mike Braun (R-IN), Dr. Paul emphasized the need for the FDA to align its regulations with the recently enacted legislation.

The FDA Modernization Act 2.0, which was passed by Congress and signed into law in 2022, removed the FDA's requirement for animal testing of new drug candidates. The legislation allows drug sponsors to use alternative methods to establish a drug's safety and effectiveness, such as cell-based assays, organ chips, computer modeling, and other New Approach Methodologies (NAMs). However, the FDA's current regulations related to animal testing do not fully conform to the new law.

In the letter addressed to Dr. Califf, the head of the FDA, the senators highlighted the inconsistencies between the amended statute and the agency's regulations. They called on the FDA to update its animal testing regulations promptly and requested information on the specific steps the FDA is taking and the timeline for implementing a revised regulatory framework.

Dr. Paul has been a vocal advocate for modernizing the FDA's approach to drug development and testing. He co-introduced the FDA Modernization Act 2.0 with Senator Cory Booker last year, and the bill received unanimous support from the Senate. The legislation recognizes that animal testing is not always a reliable predictor of toxic responses in humans and aims to allow drug sponsors to use more advanced and humane methods to demonstrate a drug's safety and effectiveness.

The outdated mandate for animal testing was established in 1938 with the passage of the U.S. Federal Food, Drug, and Cosmetic Act. However, scientific advancements and data have shown that animal testing is often an inconsistent predictor of human toxic responses. Furthermore, conducting animal testing for a single pharmaceutical product typically requires the sacrifice of hundreds of animal test subjects.

Dr. Paul's efforts to modernize the FDA's approach to drug development date back to October 2021 when he introduced the first FDA Modernization Act. In line with the spirit of the bill, Dr. Paul hosted a Puppy Press Conference with Senators Mike Braun (R-IN) and John Kennedy (R-LA) to highlight the need for humane and effective alternatives to animal testing.

The call for the FDA to update its animal testing regulations is an important step towards aligning the agency's practices with scientific advancements and ensuring that drug development processes are both effective and ethical. The senators are awaiting a response from the FDA within 30 days concerning the specific actions the agency plans to take and the timeline for implementing the revised regulatory framework.

This news release reaffirms the commitment of Dr. Rand Paul and his bipartisan group of senators to promote modern and humane approaches to drug development and testing, ultimately benefiting both humans and animals alike.

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/