Do You Think the CNPV Program has Delivered on It's Promises?

Harpreet Singh, MD, chief medical officer at Precision for Medicine and former FDA Oncology Division Director, assesses how the Commissioner’s National Priority Voucher (CNPV) program is influencing drug development and regulatory timelines.

Singh credits the program with successfully highlighting promising therapies across multiple public health domains. She notes that CNPV vouchers have been seen in oncology, antibiotics, pain management, and now in the psychedelics space. She views these mechanisms as tools to accelerate “the back end of drug development,” emphasizing that they are applied after trials have already been designed, executed, and yielded results. Because of this sequencing, she argues that the vouchers are not “fundamentally or dramatically altering the landscape” of how pivotal studies are initially conceived or conducted; rather, they represent an “evolution and not a revolution.”

She contextualizes the program by referencing prior FDA oncology initiatives, such as the Real-Time Oncology Review and the Assessment Aid. Singh recalls several precedents where supplemental oncology applications were approved within 6 to 8 weeks, underscoring that very rapid review and approval are not new concepts within the agency. Singh mentions how she also wants the agency to add more transparency for how drug developers receive the vouchers, along with asking for FDA to better explain the process behind selecting which companies and drugs are awarded.