FDA's PreCheck Strategy Faces Industry Pressure to Include Existing Drug Manufacturing Sites
SHERIDAN, WYOMING - November 13, 2025 - Drug manufacturers are urging the FDA to broaden its proposed PreCheck program beyond new factory construction, warning that excluding existing facilities could slow U.S. efforts to expand pharmaceutical production capacity. At a recent agency meeting, representatives from companies spanning gene therapy, generics, and biologics argued that PreCheck's current scope overlooks the fastest route to alleviating drug shortages and strengthening domestic supply chains.
Early-Stage Regulatory Support Designed Only for New Sites
PreCheck was introduced to streamline the regulatory oversight of newly built manufacturing plants, giving participating companies earlier FDA engagement well before their first commercial product application. The program is meant to make U.S. construction more attractive by reducing uncertainty and aligning expectations early in the buildout process.
