The U.S. Food and Drug Administration (FDA) would be directed to fully implement provisions intended to reduce unnecessary animal testing for drug development under a bipartisan bill led by U.S. Reps. Buddy Carter (R-GA) and Vern Buchanan (R-FL).
“It is inhumane to rely solely on animal testing of medical products when other, harmless methods exist that are more predictive of human outcomes,” said Rep. Carter, who on April 10 sponsored the FDA Modernization Act 3.0, H.R. 2821, alongside five original cosponsors, including Rep. Buchanan and U.S. Rep. Nanette Barragán (D-CA).
If enacted, H.R. 2821 would require the FDA to fully implement the FDA Modernization Act 2.0, enacted in 2022, to ensure that safe and effective treatments are developed for patients using advanced and innovative non-animal testing methods, according to a bill summary provided by Rep. Buchanan’s staff.
“The FDA Modernization Act 2.0, and recent actions by the Trump administration, have paved the way for modernizing FDA’s testing methods,” said Rep. Carter. “This bill will put these wins into practice, accelerating innovation and getting safer, more effective drugs to market quickly by cutting unnecessary red tape.”
Specifically, H.R. 2821 would require that not later than one year after the date of the bill’s enactment, the U.S. Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish an interim final rule to amend Federal Regulations to replace any references to ‘‘animal’’ tests, data, studies, models, and research with a reference to nonclinical tests, data, studies, models, and research, according to the text of the bill.
“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 Rep. 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.”
The U.S. House Energy and Commerce Committee is considering H.R. 2821.