MassBio CEO & President Kendalle Burlin O’Connell originally posted this update to LinkedIn:
With the House now recessed until after the midterm elections, Washington’s pre-election legislative window is beginning to close, though the Senate remains at work at least through next week. For biotech, the week brought plenty of activity, with MassBio on Capitol Hill and at FDA, Congress examining the future of U.S. biotechnology leadership, and new developments across clinical trials, research policy, and global competitiveness. Here’s what we’re watching:
MassBio Takes Biotech Priorities to Washington: MassBio was in Washington this week meeting with congressional offices and FDA leadership to discuss how policymakers can modernize clinical trials, make FDA work better for small and emerging biotechs, and strengthen the broader ecosystem needed to maintain U.S. leadership in biotechnology.
House Science Committee Examines the Balance Between Biotech Innovation and Biosecurity: The House Science, Space, and Technology, Investigationg and Oversight Subcommittee held a wide-ranging hearing Wednesday on U.S. biotechnology leadership and biosecurity. Subcommittee Chairman Rich McCormick opened by warning that American leadership is “no longer guaranteed,” while Full Committee Chairman Brian Babin argued that maintaining that leadership requires both sustained R&D and effective safeguards. The hearing ultimately extended well beyond biosecurity. Joshua Hodges of the Hoover Institution testified that the U.S. continues to lead in talent, finance, and innovation but has fallen behind China in clinical trials, manufacturing, and supply chains, telling lawmakers that “our lead is in the laboratory and our innovation” while the U.S. falls short “on the factory floor.” He also urged Congress to expand outbound-investment restrictions to biotechnology. Dr. Gigi Gronvall of Johns Hopkins argued that protecting American research is not enough if U.S. policy simultaneously weakens the research enterprise, saying American science must continue “producing something worth protecting.” She pointed to disrupted grants, workforce losses, and uncertainty around new high-risk research rules as competitiveness concerns. FDA and clinical trial competitiveness also surfaced repeatedly. Ranking Member Zoe Lofgren pointed to regulatory bureaucracy as one factor driving clinical trials offshore, while Hodges contrasted development timelines in China with substantially longer timelines in the United States.
USTR Opens Annual Review of Foreign Trade Barriers: The Office of the U.S. Trade Representative opened public comments Monday for its 2027 National Trade Estimate Report, which identifies foreign policies and practices that create barriers to U.S. exports and investment. For the biotech industry, the process provides another venue for stakeholders to raise concerns over market-access and other foreign policies that undermine the value of innovation or affect the ability of U.S. companies to compete abroad. Comments are due October 29.
FDA Seeks Input on Rare Disease Clinical Trial Design: FDA released a Request for Information focused on statistical considerations for rare disease clinical investigations, alongside a September 29 workshop hosted through the Rare Disease Innovation Hub. The agency is seeking feedback on how approaches including randomization, blinding, and more efficient trial designs can generate reliable evidence despite the small patient populations that make rare disease development uniquely challenging. Comments are due November 13.
NIH Moves Forward with Streamlined Clinical Trial Grant Application: NIH released feedback Friday on its proposal to consolidate clinical trial information into a single, semi-structured application form aimed at reducing duplication and administrative burden. Nearly two-thirds of respondents who addressed burden said they expected the new approach to reduce the effort required to prepare an application, although researchers raised concerns about page limits, complex trial designs, and fitting sufficient statistical and human-subjects information into the new structure. NIH says it is now modifying the proposal based on that feedback.
