June 29 (Reuters) – The U.S. Food and Drug Administration has selected Eli Lilly, Regeneron and five other companies for a pilot program to accelerate reviews of new domestic pharmaceutical manufacturing facilities, CNBC reported on Monday, citing an FDA spokesperson.
Lilly, Regeneron, Amneal, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics and Kyowa Kirin will participate in the FDA’s PreCheck pilot program, the report said, citing FDA’s Benjamin Nichols.
The program will allow regulators to start reviewing new manufacturing facilities while they are being built to catch and correct any issues, which the FDA estimates could save companies up to 14 months, the report said.
This comes as drugmakers, including Lilly and Regeneron, are pledging billions to shift further manufacturing to the U.S., following President Donald Trump’s push.
Drugmakers also agreed in April to slash prices of their medicines for the government’s Medicaid program for low-income people in exchange for three-year exemptions from tariffs on drug imports.
The FDA has selected Lilly’s Lebanon, Indiana, facility that will make the main ingredients of weight-loss pills and shots, and Regeneron’s Saratoga Springs, New York, site, said the report.
The PreCheck program has 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 U.S. Department of Health and Human Services, which oversees the FDA, did not immediately respond to a Reuters request for comment.
(Reporting by Puyaan Singh in Bengaluru; Editing by Sahal Muhammed)
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