Springfield Standard

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 bill aimed at directing the FDA to implement the previously passed FDA Modernization Act 2.0 (FDAMA 2.0). The legislation seeks 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.

Senator Cory Booker highlighted the significance of the previous act: “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. 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 3.0 aims to reduce unnecessary animal testing while advancing scientific innovation by fully implementing FDAMA 2.0, which could lead to faster and more reliable treatments for patients. According to reports, an astonishing 90-95% of drugs that pass animal tests fail in human clinical trials, wasting precious time for patients.

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

Despite nearly two years since FDAMA 2.0 was enacted into law, the FDA has yet to update its regulations accordingly, leaving numerous outdated requirements for animal testing in place.

The new bill mandates that the FDA update its regulations within six months of enactment and includes a technical correction addressing a duplicated section heading.