FDA unveils drugs to receive expedited review in support of ‘national priorities’

WASHINGTON (AP) — The Food and Drug Administration on Thursday announced the first round of experimental drugs that will receive drastically expedited reviews at the agency, part of an effort to prioritize medicines the Trump administration deems as “supporting U.S. national interests.”

The nine medicines announced by the FDA include potential treatments for vaping addiction, deafness, pancreatic cancer and other conditions.

Several of the drugs would compete with higher-priced drugs already on the U.S. market.

At the White House, President Donald Trump highlighted the injectable infertility drug, Pergoveris, which is currently sold in Europe for patients going through IVF treatments. Trump said FDA approval of the drug in the U.S. would help lower IVF costs for American families, one of his campaign pledges.

Another drugmaker received the specialty review to expand U.S. manufacturing of ketamine, the powerful anesthetic that has grown into a trendy psychedelic treatment.

Under the program announced earlier this year, the FDA will aim to decide whether to approve the drugs in one to two months, an unprecedented pace for the in-depth safety and effectiveness reviews performed by agency scientists.

FDA’s accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.

Since arriving at the agency, FDA Commissioner Dr. Marty Makary has suggested the agency could dramatically speed up approvals for certain high-priority drugs, pointing to the truncated process used to authorize the first COVID-19 vaccines under Operation Warp Speed.

Many aspects of the so-called Commissioner’s National Priority Voucher program overlap with older FDA programs. But the broad criteria for awarding the vouchers gives Makary and other FDA officials unprecedented discretion in deciding which companies will benefit from the sped-up reviews.

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