New report details how U.S. can maintain biotech competitiveness

The Reagan-Udall Foundation for the FDA just released a new report on strengthening early-stage drug development in the United States. The report reflects insights shared by academic medical centers, biopharmaceutical companies, clinical research organizations (CROs), patient organizations, and regulatory agencies in a March 2026 roundtable. Biotechnology Innovation Organization (BIO) provided funding for the project.

The report comes as China accelerates its drug development capabilities, challenging the United States’ historical biotech leadership. To maintain global competitiveness—and continue developing innovative medicines for American patients—the United States must strengthen its support for research and development to enable a more efficient pathway for innovative treatments to reach patients.

The report details key challenges to early-stage U.S. drug development and lays out a number of core recommendations to address them.

Current challenges

The United States is on the verge of losing its historic lead in drug development. Our share of the global pharmaceutical pipeline has decreased from 47% in 2013 to 36% in 2025, barely ahead of China.

The U.S. also has recorded an outright decline in early-stage “Phase 1” clinical trials. The report observes that clinical development has become more difficult and expensive, and that existing regulatory frameworks are slow to adapt to these new challenges. That, in turn, could lead to a reduction in new therapies—and a dependence on China and others for key treatments. The United States must strengthen support and incentives for early-stage drug development.

Key recommendations from the report

• Modernize Investigational New Drug Requirements and Processes: Updating submission requirements, improving review processes, and clarifying data requirements for Investigational New Drugs would allow companies to begin human testing for promising therapies more quickly while maintaining high safety standards.
• Modernize Phase 1 Clinical Trials and Tools: More innovative clinical trial designs that include patient perspectives earlier and allow AI-enabled tools can improve Phase 1 Trials.
• Optimize FDA–Sponsor Early-Stage Engagements and Processes: Increasing communication and clarifying FDA review requirements would reduce uncertainty for clinical trial sponsors as they pursue early-stage drug development.
• Build a Streamlined and Dedicated U.S. Phase 1 Infrastructure: Building and funding a network of Phase 1 trial sites could streamline the clinical trial process, allowing greater early-stage development.
• Mitigate Litigation Risk for Phase 1 Clinical Trial Sites: Exploring reforms that lower unnecessary risks for trial sponsors could reduce barriers to pursuing clinical trials while maintaining rigorous standards for patient safety.

To maintain global competitiveness and preserve patient access to promising new medicines, the United States must strengthen support for cutting-edge R&D. That starts with removing barriers and actively incentivizing the early-stage trials that lead to breakthrough therapies.

Read the report.

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