‘Just Agree to It:’ Pazdur Said He Was Told To Cosign FDA’s Reduced Trial Requirements

Why It Matters

Cutting trial requirements could accelerate drug launches but may compromise patient safety, while leadership churn erodes confidence in the FDA’s regulatory rigor.

Key Takeaways

• Pazdur quit over forced one‑trial approval policy
• FDA aims to cut required trials from two to one
• Commissioner Makary accused of compromising review independence
• Fourth CDER director change in 2025 signals instability
• Critics warn safety risks from accelerated drug approvals

Pulse Analysis

The FDA has long required at least two pivotal clinical trials to substantiate a drug’s efficacy and safety before granting approval. In December, the agency announced a shift to a single‑trial model, arguing that it would reduce development costs and bring therapies to patients faster. Proponents cite advances in trial design, biomarkers, and real‑world evidence as justification, while skeptics warn that fewer data points could obscure rare adverse events and limit long‑term efficacy insights. This policy change reflects broader pressure to streamline drug pipelines amid rising healthcare expenditures.

Pazdur’s resignation underscores the tension between scientific independence and political urgency at the FDA. After 26 years of service, the veteran oncologist described a “breached wall” between the commissioner’s office and career reviewers, suggesting that policy directives are now being imposed without the usual consensus of expert panels. Such leadership turnover—four CDER heads in a single year—raises concerns about institutional memory and the agency’s ability to maintain consistent standards. Industry observers fear that rapid policy shifts could create uncertainty for pharmaceutical companies planning trial strategies and regulatory submissions.

Looking ahead, the FDA faces a delicate balancing act: preserving rigorous safety assessments while responding to calls for faster access to innovative treatments. Stakeholders, including investors and patient advocacy groups, will watch closely how the single‑trial approach is implemented and whether additional safeguards, such as post‑marketing commitments, are strengthened. Stable leadership will be crucial to navigate these reforms, ensuring that accelerated pathways do not erode public trust. Companies may need to adapt by leveraging adaptive trial designs and real‑world data to meet evolving evidentiary expectations, while regulators must transparently communicate the rationale and safeguards behind any expedited approvals.