MassBio CEO & President Kendalle Burlin O’Connell originally shared this update on LinkedIn.
Washington had a busy week for biotech. From a long-overdue funding lifeline for early-stage companies to growing questions about FDA’s direction, the policy landscape is moving fast. MassBio is in the middle of all of it.
- SBIR/STTR Reauthorization Clears the Senate: After a five-month lapse that left early-stage companies without access to one of the most critical sources of non-dilutive funding in the country, the Senate unanimously passed the Small Business Innovation and Economic Security Act this week. The bipartisan legislation would extend the SBIR and STTR programs through September 30, 2031, providing long-needed stability for innovative small businesses. MassBio has been deeply engaged in these negotiations and applauds the Senate’s action. With the House expected to take up the bill the week of March 16, we are urging swift passage so early-stage biotechs can once again access the seed funding that fuels discovery, enables hiring, and moves promising science toward patients.
- FDA Regulatory Instability in Gene Therapy and Rare Disease: This week’s uniQure news crystallized a troubling pattern for the gene therapy and rare disease field. The FDA formally told the company that its Huntington’s disease gene therapy lacks sufficient evidence for a marketing application, and that a Phase 3 trial is required. The stock drop reflects broader concerns across the gene therapy space as FDA’s practices continue to be in dispute with statements from leadership. For Massachusetts biotechs, investors, patients, and stakeholders focused on cell and gene therapy and rare disease, unpredictable shifts in evidentiary standards create real risk to timelines, financing, and patient access. MassBio will continue to call for regulatory clarity and consistency in gene therapy and across FDA.
- FDA’s Reviewer Bonus Program: We’re learning more about a new program at FDA designed to reward reviewers for completing drug application reviews ahead of schedule. With the agency still rebuilding after significant workforce losses over the past year, the initiative reflects Commissioner Marty Makary’s push for efficiency and modernization. While the intent is encouraging, we have real questions about implementation and whether FDA should instead focus on maintaining appropriate staffing levels. We’ll be watching closely as this pilot unfolds.
- Senate Aging Committee Hearing (Foreign Dependence on China’s Drug Supply): On March 11, the Senate Special Committee on Aging will hold a hearing titled “Foreign Dependence: How China Captured America’s Drug Supply.” Witnesses will include former Congressman Ted Yoho, China expert Gordon Chang, and ChinaRX author Rosemary Gibson. The hearing continues a sustained effort in Congress to expose U.S. reliance on China for active pharmaceutical ingredients and finished generic drugs, a vulnerability that spans national security, public health, and supply chain resilience. We’ll be watching to hear whether Senators discuss any specific proposals, including reshoring incentives and procurement preferences for domestically manufactured products, and will assess how they might impact our companies.
- USITC to Investigate Chinese State Support in Biotech and Pricing Practices: On February 26, the U.S. International Trade Commission announced it will investigate Chinese state support and pricing practices in the biotechnology sector (including genomic sequencing, synthetic biology, and active pharmaceutical ingredient manufacturing) and assess how these practices may be affecting the market share and competitiveness of U.S. industry. A public hearing is scheduled for May 27-28, with a final report due January 22, 2027. MassBio encourages members to reach out to discuss this investigation if you believe you might be affected by Chinese pricing practices or by potential policy responses that could lead to cost or supply chain risks.