An FDA program that seeks to expedite drug reviews for companies in line with the Trump administration’s priorities should focus on efficiency in evaluations, not speed, the agency’s former drughead said Thursday.
“This voucher program has an emphasis on speed, which I think is a very sophomoric aim at aspiration,” said Richard Pazdur, who briefly served last year as the director of the Food and Drug Administration’s Center for Drug Evaluation and Research. “It should be about efficiency.”
“You have to understand the process because it’s not just saying we’re going to approve drugs in two months or three months,” Pazdur said at a meeting held by Friends of Cancer Research, a nonprofit research think tank. “It’s what can be done with the review process that we could really expedite the review.”
Pazdur was tapped last year to be the agency’s top drug official, but announced plans to retire weeks after starting the job. The 26-year veteran of the FDA, who also served as the director of the Oncology Center of Excellence, has criticized agency Commissioner Marty Makary’s program that aims to speed product reviews for select manufacturers.
At least 18 products have now received a voucher under the Commissioner’s National Priority Voucher pilot program since it was established in June 2025. The agency in December 2025 announced its first review decision under the program.
While the program could reduce drug application review times from as long as 10 months to as quickly as one month, Pazdur emphasized that different drug applications can expect distinct review times.
“A 50 patient study in a terminal disease population would have a much different review time than somebody’s application that has 5,000 patients and a benign disease,” he said.
Janet Woodcock, who previously served as principal deputy commissioner, pressed on the trade-offs that voucher programs have on the FDA.
“Who does it penalize? The review staff,” Woodcock said. “It probably penalizes all other applications that are before the agency and the people who need advice from agency.”
The review staff is “scrambling around trying to get this done in a hurry,” she said.
Aside from an expedited review, the national priority voucher provides recipients with enhanced communications with the FDA, multidisciplinary team-based evaluation, and accelerated approval if applicable requirements are met.
Political Influence
The former agency leaders also shared concerns about whether politics were involved in recent decision-making at the FDA. The drug approval process has historically depended on science to review whether the products are safe and effective.
Pazdur said he was concerned about the “political influence” inside the agency and believes that a “firewall has been transgressed.”
“If we keep on just changing administrations with different goals and aspirations, and we’re going to change with another administration that comes in, I think we really have to take a look at the FDA in general,” Pazdur added. “Should it be a political body?”
Woodcock said she had been subject to political pressure during her tenure at the FDA, but the center directors and commissioners would protect staff from that.
“There has to be some interface between the political world,” she said. “Science doesn’t actually tell you the answers, it tells you the facts.”