How FDA Instability Is Reshaping Pharmaceutical Development

Richard Pazdur, former director of the FDA's Oncology Center of Excellence, with 26 years of experience at the organization, spoke at a panel during CPHI Americas 2026, held in Philadelphia from June 2-4. He offered an assessment of where the agency stands today.

Is Regulatory Inconsistency a Systemic Problem?

Pazdur directly stated that inconsistency in the review process is real, and it is tied in part to how applications are evaluated across the lifecycle of a submission. He highlighted the need to revisit Special Protocol Assessments, formal agreements between sponsors and the agency on study design, noting these frameworks, developed more than a decade ago, need modernization. He emphasized that the agency's focus remains on primary endpoints and core statistical principles but acknowledged that inconsistent application of standards remains a challenge the agency must actively address.

Variability in regulatory expectations creates uncertainty in trial design, submission strategy, and timelines. Pazdur advocated for greater use of regulatory plan templates, where sponsors and reviewers work from a shared document, reducing duplicative reporting across review layers. He also pointed to real-time oncology review, where study data are submitted to the agency ahead of the formal application, as a model that can meaningfully compress development timelines.

Advisory committees, he argued, remain essential to transparency and should be strengthened rather than sidelined. He recommended making committee member selection more open and inclusive, involving industry representatives, patient groups, and clinical trialists alongside agency staff. He also called for more focused committee discussions and suggested moving open public hearings to the start of proceedings to improve flow and reduce redundancy.

What Is the Real Impact of Staff Turnover?

Pazdur spoke on how the departure of experienced personnel, including senior scientific and leadership staff, is not simply a numbers problem. It is a quality problem. Complex regulatory decisions require deep scientific expertise, and the loss of institutional knowledge compounds as regulatory challenges grow more sophisticated.

He described a palpable sense of anxiety within the agency’s workforce, noting that scientists with advanced degrees require an environment that supports open exchange of ideas. With acting leadership currently in place across multiple senior positions, the absence of stable direction is a real operational concern. For sponsors navigating submissions, this translates into a less predictable review environment.

How Is the FDA Rethinking Dosing?

Two programs Pazdur championed at the agency illustrate where oncology drug development is heading. Project Optimus challenges the long-standing practice of pushing toward maximum tolerated doses in oncology, arguing that doses patients cannot sustain over time may ultimately undermine clinical outcomes. He acknowledged industry resistance but maintained that dose optimization must be treated as a core development responsibility rather than an afterthought.

Project Orbis, meanwhile, was designed to address the lag in approvals for smaller regulatory markets. By coordinating simultaneous submissions across partner agencies, including those in Canada, Australia, and Switzerland, the program accelerates access to promising therapies globally and promotes consistent standards of care that support more coherent subsequent development.

On the question of Chinese clinical trial data, Pazdur drew a clear line between clinical and manufacturing considerations. He supports incorporating international trial data, including from China, into multi-regional development programs, while separately advocating for domestic onshoring of manufacturing, a distinction he described as both practical and important for US competitiveness. He added that decentralized trials and integration of clinical data into electronic health record systems could dramatically improve trial access and data quality across diverse patient populations.