A former general counsel for multinational pharmaceutical companies and a multinational retail dietary supplement company, Jean has significant experience handling regulatory compliance matters for both private and publicly held pharmaceutical, medical device and dietary supplement companies. She regularly provides strategic legal and compliance reports to boards of directors and serves as a trusted legal adviser to executive management and business leaders. Jean’s practice has a particular focus on operations and compliance systems, including Foreign Corrupt Practices Act of 1977 (FCPA), anti-bribery, consent decrees and off-label promotion.
Having spent more than 30 years in-house at major multinational pharmaceutical companies and a major dietary supplement company, Jean possesses an in-depth knowledge of food and drug law and the regulatory and compliance issues facing clients in the pharmaceutical, medical device and dietary supplement industries. She has extensive experience in drug, medical device and dietary supplement promotional review and advises senior management on new Food and Drug Administration (FDA) rules, proactive submissions to the FDA, Current Good Manufacturing Practice (cGMP) compliance and other significant enforcement issues. She regularly counsels clients on commercial and regulatory/compliance efforts, helping to establish and execute comprehensive compliance programs as well as implement strategies to manage and reduce legal expenses.
- Developed and managed pharmaceutical and medical device compliance programs and policies as chief compliance officer.
- Created and led compliance risk committees, minimizing overall risk in product liability, antitrust and corporate compliance by advising on overall company strategies.
- Negotiated and drafted regional supply, distribution and license agreements.
- Minimized government enforcement by conducting training on the False Claims Act, anti-kickback statutes, Health Insurance Portability and Accountability Act (HIPAA), off-label promotion, Stark laws and Medicare and Medicaid conditions of participation.
- Drafted and negotiated a variety of product purchase and licensing agreements.
- Drafted and negotiated large, multisite collaborative clinical trial agreements.
- Coordinated the creation and implementation of internal compliance tracking systems.
- Filed and maintained Lanham Act actions against competitor companies.
- Counseled managed markets group on pricing and reimbursement, Physician Payments Sunshine Act and competition law.
- Counseled companies on grant committees and legal representative for regulatory promotional material.
- Negotiated and drafted successful co-promotion agreements.
- Managed significant product liability and class action lawsuits.
Before Fox Rothschild
Prior to joining Fox Rothschild, Jean spent more than a decade as general counsel to several major pharmaceutical companies and a retail dietary supplement company. She was most recently senior vice president legal, general counsel and corporate secretary to The Vitamin Shoppe. Jean also served as U.S. general counsel and chief compliance officer at Ferring Pharmaceuticals Inc.; vice president, general counsel and corporate secretary at NovaDel Pharma Inc.; associate general counsel at Pfizer, Inc.; senior attorney, product trade and regulations at BASF Corporation; legal/regulatory director at Pharmacia, Inc.; an associate at an international law firm; and regulatory attorney and senior regulatory specialist at Abbott Laboratories.
Beyond Fox Rothschild
Jean is a frequent author and speaker, having given presentations for ALM, the American Conference Institute (ACI) and the General Counsel Institute, among others. She also served as an adjunct professor at Seton Hall University School of Law from 2004-2006, where she taught FDA Law, Anti-kickback and False Claims Law.