Life sciences and healthcare companies are among the most frequent targets of government enforcement attention. Sidley’s Global Life Sciences (GLS) Enforcement team partners with clients across the industry — from the companies that make drugs and devices and those in the distribution chain to the healthcare providers delivering care – to defend against government civil and criminal enforcement actions, advise on enforcement risk stemming from questions of regulatory compliance, conduct efficient internal reviews, 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 Enforcement practice works solely 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 and manufacturing issues informed by experienced personnel, such as those with related technical education 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 without any negotiated resolution or litigation.
- Government agency insight: We are engaged daily on behalf of clients with the Department of Justice (DOJ), Food and Drug Administration (FDA), 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, 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, and 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, 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.
False Claims Act Enforcement and Litigation
Over the past 25 years, we have guided life sciences and healthcare companies through hundreds of investigations under the federal FCA. For our life sciences clients, these matters have ranged from responding to allegations relating to violations of the Anti-Kickback Statute (AKS) and Beneficiary Inducement Statute (BIS), off-label and other promotional conduct, violations of current Good Manufacturing practices, and drug pricing rules. For our healthcare provider clients, these matters have covered alleged billing and coding violations, quality of care issues, non-compliance with Medicare Advantage rules, pharmacy pricing issues, and compliance with the AKS, the BIS, the Stark Law, and regulations addressing electronic medical records.
While many of these matters are resolved non-publicly, we routinely represent life sciences and healthcare companies in such matters through all stages of litigation, both against state and federal governments and private whistleblowers under the FCA’s qui tam provision. Our lawyers have appeared in federal and state courts in FCA matters across the country, in all federal circuit courts, and at the U.S. Supreme Court. Our litigation strategy in these cases is informed by our deep knowledge of relevant regulatory considerations.
Food, Drug, and Medical Device Compliance and Enforcement
Sidley has built a preeminent compliance and enforcement practice focused on manufacturing quality both domestically and internationally.
The FDA has a record of aggressive enforcement of its current Good Manufacturing Practice (cGMP)/Quality System Regulation (QSR) regulations against life sciences companies through its inspectional authority. Agency advisory and enforcement action in this area can have immediate and significant consequences for regulated companies—from holds on outstanding applications with the agencies to injunctions against continued manufacturing or shipment of product into the United States market.
Our team includes numerous former FDA Office of Chief Counsel lawyers and former FDA investigators that now serve our clients as consultants. Our deep bench and technical range of experience allow us to partner with clients to develop response strategies after inspections and advocate credibly to the FDA leadership. Moreover, our FDA enforcement team has white collar enforcement lawyers with strong knowledge in FDA protocols who are able to represent clients if matters are referred for DOJ investigation. Our extensive history working with the FDA and DOJ provides us with the ability to assess complex issues quickly and develop appropriate strategies for clients facing such investigations.
Anticipating a more robust inspectional effort from global regulators, our lawyers also help businesses worldwide prepare for regulatory inspections, promptly responding to issues and enforcement activities, while coordinating action plans and communications with regulators, consumers, and the public.
Department of Justice Criminal Investigations
Sidley has advised life sciences and healthcare companies in a wide range of white collar criminal matters on the Food Drug and Cosmetic Act (FDCA), the Foreign Corrupt Practices Act (FCPA), and the Controlled Substances Act (CSA). Government agencies have broad regulatory authority over all aspects of healthcare and life sciences activities that usually includes criminal enforcement authority. We have handled dozens of these criminal investigations, with experience in virtually every issue that can arise, and a strong track of obtaining declinations and favorable criminal resolutions. Our white collar lawyers’ knowledge of the federal regulatory framework and experience in the industry enables us to provide the highest quality legal representation in an efficient, cost-effective manner.
Acknowledged as a leading firm for our corporate investigations and anti-corruption practices, our lawyers work closely with clients in the life science and healthcare industries in litigation and regulatory settings to develop proactive compliance programs to mitigate risks and exposure. Our lawyers have a proven record of defending and assisting clients with multi-jurisdictional investigations conducted in response to government inquiries.
In particular, we have handled high-stakes matters involving the enforcement of the FCPA and other international anti-corruption laws against healthcare and life sciences companies. Drawing on the firm’s global capabilities, our lawyers conduct internal investigations, create and implement compliance programs, and perform risk assessments. We also conduct due diligence on potential merger and acquisition targets, joint venture partners, and high risk third parties to fully assess and counsel clients on issues that may arise from international licensing, sales, and marketing.
Our legal teams are also experienced in handling DEA enforcement actions and advising clients on oversight regulations regarding manufacturers, distributors, prescribing practitioners, and pharmacies to stay a step ahead of administrative sanctions.
Other Fraud and Abuse-Related Enforcement Actions
We have helped companies respond to scores of other inquiries under other federal and state laws, including DOJ inquiries relating to the Controlled Substances Act, state Attorney General inquiries under unfair/deceptive trade practices laws, payment suspensions from Medicare and Medicaid, and administrative audits conducted by federal healthcare program contractors including Unified Program Integrity Contractors (UPICs).
Throughout a healthcare company’s enforcement experiences, Sidley’s GLS Enforcement lawyers serve as trusted advisors on managing enforcement risk through compliance reviews and other regulatory assessments.
Securities and Exchange Commission (SEC)
We advise and defend public life sciences companies in a myriad of securities-related matters. Our Chambers-ranked, experienced team, which includes many former SEC officials, provides insight into leading developments on the informal interpretations, practices, and positions of the SEC, as well as multidisciplinary disclosure advice that aligns with the strategic goals of our clients and their businesses. Maintaining strong working relationships with regulators in the U.S., Europe, and Asia. We have guided public companies through the spectrum of regulatory challenges and counseled clients on prospective compliance issues, risk-mitigation measures, and regulatory disclosures.
