Mark S. Paxton

Of Counsel

Mark Paxton




Before entering back into private practice in 2023, Mark most recently served as the FDA sponsor representative for the Surgeon General of the Army, where he served as the final decision maker on all regulatory submissions to the U.S. Food and Drug Administration (FDA). In that capacity, Mark oversaw approximately 80 different military medical projects covering drugs, biologics and devices amounting to over 200 submissions per year. To support those efforts, Mark worked with a professional team of approximately sixty-five (65) regulatory scientists, product and clinical development scientists, and others responsible for compliance with FDA GxP requirements.

Prior to serving our nation’s warfighters, he served as CEO of RX-360, an international pharmaceutical supply chain consortium dedicated to patient safety. Mark’s role at Rx-360 followed his service as Regulatory Counsel in the CDER Office of Compliance where he was responsible for developing supply chain security policies, both domestically and internationally, including serving as the overseer of a major global initiative under Asia-Pacific Economic Cooperation (APEC) to establish best practices to ensure product quality moving in international commerce.

Before joining FDA, Mark served as Associate Vice-President, International Regulatory Affairs at the Pharmaceutical Research and Manufacturers of America (“PhRMA”). There, Mark established a number of on-going dialogs and work programs with drug regulatory authorities throughout, Japan, China, East Asia, India, Europe and Latin America. Those efforts were designed to assist regulators and constituent companies operating in these foreign markets to better understand complex regulatory issues arising from the globalization of the pharmaceutical industry.

Mark was born in Okinawa, Japan, and moved to Careysburg, Liberia with his family when he was 2 years old. He stayed in Liberia until he graduated from the American Cooperative School (ACS) in 1978, but frequently coming back to visit friends and colleagues.

Mark is a regulatory attorney by education, experience, and training, and prior to joining PhRMA was in private practice in Lexington, Kentucky where he focused his practice on food and drug law. Mark received his B.S. (1991) and M.S. (1993) degrees in Economics from the University of Kentucky, and his J.D. from the University of Dayton School of Law in 1998.


  • University of Dayton School of Law, Juris Doctor, Dean’s Merit Scholar ( 1998)
  • University of Kentucky, College of Business and Economics, M.S. Economics (1993)
  • University of Kentucky, College of Business and Economics, B.S. Business and Economics, Honors (1991)

Bar Admission(s)

  • Kentucky (1998)

Practice Areas

  • Drug, Biologic and Device approval strategies
  • Multi-regional clinical trials
  • Global Regulatory Requirements
  • Current Good Manufacturing Practice
  • Good Clinical Practice
  • Good Laboratory Practice
  • Quality management systems
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