Jean W. Frydman Partner Princeton, NJ Tel: 609.895.6630 Fax: 609.896.1469 jfrydman@foxrothschild.com 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. Representative Matters 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. Practice Areas Corporate Food & Beverage FDA Law Health Law Life Sciences Medical Technology Pharma & Biotech Administrative Law & Government Relations China Bar Admissions District of Columbia Illinois New Jersey Court Admissions District of Columbia Court of Appeals U.S. District Court, District of New Jersey U.S. District Court, Northern District of Illinois Education
Chicago-Kent College of Law (J.D.) Central Michigan University (M.A., summa cum laude) Ohio State University (B.S.) o Allied Health Professions School of Medical Technology o Professional License: ASCP # MT101519 Memberships American Bar Association American Corporate Counsel Association General Counsel Roundtable Corporate Secretary Pharmaceutical Compliance Forum Food and Drug Committee for New Jersey Corporate Counsel, Chair (1997, 1998, 2001-2004) Food and Drug Law Institute, Academic Programs Committee Regulatory Affairs Professionals Society Board of Directors Resource Center for Women & Children, Somerset County, Trustee Publications August 15, 2017 FDA Approving Orphan Drugs at a Record Pace FDA Alert May/June 2017 21st Century Cures Act Implementation FDLI Member Magazine January 18, 2017 For Medical Device and Pharma Sector, New Law Streamlines FDA Approval Process, Adds $6 Billion in Funding Health Law Alert August 11, 2016 FDA Says Dietary Supplements Subject to Strict New Guidance Life Sciences Alert News April 2, 2018 FDA Digital Health Program Not Broad Enough, Industry Says
Bloomberg Big Law Business March 5, 2018 How To Guide Your Client's New Drug Past an FDA Quick Kill Law360 September 26, 2016 Fox Rothschild Transactions Named Among Finalists for M&A Advisor Awards August 15, 2016 Top 10 in Law Blogs: Alert: FDA Says Dietary Supplements Subject to Strict New Guidance The LexBlog Network May 3, 2016 Top 10 in Law Blogs: FDA Approves Second Biosimilar Drug Since the Biologic Price Competition and Innovation Act of 2009 Was Passed Real Lawyers Have Blogs April 27, 2016 Jean Frydman To Serve on FDLI Academic Programs Committee March 31, 2016 Humanwell Healthcare Group and PuraCap Pharmaceutical LLC to Acquire Epic Pharma, LLC PR Newswire March 11, 2016 New Partners Yearbook 2016 New Jersey Law Journal March 2, 2016 Jean Frydman to Serve on Food and Drug Law Institute s Global Business Conference November 9, 2015 Movers The National Law Journal October 7, 2015 Fox Rothschild Adds Pharma Compliance Pro To NJ Office Law360 October 6, 2015 Fox Rothschild Expands Princeton Office With Addition of Jean W. Frydman September 27, 2015 Lateral Moves The Am Law Daily Events
Inside the FDA's Enforcement Toolbox: Plenty of Hammers December 7, 2017 at 12:00pm 1:00pm Webinar Hosted by: Fox Rothschild Ethical Mistakes Made by Lawyers September 15, 2017 at 8:00am 7:00pm The Hanover Marriott Hosted by: Association of Corporate Counsel of New Jersey How the Internet of Medical Things Will Transform Your Health But What About Your Privacy? January 12, 2017 at 8:30am 10:00am SYNCHRONOSS Hosted by: Association of Corporate Counsel (ACC) New Jersey Chapter Is There a Parallel Path? (Regulatory, IP Strategies, & Other Options) November 16, 2016 at 8:30am 10:30am The Grain House Hosted by: Association of Corporate Counsel (ACC) New Jersey Chapter Bribery and Corruption Risks in the Global Market March 16, 2016 at 11:30am 12:30pm Morgan Lewis & Bockius LLP Hosted by: The Food and Drug Law Institute FDA Practice: Soup to Nuts March 3, 2016 at 9:00am 10:00am Video Conference Hosted by: Fox Rothschild LLP