Washington, D.C. — A coalition of U.S. biomedical innovators, investors, and patient advocates has issued an urgent appeal to Congress, warning that recent upheavals at the Food and Drug Administration (FDA) are putting the nation’s biomedical leadership — and patient health — at serious risk.
In a detailed letter sent to Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Bill Cassidy, the group outlines growing concern over the FDA’s loss of experienced personnel, the impact of a hiring freeze, and what they call a dangerous erosion of institutional knowledge.
Key Concerns Raised
The letter underscores four primary issues currently plaguing the agency:
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Delays in Regulatory Timelines:
Biotech companies report missing critical meeting dates and approval deadlines due to a shortage of experienced FDA staff. Some are even turning to foreign regulatory agencies, like the European Medicines Agency, to keep development on track — a shift that effectively offshores U.S. investment and innovation. -
Loss of Judgment and Experience:
Departures of senior FDA officials have led to internal confusion and regulatory inconsistency, particularly in “edge cases” — the kind that often involve groundbreaking technologies or accelerated approval pathways. Several companies describe recent interactions with the FDA as marked by conflicting feedback and an absence of decision-making authority. -
Breakdown in Communication and Consistency:
Companies cite receiving unclear, contradictory, or medically questionable feedback from inexperienced FDA reviewers. Meanwhile, agency representatives have missed key multi-stakeholder meetings intended to reform regulatory pathways, leaving industry leaders uncertain about FDA alignment. -
Threats to PDUFA and Timely Drug Approvals:
The recent Reduction in Force (RIF) has impacted staff responsible for implementing the Prescription Drug User Fee Act (PDUFA), a critical mechanism through which industry funds the FDA’s review processes. The letter warns that lapses could jeopardize reauthorization and the FDA’s ability to collect fees.
Concrete Recommendations
To stabilize the FDA and restore industry confidence, the letter outlines the following targeted actions:
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Immediately unfreeze hiring for critical roles such as Head of Human Tissue, Head of Clinical Evaluations, and Head of Cell and Gene Therapy.
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Rehire key staff with deep institutional knowledge, including Chris Joneckis, Betsy Valenti, Yaeming Chae, Isaac Dorfman, Andy Kish, Patrick Zhou, Emily Ewing, and Josh Barton.
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Expand successful models like the Rare Disease Hub to other therapeutic areas, promoting collaboration between the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
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Maintain flexibility in regulation, warning against over-systematization that could hinder innovation in response to new scientific advances.
A Pivotal Moment for the FDA
While the signatories express support for FDA modernization and greater efficiency, they caution against reforms that could undercut the agency’s unique ability to apply science-driven, case-specific judgment. They stress that preserving experienced personnel now will ensure any future reorganization is done with the benefit of deep institutional insight.
The letter closes by urging Senator Cassidy and Congress to act swiftly to protect an agency whose performance affects every American — from biotech entrepreneurs to patients in need of life-saving treatments.
