Senators Marshall, Booker Introduce the FDA Modernization Act 3.0

Washington, D.C. – U.S. Senators Roger Marshall, M.D., Cory Booker (D-NJ), Eric Schmitt (R-MO), Rand Paul (R-KY), Angus King (I-ME), Sheldon Whitehouse (D-RI), John Kennedy (R-LA), Richard Blumenthal (D-CT) and Ben Ray Luján (D-NM) reintroduced the FDA Modernization Act 3.0, a bipartisan bill to direct the FDA to implement the FDA Modernization Act 2.0 (FDAMA 2.0), legislation passed by Congress to modernize drug testing protocols and improve patient outcomes.

The FDA Modernization Act 3.0 is a bipartisan effort to reduce unnecessary animal testing while advancing scientific innovation. By fully implementing FDAMA 2.0, drug development can be both more humane and more efficient, ultimately leading to faster and more reliable treatments for patients. An astonishing 90-95% of drugs that pass animal tests go on to fail in human clinical trials, wasting precious time for patients. 

“Congress has continued to press the FDA to modernize its research and shift away from testing on animals to more humane models that would expedite our drug development. However, there is more work to be done. I am proud to be a part of this bipartisan legislation to advocate for the FDA to abide by the directives Congress has passed into law,” said Senator Marshall.

“It’s been over two years since Congress ended the statutory mandate that investigational new drugs (INDs) undergo mandatory animal testing before human clinical trials,” said Senator Booker. “We cannot allow the FDA to continue to delay on implementing this critical law. If passed, this bipartisan legislation will require FDA to finally update its regulations and will pave the way for more scientifically reliable and humane methods of drug development. 

“The FDA Modernization Act 3.0 builds on the critical reforms we achieved with FDA Modernization Act 2.0, ensuring that modern, humane, and scientifically advanced testing methods can finally replace outdated animal testing. For too long, bureaucratic inertia has delayed the implementation of these changes, which are vital to saving lives, reducing costs, and bringing life-saving treatments to patients more efficiently. This legislation sends a clear message: Americans deserve a regulatory system that embraces innovation, not one stuck in the past,” said Dr. Rand Paul

“The Biden administration had two years to implement the FDA Modernization Act 2.0, but it didn’t act. Congress should send this bill to Pres. Trump’s desk to help protect animals from mandatory testing at the FDA,” said Senator Kennedy. 

“Modern technology has led to innovative medical solutions—it’s time we take advantage of them and move on from outdated, unnecessary animal testing. With the FDA Modernization 3.0 Act, we protect animals from often inhumane testing and update our drug testing protocols, paving the way for more accurate and reliable health care treatments,” said Senator Blumenthal.

BACKGROUND

In 2022, FDAMA 2.0 was signed into law by President Biden. This law removed the longstanding requirement under the Federal Food, Drug, and Cosmetic Act (FDCA) that investigational new drugs (INDs) undergo mandatory animal testing before human clinical trials. Instead, the law provided FDA and drug developers the option to use advanced, non-animal methods such as cell-based assays, organ chips, computer modeling, and bioprinting. 

Despite FDAMA 2.0 being enacted into law over two years ago, the FDA has yet to update its regulations to conform with the law, leaving numerous FDA regulations that continue to require animal testing. The FDA Modernization Act 3.0 seeks to resolve this by mandating the FDA to update its regulations within twelve months of the bill’s enactment. It also includes a technical correction to the statute by addressing a duplicated section heading. 

To read the full text of the bill, click here.