Phlow Corporation

Rule Changes

Operating under a $354 million BARDA contract to build domestic API and drug production capacity

Only 9% of the factories making active pharmaceutical ingredients for American medicines are in the U.S.; China and India account for roughly two-thirds. For decades, this arrangement kept drug prices low and went largely unchallenged, until the COVID-19 pandemic exposed how quickly a foreign export ban could empty American pharmacy shelves. The FDA is assembling three programs to reverse this dependency: PreCheck to accelerate new factory buildouts, priority reviews for domestically made generics, and a proposed three-year fee waiver for new domestic plants under the next Generic Drug User Fee Amendments (GDUFA) reauthorization.

Updated May 29