The U.S. Food and Drug Administration began accepting applications on Saturday for its groundbreaking PreCheck pilot program, an initiative designed to strengthen the domestic pharmaceutical supply chain and reduce American dependence on overseas drug manufacturing. The program launch comes as part of a broader federal effort to bring critical medicine production back to the United States after decades of offshoring.
FDA Commissioner Marty Makary announced the program with pointed criticism of past policies. He stated that after 35 years of globalists taking pharmaceutical manufacturing overseas, the FDA is taking bold steps to bring it back. The commissioner emphasized that PreCheck represents a fundamental shift in how the agency approaches domestic manufacturing support.
The pilot program operates through two distinct phases designed to streamline the regulatory pathway for new pharmaceutical facilities. During the Facility Readiness Phase, drug manufacturers receive frequent communication with the FDA during key development stages of a new manufacturing plant, including facility design, construction, and pre-production activities. This early engagement aims to prevent costly regulatory surprises later in the process.
The second Application Submission Phase provides collaborative pre-submission meetings and inspections to resolve potential issues and expedite assessment of manufacturing information within drug applications. Companies participating in the program will benefit from facility-specific Drug Master Files that allow the FDA to evaluate manufacturing elements prior to formal drug application submission.
The urgency behind PreCheck reflects stark statistics about the current state of American pharmaceutical manufacturing. More than half of pharmaceuticals distributed in the United States are manufactured overseas, and the country relies heavily on foreign sources for active pharmaceutical ingredients. Of the manufacturers producing APIs used in FDA-approved products, only 11 percent are based in the United States.
Applications for the initial cohort will be accepted until March 1, with FDA officials selecting finalists on April 1. Participants will have one month to provide additional information, and the final selection of initial PreCheck participants is scheduled for June 30. Facilities will be chosen based on alignment with national priorities, including the type of 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 will be given to facilities producing critical medications.
Comments