Cambridge, Mass.– A new report from the Massachusetts Biotechnology Council (MassBio) is sounding the alarm over a wave of federal policy changes that threaten to destabilize the U.S. biotechnology industry, with Massachusetts—one of the sector’s strongest hubs—particularly at risk.
According to the analysis, sweeping reductions in NIH funding, deep staffing cuts at the FDA, and new international trade restrictions are already sending shockwaves through the nation’s life sciences ecosystem. The cumulative effect, MassBio warns, could severely hinder innovation, undermine national security, and cost thousands of high-skilled jobs.
“This analysis makes clear that without policy stability and renewed investment, we will cede leadership in a sector that defines the future of medicine, creates high-wage jobs, and safeguards our economic and national security,” said MassBio President and CEO Kendalle Burlin O’Connell. “The urgency here is real—many of these impacts may become irreversible if action isn’t taken soon.”
The report outlines a chain reaction of disruptions across the biotech value chain. Academic researchers are facing grant shortfalls, early-stage companies are struggling to attract venture capital, clinical trials are being delayed due to regulatory bottlenecks, and larger firms are scaling back research and manufacturing plans. With international competitors, especially in Asia, accelerating their investment in biotech, the U.S. risks losing its long-held edge in medical innovation.
Among the report’s key findings:
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NIH Cuts Jeopardize Research: Every $1 million in NIH grants supports over eight jobs and contributed to nearly all drug approvals over the past decade. Cuts are now threatening the foundation of early-stage science and downstream clinical pipelines.
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FDA Staffing Losses Slow Approvals: Workforce reductions at the FDA are causing regulatory delays, raising costs, and creating uncertainty around the approval of next-generation therapies. Half of surveyed companies report being negatively impacted, with two-thirds concerned about future delays.
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Trade Barriers Disrupt Drug Supply: With more than 70% of active pharmaceutical ingredients sourced from abroad, new tariffs could drive up hospital drug costs by 15% and force biotechs to delay filings as they search for new partners.
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Capital Flight Threatens Innovation: Regulatory uncertainty and macroeconomic turbulence are driving venture capital away from biotech. Early-stage deal values have hit a four-year low, signaling a potential choke point for the next generation of medical breakthroughs.
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Global Competition Rising: Asia now leads the world in biotech patent filings and IPOs, with China taking the lead in several innovation metrics. Without intervention, the report warns, the U.S. may find itself trailing in critical areas of drug development and manufacturing.
MassBio is urging policymakers to take immediate corrective steps, including restoring NIH funding, rebuilding FDA regulatory capacity, avoiding protectionist trade policies, and developing a comprehensive federal innovation strategy.
“Strategic investment in research, a fully staffed regulator, and stable, open supply chains are imperative,” said Burlin O’Connell. “The choice is stark: lead the world in biotechnology or watch critical discoveries, economic growth, and strategic leverage migrate to rival nations.”
