WASHINGTON, Oct. 16 — The Food and Drug Administration (FDA) on Thursday announced nine experimental drugs that will receive expedited reviews as part of a new initiative to advance medicines deemed vital to U.S. national interests of fast-tracks nine drugs.

The agency said the selected fast-tracks nine drugs target a range of conditions, including vaping addiction, deafness, and pancreatic cancer. The program aims to shorten review timelines from the usual 10 months to as little as one to two months.

At a White House briefing, President Donald Trump highlighted Pergoveris, an injectable infertility drug currently sold in Europe for patients undergoing in vitro fertilization (IVF). He said its potential approval in the United States would help reduce IVF treatment costs, aligning with his campaign pledge to make family care more affordable.

“The FDA is focused on getting these medicines to Americans faster while maintaining safety standards,” Trump said.

Focus on U.S. health priorities

Several of the selected fast-tracks nine drugs could compete with higher-priced products already available in the U.S. market, potentially introducing lower-cost alternatives. Another drugmaker in the program received approval for expedited review to expand domestic production of ketamine, an anesthetic that has seen increasing use as a treatment for depression and other mental health conditions.

FDA Commissioner Dr. Marty Makary said the initiative reflects a shift in how the agency approaches urgent health and national security concerns. “We are rethinking the balance between speed and safety to address priority needs,” Makary said.

The new effort, called the Commissioner’s National Priority Voucher program, allows the FDA to designate certain medicines for accelerated evaluation based on their relevance to national interests.

Review timeline cut to two months

Traditionally, the FDA’s accelerated approval process takes about six months for drugs that target life-threatening diseases. Regular reviews can extend up to 10 months. Under the new system, the agency aims to make approval decisions in as little as 30 to 60 days—an unprecedented pace for detailed safety and efficacy assessments.

Makary has compared the new process to the expedited procedures used during Operation Warp Speed, which authorized COVID-19 vaccines in record time. The commissioner said the FDA would continue to apply rigorous scientific standards despite the shorter timelines.

Critics of past acceleration efforts have warned that faster reviews could increase the risk of safety issues surfacing after approval. However, Makary said additional post-market surveillance would help ensure ongoing monitoring of safety data.

Potential impact on drug prices

Industry analysts suggest that the inclusion of lower-cost alternatives in the program could drive down prices in markets dominated by expensive treatments. Expedited reviews may also encourage more companies to pursue FDA approval for drugs already available in other countries.

The FDA did not release full details on how the first nine drugs were selected but indicated that the list includes therapies addressing both public health and manufacturing priorities.

While the program shares features with earlier initiatives such as the Breakthrough Therapy and fast-tracks nine drugs designations, the broader eligibility criteria give the FDA greater discretion in determining which drugs qualify.

The agency said additional rounds of selections are expected later this year.

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