WASHINGTON – Senator Eric Schmitt and Sen. Booker’s FDA Modernization Act 3.0 (FDAMA 3.0) has passed the United States Senate:
“The FDA Modernization Act 3.0 is aimed to do exactly what this legislation is named to do–modernize the FDA and remove overbearing animal testing requirements and regulations on new drugs. I am thankful for the support of my colleagues in helping to ensure the passage of this critically important legislation,” said Senator Eric Schmitt.
BACKGROUND:
The FDA Modernization Act 3.0 is a bipartisan effort to reduce unnecessary animal testing while advancing scientific innovation. By fully implementing FDAMA 3.0, drug development can be both more humane and more efficient, ultimately leading to faster and more reliable treatments for patients. The bill was introduced in September, led by Senator Schmitt and Senator Booker.
In 2022, President Biden signed FDAMA 2.0 into law, eliminating the longstanding requirement under the Federal Food, Drug, and Cosmetic Act (FDCA) for investigational new drugs (INDs) to undergo mandatory animal testing before human clinical trials. Instead, the law permitted 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.