Bowling Green Today

Dr. Rand Paul, along with a bipartisan group of nine senators, has 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 The legislation, which was passed last year, ended the outdated mandate that required investigational new drugs to be tested on animals in pre-clinical trials.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 did not ban animal testing altogether but allowed drug sponsors to use modern alternative methods to demonstrate the safety and effectiveness of drugs where appropriate. In the letter, the senators highlight the importance of aligning FDA regulations with the intent of the legislation.

"We write to you about the investigational new drug development work of the FDA in the wake of the enactment of the FDA Modernization Act 2.0," the letter states. "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 point out that the current FDA regulations related to animal testing are no longer fully in line with the applicable law. They highlight specific examples of inconsistencies, such as the requirement for amendments to an Investigational New Drug (IND) application to be supported by animal toxicology studies or other human studies, and the call for a summary of the drug's effects in animals and humans in the IND Investigator's Brochure.

The letter concludes with a request for information on the steps the FDA is taking to update its animal testing regulations and the timeline for implementation of a revised framework.

The FDA Modernization Act 2.0, introduced by Dr. Rand Paul and Senator Cory Booker, was unanimously passed by the Senate and signed into law in 2022. The legislation acknowledges 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 effective and humane.

In a press release, Dr. Paul emphasized the importance of updating FDA regulations to align with the intent of the legislation. "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 said.

The senators' efforts to update animal testing regulations are part of a broader push for modernization and progress in drug development. The FDA Modernization Act 2.0 represents a significant step towards promoting the use of alternative methods and reducing reliance on animal testing in the pharmaceutical industry.

As the FDA considers the senators' request, it is expected that the agency will take into account the advancements in scientific and technological methods that can provide more accurate and reliable data on drug safety and effectiveness. The use of cell-based assays, organ chips, computer modeling, and other New Approach Methodologies (NAMs) can offer valuable insights into the effects of drugs without the need for extensive animal testing.

The senators' letter urges the FDA to act expeditiously in updating its animal testing regulations to reflect the full scope of the governing statute. By doing so, the FDA can ensure that drug sponsors have the flexibility to use modern alternative methods that are both scientifically valid and more ethical.

The call to update animal testing guidance aligns with the ongoing efforts to promote the responsible use of animals in scientific research. By embracing alternative methods, the pharmaceutical industry can contribute to the advancement of medical science while also considering the well-being of animals.

In conclusion, Dr. Rand Paul and a bipartisan group of senators are urging the FDA to update its animal testing regulations in accordance with the FDA Modernization Act 2.0. The legislation, passed last year, aims to promote the use of alternative methods to demonstrate the safety and effectiveness of drugs. The senators highlight the need to align FDA regulations with the intent of the legislation and urge the agency to act expeditiously in updating its animal testing guidance. By embracing modern alternative methods, the pharmaceutical industry can contribute to the advancement of medical science while also considering the well-being of animals.

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/