J. Andrew Harrison
330 East Kilbourn Avenue
Milwaukee, WI 53202
Phone: (414) 721-0467
Fax: (414) 721-0491
Andrew Harrison regularly counsels pharmaceutical, biotechnology and medical device manufacturers and distributors as well as pharmacies and outsourcing facilities on a wide array of U.S. Food and Drug Administration (FDA), Drug Enforcement Agency (DEA) and Office of the Inspector General (OIG) compliance matters, including regulatory strategy, policy, compliance and enforcement.
Andrew has experience advising clients on federal and state government inspections (resolution of Form 483s) and enforcement matters (untitled letters, warning letters, injunctions, seizures and consent decrees), federal good manufacturing practices (GMP), good clinical practices (GCP), recalls, data integrity issues, advertising and promotional materials, internal investigations and governmental administrative inquiries. In addition, he leverages his compliance and enforcement expertise to advise on various other regulatory matters, including due diligence assessments of merger and acquisition arrangements, development of robust policies and standard operating procedures that meet federal requirements and in implementation of regulatory risk mitigation programs for new and innovative products and technologies in key areas of policy and regulatory development.
Prior to joining Hall Render, Andrew was most recently the Vice President, Associate General Counsel & Group Compliance Officer at AmerisourceBergen Corporation. Andrew also served in senior regulatory leadership roles as General Counsel and Chief Regulatory Affairs Officer at Regulatory Compliance Associates Inc. and Executive Global Quality & Compliance at GE Healthcare and Baxter Healthcare Corporation. He holds a B.S. degree in Microbiology from East Tennessee State University and an M.S. degree in Regulatory Science from Johns Hopkins University and received his J.D. degree from the University of Illinois at Chicago – John Marshall Law School. Andrew is admitted to the Supreme Court of the State of Illinois, Wisconsin and his practice within the District of Columbia is limited to matters before federal courts and agencies.
A father to four children, Andrew resides in Pewaukee, Wisconsin with his wife, Teresa.
East Tennessee State University - B.S., 1999; Johns Hopkins University - M.S., 2016
University of Illinois at Chicago - John Marshall Law School - J.D., 2006
- Food & Drug Law Institute
- American Health Lawyers Association
- Association of Certified Fraud Examiners
- Regulatory Affairs Professionals Society
- American Society for Quality