Key Lessons You Need to Know from
Enforcement Actions in the Life Sciences
Industry in 2020 and the Outlook for 2021

The life sciences industry knows that government enforcement actions offer critical insights into emerging legal and compliance risks that may impact their business. In 2020, there were several key enforcement actions that are essential to know to ensure that your business operations continue to address operational risks. In this session, we will discuss key areas of government enforcement from key 2020 investigations and settlements, including areas of government scrutiny and legal theories underlying these actions. We will gleam insights from government complaints and settlement agreements, as well as OPDP enforcement letters. We also will discuss emerging trends in corporate integrity agreements arising from these matters, and discuss the outlook in industry enforcement for 2021.

Key Takeaways From this Session

  1. Know the 2020 key enforcement actions in the life sciences industry
  2. Analyze these recent enforcement actions to understand emerging areas of enforcement risk
  3. Discuss the laws and causes of action relevant to key enforcement areas, including False Claims Act, Anti-Kickback Statute and Foreign Corrupt Practices Act
  4. Understand the legal theories the government uses in these actions and how they relate to the areas of enforcement
  5. Learn new trends in corporate integrity agreements with the HHS OIG
  6. Consider ways to incorporate better industry practices into your risk mitigation strategy to address emerging risk areas
  7. Identify ways to strengthen your company’s corporate compliance program

SPEAKERS

Sarah K. diFrancesca

PARTNER, DINSMORE &. SHOHL LLP


Sarah K. diFrancesca is a partner in the Health Care & Life Sciences practices at Dinsmore & Shohl LLP. Sarah’s practice focuses on complex health care litigation, investigations, regulatory compliance, and fraud and abuse relevant to clinical-stage and commercial pharmaceutical, biotechnology, and medical device companies and clinical laboratories. Her experience includes defending health care and life sciences companies and individuals in criminal and civil False Claims Act investigations regarding complex government theories of health care fraud, false claims, misbranding, off-label promotion and kickbacks. This includes negotiating and implementing settlements and corporate integrity agreements, and advising clients on regulatory self-disclosures.

Sarah also advises companies on the Anti-Kickback Statute, fraud and abuse laws, FDA and regulatory compliance matters, transparency laws, and industry codes of conduct. This includes conducting internal compliance investigations, advising on promotional practices, implementing and improving corporate compliance programs, compliance auditing and monitoring, and transactional diligences. Sarah counsels boards of directors, compliance committees, and management executives on compliance and regulatory issues. She also develops and conducts compliance training programs for sales representatives, promotional review committees, and management teams.

Craig Bleifer

PRINCIPAL, CRAIG B. BLEIFER LLC; former General Counsel for Novo Nordisk and Daiichi Sankyo


Craig Bleifer is the former general counsel for Novo Nordisk, Inc., and previously was the general counsel for Daiichi Sankyo, Inc.  He is the principal of Craig B. Bleifer, LLC, a law and consulting practice focused on advising and counseling clients on healthcare industry topics.  www.CraigBleifer.com Craig has over 20 years’ experience in the US and Global healthcare industry and nearly 30 years as an attorney.  He is the Past Chair, PhRMA Law Section Executive Committee, and Past Chair, Healthcare Institute of New Jersey.  He has been awarded General Counsel of the Year by NJBIZ, and was awarded In-House Legal Department of the Year by New Jersey Law Journal.  Contact: craig@CraigBleifer.com.