Kurt R. Karst
Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. He helps clients develop strategies for product lifecycle management, obtaining approval, managing post-marketing issues, and defining periods of exclusivity. As the co-founder and primary author of Hyman, Phelps & McNamara's FDA Law Blog, Mr. Karst often leads the response to new rules and regulations, sharing his interpretation with the broader legal community.
Mr. Karst's knowledge of FDA precedents and timely analysis of developments helps clarify and shape the industry's understanding of Hatch-Waxman, in particular. He is a prolific writer, contributing to the blog and publishing articles in major legal journals. Mr. Karst has co-authored and contributed to several text books, including Generic and Innovator Drugs: A Guide to FDA Approval Requirements; Pharmaceutical, Biotechnology, and Chemical Inventions; Fundamentals of US Regulatory Affairs; and FDLI's Drug and Biologic Approvals: The Complete Guide for Small Businesses-FDA Financial Assistance and Incentives.
Mr. Karst clerked for Hyman Phelps & McNamara while attending law school and served as articles editor for the American University Law Review. Before joining the firm, Mr. Karst lobbied for F. Hoffmann-La Roche Inc. In 1995, he was awarded a Fulbright Scholarship for post-graduate studies in Germany.
Prescription Drugs and Biologics
• Counsels clients on Hatch-Waxman patent and exclusivity matters.
• Develops strategies around exclusivity status and Orange Book Patent Listings.
• Obtains approvals for INDs, NDAs, and ANDAs.
• Helps clients obtain orphan drug designations as part of a broader product strategy.
• Advises clients on PDUFA and GAIN.
• Provides counsel on REMS.
OTC Drugs and Cosmetics
• Helps clients market OTC drugs.
• Advises clients on marketing and unapproved drug enforcement issues.
Awards & Recognition
• Who's Who Legal Directory, Life Sciences, Regulatory Section, 2015
• Who's Who Legal Directory, Life Sciences, Patent Litigation Section, 2015-2016
Articles / Publications
see fewer articles
• Pharmaceutical, Biotechnology and Chemical Inventions: World Protection and Exploitation,
• Generic and Innovator Drugs: A Guide to FDA Approval Requirements, Eighth Edition,
• FDA Amendments Act - HPM Issues Detailed Summary and Analysis,
• The Drug User Fee Catch-22,
• FDA Announces Proposed Regulations to Overhaul and Expand the Availability of Experimental Drugs and to Clarify Permissible Charges to Patients,
December 12, 2006
• Rep. Waxman and Sens. Schumer and Clinton Introduce Biogenerics Bill,
September 29, 2006
• FDA's Final Compliance Policy Guide for Marketed Unapproved Drugs ─ Is Agency Enforcement at a Crossroads, or Stuck in a Traffic Circle?,
August 11, 2006
• New Law Reins in "Authorized Generics" Despite Generic Industry Court Losses, But Leaves Several Ambiguities,
• District Court Rules on Simvastatin 180-Day Exclusivity,
May 5, 2006
• FDA Issues Long-Awaited Prescription Drug Labeling Regulations,
January 26, 2006
• FDA's Unauthorized User Fee Money Grab,
August 12, 2005
• FDA Draft Guidance on Exploratory IND Studies,
April 22, 2005
• FDA Issues Good Review Management Principles and Practices Guidance Document,
April 22, 2005
• How FDA's New Labeling Rule Could Preempt State Law
• Comments, Pediatric Testing of Prescription Drugs: The Food and Drug Administration's Carrot and Stick for the Pharmaceutical Industry
see more speaking engagements
• DIA Combination Products Conference, Generics for Combination Products: It’s Complicated, October 24-26, 2017
• 2017 Rare Diseases and Orphan Products Breakthrough Summit, An Evergreen & Sustainable Approach to Orphan Drugs, October 17, 2017
• Paragraph IV Disputes, Brand and Generic Perspectives on the FDA Final MMA Rule: Assessing Its Impact on Hatch-Waxman Practice, October 3, 2017
• FDA Boot Camp, Post-Conference Workshop: Hatch-Waxman and BPCIA in the Trenches: Deconstructing and Constructing an Exclusivity Dispute, September 13-15, 2017
• FDA Boot Camp, Hatch-Waxman and BPCIA Overview, September 13-15, 2017
see more blog entries
• United Therapeutics Sues FDA After Agency Denies Orphan Drug Exclusivity for ORENITRAM,
August 9, 2017
• Fitting New Scientific Advances Into an Old Regulatory Paradigm (Part 2): Gene Therapy and Orphan Drug “Sameness”,
July 26, 2017
• Fitting New Scientific Advances Into an Old Regulatory Paradigm: Fusion Proteins and Orphan Drug “Sameness”,
July 25, 2017
• All Backed Up: FDA Reverses Course and Denies NCE Exclusivity for PREPOPIK,
July 23, 2017
• FDA’s Hatch-Waxman Public Meeting and Progression of the Agency's Drug Competition Action Plan,
July 19, 2017