Edgar J. Asebey, Esq.
Of Counsel
Edgar J. Asebey is a regulatory and transactional attorney with over two decades of experience in federal regulation of pharmaceutical, biotechnology, medical device, food, dietary supplement and cosmetics companies. Since 2015, he has been working on Cannabis-related matters and transactions and since 2018 he has provide regulatory compliance, business transactional, venture finance and international trade services to hemp/CBD companies. Edgar brings a wealth of knowledge and over 20 years of experience to life science, Cannabis and hemp/CBD clients who require novel solutions to complex issues.
Edgar practices before the Food and Drug Administration (FDA), United States Department of Agriculture (USDA), Customs and Border Protection (CBP), Environmental Protection Agency (EPA), and the Federal Trade Commission (FTC), representing client companies on regulatory compliance, product approval/registration and FDA enforcement defense matters. He also assists clients with international and domestic business transactions, IP licensing, venture finance, trademark protection and import/export matters.
Edgar studied molecular biology at the University of Chicago and spent 5 works working in molecular biology research laboratories at the University of Chicago and the University of Illinois. Early in his career he served as a Patent and Licensing Advisor to the Natural Products Branch of the National Cancer Institute at the National Institutes of Health (NIH). He founded and served as president of Andes Pharmaceuticals, Inc., a natural products drug discovery company, from 1994 to 2000 and has served as in-house counsel to two life sciences companies. Most recently he was an equity partner in the Health Care & Life Sciences Practice Group at Jones Day. Edgar is currently a partner at Keller Asebey Life Science Law, PLLC.
While Edgar holds licenses to practice law in Florida and Washington, D.C. he can represent clients on federal regulatory matters in all 50 states. He is a member of the American Bar Association (Section on Administrative Law & Regulatory Practice: Food and Drug Committee and International Committee), Food & Drug Law Institute (FDLI), Dade County Bar Association, and BioFlorida.
Licenses
State of Florida Bar License
District of Columbia Bar License
Education
The Catholic University of America, Columbus School of Law
Washington, DC
Juris Doctorate
Authored one law review article and 3 book chapters while attending law school:
- Biodiversity Prospecting: Fulfilling the Mandate of the Biodiversity Convention, in Vanderbilt Journal of Transnational Law, Volume 28, No. 4, October 1995. (Law Review Article)
- Quid Pro Quo: Alternatives for Equity and Conservation, in Valuing Local Knowledge: Indigenous People and Intellectual Property Rights, Stephen B. Brush, (ed.), Island Press, 1995. (Book Chapter)
- Indigenous Knowledge and Intellectual Property: Towards Equitable Compensation, in Biodiversity, Biotechnology & Sustainable Development in Health and Agriculture, J.M. Feinsilver (ed.) PAHO, 1996. (Book Chapter)
- Andes Pharmaceuticals, Inc.: A New Model for Biodiversity Prospecting, in Biodiversity, Biotechnology & Sustainable Development in Health and Agriculture, J.M. Feinsilver (ed.) PAHO, 1996. (Book Chapter)
University of Illinois Abraham Lincoln School of Medicine
Chicago, IL
- MD Candidate with graduate studies in molecular biology & biophysics
- Conducted research in Department of Physiology & Biophysics
- Area of research: cAMP-Protein kinase binding
- Awarded Dean’s Scholarship for Biomedical Research (1987)
The University of Chicago, The College
Chicago, IL
Bachelor of Arts, Biology (Concentration: Molecular Biology)
- Awarded Edmundson-Garber Scholarship for Undergraduate Research (1985)
Publications & Speaking Engagements
Edgar has a total of 68 published articles, book chapters or speaking engagements. The most recent include:
- Legal Guide to the Business of Marijuana, by James T. O’Reilly and Edgar J. Asebey, Practicing Law Institute, forthcoming May 2020. (Book)
- Understand “The Man”: FDA Compliance & Enforcement of CBD Products in 2020, Moderator and panelist, CBD Industry Association Mastermind Summit & Expo, Bonita Springs, FL, February 8-9, 2020 (Conference)
- Latin American Industry Dynamics, BioFlorida Annual Meeting, Regulatory Panel, Fort Lauderdale, Florida, October 15, 2018. (Conference)
- Free Up the Guacamole, Round Up the Glyphosate: How Imported Foods’ Chemical Residues are Confronted, (Co-authored with Prof. James T. O’Reilly), Natural Resources & Environment, Summer 2018; American Bar Association, Section of Environment, Energy, and Resources. (Quarterly Journal)
- 2018 Regulatory Update: Wound Care Management & Regenerative Medicine, BioFlorida, of Florida, Clinical and Translational Research Institute, Gainesville, FL, April 12, 2018. (Conference)
- FSMA in 2018: New Opportunity or Just Another Burden?, Disruption in the Marketplace With a Taste of Food & Beverage, Mazars Food & Beverage Roundtable at The Breakers Palm Beach, Palm Beach, FL, February 5 2018. (Conference)
- Developments in Administrative Law and Regulatory Practice, (Co-authored with Katharine Van Tassel and Prof. James T. O’Reilly), Food and Drug Law, American Bar Association, February 2017.
- Top Ten Priorities for FDA in 2018, Administrative Law Conference, American Bar Association, Washington, DC, October 20, 2017. (Conference, CLE)
- Regulacion de Cosmeticos en los EEUU: Entrenamiento para Exportadores Colombianos, United Nations Industrial Development Programme (UNIDO)/ProColombia Seminar Series, Seminar presented in Cali, Medellín and Bogotá, Colombia, May 22 – 26, 2017. (Seminar, in Spanish)
- La Ley FSMA de la FDA: Lo Que Todo Exportador Debe Saber en 2017, Feria Internacional Agroalimentaria 2017, Santo Domingo, Dominican Republic, May 19, 2017. (Conference)
Areas of Practice
- FDA Regulatory Compliance
- New Dietary Ingredient & Food Additive Petitions
- NDA, ANDA & BLA Applications
- FDA Enforcement Defense
- FDA Form 483 Letters
- FDA Warning Letters
- CGMP Compliance
- Hemp Biomass / CBD Due Diligence
- Hemp / CBD Purchase/Sell Agreements
- Advertising & Promotion Compliance
- Dietary Supplement & Cosmetic Label Compliance
- OTC Drug Listing
- FDA Food Facility Registration
- International Trade & Customs
- International Business Transactions
- Removal from FDA Import Alert
- Licensing Agreements
- Trademark Registration & Enforcement
- Venture Finance & M&A Advisory
- Corporate Formation