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
• 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
• 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
see more blog entries
• Should the Best Pharmaceuticals for Children Act be Amended to Accommodate 505(b)(2) NDA Labeling Carve-outs? “YES”, According to a Bill in the Senate,
July 4, 2017
• ANDA Arbitrage & the New ANDA Holder Program Fee Under GDUFA II,
June 28, 2017
• GAO Examines FDA’s Implementation of GDUFA: Application Review Times Have Improved, But the Agency Needs a Plan for Carryover Fees,
June 27, 2017
• FDA, Ahead of GDUFA II Enactment, Starts the Ball Rolling with Pre-Submission Facility Correspondence Guidance,
June 20, 2017
• Should Free Speech Protections Include an Exception for Exclusivity-Protected Information?,
June 8, 2017