How the FDA Can Better Serve Manufacturers

The Food and Drug Administration needs agency-wide modernization, the NAM told policymakers last week—especially in its approach to innovation and patient and consumer access.

The conversation: The NAM’s message to the Senate Committee on Health, Education, Labor and Pensions is in part a response to an earlier committee report, “Patients and Families First: Building the FDA of the Future.” The NAM provided manufacturers’ take on transforming the FDA, offering recommendations that would promote consistency, transparency and efficiency across its many centers.

The NAM shared the following recommendations with policymakers:  

• Ensure all FDA centers comply with statutory deadlines to avoid delays that hinder product development and market entry.
• Establish clear review criteria and performance metrics so manufacturers and stakeholders can track progress and understand decision-making.
• Formalize engagement with regulated industry to improve regulatory clarity and incorporate real-world expertise.
• Create predictable, adaptable pathways across all FDA centers to support innovation, particularly as technologies evolve rapidly.

Supporting innovation: The NAM also recommended that the FDA adopt a framework for AI that supports innovation while maintaining appropriate oversight, increase accountability for user fee programs, reduce impediments to U.S.-based clinical trials and improve trial design, streamline approvals for new over-the-counter medication and ensure uniform national standards for food and ingredient regulations.

The last word: “A modernized FDA—one that is efficient, transparent and driven by Gold Standard Science—is essential to strengthening U.S. manufacturing competitiveness and ensuring Americans have access to safe, innovative and high-quality products,” said NAM Vice President of Domestic Policy Jake Kuhns and NAM Director of Health Care Policy Jess Wysocky.