WASHINGTON (AP) — The Food and Drug Administration on Thursday announced the first wave of experimental drugs that will undergo a much faster review at the agency as part of an effort by the Trump administration to prioritize drugs it deems “supporting U.S. national interests.”
The nine drugs announced by the FDA include potential treatments for vaping addiction, hearing loss, pancreatic cancer and other diseases.
Some drugs will compete with more expensive drugs already on the U.S. market.
At the White House, President Donald Trump highlighted Pergoberis, an injectable fertility drug currently being sold in Europe to patients undergoing IVF treatment. President Trump said that if the FDA approves the drug in the United States, it will help reduce IVF costs for American families, one of his campaign promises.
Another drug company received a professional review to expand U.S. manufacturing of ketamine, a powerful anesthetic that has become a trendy psychedelic treatment.
Under the program announced earlier this year, the FDA aims to decide whether to approve drugs within one to two months, an unprecedented pace for thorough safety and efficacy reviews by the agency’s scientists.
The FDA’s expedited approval program typically makes decisions within six months for drugs that treat life-threatening illnesses. A routine drug review takes approximately 10 months.
Since taking office, FDA Commissioner Dr. Marty McCulley has suggested that the agency could dramatically speed up approval of certain high-priority drugs, noting that the process used to authorize the first COVID-19 vaccines under Operation Warp Speed has been shortened.
Many aspects of the so-called Commissioner’s National Priority Voucher Program overlap with the old FDA program. But the broad criteria for awarding vouchers gives McCurry and other FDA officials unprecedented discretion in deciding which companies will benefit from expedited reviews.
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