WASHINGTON — The U.S. Food and Drug Administration has identified the first nine experimental drugs to undergo a drastically expedited review process, a new initiative by the Trump administration to prioritize medicines deemed critical to national interests.
The selected drugs include potential treatments for conditions such as pancreatic cancer, deafness, and vaping addiction. Several of the candidates are also intended to compete with higher-priced medications already on the U.S. market.
President Donald Trump highlighted one of the drugs, Pergoveris, an injectable infertility treatment used in Europe for IVF procedures. He noted that its U.S. approval would help lower IVF costs for American families, a key campaign pledge. Another selected drugmaker will receive an expedited review to expand domestic manufacturing of ketamine, a powerful anesthetic that is also increasingly used as a psychedelic-assisted therapy.
Under the new program, the FDA will seek to make an approval decision within one to two months, an unprecedented timeline for the agency’s comprehensive safety and effectiveness reviews. By comparison, the FDA’s standard drug reviews take about 10 months, while its accelerated approval program for life-threatening diseases generally takes six months.
FDA Commissioner Dr. Marty Makary has advocated for speeding up approvals for high-priority drugs, citing the truncated process used to authorize the first COVID-19 vaccines. The initiative, called the Commissioner’s National Priority Voucher program, grants Makary and other FDA officials significant discretion in determining which companies will benefit from the accelerated pathway.
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