Overview
James (Jamie) Ravitz is the co-head of the Firm’s Life Sciences industry practice and head of McDermott’s Food and Drug Administration (FDA) practice. He works alongside clients across the entire spectrum of life sciences and healthcare law, including regulatory counsel, compliance, and investigations and government enforcement. He is particularly focused on Food and Drug Administration (FDA) regulatory counseling. Jamie works in partnership with companies and investors across the complete ecosystem of FDA-regulated products—drugs, devices, health technologies, biologics, food, cosmetics and cannabis— to help them achieve their business goals.
Jamie works with manufacturers and distributors of FDA-regulated products, with deep experience on novel drugs, biologics and cutting-edge products, from the product concept stage through to post-market and product marketing to facilitate market success and reduce enforcement risk. Jamie is a valuable addition to healthcare and life sciences transaction matters, assisting clients with FDA-related due diligence to maximize value and minimize risk and roadblocks during the transaction.
When compliance or enforcement matters arise, Jamie takes a proactive, business-focused approach to address the issues with minimal business disruption. He also works with clients on the regulatory components of internal investigations, enforcement activity and consumer protection litigation when they arise. He has worked with clients on numerous internal investigations and responses to Office of Inspector General (OIG) and US Department of Justice (DOJ) subpoenas and has assisted in the defense and settlement of qui tam whistleblower suits alleging violations of the False Claims Act.
Jamie is a recognized thought leader in the health law and medical device spaces. He is a regular speaker at health and life sciences industry conferences and has served as an advisory board member to bio-innovation centers and trade media editorial boards.
Prior to joining McDermott, Jamie served as leader of the FDA, healthcare and consumer products compliance practice at a large international law firm.
Results
- Represented drug manufacturer in acquisition of approved drug from international pharmaceutical company*
- Advised leading non-profit in regulatory matters involving an experimental psychotherapeutic drug product application and post-market commercialization*
- Secured Regenerative Medicine Advanced Therapy Designations for novel human-derived regenerative medicine biologics*
- Represented leading regenerative medicine wound care manufacturer in obtaining a Biologics Licensing Application for novel oral wound treatment product*
- Defended ophthalmology practice in settlement of qui tam whistleblower action for anti-kickback and false claims violations*
- Counseled private equity groups in multiple platform acquisitions and roll-ups in various medical product and health services M&A transactions*
- Represented leading underwriter in over a billion dollars of biotech focused at-the-market (ATM) and follow-on public offerings*
* matter handled prior to joining McDermott
Recognitions
- Chambers USA
- U.S. News & World Report – Best Lawyers
- LMG Life Sciences, Leading Lawyer, Practitioner, FDA: Pharmaceutical, 2023
Community
- BNA, Inc. – Medical Device Law and Industry, Member, Editorial Advisory Board
- Medical Product Outsourcing, Member, Editorial Advisory Board
- FDAnews Devices and Diagnostics Newsletter, Member, Editorial Advisory Board
Credentials
Education
Boston University School of Law, JD, 1998
Brandeis University, BA, 1993
Admissions
District of Columbia
Illinois
