FDA opens up drugs to receive expedited review in support of ‘national priorities’
WASHINGTON (AP) – The Food and Drug Administration announced Thursday the first round of experimental drugs that will receive sharply accelerated review at the agency, part of an effort by the Trump administration to prioritize drugs it considers “supportive of U.S. national interests.”
The nine drugs announced by the FDA include potential treatments for vaping addiction, deafness, pancreatic cancer and other conditions.
Several drugs will compete with higher-priced drugs already in the US market.
At the White House, President Donald Trump highlighted the injectable infertility drug, Pergovaris, which is currently sold in Europe for patients undergoing IVF treatment. Trump said FDA approval of the drug in the US would help lower IVF costs for American families, one of his campaign pledges.
Another drugmaker has received special scrutiny in the United States for expanding its production of ketamine, the powerful anesthetic that has become a popular psychedelic treatment.
Under the program announced earlier this year, the FDA will aim to decide whether to approve drugs within one to two months, an unprecedented speed for in-depth safety and efficacy reviews performed by agency scientists.
The FDA’s accelerated approval program typically issues decisions for drugs that treat life-threatening diseases within six months. A regular drug review takes about 10 months.
Since coming to the agency, FDA Commissioner Dr. Marty Macari has suggested that the agency could dramatically speed up the approval of some high-priority drugs, pointing to the truncated process used to approve the first COVID-19 vaccine 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 vouchers gives Macari and other FDA officials unprecedented discretion in deciding which companies will benefit from expedited reviews.
___
The Associated Press receives support from the Department of Health and Science Howard Hughes Medical Institute’s Science and Educational Media Group and the Robert Wood Johnson Foundation. AP is solely responsible for all content.
