Hearing to Examine FDA's Role in Strengthening U.S. Drug Development
The House Energy and Commerce Subcommittee on Health will hold a hearing 7/15 examining how FDA can help strengthen U.S. leadership in biomedical innovation amid growing concerns that early-stage drug development is increasingly shifting overseas. The hearing, titled "Maintaining America's Leadership in Biomedical Innovation: FDA's Role in Advancing U.S. Drug Development," will feature testimony from representatives of the Reagan-Udall Foundation for the FDA, IQVIA, Breakthrough T1D, Brigham and Women's Hospital, Harvard Medical School, and the Council on Foreign Relations, according to new details from the subcommittee.
According to a memo prepared by committee majority staff, lawmakers will examine whether regulatory and operational reforms could accelerate early-stage clinical research in the U.S. while maintaining FDA's standards for safety and effectiveness. It cites increasing concern that preclinical research and Phase 1 and Phase 2 clinical trials are migrating to countries including China and Australia, where sponsors can initiate studies more quickly and at lower cost than in the U.S. Committee staff note that China conducted more than 7,100 registered clinical trials in 2024, compared with roughly 6,000 in the United States, following a series of regulatory reforms designed to accelerate drug development.
The hearing will also focus on HHS' recently launched Operation TrialBlazer initiative, which aims to modernize clinical trial regulations, improve transparency, and streamline early-stage research to restore U.S. leadership in clinical development. Industry stakeholders have urged FDA to consider reforms including risk-based IND) submission requirements, rolling IND submissions, and a notification pathway for certain Phase 1 clinical trials similar to Australia's Clinical Trial Notification system.
The committee memo outlines several areas where lawmakers may seek changes to the drug development process, beginning with discovery and preclinical testing through IND review, clinical trials, FDA application review, and post-market safety oversight. It notes that while FDA generally completes IND safety reviews within 30 days, initiating a clinical trial in the U.S. typically takes about 145 days because of additional institutional review board processes.
Among the key policy questions lawmakers plan to explore are how Congress and FDA can modernize early-stage clinical development without compromising safety standards, whether innovative trial designs and digital technologies can improve research efficiency, how greater transparency could accelerate trial activation and patient enrollment, and what consequences the United States could face if it loses its leadership position in biomedical innovation and domestic biopharmaceutical manufacturing.
Witnesses scheduled to testify include Cynthia Verst of IQVIA, Susan Winckler of the Reagan-Udall Foundation for the FDA, Aaron Kowalski of Breakthrough T1D, Thomas Hwang of Brigham and Women's Hospital and Harvard Medical School, and Thomas Bollyky of the Council on Foreign Relations.