The Food and Drug Administration announced the launch of a new program to fast-track agency approvals for drug manufacturers working on products that could cure chronic disease, prepare for a pandemic, or address other national public health priorities.

FDA Commissioner Dr. Marty Makary announced on Tuesday that, beginning this year, the Commissioner’s National Priority Voucher, or CNPV, program would reduce approval times from the current 10 to 12-month wait to only one or two months following a final drug application submission. 

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“In order to modernize the FDA, we have to keep innovating our regulatory processes. This new program is one step closer to doing that,” said Makary in a video address on X Tuesday morning. 

The defining criteria of what constitutes a “national priority” is broad, according to the agency’s FAQ page for the new program. But Makary said in his video address that bolstering domestic manufacturing of pharmaceuticals is a national security priority that would fit under the umbrella of the program. He also said that any application to tackle an “unmet public health need” or improve pandemic preparedness would qualify.

Reducing the regulatory hoops for developers of treatments for chronic conditions and rare diseases has been a long-term priority for some of the key players in the FDA and Health and Human Services more broadly.

Dr. Vinay Prasad, the new director of the Center for Biologics Evaluation and Research at FDA, and HHS Deputy Secretary Jim O’Neill, a prominent biotech investor, have both expressed the need to dramatically reduce the time it takes for new drugs to come to market, especially for rare diseases.  

Earlier this month, Makary and Prasad held a roundtable listening session with industry leaders and researchers in gene therapy. The meeting’s theme was decreasing regulatory barriers to entry, particularly for rare disease treatments.

Although HHS Secretary Robert F. Kennedy Jr. and his “Make America Healthy Again” movement have been highly critical of regulatory agencies as captured by pharmaceutical companies, the new voucher program would put drugmakers in a closer working relationship with the agency for high-priority projects.

Drug manufacturer applicants to the program are required to submit their preliminary biochemical safety information and draft labeling of the product 60 days prior to submitting the final application.

“At the core of this program is the ability of companies to pre-submit their application packet with essentially everything except the final clinical trial results,” Makary said in his video address. 

During the first year of the program, the FDA plans to limit the number of vouchers “to companies aligned with US national priorities,” according to the agency’s press release. 

“I’m committed to fostering innovation that saves lives,” Makary said on X. “The National Priority Voucher Program brings the agility of frontline medical decision-making to our regulatory processes.”