The U.S. Food and Drug Administration (FDA) announced the opening of applications for its FDA PreCheck pilot program on Sunday, signaling a significant move toward revitalizing the nation’s pharmaceutical manufacturing landscape. This initiative focuses on enhancing the domestic pharmaceutical supply chain through increased regulatory predictability, facilitating the growth of U.S.-based manufacturing facilities, and refining the assessment process for facilities prior to drug application submissions.
FDA Commissioner Marty Makary emphasized that this pilot program constitutes a segment of broader governmental efforts designed to counteract long-standing trends favoring offshore drug production. The goal is to render the U.S. pharmaceutical sector more robust, self-reliant, and competitive on the global stage.
Program Structure and Facility Selection Criteria
The FDA intends to identify a preliminary cohort of new pharmaceutical manufacturing facilities to join the FDA PreCheck program, with official PreCheck activities set to begin in 2026. The selection process for these facilities is guided by their strategic alignment with national priorities. Key considerations include the types of pharmaceutical products produced, the developmental status of the facility, the anticipated timeframe to supply medicines to the U.S. market, and the adoption of innovative manufacturing methods.
Facilities that produce critical medicines specifically destined for the U.S. population will be given additional weighting during the selection process, reflecting their importance in meeting national drug supply needs.
The PreCheck program rollout is delineated into two distinct phases. The first, known as the Facility Readiness Phase, offers applicants early technical guidance through pre-operational evaluations and the creation of a facility-specific Drug Master File. This phase enables FDA inspectors to appraise manufacturing elements in advance of any formal drug application submissions, potentially expediting future reviews.
The second stage, the Application Submission Phase, involves structured pre-submission consultations and targeted inspections to identify and address manufacturing concerns proactively. This early engagement aims to reduce potential delays in regulatory approvals and accelerate the review process of manufacturing information linked to drug approvals.
Overall, the FDA’s PreCheck program is designed to streamline the approval process for domestic drug manufacturing plants while mitigating supply chain risks. The program intends to incentivize pharmaceutical companies to invest in U.S. manufacturing infrastructure, thereby strengthening overall supply security.
Eli Lilly’s Significant Expansion in U.S. Manufacturing
In a parallel development, pharmaceutical company Eli Lilly and Co. revealed plans on Friday to invest more than $3.5 billion in a new manufacturing facility located in the Lehigh Valley region of Pennsylvania. This facility will specialize in the production of injectable medicines and medical devices, focusing on next-generation therapies targeting weight management.
A central element of this new site will be manufacturing of retatrutide, an investigational triple hormone receptor agonist that modulates GIP, GLP-1, and glucagon receptors, representing a promising approach in weight-loss treatment. The investment is part of Lilly’s ongoing commitment to increase U.S.-based medicine production, marking the fourth new manufacturing location the company has announced since February 2025.
The Pennsylvania facility plans to create approximately 850 permanent jobs, with construction anticipated to begin in 2026. Construction activity itself is expected to generate around 2,000 jobs. The facility’s operations are projected to commence in 2031, indicating a long-term production commitment to the U.S. market.
Market Reaction and Industry Implications
Following the announcement, Eli Lilly’s shares rose 1.70%, trading at $1054.73 on Monday, reflecting investor optimism regarding the company’s expansion and the FDA’s regulatory support initiatives. This advancement underscores a broader trend toward reshoring pharmaceutical manufacturing in response to supply chain vulnerabilities and geopolitical considerations.
The FDA’s PreCheck program and Lilly’s investment collectively represent strategic advancements aimed at enhancing the domestic pharmaceutical infrastructure, with implications for regulatory processes, workforce development, and U.S. drug supply security.