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 more 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
see more speaking engagements
• RAPS Regulatory Convergence, Effective Orphan Drug Development in a Challenging Regulatory Environment, September 9-12, 2017
• DIA 2017 Conference, Drug Pricing: Access Versus Innovation, June 18-22, 2017
• National Organization for Rare Diseases, Corporate Council Meeting, The ‘Evergreening’ Issues with Orphan Drugs, May 19, 2017
• Paragraph IV Disputes, Q&A with the FDA on the Final MMA Rule: Understanding the Impact for Hatch-Waxman Practice, April 24-26, 2017
• Hatch-Waxman and BPCIA Overview (Drugs, Biologics and Biosimilars, March 22-24, 2017
see more blog entries
• Examining the “Drug Innovation Paradox”: Should the Length of Exclusivity Reflect the Time it Takes to Develop a Drug?,
May 10, 2017
• FDA User Fee Package Includes “Technical Corrections” to Address Orphan Drug Clinical Superiority,
May 9, 2017
• FDA’s Ruling on Generic ZITHROMAX 180-Day Exclusivity: A Little Something for Everyone!,
May 8, 2017
• How Long is 60 Days? 59 Days and Change, or a Full 60 Days? A New Challenge to PTE Application Timeliness Raises the Issue,
May 4, 2017
• Texas Department of Criminal Justice Challenges FDA Thiopental Sodium Import Prohibition,
May 1, 2017