Washington, D.C. - Reps. Earl L. "Buddy" Carter (R-GA), Nanette Barragán (D-CA), Diana Harshbarger (R-TN), and Vern Buchanan (R-FL) today introduced the Food and Drug Administration (FDA) Modernization Act 3.0, a bill that will 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 was signed into law in December 2022, updating the statutory definition of nonclinical test to include methods other than animal testing, such as cell-based assays or computer modeling. However, additional clarity is needed for these approaches to be accepted by FDA and utilized by drug developers. In addition to tasking FDA with updating regulations to conform with the important definitional change in the FDA Modernization Act 2.0, this bill would require FDA to establish a process to qualify nonclinical testing methods and expedite drug applications that incorporate such approaches.
“The FDA Modernization Act 3.0 will allow for 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,” said Rep. Carter.
“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 more safe and effective delivery of drugs to patients. As an animal lover, I am proud to lead this bipartisan effort with Rep. Carter to reduce practices of animal testing for drug development,” said Rep. Barragán.
“The FDA’s outdated animal testing rules are harming animals, hurting patients, and stalling medical innovation,” said Congresswoman Diana Harshbarger. “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. As a compound pharmacist for more than 30 years, I understand that ensuring East Tennesseans have affordable access to safe medicines is of the utmost priority, and this bill is a step toward delivering safe medicines in a more humane way.”
“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,” said Congressman Buchanan. “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.”
Click here to read the full bill text.
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