The US Food and Drug Administration (FDA) has revealed plans to issue new Commissioner’s National Priority Vouchers (CNPVs) to companies “supporting US national interests”. 

The new voucher may be redeemed by drug developers to participate in a novel priority programme that shortens drug review time from approximately 10-12 months to one to two months following a sponsor’s final drug application submission. 

The new CNPV process will convene experts from FDA offices for a team-based review rather than using the standard review system. 

The clinical information will be reviewed by a multidisciplinary team of physicians and scientists who will pre-review the submitted information and convene for a one-day meeting. 

“Using a common-sense approach, the national priority review programme will allow companies to submit the lion’s share of the drug application before a clinical trial is complete so that we can reduce inefficiencies. The ultimate goal is to bring more cures and meaningful treatments to the American public,” said FDA Commissioner Marty Makary.  

“As a surgical oncologist, we often made multidisciplinary decisions with a team of doctors on major life-and-death questions for patients, incorporating the latest medical studies in a one-day tumour board-style discussion. This voucher harnesses that model to deliver timely decisions for drug developers.”   

In addition to receiving the benefits of this programme, the agency says it may also grant an accelerated approval, if the product for which the voucher is used meets the applicable legal requirements for accelerated approval. 

US national health priorities

To qualify, sponsors must submit the chemistry, manufacturing, and controls (CMC) portion of the application and the draft labelling at least 60 days before submitting the final application.  

The vouchers will be available to companies that are aligned with the national health priorities of: 

  • Addressing a health crisis in the US 
  • Delivering more innovative cures for the American people 
  • Addressing unmet public health needs 
  • Increasing domestic drug manufacturing as a national security issue 

The new vouchers can be directed towards a specific investigational new drug of a company or be granted to a company as an undesignated voucher.

Diana Spencer, Senior Digital Content Editor, DDW