Eva Temkin Discusses “Commissioner’s National Priority Vouchers” in BioSpace
Eva Temkin, Arnold & Porter Life Sciences & Healthcare Regulatory partner and former Acting Policy Staff Director at the U.S. Food and Drug Administration (FDA)’s Office of Therapeutic Biologics and Biosimilars, was quoted in the BioSpace article, “Pressure On, Purpose Questioned as Second Round of FDA Priority Review Vouchers Revealed,” offering insight into how the accelerated-review initiative is influencing review dynamics and agency workloads.
Eva Temkin, Arnold & Porter Life Sciences & Healthcare Regulatory partner and former Acting Policy Staff Director at the U.S. Food and Drug Administration (FDA)’s Office of Therapeutic Biologics and Biosimilars, was quoted in the BioSpace article, “Pressure On, Purpose Questioned as Second Round of FDA Priority Review Vouchers Revealed,” offering insight into how the accelerated-review initiative is influencing review dynamics and agency workloads.
Eva noted that the first nine awardees of the FDA’s new Commissioner’s National Priority Voucher (CNPV) program varied widely in their stages of development, highlighting the unusual breadth of the program’s early selections.
“One thing that struck me is how disparate they are, particularly across stages of development,” she said. “You have some that are very close to the end, and you have some that are still in Phase III.”
Eva also cautioned that the rapid review timelines could create significant resource pressures for FDA staff and slow the review of other applications. “It is extremely resource intensive to do the kind of expedited review that is being imagined here,” she said, noting that attention directed toward CNPV-backed reviews inevitably comes at the expense of other products. “The pie doesn’t just get bigger.”
