Nikhil Prasad Fact checked by:Thailand Medical News Team Oct 22, 2025 4 months, 3 days, 1 hour, 45 minutes ago
U.S. Medical News: FDA Fast Tracks Life Saving Medicines Under National Priority Program
The U.S. Food and Drug Administration (FDA) has announced a bold new plan to fast-track nine experimental drugs under a newly established Trump administration initiative. This program, known as the Commissioner’s National Priority Voucher (CNPV) pilot, is designed to prioritize medicines deemed essential to “U.S. national interests,” focusing on urgent health needs and domestic drug manufacturing. Among the selected treatments are potential new therapies for vaping addiction, deafness, pancreatic cancer, and infertility. This
U.S. Medical News report highlights that under this new plan, the FDA aims to reduce its standard review time from ten months to an unprecedented one or two months—a transformation that could reshape the speed of medical innovation in the United States.
Trump Administration Accelerates FDA Approval for Nine Key Drugs
Fertility and Mental Health Drugs Among Top Priorities
One of the most talked-about inclusions is Pergoveris, an injectable fertility drug already available in Europe, which will now be reviewed for U.S. approval. President Donald Trump emphasized that the approval of Pergoveris could significantly lower the cost of in vitro fertilization (IVF) treatments, which are currently priced out of reach for many families. Another priority under this program is domestic ketamine production. Ketamine, initially developed as an anesthetic, has gained new relevance as an emerging therapy for treatment-resistant depression and other mental health conditions. Increasing its U.S. supply chain capacity aims to prevent shortages and reduce dependency on foreign imports.
Revolutionizing the Drug Review Process
FDA Commissioner Dr. Marty Makary, who introduced the program earlier this year, stated that the initiative builds upon lessons learned from Operation Warp Speed—the rapid vaccine approval program during the COVID-19 pandemic. The CNPV system streamlines reviews by creating multidisciplinary FDA teams that assess applications concurrently rather than sequentially, shortening decision-making timeframes to 30–60 days. Each sponsor will also benefit from enhanced communication with review staff throughout development.
List of Drugs Chosen for National Priority Review
The nine selected drugs and biologics are:
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Pergoveris – Infertility treatment
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Teplizumab – Type 1 diabetes therapy
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Cytisinicline – Anti-vaping and nicotine addiction treatment
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DB-OTO – Gene therapy for deafness
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Cenegermin-bkbj – Restores corneal function and vision
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RMC-6236 – Investigational drug for pancreatic cancer
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Bitopertin – Treatment for porphyria<
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Ketamine – Domestic anesthetic production
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Augmentin XR – U.S.-based antibiotic manufacturing
Each of these drugs meets one or more of the national priority goals: addressing major unmet medical needs, improving affordability, reducing healthcare burdens, or supporting domestic pharmaceutical production.
Balancing Speed with Safety
Although the program has been widely praised for its efficiency, some experts have raised concerns about the broad criteria for eligibility and the potential risk of reduced scrutiny in the approval process. The FDA has assured that the agency retains authority to extend review times if applications are incomplete or safety data are insufficient. The program’s long-term success will depend on balancing accelerated access with uncompromising safety standards.
Conclusion
The Trump administration’s fast-tracking initiative could mark a defining moment in U.S. healthcare policy by aligning national priorities with medical innovation. If successful, it will not only make lifesaving therapies available faster but also strengthen America’s pharmaceutical independence, lower treatment costs, and improve access for millions of patients.
Reference:
https://www.fda.gov/news-events/press-announcements/fda-awards-first-ever-national-priority-vouchers-nine-sponsors
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