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

WASHINGTON –  This week, U.S. Senators Eric Schmitt (R-MO) and Cory Booker (D-NJ) led a bipartisan group of Senators in introducing 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:

“The FDA Modernization Act 3.0 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. 

“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 Cory 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.”

BACKGROUND:

• 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.
• 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.

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