FDA Unveils Drugs That Will Undergo Expedited Review

WASHINGTON (AP) – The Food and Drug Administration announced on Thursday the first round of experimental drugs that will receive significantly accelerated exams to 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 addictiondeafness, 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 in IVF treatments. Trump said FDA approval of the drug in the United States would help lower IVF costs for American families, one of his campaign promises.

Another drugmaker received specialist review to expand U.S. manufacturing of ketaminethe powerful anesthetic that has become a trendy product 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 extensive safety and effectiveness reviews conducted by the agency’s scientists.

The FDA’s accelerated approval program generally makes decisions within six months for drugs that treat life-threatening illnesses. Regular medication reviews take about 10 months.

Since my arrival at the agency, FDA Commissioner Dr. Marty Makary suggested 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 so-called Commissioner’s National Priority Voucher the program overlaps 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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