FDA FY 2026 Legislative Agenda: What Device and Drug Makers Should Watch

The U.S. FDA’s fiscal‑year 2026 legislative request, released in July 2025, outlines a wish list of expanded authorities reflecting the agency’s evolving priorities. The proposals seek new tools to prevent unsafe imported medical devices from reaching patients, including authority to restrict shipments from countries with repeat violations and to require pre‑export certifications or enhanced documentation. The agency also wants to increase supply‑chain transparency by mandating that drug labels name the original manufacturers of active ingredients and excipients, with traceability available via QR codes or online portals. Another proposal would require companies to report the identity of each supplier and the degree of reliance on them so that FDA can monitor supply chain vulnerabilities more effectively.

Other notable requests include explicit authority to ensure that all data supporting a product’s application remain available and verifiable throughout its life cycle and to more quickly penalize companies when fraudulent data are discovered. The FDA also proposes abolishing the separate “interchangeable” category for biosimilars so that all biosimilars would be automatically substitutable, and it wants the legal power to require destruction of imported products that pose significant health risks rather than allowing exporters to re‑route them. These proposals, along with ongoing congressional debates over FDA funding levels, signal potential shifts in enforcement and regulatory focus that could affect how device and drug manufacturers manage imports, supply chains, data integrity and product labeling in the coming years.