A bipartisan coalition of U.S. Senators has introduced the FDA Modernization Act 3.0, aiming to expedite the FDA's adoption of non-animal testing methods for drug development. This bill seeks to ensure the full implementation of the FDA Modernization Act 2.0 (FDAMA 2.0), which was signed into law in 2022 to modernize drug testing protocols and improve patient outcomes.
Streamlining Drug Development with Non-Animal Methods
FDAMA 2.0 removed the previous requirement for investigational new drugs (INDs) to undergo mandatory animal testing before human clinical trials. Instead, it permitted the use of advanced, non-animal methods such as cell-based assays, organ chips, computer modeling, and bioprinting. The FDA Modernization Act 3.0 addresses the slow regulatory updates following the enactment of FDAMA 2.0, mandating the FDA to update its regulations within six months of the bill's enactment.
Senator Cory Booker (D-NJ), a key proponent of the bill, stated, "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."
Addressing Regulatory Delays and Improving Efficiency
Despite the passage of nearly two years since FDAMA 2.0, the FDA has not yet updated its regulations to reflect the law, leaving numerous regulations that still call for animal testing. The FDA Modernization Act 3.0 includes a technical correction to address a duplicated section heading in the statute.
Senator Rand Paul (R-KY) emphasized the importance of the new bill: "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."
The Promise of Modernized Drug Testing
The bipartisan effort aims to reduce unnecessary animal testing while advancing scientific innovation. According to the bill's proponents, approximately 90-95% of drugs that pass animal tests ultimately fail in human clinical trials, resulting in wasted time and resources. By fully implementing FDAMA 2.0, drug development can become more humane and efficient, potentially leading to faster and more reliable treatments for patients.
