Compliance and Enforcement Update - Navigating What's Next Session 2

This session from Navigating What Is Next: AI, Compliance, and Regulation in Life Sciences features a joint presentation by Amanda Johnston, Partner at Gardner Law, and Dr. Cord Willhöft, Partner at Fieldfisher. Together, they examine how U.S. and E.U. regulators are reshaping compliance expectations for life sciences companies in 2025.

The discussion highlights the increasing use of data analytics in U.S. enforcement, the renewed DOJ–HHS False Claims Act Working Group, the rise of qui tam activity, and the focus on individual accountability. Johnston outlines the high-risk areas currently drawing scrutiny, including speaker programs, pricing arrangements, reimbursement support, and Medicare Advantage submissions.

From the E.U. perspective, Dr. Willhöft explains the tightening rules governing interactions with healthcare professionals and organizations, including strict limits on gifts, hospitality, and sponsorships. He reviews recent court decisions on “minor value” thresholds, heightened evidence requirements for advertising claims under the MDR, and the growing role of competitor complaints in enforcement.

Session Highlights

U.S. enforcement shifts toward predictive analytics, data-sharing, and cross-agency monitoring

DOJ–HHS False Claims Act Working Group priorities

Key compliance risks including honoraria, meals, speaker programs, and off-label promotion

Rising FCA recoveries and expectations for executive accountability

E.U. restrictions on hospitality, gifts, and benefits to HCPs and HCOs

Recent judicial decisions narrowing acceptable “minor value” standards

Court expectations for randomized, double-blind, placebo-controlled evidence to support product claims

Convergence of U.S. and E.U. expectations for documentation, auditability, and proactive compliance

About the Speakers

Amanda Johnston advises FDA-regulated companies on compliance program design, investigations, and enforcement matters, helping organizations strengthen documentation, audit trails, and internal controls.

Dr. Cord Willhöft is a leading E.U. regulatory attorney who counsels companies on MDR requirements, advertising and promotional restrictions, and cross-border compliance risk.

How Gardner Law Can Help

Gardner Law supports medical device, pharmaceutical, digital health, and life sciences companies in building compliance programs, preparing for inspections, navigating investigations, and aligning global policies with U.S. and E.U. enforcement expectations. Contact our team to learn how we can help your organization strengthen compliance readiness and mitigate regulatory risk.