Bowling Green Today

U.S. Senator Rand Paul 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 signed by a bipartisan group of nine senators, Dr. Paul emphasized the need for the FDA to align its regulations with the provisions of the Act.

The FDA Modernization Act 2.0, which was passed last year, removed the outdated mandate that required investigational new drugs to be tested on animals in pre-clinical trials. While the legislation did not ban animal testing, it allowed drug sponsors to use alternative methods to demonstrate a drug's safety and effectiveness where appropriate.

Dr. Paul, along with Senators Cory Booker, Mike Braun, Angus King, Roger Marshall, Tim Kaine, John Kennedy, Ben Ray Luján, and Eric Schmitt, sent a letter to FDA Commissioner Dr. Califf to highlight the need for updated regulations. The letter stated, "During one of your appearances before the U.S. Senate Committee on Health, Education, Labor, and Pensions, you spoke favorably about the shift toward human-based biology, noting that alternative methods may include cell-based assays, organ chips and micro-physiological systems, computer modeling, bioprinting, and a growing variety of other New Approach Methodologies (NAMs)."

The senators pointed out that the FDA's current regulations related to animal testing no longer fully conform with the FDA Modernization Act 2.0. They highlighted specific examples of inconsistencies between the amended statute and FDA regulations, such as the requirement for additional information from animal toxicology studies in Investigational New Drug (IND) applications.

In the letter, the senators asked the FDA to provide information on the specific steps it is taking to update its animal testing regulations and the timeline for implementing a revised regulatory framework. They requested a response within 30 days.

The FDA Modernization Act 2.0, introduced by Dr. Paul and Senator Cory Booker, was unanimously passed by the Senate and signed into law in 2022. It aimed to address the limitations of animal toxicity testing, which has been shown to be an inconsistent predictor of toxic responses in humans. Additionally, animal testing often requires the sacrifice of hundreds of animals for a single pharmaceutical product.

Dr. Paul and Senator Booker had previously introduced the first FDA Modernization Act in 2021. In support of the bill, Dr. Paul hosted a Puppy Press Conference with Senators Mike Braun and John Kennedy.

The call for updated animal testing regulations aligns with the growing recognition of the need to prioritize human-based biology and explore alternative methods for drug safety and effectiveness testing. The senators' letter to the FDA urges the agency to act swiftly in updating its regulations to align with the provisions of the FDA Modernization Act 2.0.

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/