FDA Selects 7 Drugmakers for PreCheck Pilot to Speed Approvals

The U.S. Food and Drug Administration (FDA) has selected seven pharmaceutical companies to participate in the PreCheck pilot program, a framework designed to bolster the U.S. drug supply chain. Among the selected companies are Eli Lilly (LLY) and Regeneron (REGN).

Program Details

PreCheck is a voluntary initiative that allows companies to submit their facilities for pre-review by the FDA, potentially speeding up the approval process for new products. The program aims to improve drug supply chain resilience and reduce reliance on foreign sources.

Company Stance

Eli Lilly and Regeneron have confirmed their participation, expressing commitment to enhancing supply chain security. Neither company has disclosed specific facilities to be reviewed.

Regulatory Context

The program comes amid FDA efforts to boost domestic manufacturing of critical drugs, especially after shortages during the COVID-19 pandemic. It mirrors prior initiatives like "priority review" for expedited approvals.

Potential Financial Impact

Long-term, the program could reduce regulatory costs for participating companies and accelerate time-to-market. However, the FDA has not detailed direct financial incentives.