FDA unveils drugs to receive expedited review in support of ‘national priorities’
WASHINGTON– WASHINGTON — The Food and Drug Administration on Thursday announced the first round of experimental drugs that will receive significantly accelerated reviews by the agency, part of an effort to prioritize drugs that the Trump administration considers to “support the national interests of the United States.”
The nine drugs announced by the FDA include potential treatments for vaping addiction, deafness, pancreatic cancer and other conditions.
Several drugs would compete with more expensive drugs already on the American market.
At the White House, President Donald Trump highlighted the injectable infertility drug Pergoveris, which is currently sold in Europe for patients undergoing IVF treatments. Trump said the FDA’s approval of the drug in the United States would help lower the costs of IVF for American families, one of his campaign promises.
Another drugmaker has received specialized review to expand U.S. production of ketamine, the powerful anesthetic that has become a trendy psychedelic treatment.
Under the program announced earlier this year, the FDA will work to decide whether to approve drugs within one to two months, an unprecedented pace for the in-depth safety and effectiveness reviews conducted by the agency’s scientists.
The FDA’s accelerated approval program typically issues decisions within six months for drugs intended to treat life-threatening illnesses. Regular medication reviews take about 10 months.
Since joining the agency, FDA Commissioner Dr. Marty Makary has suggested that the agency could significantly speed up approvals of some high-priority drugs, pointing to the truncated process used to authorize the first COVID-19 vaccines under Operation Warp Speed.
Many aspects of the commissioner’s so-called National Priority Voucher program overlap with previous FDA programs. But the broad criteria for awarding vouchers gives Makary and other FDA officials unprecedented latitude in deciding which companies will benefit from expedited reviews.
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