FDA picks Lilly, Regeneron for fast-track manufacturing review program

The US Food and Drug Administration selected Eli Lilly (LLY), Regeneron (REGN) and five other companies to take part in a pilot program aimed at accelerating reviews of new domestic pharmaceutical manufacturing facilities.

Lilly and Regeneron are among a group of drugmakers pledging billions of dollars to shift more manufacturing to the US, as the Trump administration pushes to strengthen the country's domestic drug supply chain.

Amneal Pharmaceuticals (AMRX), 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 allows regulators to begin reviewing new manufacturing facilities while they are still under construction, in order to catch and correct issues earlier.

The FDA selected Lilly's Lebanon, Indiana facility, which produces the main ingredients for its weight-loss pills and injections, along with Regeneron's Saratoga Springs, New York site.

Drugmakers separately agreed in April to cut the prices of their medicines for Medicaid, the government health insurance program for low-income Americans, in exchange for three-year exemptions from tariffs on imported drugs.

The PreCheck program follows a two-phase approach to facilitating new US drug manufacturing facilities. The first phase provides for more frequent communication with the FDA on facility design, construction and pre-production. The second phase facilitates pre-application meetings and early feedback intended to streamline the development of manufacturing and quality-control processes.