Drugs

Hearing on FDA's Role in Retaining Biomedical Innovation in U.S.

The House Energy and Commerce Committee's Subcommittee on Health has announced a 7/15 hearing to examine how FDA can help strengthen the nation's leadership in biomedical innovation as lawmakers begin laying the groundwork for the next reauthorization of the agency's user fee programs.

Committee chairman Brett Guthrie (R-KY) and Health Subcommittee chairman Morgan Griffith (R-VA) say the hearing, titled "Maintaining America's Leadership in Biomedical Innovation: FDA's Role in Advancing U.S. Drug Development," will explore ways to streamline the agency's drug development and clinical trial requirements while supporting early-stage research, domestic biopharmaceutical manufacturing, and the broader biotechnology sector.

"As we look ahead to the reauthorization of FDA's user fee programs next year, this hearing will help inform the Committee's work to advance more efficient drug development and ensure the U.S. remains the global leader in biomedical innovation," Guthrie and Griffith said in a joint statement.

The hearing is scheduled for 10:15 a.m. EDT in Room 2123 of the Rayburn House Office Building. It will be open to the public and livestreamed by the House Energy and Commerce Committee.

Last month, HHS launched a broad, department-wide initiative (Operation TrialBlazer) aimed at speeding clinical research, reducing regulatory barriers, and attracting more clinical trials back to the U.S. (see earlier story). A centerpiece of the initiative is a new FDA proposal to establish a pilot program designed to shorten the timeline between drug discovery and first-in-human Phase 1 clinical trials. The agency will also be clarifying regulatory expectations for sponsors in ways that could reduce early-stage development timelines by six to 12 months, according to HHS.

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