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.
J.D., American University Washington College of Law
B.A., Political Science and German, Marquette University
District of Columbia
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.