Main Practice Areas


  • FDA Regulatory Compliance & Counseling
  • FDA Enforcement Defense
  • Life Sciences & Health Care Transactions
  • Licensing & Technology Transactions
  • Life Science M&A


Bio


Edgar Asebey has extensive experience in government regulation of pharmaceutical, biotechnology, medical device, food, dietary supplement, and cosmetics companies.  He counsels clients on complex regulatory strategies and product approval/clearance matters and represents clients before the FDA, FTC, USDA and EPA. He has managed pharmaceutical, medical device and food product recalls and regularly provides enforcement defense services to life science companies.  Mr. Asebey counsels clients and performs regulatory due diligence in support of financings, public offerings and M&A transactions.  He advises stem cell and regenerative medicine companies on regulatory compliance matters and has also advises telemedicine and health IT companies on the intricacies of FDA regulation of Medical Device Data Systems (MDDS), mobile medical apps, and clinical decision support (CDS) software.

Mr. Asebey assist clients in the preparation of FDA submissions, including NDAs, ANDAs and 510(k) premarket notifications and has in-depth knowledge on implementation of and compliance with the Food Safety Modernization Act (FSMA).  He also currently serves as outside counsel to a medical device and two in vitro diagnostic companies.

Mr. Asebey previously practiced at Jones Day where he was a partner in the Health Care and Life Sciences practice group and advised life science and food clients on acquisitions ranging from $240M to $1.9B.  Early in his career, he worked as a patent and licensing advisor at the U.S. National Cancer Institute (NCI) at NIH where he evaluated inventions for patentability, drafted and negotiated CRADAs and sponsored research agreements and patent licensing agreements with pharmaceutical and biotechnology companies.  After leaving the NCI, Mr. Asebey founded and ran a drug discovery company that specialized in discovering and developing novel antineoplastic compounds derived from natural products.

Education

B.A., The University of Chicago
M.D. Candidate, University of Illinois, Abraham Lincoln School of Medicine
J.D., The Catholic University of America (Washington, D.C.)

Admissions

District of Columbia
State of Florida


Professional Activities
Past Co-Chair, Committee on Food & Drug, ABA Administrative Law & Regulatory Practice Section
Member, Food & Drug Law Institute (FDLI)
Executive Committee Member, NE Chapter of BioFlorida
Member, BioFlorida
Past Chair, Bioscience Subcommittee, Greater Miami Chamber of Commerce
Dade County Bar Association, Member


External Publications


“Free Up the Guacamole, Round Up the Glyphosate: How Imported Foods’ Chemical Residues are Confronted”, Natural Resources & Environment, Summer 2018;  American Bar Association, Section of Environment, Energy, and Resources. (Pending publication)
“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)
“Pharmaceutical & Medical Device Regulatory Update”, Jones Day bi-weekly publication, Washington, D.C. (March 2015-October 2016, 34)
“Food Dietary Supplement & Cosmetics Regulatory Update”, Jones Day bi-weekly publication, Washington, D.C. (March 2015-March 2016,  26 issues)
“Data Integrity in Clinical Trials Remains a Hot Issue in 2015”, UPDATE, Food & Drug Law Institute. (May/June 2015)
“FDA Regulatory Compliance & South Florida Opportunities”, Daily Business Review, Miami, FL. (November 11, 2014)
“Counseling Clients on Compliance with Off-Label Promotion Laws”, in Aspatore Special Report: Navigating Recent off-Label Promotion Developments. (September 2013).
“FDA 2.0 – The Same But Way More: The Impact of the Food Safety Modernization Act on Importers and Others”, North American Free Trade & Investment Report, Vol. 21, No.7.  (April 15, 2011)
“Biodiversity Prospecting: Fulfilling the Mandate of the Biodiversity Convention”, in Vanderbilt Journal of Transnational Law, Volume 28, No. 4. (October 1995)
“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)
“Andes Pharmaceuticals, Inc.: A New Model for Biodiversity Prospecting”, in Biodiversity, Biotechnology & Sustainable Development in Health and Agriculture, J.M. Feinsilver (ed.) PanAmerican Health Organization (PAHO). (1996)
“Indigenous Knowledge and Intellectual Property: Towards Equitable Compensation”, in Biodiversity, Biotechnology & Sustainable Development in Health and Agriculture, J.M. Feinsilver (ed.) PanAmerican Health Organization (PAHO). (1996)


Select Speaking Engagements


“2018 Regulatory Update: Wound Care Management & Regenerative Medicine” BioFlorida Seminar Series, Univ. of Florida, Clinical and Translational Research Institute, Gainesville, FL. (April 12, 2018)
“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)
“Top Ten Priorities for FDA in 2018”, Annual Administrative Law Conference, American Bar Association, Washington, D.C. (October 20, 2017)
“Regulacion de Cosmeticos en los EEUU: Entrenamiento para Exportadores Colombianos”, United Nations Industrial Development Programme (UNIDO)/ProColombia Seminar Series, Cali/Medellín/Bogotá,  Colombia. (May22 – 26, 2017)
“La Ley FSMA de la FDA: Lo Que Todo Exportador Debe Saber en 2017”, Feria Internacional Agroalimentaria 2017, Santo Domingo, Republica Dominicana. (May 19, 2017)
Top Ten Priorities for FDA in 2018, Administrative Law Conference, American Bar Association, Washington, D.C. (December 9, 2016)
“FSMA, Imports and International Issues, Food & Drug Law Institute (FDLI)”, Introduction to Food Law, Food & Drug Law Institute, Winston & Strawn, Chicago, IL.  (July 23, 2016)
“Food Safety Modernization Act (FSMA) & International Trade Compliance”, International Litigation, Arbitration & Transactions (ILAT) Conference, The Florida Bar International Law Section, Miami, Florida.  (February 26, 2016)
“FSMA, Imports and International Issues, Food & Drug Law Institute (FDLI)”, Introduction to Food Law, Food & Drug Law Institute, K&L Gates, Washington D.C. (February 23, 2016)
“Off-Label Drug Promotion: Free Speech, Caronia & Amarin”, BioFlorida Annual Meeting, Regulatory Panel, Orlando, Florida. (October 12, 2015)
“Food Safety Modernization Act (FSMA): 2015 Implementation Update”, South Florida Food Forum Miami, Florida. (October 1, 2015)
“FDA & Drug Exclusivity Litigation in 2015”, Jones Day Conference on Enforcement and Compliance Trends in the Life Sciences Industry, Osaka, Japan. (September 18, 2015)
“Off-Label Drug Promotion: FDA Regulations, Guidances & Free Speech”, Jones Day Conference on Enforcement and Compliance Trends in the Life Sciences Industry, Tokyo, Japan. (September 17, 2015)
“FDA's Top Enforcement Priorities for 2015”, Jones Day Conference on Enforcement and Compliance Trends in the Life Sciences Industry, Tokyo, Japan. (September 17, 2015)
“2015 FSMA Implementation: FSVP & Fresh Produce Rules”, Food Marketing Institute (FMI) Annual Legal Conference, Savannah, Georgia. (March 23, 2015)“Implementación de la ley FSMA: Implicaciones para Exportadores Colombianos en 2015”, ProColombia Seminar Series, Cali/Medellín/Barranquilla/Bogotá (December 1-4, 2014)


Languages
English & Spanish

Edgar J. Asebey

Of Counsel 


Halloran Farkas + Kittila LLP

South Florida Office
351 S. Cypress Road Suite 307

Pompano Beach, FL 33060
Direct:  (954) 603-1728 

Email:   ea@hfk.law