Manufacturing and regulatory executives from companies such as AbbVie, Amgen, and Eli Lilly have raised concerns about the U.S. Food and Drug Administration’s (FDA) rules on post-approval changes to pharmaceutical manufacturing. They argue that current regulations hinder efforts to establish new drug production facilities in the United States.
During a recent meeting focused on the FDA’s PreCheck program, these companies called for two main changes. First, they asked the FDA to separate pre-approval inspections from applications for marketing authorization. Second, they urged revisions to the agency’s approach to post-approval changes—such as moving production from foreign sites to domestic ones—to reduce regulatory burdens and speed up reshoring of manufacturing.
Simon Hotchin, vice president of regulatory affairs at Amgen, told the FDA that outdated frameworks for managing post-approval changes in biologics present a significant barrier to domestic facility development. He said that although biologics are more complex than small molecules and face stricter requirements when making manufacturing changes, some technologies like monoclonal antibodies are now well understood and could be transferred between sites reliably.
“There are some common modalities, things like monoclonal antibodies, that are very well understood at this point. But the current framework for post-approval changes is somewhat one-size-fits-all, across biologics in particular,” Hotchin said.
Julia Edwards, senior vice president of global regulatory affairs at Eli Lilly, agreed with Hotchin’s assessment. She described existing submission categories for post-approval changes as “relatively inflexible” and said current requirements are “extremely restrictive.”
Amgen also provided written feedback stating that biologics-specific rules cause unnecessary delays in bringing supply and innovation into the U.S., advocating for a risk-based approach rather than treating all biologics equally.
Kevin Fitzpatrick, senior vice president for quality assurance at AbbVie, voiced support for modernizing the post-approval process. He cited the age of the FDA’s scale-up and post-approval change (SUPAC) guidance documents—published in the late 1990s—as evidence that updates are needed.
Christopher Shilling, chief regulatory officer at Forge Biologics, suggested after attending the meeting that some facility additions or modifications might not require inspections if there is enough historical evidence or prior inspection records. “Is there a scenario where the agency would be able to risk assess some of these facility additions, facility changes or copy-and-paste type of facility construction?” Shilling told BioSpace. “There may already be enough historical evidence, prior inspection records and experience with the facilities to say those sorts of changes may not warrant an inspection.” He added that this approach could help lower regulatory burdens on drugmakers while allowing regulators to focus resources elsewhere.
Off-patent drug manufacturers have also joined calls for reform. A spokesperson from the Association for Accessible Medicines (AAM), representing generics and biosimilars producers, expressed support for accelerating processes related to post-approval changes. The spokesperson noted that moving production between sites remains costly and time-consuming due partly to FDA requirements but sees potential improvements by speeding up transfers between compliant facilities.
AAM proposed extending principles from a 2025 guidance document—which allows remote assessments and use of recent inspection history—to cover post-approval site transfers as well. The group also recommended broadening SUPAC guidance beyond its current scope so more products could benefit from consistent standards when relocating production or making other modifications.
Currently, only certain dosage forms such as immediate-release formulations fall under SUPAC guidance; manufacturers can submit a CBE supplement detailing necessary documentation before distribution begins. For other products like sterile injectables not covered by SUPAC guidelines, companies must file prior approval supplements (PAS), which often take months for FDA review.
The FDA has yet to issue any public response beyond remarks made during its PreCheck meeting—which was designed primarily as an information-gathering session rather than an opportunity for feedback or policy announcements.
Efforts around reshoring pharmaceutical manufacturing remain active topics within both industry circles and government initiatives; recently announced deals include Johnson & Johnson’s plan to build new plants in North Carolina and Pennsylvania as part of a $55 billion investment package aimed at boosting U.S.-based drug production.
