Pazdur Warns: FDA Firewall and Voucher Program Under Scrutiny
Estimated reading time: 5 minutes
Key takeaways
- Pazdur says the FDA’s firewall between political appointees and drug reviewers has been breached.
- Transparency concerns surround the voucher program that accelerates reviews for drugs chosen by Trump administration officials.
- Meetings on voucher drugs are held in limited spaces, with staff reporting directly to the FDA commissioner.
- The comments reflect broader industry anxieties about governance and policy directions under the current administration.
Table of contents
Background: Pazdur’s departure and remarks
Richard Pazdur, a veteran regulator at the Food and Drug Administration who left the agency last month, said Monday the firewall between political appointees and drug reviewers at the agency “has been breached,” and that there is not enough transparency around a new voucher program that grants accelerated review to certain drugs selected by Trump administration officials.
Pazdur said meetings about the voucher drugs should be open to the public or at least to the FDA staff, but “at the present time, it’s being held in a conference room that is adjacent to the commissioner’s personal office. There’s not enough room in that office even for the entire review staff that has worked on that application to attend this meeting”.
Voucher program transparency concerns
Pazdur highlighted a notable lack of transparency around a voucher program that grants accelerated review to drugs selected by top officials. He argued that the process should be more publicly accessible to ensure checks and balances in a system designed to accelerate patient access to therapies.
“There is not enough openness about how these decisions are made, who is influencing them, and how the staff can participate in the review,” he said, underscoring broader worries about how policy choices interact with scientific judgment.
Attendee reporting lines and governance
Most of the small group of people who meet to discuss the voucher drugs, if not all of them, directly report to FDA Commissioner Marty Makary, Pazdur said, and that’s “problematic.” This framing raises questions about the independence of the review process and the potential for political considerations to shape scientific judgments.
Policy implications for industry
The exchange reflects a moment of heightened sensitivity around how expedited pathways are governed. For biotech developers and investors, it underscores the importance of transparency, robust data standards, and clear governance when engaging with fast-track programs. It also signals that industry should monitor how any policy shifts—whether under a new administration or a changing regulatory climate—could alter timelines and risk assessments for novel therapies.
Reader resources and related coverage
To stay informed, readers can explore ongoing STAT coverage on FDA oversight, policy changes, and the intersection of politics with science. Related reads include: AI-enabled devices and wearables oversight, and broader policy shifts in dietary guidelines and healthcare regulation.
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Source: https://www.statnews.com/2026/01/13/richard-pazdur-jpm-fda-chaos-at-agency-stat-event/
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