Auchincloss, Griffith Introduce Faster Clinical Trials Act
FOR IMMEDIATE RELEASE
CONTACT: Georgina.Burros@mail.house.gov (Auchincloss)
AUCHINCLOSS, GRIFFITH INTRODUCE FASTER CLINICAL TRIALS ACT
WASHINGTON, D.C. — Today, Reps. Jake Auchincloss (D-MA) and Morgan Griffith (R-VA) released the Faster Clinical Trials Act. The proposal would speed the development of new treatments, invest in clinical research, and propel U.S. leadership in biomedical innovation.
For decades, the United States has led the world in biomedical research and development; the testing and approval process by which potential medicines are deemed safe and effective; and the distribution of those medicines into clinical settings. However, America’s fragmented and friction-filled clinical research enterprise has not kept pace with the speed of science nor the investment by other nations. The difficulty of integrating clinical trials into U.S. sites of care has slowed down American development, testing, and approval.
The Faster Clinical Trials Act would upgrade America’s science infrastructure—the data, research sites, and clear standards needed to develop treatments—while preserving the Food and Drug Administration’s (FDA) high standards for safety and effectiveness.
Bringing trials into everyday care
This legislation would establish a Center for Clinical Trial Innovation (CCI) within the FDA’s drug review center. The CCI would lead implementation of the Cures in Care Initiative, working with clinical sites to bring research into routine care.
Within one year of enactment, the center would establish at least three trial networks, prioritizing community health centers, rural clinics, and other sites with fewer resources. Training, shared technology, and technical support would help providers conduct trials where patients already receive care.
Removing barriers with the FDA
The proposal would direct the FDA and federal partners to connect health records and research systems, protect patient privacy, and reduce duplicate ethics reviews.
It would create a faster review process for lower-risk Phase 1 trials, including qualified third-party reviews with quality checks by the FDA. It would also advance human-based models, artificial intelligence, and alternatives to animal testing.
To prevent avoidable delays, the FDA would address common causes of clinical holds and improve support for researchers. The bill would align global trial standards, strengthen oversight of foreign research, and promote generic and biosimilar competition. It would also strengthen the FDA’s Rare Disease Innovation Hub to support flexible trial designs and help developers navigate review.
Building better evidence for treatment
The draft would establish a legal framework for the FDA’s Oncology Center of Excellence and a process to update cancer drug labels using genomic evidence, helping identify patients who may not benefit from certain treatments.
It would also build on All of Us to establish a national biobank linking biological samples, genomic data, and health records.
Together, these changes aim to deliver better evidence and faster trials for American patients—not lower standards.