The U.S. Food and Drug Administration on Thursday announced a new program to speed up construction and review of drug manufacturing plants in the country to boost domestic drug supply.
The program, called FDA PreCheck, aims to streamline review of domestic pharmaceutical plants and eliminate unnecessary regulatory requirements, in line with President Donald Trump’s executive order in May to shift manufacturing of drugs to the United States.
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“The FDA PreCheck initiative is one of many steps FDA is taking that can help reverse America’s reliance on foreign drug manufacturing and ensure that Americans have a resilient, strong, and domestic drug supply,” FDA Commissioner Marty Makary said in a statement.
The regulator in June launched a program to incentivize drug developers that align with national priorities, including increased domestic manufacturing, with considerably shorter review times for their marketing applications.
Several major drugmakers, including AstraZeneca (AZN.L), opens new tab, Eli Lilly (LLY.N), opens new tab and Johnson & Johnson (JNJ.N), opens new tab, have pledged billions of dollars to scale up their U.S. footprint.
The Trump administration has threatened to impose tariffs on pharmaceutical imports, starting “small” and eventually hiking it as much as 250% in an effort to boost domestic production.
The FDA PreCheck program introduces a two-phase approach to facilitate new U.S. drug manufacturing facilities.
The initial phase would provide for more frequent communication with the FDA, including for facility design, construction and pre-production.
The second phase would facilitate pre-application meetings and early feedback to help streamline the development of manufacturing and quality control processes, the agency said.
The FDA plans to hold a public meeting on September 30 to discuss the new program.
