FDA Launches PreCheck Pilot Program, Aimed at Strengthening U.S. Drug Manufacturing

The U.S. Food and Drug Administration has officially launched a major initiative to reshape domestic pharmaceutical production. On February 1, 2026, the FDA began accepting requests to participate in the FDA PreCheck pilot program, designed to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability, facilitating the construction of manufacturing sites in the U.S., and streamlining aspects of pharmaceutical manufacturing facility assessments in advance of a specific product application.

Launch and Purpose of PreCheck Pilot

The FDA PreCheck program aims to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of manufacturing sites in the United States. Currently, more than half of pharmaceuticals distributed in the U.S. are manufactured overseas. Further, the U.S. is reliant on overseas sources for active pharmaceutical ingredients (APIs). Of the manufacturers that produce APIs used in FDA-approved products, only 11% are U.S. manufacturers.

To help bolster pharmaceutical supply chain resiliency in the U.S., on May 5, 2025, the President issued Executive Order 14293, "Regulatory Relief to Promote Domestic Production of Critical Medicines." EO 14293 directs FDA to review existing regulations and guidance that pertain to the development of domestic pharmaceutical manufacturing and take steps to "eliminate any duplicative or unnecessary requirements…; maximize the timeliness and predictability of agency review; and streamline and accelerate the development of domestic pharmaceutical manufacturing."

FDA Commissioner Marty Makary emphasized the program's strategic importance, stating that "After 35 years of globalists taking pharmaceutical manufacturing overseas, the FDA is taking bold steps to bring it back. The PreCheck program is one of several powerful incentives we are providing to make the U.S. pharmaceutical manufacturing sector more resilient and competitive."

Selection Criteria and Priorities

The agency will select an initial cohort of new pharmaceutical manufacturing facilities and begin conducting PreCheck activities in 2026. Facilities will be selected based on overall alignment with national priorities across multiple selection criteria, such as products to be manufactured, phase of facility development, timeline to producing pharmaceutical products for the U.S. market, and innovation in facility development. Additional priority consideration will be given to facilities producing critical medications for the U.S. market.

PreCheck finalists will be notified by April 1, 2026, and final selections will be made by June 30, 2026. The PreCheck Pilot Program serves as a test model to help identify implementation challenges, establish best practices, and inform critical parameters and potential future scalability. Performance metrics and stakeholder feedback will be systematically evaluated to optimize the PreCheck Pilot Program effectiveness.

Although industry comments and feedback urged the FDA to use the PreCheck Pilot to support expansion of manufacturing in both new and existing facilities, it appears the pilot will focus primarily on new facilities. The agency may consider factors such as alignment with national priorities, the stage of facility development, and the degree of technological innovation.

Two-Phase Structure of PreCheck

FDA PreCheck consists of two phases. In Phase 1, the Facility Readiness Phase, selected manufacturers will engage with FDA for early technical advice before a facility is operational through pre-operational reviews and utilization of a facility-specific Drug Master File to facilitate efficient evaluation of facility-specific elements prior to, and in support of, the submission of a drug application. In Phase 2, the Application Submission Phase, FDA and applicants build upon Phase 1 and engage through pre-submission meetings and inspections to resolve issues and expedite assessments of manufacturing information in a drug application.

The Facility Readiness Phase provides manufacturers with more frequent FDA communication at critical development stages, including facility design, construction, and pre-production. This phase also encourages companies to provide comprehensive facility-specific information through a Type V Drug Master File (DMF), such as site operations layout and description, Pharmaceutical Quality System elements, and Quality Management Maturity practices.

The second phase, referred to as the "Application Submission Phase," focuses on streamlining the development of the Chemistry, Manufacturing, and Controls (CMC) section of a new drug application or BLA. In this phase, FDA will provide applicants and their manufacturers an opportunity to provide FDA with advanced awareness of facility and manufacturing strategies for specific drugs, while enabling earlier assessment and inspection activities within the review cycle. The Agency will also provide CMC feedback on anticipated data or logistical needs to support review and inspection processes in a timely manner.

Industry Feedback in Program Design

The FDA incorporated extensive industry feedback into the program design based on comments made during the "Onshoring Manufacturing of Drugs and Biological Products" public meeting held on Sept. 30, 2025, and public comments received through Federal Register publication. Industry strongly supported early engagement during facility development and streamlined documentation processes.

Hogan Lovells described how the administration is using "both carrot and stick" to encourage onshoring manufacturing in the U.S., citing the potential benefits of FDA's newly launched PreCheck program, which is a voluntary initiative designed to promote onshoring by streamlining regulatory oversight and fostering early engagement in manufacturing facility development.

While a new facility setup program aimed at encouraging onshoring received a positive reception at a recent meeting, industry representatives said the current rules on existing production plants are the main regulatory issues facing manufacturing teams. During last year's consultations, manufacturers, service providers and trade groups welcomed PreCheck as a program that could reduce the risk of facility-related drug rejections. Yet respondents also called for clarity on specifics that they said would shape the program's impact.

Potential Drawbacks and Criticisms

Despite the broadly positive industry reception, industry stakeholders and regulatory experts have identified several limitations and concerns with the PreCheck program. While PreCheck may help selected newly built facilities prepare for pre-approval inspections, the current proposals offer no relief for the problems faced by existing production plants. Shilling said chemistry, manufacturing and controls (CMC) inspection issues "continue to plague" some biologic approval applications.

Greater agency interaction during the facility design and construction phase could mitigate certain regulatory compliance issues, but the program may stretch the boundaries of FDA's human resources. As announced, the PreCheck program seems of limited value to manufacturers as the agency does not employ engineering or construction experts, so any FDA investigator feedback on facility-based cGMP matters may not reflect other important considerations.

For example, cGMP compliance is highly dependent on actual practices within an operational facility as well as the relevant written policies and procedures, which would not be addressed in PreCheck-related feedback. With respect to the program's Application Submission Phase, moreover, additional CMC meetings appear to have little value as drug sponsors currently have multiple opportunities to request CMC meetings with FDA throughout the clinical development process.

Additionally, biopharma companies and CDMOs have yet to receive a public response to their feedback from the FDA. As it stands, questions as fundamental as whether CDMO-run facilities can participate in PreCheck are unanswered. Responding to the calls for the agency to rethink tasks such as pre-approval inspections, Ramanadham said, "PreCheck may not be built to handle everything."

The FDA's significant staffing reductions may also impact the program's implementation. ProPublica released a report detailing the significant workforce reductions at the Department of Health and Human Services (HHS), with more than 20,000 positions eliminated or vacated since the Trump administration began. According to ProPublica's analysis of the HHS employee directory, FDA has lost 21% of its overall staff. These reductions have affected scientists, investigators, and regulatory professionals, and could potentially impact the FDA's ability to perform its essential public health and regulatory functions.

Looking Ahead

FDA will create a more predictable regulatory pathway, accelerate domestic pharmaceutical manufacturing, and protect patient safety through the implementation of the PreCheck Program. Analysts have suggested that PreCheck could be a major boost to smaller pharma companies, which have a high exposure to risk when embarking on expensive facility investments, by reducing regulatory uncertainty and helping to offset their lower regulatory affairs capacity when dealing with the FDA compared to larger groups.

As pharmaceutical companies evaluate their manufacturing strategies, the PreCheck program represents a significant policy shift aimed at reversing decades of offshoring. However, its ultimate success will depend on the FDA's ability to provide clear guidance, manage resource constraints, and address the broader regulatory challenges that industry stakeholders have identified.

Source: https://www.fda.gov/news-events/fda-newsroom/press-announcements