The FDA’s Commissioner’s National Priority Review Voucher (CNPV) pilot is coming under fresh pressure as stakeholders say key operational details are missing, including how candidate products are selected and the role of senior leadership in the process. Some experts are recommending a pause for reevaluation or even cancellation. Michael Abrams, managing partner at Numerof & Associates, told BioSpace that the program lacks clarity and said a pause would force designers to be more explicit. Peter Pitts, a former FDA associate commissioner and president of the Center for Medicine in the Public Interest, argued the approach is redundant with existing expedited pathways and should not override established center-level review processes. CNPV was introduced last year to explore streamlining for a subset of products tied to national priorities, including unmet medical needs and public health considerations. The FDA has distributed 22 vouchers so far and approvals via expedited pathways include Eli Lilly’s GLP-1 pill Foundayo and a hearing loss gene therapy from Regeneron, according to the article.