Dan Kracov and Eva Temkin Talk With Law360, STAT, and Regulatory Focus on FDA’s New Fast-Track Voucher Program

Life Sciences & Healthcare Regulatory partners Dan Kracov and Eva Temkin were recently featured in Law360, STAT, and Regulatory Focus, commenting on the U.S. Food and Drug Administration’s (FDA) newly announced Commissioner’s National Priority Voucher program — a pilot initiative aimed at accelerating drug reviews for companies advancing national public health priorities.

Kracov, who chairs the firm’s global life sciences industry group, told Law360 that the proposed expedited review offers an attractive incentive for drug developers. “It’s a fascinating proposal,” he said, noting that the lack of clarity on eligibility and selection criteria leaves “a lot of pieces” missing. He added that any company with a shot at a voucher will want to make the case, and those that lose out to a competitor may challenge the decision. Ultimately, he emphasized that the FDA’s decision-making should be “science- and public health-based.”

Temkin, a former FDA official, shared her perspective in STAT and Regulatory Focus, expressing skepticism about the feasibility of the program’s promised one- to two-month review timeline. “It’s very hard to imagine how a one- to two-month review timeline can be practicable,” she told STAT, pointing to the complex and often evolving nature of proposed labeling and review standards. She also raised concerns about the agency’s current resource constraints, stating, “The optimist in me would like to think that this means that people will be brought back and that the agency will be brought back to full strength in order to accomplish these kinds of goals. The pessimist in me is nervous about what it looks like when additional labor-intensive, resource-intensive review processes and decision-making is layered on top of an already strapped FDA.”

Read the Law360 article, FDA Unveils Voucher Program For Fast-Paced Drug Reviews (subscription required).

Read the STAT article, FDA announces a new priority review program in bid to further administration goals (subscription required).

Read the Regulatory Focus article, FDA announces new voucher program for drugs tied to national priorities.