FDA's latest onshoring move homes in on streamlined facility registration, foreign plant scrutiny

 In an initiative to increase the efficiency of drug manufacturing in the United States, the FDA has proposed a streamlined pathway for registering production facilities that operate under a “hub-and-spoke” model.

The new rule would cut red tape, allowing manufacturing entities that have equivalent production units at different locations to register as a single establishment instead of having each unit register and gain clearance separately.

“The FDA is proposing changes to our establishment registration regulations that would reflect how distributed manufacturing actually works—as one single establishment,” Michael Davis, M.D., Ph.D., the acting director of FDA’s Center for Drug Evaluation and Research, said in a release. “The proposed changes would make it easier for innovative manufacturers to operate efficiently, and give the FDA a clearer, more accurate picture of how and where drugs are being made.”

The proposal would reduce registration costs for manufacturers and generate “long-term efficiencies for both industry and the agency,” the FDA said.

The U.S. regulator also proposes to clarify the registration requirements for foreign manufacturers, especially those who make active pharmaceutical ingredients (API). The FDA noted that, as things stand, some foreign manufacturing facilities that only distribute to other foreign establishments currently may not be registered with the regulator, limiting its visibility toward "upstream supply chains."

The proposal would force such establishments to register with the FDA and report what they produce. The agency said that the documentation of these manufacturers would allow it to detect and respond to safety issues.

The agency estimates (PDF) that there are 25 unregistered foreign manufacturers that produce ingredients for branded drugs that are sold in the U.S. and 1,600 unregistered manufacturers who make components for over-the-counter treatments. 

The FDA “should be able to trace exactly” where ingredients in medicines come from, Davis added. “Closing this registration gap for foreign establishments is a concrete step toward increasing the supply chain transparency that patients deserve.”

Since taking office in his second term, President Donald Trump has pushed to reduce the reliance of the U.S. on foreign imports, including drugs. The administration has made deals with many of the industry's biggest drug manufacturers, reducing their exposure to tariffs in exchange for commitments to build manufacturing facilities in the U.S.

Last month, biopharma giants Eli Lilly and Regeneron, as well as rapidly growing contract manufacturers Fujifilm Biotechnologies and Cellares, were among seven companies selected by the FDA for its PreCheck Pilot Program, another initiative designed to strengthen drug manufacturing and bolster supply chain resilience in the United States.

https://www.fiercepharma.com/manufacturing/fda-moves-streamline-registration-drug-manufacturing-facilities-us