Brett P. Giroir M.D., Former Acting FDA Commissioner and Assistant Secretary for Health, Says New Commissioner's National Priority Voucher Program (CNPV) Can Help Speed Innovative "Upstream" Therapies to Patients 

ATLANTA, June 23, 2025 /PRNewswire/ -- The former Acting Commissioner of the Food and Drug Administration (FDA) and Assistant Secretary for Health in the first Trump Administration, Brett P. Giroir M.D., today said the new expedited drug review proposal announced by FDA last week could help speed new, innovative therapies to patients and boost smaller drug innovators' ability to better address unmet public health needs. 

Giroir, CEO of Altesa BioSciences, said: "FDA Commissioner Makary's timely initiative can better enable smaller biotech innovators with breakthrough 'upstream' therapies to compete with Big Pharma's fixation on costly 'downstream' chronic care," said Giroir. "I plan to discuss this 'upstream' versus 'downstream' dynamic frequently moving forward." 

The Commissioner's National Priority Voucher (CNPV) program provides drug developers the opportunity to redeem a voucher to participate in a novel priority FDA program. This would shorten its review time from approximately 10-12 months to 1-2 months, following a sponsor's final drug application submission. 

Giroir, who also served as Admiral in the US Public Health Service Commissioned Corps and the national Covid "testing czar" during the 2020 pandemic, noted that by building on the investments made by the federal government during COVID, home tests for the majority of viruses that can be debilitating to vulnerable populations will soon be available -- including people living with chronic lung diseases like COPD or asthma. 

"We seek to lay the foundation for a new paradigm of prevention and treatment that moves us 'upstream' to intervene before health crises occur," continued Giroir. "The general thrust and intent of FDA's expedited drug review plan aligns perfectly with our mission to deliver transformative respiratory therapeutics at a time when they can be most effective." 

About Altesa BioSciences, Inc.
Altesa BioSciences is a clinical-stage pharmaceutical company dedicated to developing new treatments for age-old threats to human health: high-consequence viral infections. These infections are particularly severe in vulnerable people, including those with chronic health conditions, like lung diseases, as well as the elderly and many people in underserved communities.

Media Inquiries: Mia Heck
Cellular (210) 284-0388
MHeck@Altesa.com

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SOURCE Altesa Biosciences Inc.