Michael J. Werner

Michael Werner is a Washington, D.C., public policy and regulatory attorney and a co-leader of Holland & Knight's Healthcare & Life Sciences Team. He also is a co-leader of the Public Policy & Regulation Group's Healthcare & Life Sciences Policy Team. 

Mr. Werner has almost three decades of healthcare law, lobbying, regulatory and reimbursement experience in Washington. He focuses on issues affecting FDA-regulated entities, including biotechnology and pharmaceutical companies developing and manufacturing prescription and over-the-counter (OTC) drugs, biosimilars, cosmetics, dietary supplements and digital-health technologies. His specific areas of knowledge include FDA regulations regarding product approval, marketing and distribution, and Medicare, Medicaid and commercial insurance reimbursement.

He is an internationally regarded thought leader in the regulation and reimbursement of cell therapy, gene therapy, tissue engineering and regenerative medicine products. In that capacity, he has assisted numerous companies and product developers navigating these issues and is the principal architect of the Regenerative Medicine Advanced Therapy expedited approval pathway at the FDA. He also has experience in human subject protection issues such as institutional review board (IRB) review and informed consent, as well as conflicts of interest and other bioethics issues arising from research and uses of new technologies.

Mr. Werner is the co-founder and senior policy counsel of the Alliance for Regenerative Medicine, the leading global organization representing the cell therapy, gene therapy, tissue engineering and regenerative medicine sector.

Representative Engagements

• Advising companies on premarket and postmarket FDA regulatory strategies, including product classification, application filings, GMP requirements and manufacturing issues, and compliance
• Performing "regulatory or reimbursement due diligence" for investors in biotechnology and medical device companies
• Representing companies in meetings with FDA officials
• Helping companies navigate the regulatory pathway to market for novel technologies
• Advising companies on FDA marketing rules and labeling claims
• Counseling clients during inspections and post-inspection matters, responses to Form 483s, untitled and warning letters, and other enforcement actions
• Applying for appropriate product codes to facilitate tracking and future payment of FDA-regulated products
• Organizing and managing coalitions of healthcare stakeholders to secure policy objectives through representation before the U.S. Congress, Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS), and other federal agencies
• Lobbying Congress
• Providing analysis and strategies for reimbursement under Medicare (Part A and Part B) and Medicaid

Before joining Holland & Knight, Mr. Werner was president of The Werner Group, a Washington-based firm that provided lobbying, regulatory and bioethics consulting services for biotechnology and pharmaceutical companies, physicians, health plans, investors, and patient advocacy groups. Prior to founding The Werner Group, he was chief of policy for the Biotechnology Innovation Organization (BIO), representing more than 1,000 biotechnology companies in the U.S. and other countries. In that role, Mr. Werner was responsible for nearly all major issues affecting biotech companies, including drug evaluation and review by the FDA, CMS policies and reimbursement, Medicare, intellectual property, stem cell research and other bioethics issues.

Mr. Werner is a heavily sought-after speaker for meetings and conferences, and the author of more than 60 published articles. He is a frequent media commentator and has appeared in The New York Times, The Wall Street Journal, Science, Scientific American, The Washington Post, BIOWorld, Congressional Quarterly and The Baltimore Sun, as well as on many TV and radio news programs. He co-authored "Life Sciences Compliance: A Pre-Market and Post-Market Roadmap," published by Bloomberg BNA in 2014.