Georgia Mountain News

Washington, D.C. - Representatives Earl L. "Buddy" Carter, Nanette Barragán, Diana Harshbarger, and Vern Buchanan have introduced a new bill aimed at advancing innovation for animal-free drug testing methods. The bill, known as the Food and Drug Administration (FDA) Modernization Act 3.0, seeks to facilitate the development, qualification, and adoption of testing methods that reduce or replace the use of animals in nonclinical testing.

The FDA Modernization Act 2.0, which was signed into law in December 2022, already updated the statutory definition of nonclinical tests to include methods other than animal testing, such as cell-based assays or computer modeling. However, further clarity is required for these approaches to be accepted by the FDA and used by drug developers. The new bill not only tasks the FDA with updating regulations to align with the important definitional change in the FDA Modernization Act 2.0 but also mandates the establishment of a process to qualify nonclinical testing methods and expedite drug applications that incorporate such approaches.

According to Rep. Carter, "The FDA Modernization Act 3.0 will allow for the development of safe, effective treatments and therapies without unnecessary animal suffering. We have a law allowing for animal-free testing methods on the books, and it's time we put it to use by expanding testing options."

Rep. Barragán, an animal lover, emphasizes the need for more humane drug testing methods: "Every animal should be treated humanely and not be subjected to cruel laboratory testing methods for human drug development. A stronger implementation of the FDA Modernization Act 2.0 will not only support alternatives for more humane drug testing but also support the safer and more effective delivery of drugs to patients."

Congresswoman Harshbarger, a compound pharmacist for over 30 years, highlights the outdated nature of the FDA's animal testing rules and the potential harm they cause: "The FDA's outdated animal testing rules are harming animals, hurting patients, and stalling medical innovation. The FDA Modernization Act 3.0 will cut burdensome red tape to allow drug manufacturers to use modern and more humane alternatives to improve safety for animals and patients alike."

Congressman Buchanan, referring to the FDA Modernization Act of 2021, expresses his support for the bill and the importance of animal welfare: "The FDA Modernization Act of 2021 was a monumental win that will streamline drug development and spur innovation without having to sacrifice at the expense of animal welfare. I look forward to building upon that success with Congressman Carter and ensuring the FDA follows through on delivering speedier cures for diseases without subjecting animals to inhumane and counterproductive experiments."

The introduction of the FDA Modernization Act 3.0 marks another step forward in promoting animal-free drug testing methods and reducing the reliance on animal experimentation. By encouraging the use of innovative, more humane alternatives, this bill aims to improve the safety and efficacy of drug development while minimizing animal suffering.