Lilly, Regeneron selected for US program to review new manufacturing plants faster (updated)

Regeneron Pharmaceuticals

Mon 20:11

Updates to change sourcing

    June 29 (Reuters) - The U.S. Food and Drug Administration on Monday selected Eli Lilly LLY.N, Regeneron REGN.O and five other companies for a pilot program to accelerate reviews of new domestic pharmaceutical manufacturing facilities.
Drugmakers, including Lilly and Regeneron, are pledging billions to shift more manufacturing to the U.S. as President Donald Trump's administration pushes to strengthen the country's domestic drug supply chain.
Apart from the two companies, Amneal AMRX.O, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics and Kyowa Kirin 4151.T will also participate in the FDA's PreCheck pilot program, according to a release from the agency. 
The program will allow regulators to start reviewing new manufacturing facilities while they are being built to catch and correct any issues.
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 makes the main ingredients of weight-loss pills and shots, and Regeneron's Saratoga Springs, New York site.
CNBC first reported on the selections for the pilot program earlier on Monday.
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.

 (Reporting by Puyaan Singh and Juveria Tabassum in Bengaluru; Editing by Sahal Muhammed)
 ((Puyaan.Singh@thomsonreuters.com;))