FDA Modernization Act 3.0

Mr. Speaker, I thank the gentleman for yielding.

Mr. Speaker, I rise today in strong support of my bill, H.R. 2821, the FDA

Modernization Act 3.0, bipartisan legislation that ensures the FDA fully embraces modern science while reducing unnecessary animal testing.

Many of our families would feel incomplete without the pets and animals that bring unconditional love into our lives. Yet every year, millions of animals, including dogs, man's best friend, are still subjected to testing in the development of new medicines.

As policymakers, we have a responsibility to protect those who cannot protect themselves. That responsibility includes embracing scientific innovation that can reduce unnecessary animal suffering while continuing to deliver safe and effective treatments to patients.

In 2022, Congress took an important first step by passing the FDA Modernization Act 2.0. I was proud to help lead that effort. That law gave drug developers the ability to use modern, scientifically validated alternatives to traditional animal testing when appropriate.

Congress made its intent clear. We wanted to encourage more effective, more humane, and more innovative approaches to drug development.

Unfortunately, the previous administration failed to fully implement the law. Without clear implementation, too many researchers have lacked the certainty they need, and too many animals continue to be used in testing that modern science can increasingly replace.

H.R. 2821 ensures the FDA finally carries out the will of Congress. This bill is not lowering standards. It is about raising them.

Today's researchers have access to technologies that simply did not exist a generation ago: advanced human cell models, organ-on-a-chip technology, artificial intelligence, and computational modeling. These innovative tools have the potential to better predict how medicines will perform in humans while reducing reliance on animal testing. Our laws should reflect the science of today, not the science of decades past.

Modernizing drug development doesn't just benefit animals. It benefits patients. By providing greater clarity and encouraging the use of validated alternative methods, we can make the drug development process more efficient. That means fewer unnecessary delays and more innovation. Ultimately, that means lifesaving treatments can reach patients more quickly without compromising the FDA's rigorous standards for safety and effectiveness.

This is a commonsense, bipartisan bill. It reflects a simple principle: We can advance medical innovation while improving animal welfare. Those goals are not in conflict. In fact, they go hand in hand.

Mr. Speaker, the FDA Modernization Act 3.0 fulfills the promise Congress made when we passed the FDA Modernization Act 2.0. It ensures that modern science is fully incorporated into our regulatory process. It helps reduce unnecessary animal testing and strengthens American medical innovation. It also helps bring new therapies to patients more efficiently.

I urge my colleagues to support H.R. 2821, the FDA Modernization Act 3.0.

Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 2821) to require the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to publish a final rule relating to nonclinical testing methods.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and include extraneous material on this legislation.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I rise today in strong support of H.R. 2821, led by my colleagues Representative Carter of Georgia and Representative Barragan, which requires the Secretary of HHS to publish rules amending certain regulations by replacing references to ``animal'' tests, data, studies, models, and research with the broader term ``nonclinical'' tests, data, studies, models, and research.

Biomedical research typically utilizes animal models to explore biological processes, analyze diseases, and explore potential therapies. However, given the concerns and scientific limitations of animal testing, researchers have increasingly turned to new approach methodologies to evaluate drugs when scientifically justified.

The scientific community has worked diligently to balance animal welfare concerns and the value of animal tests and research. I am pleased with the progress to date and look forward to seeing continued evidence-driven advancements in this space.

I commend the administration for their work to phase out animal testing where it is scientifically appropriate and for achieving the key goals in the first year of implementing the roadmap to reducing animal testing in preclinical safety studies.

Mr. Speaker, I appreciate my colleague from Georgia for putting this bill forward, and I reserve the balance of my time.

Mr. Speaker, I yield such time as he may consume to the gentleman from Georgia (Mr. Carter), a dear friend, a great member of the Energy and Commerce Committee, and a leader in this effort with the FDA. With pharmaceuticals, just about anything that is very important to the American people, he is an absolute leader in that.

Mr. Speaker, I have no additional speakers. I reserve the balance of my time.

Mr. Speaker, I encourage a ``yes'' vote on this bill, and I yield back the balance of my time.

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.

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.

Mr. Speaker, I yield 2 minutes to the gentleman from Louisiana (Mr. Carter).

Mr. Speaker, I urge passage of this bipartisan bill, and I yield back the balance of my time.