Former FDA Principal Deputy Commissioner John Norris, JD, MBA, is an Of Counsel to O’Neill and Associates. Commissioner Norris serves as a specialist in Pharmaceutical, Biotech, and Medical Device, as well as for-profit and not-for-profit Hospital, Hospital System, and Health Insurance Companies.
Dr. Norris previously served as principal deputy commissioner and COO of the FDA, where he was responsible for co-managing 14,000 employees and $5 billion annual budgets. While at the FDA, Dr. Norris co-led its last major reform. He has been an officer of, or senior-consultant to, nearly 30 major companies including Pfizer, Harvard’s Partners HealthCare System, and Konica Minolta. He has served on the boards of some 20 public and private healthcare enterprises, including Summit Technology and Caritas Christi Healthcare System (now Steward Healthcare System). Additionally, Dr. Norris served as a faculty member and teacher of healthcare policy, regulations and reimbursement at Harvard University. During his time at Harvard, he founded, housed and edited a health-law academic journal: “The American Journal of Law & Medicine.”
Dr. Norris is a thought-leader on a range of healthcare topics including, healthcare-reform, health-insurance/payment-reform, healthcare-IT-development, healthcare-system-development, healthcare-new-product-development and acquisition, healthcare-M&A-development, and health-law-development. He is skilled in finding and evaluating market need for new products, either for ideation or for development, including finding and negotiating high-value deals for new product: creation or acquisition and/or in-house refinement; clinical trials; preparation for, and achievement of, FDA and Medicare and other health-insurer approvals.
Dr. Norris is a graduate of the University of Rochester. He attended Cornell Law School and Cornell Business School and is an alumnus of Harvard’s Kennedy School of Government.