Mark Gardner, M.B.A., J.D.
Mark Gardner specializes in providing regulatory counsel to medical technology and pharmaceutical companies. Prior to practicing law, he worked in product commercialization and development at ev3 (Covidien-Medtronic), Celleration (Alliqua), and MedTox (LabCorp). Mark is regularly invited to speak, nationally and internationally, on regulatory topics that impact the life sciences industry.
Mark counsels clients on how to mitigate and navigate the compliance risks presented by the Sales and Marketing functions. He performs compliance assessments and implements compliance programs, trains companies on how to interact with healthcare professionals, and provides counseling on how to avoid and respond to enforcement actions. Mark routinely performs investigations and negotiates with the FDA and the Department of Justice (DOJ) on behalf of clients. He has convinced the government not to escalate enforcement actions on numerous occasions.
In addition to teaching FDA law as an Adjunct Professor at Mitchell Hamline School of Law, Mark sits on the Advisory Board for the school’s nationally ranked Health Law Institute and is the school’s Health Law Regulatory Compliance Competition Coach. He also sits on the Section Council for the Minnesota State Bar Association Food, Drug, and Device Law Section, and has Co-Chaired the Medical Alley Regulatory Special Interest Group. Mark is a member of Medical Alley, the American Bar Association (ABA), and the Food and Drug and Law Institute (FDLI).
*Figures include experience outside of Gardner Law.
Executives today face a much more rigorous and demanding regulatory environment than those that preceded them. My clients appreciate my prior industry experience and how I apply it in my practice. Since I’ve walked in the shoes of my clients, I know what they are going through. I can relate to their business objectives and help them achieve them in a compliant fashion. This is what sets me apart from other lawyers.
Before Gardner Law
Prior to founding the firm, Mark practiced law at DuVal & Associates, P.A. for seven years as a regulatory lawyer. Prior to that he worked in product commercialization and development at three companies over ten years: MedTox (now LabCorp) a diagnostic manufacturer and reference laboratory; Celleration (now Alliqua) a medical device start-up; and ev3 (now Covidien-Medtronic) a large medical device company.
Community Involvement & Leadership
Mark teaches FDA law as an Adjunct Professor at Mitchell Hamline School of Law. He serves on the school’s Health Law Institute Advisory Board, and as the Health Law Regulatory Compliance Competition Coach. The Health Law Institute was ranked 12th nationally in 2017 by U.S. News & World Report.
He serves on the Minnesota State Bar Association Food, Drug, and Device Law Section Council. He previously served as Chairman, Vice Chairman and Secretary for the Section. He has served as Co-Chair of the Medical Alley Regulatory Special Interest Group and in other advisory and faculty roles. Mark is a member of the American Bar Association.
Mark co-founded Bear Woods, LLC, which invests seed capital in medical technology companies.
Presentations & Articles
Mark has spoken at nearly eighty programs and symposia over the past 7 years. He is a frequent lecturer at programs and conferences on various topics such as off-label promotion and lawful dissemination methods, social media use, implementing effective compliance programs and performing compliance audits, mobile medical applications, Sunshine reporting, enforcement trends (FDA, OIG, & DOJ), and the FDA approval process. He has also authored articles about FDA, federal fraud and abuse, and disclosure laws and regulations. He is quoted by the press regarding issues that impact FDA-regulated products.
- Performing investigations of alleged employee misconduct for pharmaceutical and medical device manufacturers.
- Conducting a board-directed compliance audit for a combination product manufacturer with a 180-person sales force to determine whether the sales force was responding to off-label questions, providing reimbursement information, and covering surgical cases in a compliant fashion.
- Respond to and eventually unwinding a DOJ/FDA directed Consent Decree directed towards a dietary supplement manufacturer for alleged Current Good Manufacturing Practices violations. Mark has also taken three other companies through the Consent Decree process and achieved satisfactory outcomes for his clients in those cases.
- Resolving an FDA and U.S. Customs and Border Protection Seizure action directed at a probiotic (dietary supplement) manufacturer.
- Performing a compliance audit of a speaker bureau for a pharmaceutical manufacturer.
- Acting as the “Legal” function in the Medical, Legal, and Regulatory (MLR) review process for medical device, pharmaceutical, and combination product manufacturers.
- Serving on-site as contract general counsel for a large medical device company.
- Serving on-site as contract compliance and regulatory counsel for a small Class III medical device company.
- Acting remotely as contact compliance counsel for a mid-sized pharmaceutical company.
- Assisting manufacturers in responding to FDA warning letters.
- Performing compliance training for sales forces and management teams of pharmaceutical and medical device companies of all sizes.
- Regulatory assistance related to several major government investigations of alleged off-label promotion.
- Providing regulatory support to a major pharmaceutical company in responding to a subpoena in a qui tam GMP matter.
- Performing general compliance audits for various pharmaceutical and medical device manufacturers.
- Conducting compliance due diligence for buyers and sellers.
- Drafting a Code of Conduct and developing and implementing custom compliance policies for over 100 pharmaceutical and medical device manufacturers.
- Resolving Warning Letters, Import Alerts, and CFG holds for international and domestic medical device manufacturers.
- Acting as an expert witness in a trial on behalf of a food manufacturer.
- Providing legal support for various feasibility, IDE, and post-approval trials.
- Walking approximately 100 pharmaceutical, medical device, and diagnostic manufacturers (domestic and foreign) through the Open Payments (Physician Payments Sunshine Act) reporting process from tracking and compiling to reporting out.
- Drafting countless regulatory assessments regarding the compliance of promotional programs with FDA and FTC regulations, the Anti-Kickback Statute, False Claims Act, Stark Law, Sunshine Act, HIPAA, the Foreign Corrupt Practices Act, and other laws.
- Reviewing and drafting various agreements for regulatory compliance.
- Drafting and responding to competitive trade complaints alleging compliance violations.
- Performing regulatory classification assessments for medical device and mobile technology companies.
- Evaluating grants by serving as outside counsel for a Grants and Contributions Committee for various manufacturers.
- Establishing lawful Medical or Clinical Affairs-directed off-label dissemination policies and procedures for pharmaceutical and medical device manufacturers.
- Evaluating reimbursement tools and messaging for various manufacturers.
- Performing annual FDA-directed “Expert Reviews” for three different dietary supplement manufacturers as required by respective Consent Decrees.
- Training for company management teams and staff on Good Documentation Practices relating to the use of email, phone, messaging, and other communication methods.
- Management team and National Sales Meeting compliance training, as well as focused training on the off-label promotion, Open Payments (Sunshine Act) reporting, fraud and abuse prevention, provision of reimbursement information, retaining HCP consultants, performing clinical research, privacy training, and other topics.
- Providing regulatory counsel to diagnostic companies.
- Assisting pharmaceutical and medical device manufacturers with designing and administering Patient Assistance Programs.
- Performing privacy (HIPAA) reviews for pharmaceutical and medical device manufacturers.
- Drafting regulatory assessments for HCT/P manufacturers to determine whether their products are exempt from premarket review.