Global life sciences
Government Investigations and Enforcement
Services
Life sciences and healthcare companies are among the most frequent targets of government enforcement attention. Sidley’s Global Life Sciences (GLS) team partners with clients across the industry — from the companies that license or manufacture drugs, biologics, and devices and those in the distribution chain to the healthcare providers delivering care – to defend against civil and criminal enforcement actions, advise on enforcement risk stemming from questions of regulatory compliance, conduct proactive reviews and internal investigations under privilege, help management assess compliance issues to determine and implement appropriate investigative and corrective actions, and build compliance programs designed to mitigate enforcement risk. With decades of experience, we provide tactical insights into how enforcement priorities and processes are affected by technological advances, market demands, and policy changes, while drawing upon our global reach and deep life sciences and healthcare regulatory bench to anticipate challenges and achieve successful outcomes for our clients.
Our GLS Enforcement team brings to clients:
- Multidisciplinary teams dedicated solely to healthcare and life sciences compliance and enforcement matters: Sidley’s GLS practice is dedicated to working within the healthcare and life sciences industry, enabling our team to develop deep experience with the unique challenges and opportunities that arise in our industry’s enforcement actions, including a detailed understanding of scientific, quality, and manufacturing issues informed by experienced personnel, such as those with related technical educations and backgrounds.
- A record of success: We have successfully resolved hundreds of government enforcement matters for life sciences and healthcare companies. Some of these resulted in high-profile public resolutions, first-of-their-kind consent decrees, and corporate integrity agreements. Many others were successfully closed with government authorities declining to proceed, and without any negotiated resolution or litigation.
- Government agency insight: We engage daily on behalf of clients with numerous government enforcement agencies around the world, including the DOJ, Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), the U.S. Drug Enforcement Administration (DEA), European Medicines Agency (EMA), European Commission, National Medical Products Administration (NMPA), and the Medicines and Healthcare Products Regulatory Agency (MHRA). Our lawyers previously held senior positions in many of these agencies, including the DOJ, FDA, HHS, CMS, EMA, Swissmedic, and Ministry of Commerce of the People’s Republic of China, and maintain strong relationships and credibility with key stakeholders within these and other agencies. Leveraging our technical prowess, years of government experience, and strategic insight, as well as strong relationships with the enforcers, we advocate successfully on behalf of our clients in enforcement proceedings and to preempt and avoid such proceedings.
- An elite cross-border regulatory practice: Our lawyers advise on the most challenging issues pertaining to marketing authorization, good manufacturing practices, pharmacovigilance, fraud and abuse considerations, coding and billing rules, post-marketing compliance, and life cycle management. Our deep regulatory experience informs our work for clients in contentious and non-contentious regulatory proceedings, including matters arising before the FDA and CMS, and guides our strategy in investigations and litigation, including under the federal False Claims Act (FCA).
- Nationally recognized: Our lawyers are distinguished by their consistent recognition from leading industry publications, such as: Chambers Global, Chambers USA, Chambers Asia-Pacific, China Business Law Journal, China Law & Practice, LMG Life Sciences, Benchmark Litigation, and the Best Lawyers® “Best Law Firms” Survey.
Healthcare and life sciences companies face heightened anti-corruption risks in today’s climate of global enforcement and regulatory scrutiny. From clinical trial sponsorships and distributor arrangements to government pricing, procurement, and market access, healthcare and life sciences companies must navigate a complex landscape of local and international anti-bribery laws—particularly in emerging markets where interactions with government officials are frequent and unavoidable.
Our services. Sidley’s Global Life Sciences (GLS) Foreign Corrupt Practices Act (FCPA) and Anti-Bribery team advises healthcare and life sciences clients across the full spectrum of anti-corruption risks. We are well-versed in laws that relate to dealing with government officials and authorities around the world. With more than 90 lawyers in 14 offices worldwide, we draw on the firm’s global capabilities and highly skilled practitioners to:
- defend clients in multinational government investigations, including by the U.S. Department of Justice (DOJ), U.S. Securities and Exchange Commission (SEC), State Attorneys General in the U.S., and foreign law enforcement and regulatory authorities;
- conduct internal investigations;
- create and implement compliance programs;
- perform compliance risk assessments;
- conduct due diligence on potential merger and acquisition targets, joint venture partners, and high-risk third parties; and
- counsel clients on compliance issues that arise from international licensing, sales, and marketing.
Our unique strengths. Sidley’s GLS FCPA and Anti-Bribery team brings to clients:
- Sector-Specific Experience: We represent clients throughout the healthcare and life sciences industry, including pharmaceutical and biotechnology companies, medical device manufacturers, digital health platforms, clinical laboratories, hospital systems, and private equity investors. Our anti-corruption advice is informed by a deep understanding of Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS), European Medicines Agency (EMA), and other life sciences and healthcare regulatory frameworks, enabling us to provide holistic guidance on anti-corruption matters.
- Regulatory Agency Insight: Over the course of their careers, our lawyers have built relationships of mutual respect with the DOJ and SEC, the U.S. agencies with principal authority to enforce the FCPA. Our team features prominent practitioners and former officials from the DOJ and SEC, who bring an insider’s perspective to a wide range of FCPA and anti-corruption matters.
- Cross-Border Coordination: Our team has handled FCPA matters involving corporate activities in more than 100 countries. We regularly advise companies on managing corruption risks in clinical trials, regulatory approvals, government-sponsored healthcare programs, and third-party arrangements involving distributors, consultants, and local agents. Our international offices offer on-the-ground support in jurisdictions that present the greatest enforcement risk for healthcare and life sciences companies. In Europe, we advise on U.K. Bribery Act compliance and EU privacy regulations that affect internal investigations. In Asia, our lawyers in China, Japan, Singapore, and across Southeast Asia have led numerous anti-corruption investigations involving government interactions, distributor oversight, sample handling, and promotional conduct. We are one of the few firms authorized to practice local law in Singapore, offering seamless service in key Asia Pacific markets.
Healthcare and life sciences companies operate in a high-stakes regulatory environment where securities enforcement matters can quickly escalate. Sidley’s Global Life Sciences (GLS) platform combines deep sector knowledge with one of the country’s most respected SEC enforcement practices to guide clients through sensitive investigations, compliance challenges, and litigation risk.
Sidley’s GLS SEC Enforcement team offers:
- Sector-Specific Regulatory Defense: We represent public and pre-IPO healthcare and life sciences companies, boards, officers, and investors in SEC, DOJ, FINRA, and state AG investigations involving accounting and financial reporting, insider trading, FCPA, Regulation FD, and disclosures, including those related to clinical trials, regulatory approvals, transactions, cybersecurity, and other market-moving statements.
- Insight from Former Government Officials: Our team includes former senior officials from the SEC, DOJ, and FINRA, providing clients with strategic clarity and credibility in enforcement and compliance matters.
- Integrated Litigation and Compliance Counsel: We work seamlessly with Sidley’s FDA, healthcare regulatory, and white collar teams to manage parallel investigations, conduct internal investigations, and resolve matters involving accounting, governance, or scientific disclosures.
- Proactive Risk Management: We help life sciences clients conduct risk assessments, implement comprehensive compliance programs, conduct internal investigations, remediate disclosure practices, and prepare for regulatory and investor scrutiny—especially in connection with IPOs, restatements, and corporate transactions.
- Recognized Excellence: Sidley has been named “Law Firm of the Year” for Securities Regulation and Litigation – Regulatory Enforcement by U.S. News – Best Lawyers multiple times. Our practice and our lawyers are regularly ranked by Chambers USA for securities enforcement, regulatory, and compliance leadership.
Learn more about our SEC Enforcement and Regulatory practice.
The EU Whistleblower Directive has introduced sweeping compliance obligations for healthcare and life sciences companies operating in Europe. Through our interdisciplinary Global Life Sciences (GLS) platform, Sidley helps clients across the healthcare and life sciences ecosystems navigate these requirements with confidence.
Sidley’s GLS EU Whistleblower team delivers:
Strategic Compliance Design: We help healthcare and life sciences companies build internal reporting systems, both at the local level and global level, that comply with the EU Directive and national laws. From whistleblower policies to secure reporting channels and escalation protocols, we tailor frameworks to each client’s structure and risk profile.
Cross-Border Program Implementation: Sidley supports the rollout of whistleblower programs across multi-jurisdictional operations—navigating national variations, data transfer restrictions, language localization, and integration with HR and compliance functions across the EU and beyond. We offer general training to companies on their obligations under the EU Directive and national laws, as well as tailored trainings to employees responsible for receiving and handling internal reports.
Investigation Management and Risk Mitigation: When reports surface, we guide clients through internal investigations with discretion and regulatory sensitivity. We advise on privilege, documentation, regulator engagement, and litigation exposure—while protecting confidentiality and guarding against retaliation. We facilitate communications between companies, the whistleblower, and, where needed, competent authorities to ensure that internal investigations are conducted in compliance with applicable confidentiality and governance requirements.
Regulatory Insight Across the EU: With lawyers in key EU jurisdictions, we offer clear, jurisdiction-specific guidance on implementation, enforcement trends, and regulator interaction—grounded in practical knowledge of healthcare and life sciences operations.
Governance and Culture: We align whistleblower programs with broader compliance requirements, ethics frameworks, and transparency initiatives. Our team partners with boards and executives to strengthen governance, support accountability, and foster a culture of trust.