Aug 7 (Reuters) - 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.
"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 ),
Eli Lilly ( LLY ) and Johnson & Johnson ( JNJ ), 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.
(Reporting by Mariam Sunny in Bengaluru; Editing by Shinjini
Ganguli, Maju Samuel and Devika Syamnath)