Founding Partner
AuRIC Strategies
Stephen Mason, Founding Parter, AuRIC Strategies
Stephen Mason founded AuRIC Strategies, a consulting firm focused on assisting FDA-regulated industry develop and implement policy solutions and advance effective engagement strategies with the Agency. Stephen has over 25 years of health care policy experience, having served within Congress and FDA, as well as working for the biopharmaceutical and health insurance industries.
Prior to founding AuRIC Strategies, Stephen was an Executive Vice President at the consulting firm Greenleaf Health, where he managed the regulatory policy function and provided guidance to a broad array of FDA-regulated clients. Stephen also led U.S. regulatory policy while at Amgen.
During his tenure at FDA, Stephen served as the Assistant Commissioner for Legislation under both the George W. Bush and Obama Administrations, where he managed legislative policy within the Agency and was the primary liaison between the Administration and Congress on product regulations and initiatives impacting the innovative biopharmaceutical, biosimilar, generic drug, medical device, and food industries.
Stephen’s experience in FDA user fee negotiations is unparalleled. He has been on both sides of the table - representing FDA in PDUFA IV and supporting regulated industry in PDUFA V, VI, and VII. He has also consulted for industry on the biosimilar (BsUFA), generic drug (GDUFA), and animal drug (ADUFA) user fee programs.
Stephen holds a Bachelor of Science in Business Administration & Finance from Oakland University in Rochester, MI. He currently lives in Arlington, VA, with his wife and three sons.
Disclosure information not submitted.
Opening Plenary: Preparing for the Next Round of User Fee Negotiations
Thursday, June 6, 2024
9:00 AM – 10:15 AM EDT