Carter unveils FDA Modernization Act 3.0

U.S. Rep. Buddy Carter (R-GA) on Feb. 6 introduced a bipartisan bill to reduce or replace the use of animals in nonclinical testing.

The Food and Drug Administration (FDA) Modernization Act 3.0, H.R. 7248, was sponsored by Rep. Carter alongside 10 original cosponsors, including U.S. Reps. Vern Buchanan (R-FL), Brian Fitzpatrick (R-PA) and Nanette Barragán (D-CA). The legislation also would facilitate the development, qualification, and adoption of testing methods; improve the predictivity of nonclinical testing methods; and reduce development time for a biological product or other drug, according to the text of the bill.

“The FDA Modernization Act 3.0 will allow for development of safe, effective treatments and therapies without unnecessary animal suffering,” Rep. Carter said. “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.”

The congressman was referring to the FDA Modernization Act 2.0, which was signed into law in December 2022 to update the statutory definition of a nonclinical test to include methods other than animal testing, such as cell-based assays or computer modeling, according to a bill summary provided by the lawmakers.

Additional clarity is now needed for these approaches to be accepted by the FDA and utilized by drug developers, the summary says. 

“The FDA Modernization Act [2.0] was a monumental win that will streamline drug development and spur innovation without having to sacrifice at the expense of animal welfare,” Rep. Buchanan said. “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.”

If enacted, H.R. 7248 would task the FDA with updating regulations to conform with the definitional change in the FDA Modernization Act 2.0, and establishing a process to qualify nonclinical testing methods and expedite drug applications that incorporate such approaches, states the summary.

“Every animal should be treated humanely and not be subjected to cruel laboratory testing methods for human drug development,” said Rep. Barragán. “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.”

H.R. 7248 has been referred for consideration to the U.S. House Energy and Commerce Committee.