Event Recap: Compliance and Enforcement Update

United States Enforcement Priorities and Data-Driven Oversight

The second session of our November 6 event, Navigating What’s Next: AI, Compliance, and Regulation in Life Sciences, featured a joint presentation by Amanda Johnston and Dr. Cord Willhöft on compliance and enforcement trends shaping the life sciences sector in 2025. Johnston opened with a detailed overview of the United States enforcement landscape, emphasizing how the Department of Justice (DOJ) and Department of Health and Human Services (HHS) are expanding coordination under the False Claims Act (FCA) and Anti-Kickback Statute (AKS).

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The DOJ–HHS False Claims Act Working Group, relaunched in July 2025, has prioritized areas that include Medicare Advantage, pricing and discount arrangements, defective and unsafe medical products, and manipulation of electronic health record systems. Johnston explained that this collaboration reflects a broader shift toward data-driven analytics and cross-agency monitoring. The use of predictive models now enables regulators to identify patterns of potentially fraudulent activity in pricing, contracting, and claims.

Whistleblower activity remains at historic highs, with more than 970 qui tam filings in DOJ’s fiscal year 2024. Healthcare fraud recoveries accounted for approximately 70 percent of the $2.9 billion collected under the False Claims Act that year. Johnston noted that prosecutors are increasingly focused on individual accountability, emphasizing that corporate compliance programs must document executive involvement in decision-making and remedial action when violations occur.

“Regulators expect companies to identify risk signals before the government does. That means having surveillance and monitoring systems that are not just continuous, but coordinated, documented, and defensible.”
Amanda Johnston, Partner, Gardner Law

High-Risk Areas and Enforcement Trends

Johnston outlined several areas where manufacturers face heightened scrutiny. Examples include excessive honoraria, overpriced meals, and repetitive, uninformative speaker programs. Off-label promotion, reimbursement support programs, telehealth billing, and improper Medicare Advantage submissions have also drawn attention.

She advised that companies strengthen controls through centralized fair-market-value tracking, venue pre-approval, and auditing of consultant engagements and speaker programs. “Regulators are not just looking at what you do. They are looking at whether your internal controls are strong enough to catch what should not happen,” Johnston said, emphasizing the need for proactive monitoring in high-risk areas.

European Union Compliance Developments and Advertising Restrictions

Dr. Willhöft provided the European perspective, focusing on the tightening framework that governs interactions with healthcare professionals (HCPs) and healthcare organizations (HCOs). He explained that European law generally prohibits providing gifts or benefits that could influence prescribing or purchasing decisions. National laws, such as Germany’s Act on Advertisement of Healthcare Products (Heilmittelwerbegesetz), strictly limit benefits to items of “minor value.”

Recent court decisions have clarified that threshold. In 2024, the Higher Civil Court of Hamburg accepted €5 as an upper limit for minor gifts in the context of medical devices, acknowledging inflation and market competition. However, in 2025, the Federal Court reinstated the stricter €1 threshold, concluding that any higher value risked creating undue influence. Willhöft emphasized that “companies must reassess their internal hospitality policies across Europe to reflect the most conservative national standard.”

He also addressed enforcement of promotional and advertising claims under the Medical Device Regulation (MDR). Courts increasingly require randomized, placebo-controlled, double-blind studies to substantiate efficacy claims. Although authorities rarely initiate enforcement independently, competitor complaints and consumer protection suits have increased, resulting in legal fees and injunctions against unsubstantiated marketing.

Compliance Recommendations for Industry

Both speakers concluded that regulatory agencies in the U.S. and E.U. are converging toward a shared expectation of proactive compliance management and data-supported transparency. Johnston urged companies to enhance monitoring systems and create audit trails that link decisions to documented evidence. Willhöft encouraged global manufacturers to align policies with the MedTech Europe Code of Ethical Business Practice and verify that hospitality and sponsorship programs satisfy both local and regional rules.

How Gardner Law Can Help

Gardner Law counsels FDA-regulated and international life sciences companies on compliance program design, government investigations, and enforcement readiness. Our attorneys provide strategic support in risk assessment, internal auditing, and corrective action planning to help clients meet expectations from DOJ, OIG, and E.U. regulators. Contact us to discuss how we can help strengthen your compliance programs and enforcement readiness.