Booker, Schmitt, Paul, King, Braun, Whitehouse, Kennedy, Luján, Blumenthal Introduce the FDA Modernization Act 3.0

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

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 allowed drug developers to use advanced, non-animal methods such as cell-based assays, organ chips, computer modeling, and bioprinting.

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

“The FDA Modernization Act 2.0 was a landmark achievement for both animals and public health, paving the way for 21st century human-relevant science,” said Senator Booker. “It’s time our country takes full advantage of technologies that can more accurately predict human responses and accelerate our nation’s drug development. This bipartisan legislation will ensure the FDA finally aligns its regulations with the law.”

“The FDA Modernization Act is aimed to do exactly what the Bill is named to do – modernize our FDA and remove overbearing and often unnecessary animal testing requirements on new drugs. I’m proud to join Senator Cory Booker on this important bipartisan legislation,” said Senator Eric Schmitt.

“In 2022 I was proud to lead the charge on the FDA Modernization Act 2.0, which was a critical step in reforming our drug approval process—getting life-saving treatments to patients faster, cutting costs, and embracing non-animal testing methods. Now, with FDA Modernization Act 3.0, it’s time to build on that success and ensure reforms can proceed expeditiously. Swift passage of this legislation will continue breaking down unnecessary barriers, so Americans can access safe, effective drugs without delays and at reduced costs,” said Dr. Rand Paul.

“The FDA Modernization Act 2.0 was designed to be a win for patients and animals alike, but it can only do so if the FDA makes the changes the law required “ said Senator King. “In the 21^st century, access to cutting-edge technology allows drug developers the option to use modern animal-free testing methods in nonclinical tests where appropriate. However, it’s been nearly two years since this bill was signed into law and we have yet to see the updated regulations and reforms put in place. I’m grateful to my colleagues for their work on the FDA Modernization Act 3.0 to ensure the agency fulfills the aims of our earlier legislation.”

“The FDA Modernization Act was an important bill for protecting animals from drug testing. This bill is needed to get the FDA to update its regulations to follow the reforms put in place by our original legislation,” said Senator Mike Braun  

“It’s been nearly two years since President Biden signed the landmark FDA Modernization Act 2.0, yet the FDA continues to stall and delay the law’s implementation.  I’m glad to support Senator Booker’s bipartisan effort to push the FDA to move away from outdated animal testing to more modern drug development methods,” said Senator Whitehouse.

“The FDA has been delinquent in not implementing the law that Senator Booker shepherded to passage two years ago to eliminate an archaic animal-testing mandate for screening of new drugs,” said Wayne Pacelle, president of Animal Wellness Action and the Center for a Humane Economy. “The use of human-relevant models must be put to use in our drug development programs to benefit patients and drug sponsors and to spare beagles, primates, and other animals needless torment.”

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.

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