FDA to offer faster drug reviews to companies promoting ‘national priorities’
WASHINGTON (AP) — U.S. regulators will begin offering faster reviews to new medicines that administration officials deem as promoting “the health interests of Americans,” under a new initiative announced Tuesday.
Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months. FDA’s long-standing 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 FDA in April, Makary has repeatedly told FDA staff they need to “challenge assumptions” and rethink procedures. In a medical journal commentary published last week, Makary suggested the agency could conduct “rapid or instant reviews,” pointing to the truncated process used to authorize the first COVID-19 vaccines under Operation Warp Speed.
For the new program, the FDA will issue a limited number of “national priority vouchers” to companies “aligned with U.S. national priorities,” the agency said in a statement.