FDA's New Drug Chief Pazdur Challenges Commissioner's Expedited Approval Plans
核心洞察
Richard Pazdur (搜索), the FDA's newly appointed director of the Center for Drug Evaluation and Research (搜索), has raised concerns about the legality and safety of Commissioner Marty Makary's initiatives to expedite drug approvals.
The veteran oncology chief has questioned plans to reduce required research studies for drug decisions and exclude career scientists from politically driven health discussions.
Tensions have escalated between Pazdur and Makary over the National Priority Voucher program, which aims to shorten drug review periods from 10-12 months to 1-2 months for companies aligned with Trump administration priorities.
Richard Pazdur (搜索), the FDA's newly appointed director of the Center for Drug Evaluation and Research (搜索) (CDER), has raised serious concerns about the legality and safety of Commissioner Marty Makary's initiatives to expedite drug approvals, according to sources familiar with the matter. The veteran oncology chief, who took over the role earlier this month, has warned that several planned reforms could pose risks to public health.
Conflicts Over Expedited Review Programs
Pazdur and Makary have disagreed over the commissioner's plan to reduce the number of research studies needed to justify drug-related decisions, including changes to drug labels. The CDER director has argued that Makary's new drug-review program, which is part of President Donald Trump's initiative to reduce drug prices and boost U.S. drug manufacturing, lacks sufficient transparency and could be illegal.
The program is designed to shorten review times and expedite approvals for treatments aligned with the country's health priorities. However, Pazdur has questioned the National Priority Voucher program specifically, which aims to compress the usual 10-12 month review period to just 1-2 months for companies that align with certain national priorities of the Trump administration, such as lowering drug prices and boosting domestic manufacturing.
Scientific Independence Concerns
Beyond the expedited approval processes, Pazdur has pushed back against Makary's plan to exclude career scientists from discussions on politically driven priorities. The CDER director has argued that their involvement is crucial to maintain a safe and transparent review process.
According to sources, tensions between Pazdur and his boss have been high since these disagreements emerged. Reports indicate that Makary and his deputy haven't spoken to each other since the initial reports of their conflicts became public.
Leadership Transition and Background
Pazdur was named CDER director on November 11 following what appeared to be a lengthy courtship process, which reportedly involved Makary spending hours at Pazdur's house, assuring him he would have independence in his new post. The oncologist, who has been with the FDA since 1999 and was most recently chief of its Oncology Center of Excellence (搜索), had originally declined the CDER directorship.
He succeeds George Tidmarsh, who resigned from his post earlier this month amid an internal probe regarding his personal conduct. Tidmarsh had been on the job for just over three months.
Official Responses
In a statement provided by a spokesperson for the Department of Health and Human Services (搜索), Makary called Pazdur a "true regulatory innovator" who helps "guide our broader agenda to modernize the agency and streamline the approval process." The spokesperson also provided a statement from Pazdur, who said that he remains "committed to the mission of CDER and my current position."
The disagreements underscore broader tensions within the FDA as the agency navigates pressure to accelerate drug approvals while maintaining rigorous safety standards and scientific integrity in its review processes.