The Food and Drug Administration (FDA) is launching a new program to ramp up the United States’s domestic pharmaceutical supply chain, the agency announced Thursday.
The program, called FDA PreCheck, is aimed at streamlining the pharmaceutical plant regulatory process. The FDA says this will in turn make it easier to build drug manufacturing sites within the U.S.
FDA PreCheck would speed up the process in two phases. The first phase would provide more frequent communication between the FDA and manufacturers on developmental stages including facility design, construction and preproduction.
The second phase would allow for preapplication meetings and early feedback on how a drug product will be manufactured and controlled.
“Our gradual overreliance on foreign drug manufacturing has created national security risks,” said FDA Commissioner Marty Makary.
“The FDA PreCheck initiative is one of the 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.”
President Trump has said he wants drug companies to increase their domestic production to strengthen national security, among other reasons.
He has pledged to impose tariffs on drug companies to get them to comply and threatened early this week to impose tariffs of up to 250 percent on pharmaceutical imports.
Some drug companies are pouring billions of dollars into creating new domestic manufacturing plants.
The drug company Eli Lilly said in February it plans to spend about $27 billion to build four new manufacturing plants.
AstraZeneca is investing $50 billion over the next five years to expand its U.S. manufacturing. Johnson & Johnson announced in March it will spend more than $55 billion on research and to build three new manufacturing plants and expand several existing ones.
The FDA is hosting a public meeting about the new program on Sept. 30 where the agency will present a draft framework.
Participants will discuss the strengths and weaknesses of the proposed framework and “additional considerations” that could help the pharmaceutical industry overcome challenges with onshoring, according to an unpublished notice on the meeting.
These challenges may involve “pharmaceutical ingredients (APIs) and finished drug and biological products” as well as options the FDA has to further facilitate domestic production.
