FDA Modernization Act 3.0

The House debated H.R. 2821, the FDA Modernization Act 3.0, which requires the FDA to issue a rule updating its drug-testing regulations to reference modern, non-animal testing methods in place of animal tests. Members from both parties spoke in support: Representative Buddy Carter, who introduced the bill, said it would make the FDA follow through on allowing alternatives to animal testing, reducing animal suffering and helping new medicines reach patients faster. Representative Troy Carter, a Democratic co-lead, noted that Congress had already authorized such alternatives but the FDA had not yet updated its rules, and said this bill directs the agency to write them. The debate was brief and the bill had bipartisan backing, with no opposing points recorded in the discussion.Written by AI from the debate. Updated .

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2 statements

Frank Pallone, Jr., NJ

Democrat
“I want the House to pass this bill. It tells the FDA to update its rules so drug makers can use new scientific methods instead of animal testing.”
Official Congressional Record

Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise in support of H.R. 2821, the FDA Modernization Act 3.0, led by Representative Barragan and Representative Carter of Georgia. The FDA Modernization Act 3.0 would require the Food and Drug Administration to update regulations to replace references to animal tests, data, studies, models, and research in specified sections of Title 21 of the Code of Federal Regulations with references to nonclinical tests. This would bring FDA’s regulations in line with a law passed in 2022 that allowed for alternatives to animal testing in drug development, including those that leverage recent scientific advancements, such as computer modeling and cell-based assays. I encourage all my colleagues to vote ``yes’’ on H.R. 2821, and I reserve the balance of my time.

Troy A. Carter, LA

Democrat
“I want the House to pass this bill. Congress already allowed drug makers to use alternatives to animal testing, but the FDA has not updated its rules yet. This bill forces the FDA to write those rules. It will help end unnecessary testing on animals and speed up safer medical research.”
Official Congressional Record

Mr. Speaker, I rise in strong support of H.R. 2821, the FDA Modernization Act 3.0, introduced by the gentleman from Georgia (Mr. Carter). I am proud to co-lead this bill with him and a bipartisan group of my colleagues: Representatives Barragan, Buchanan, DeLauro, and Harshbarger. Over 3 years ago, the FDA Modernization Act 2.0 was signed into law, allowing the agency to approve human drugs without requiring animal testing through modern, often more effective, alternatives. Despite this progress, the FDA has still not issued updated regulations to clarify where alternatives to animal testing are, in fact, permissible. This legislation takes action to close the gap by requiring the FDA to fully implement the reforms that Congress has already enacted and to help reduce unnecessary animal testing in drug development. By ensuring the full implementation of the FDA Modernization Act 2.0, this legislation will help modernize and transform drug development for the 21st century; accelerate safer, more effective medical breakthroughs; and advance more humane scientific research. This is long overdue. We see the unnecessary slaughtering of animals for research when there are other alternatives that may be, in fact, more humane, more effective, and more cost effective, yet we continue to do the same thing as if. I am proud to be a part of this bill that will go a long way toward protecting lives, advancing technological scientific finds, and creating a better, more humane system. Overall, our bill is a big win for patients, a big win for innovation, and a big win for animal welfare. Mr. Speaker, I encourage all my colleagues to vote ``yes’’ on passing this critical legislation.

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