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
FDA Amendments Act - HPM Issues Detailed Summary and Analysis,
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,
see more speaking engagements
International Conference and Expo on Generic Drug Market and Contract Manufacturing, October 31 - November 2, 2016
KRK Speech: “Biosimilars in the United States: A Progress Report and A Peek Into the Future”
Regulatory Operations and Submissions, April 27-28, 2016
AJV 4/27 Speech: “Dossier Considerations for Submissions Eligible Expedited Review Programs”; KRK 4/28 Speech: “Successful Orphan Drug Applications”
Webinar re Section 505(b)(2), March 24, 2016
FDA Boot Camp, May 9-11, 2016
KRK 3/10 Panelist: “Hatch-Waxman and BPCIA Overview”]
FDA Boot Camp , September 30 - October 1, 2015
Kurt Karst is speaking on the "Hatch Waxman and BPCIA Overview" on March 11, 2015
see more blog entries
FDA’s Orange Book Preface Gets a Facelift: What’s New?,
February 3, 2016
Trailblazer Amarin Continues to Blaze New Trails: ANDA Paragraph IV Litigation Dismissed,
January 27, 2016
FTC Releases Latest Staff Report on Drug Patent Settlement Agreements; Post-Actavis Trends Seem to Be Forming,
January 19, 2016
Briefing in Appeal Over Colchicine 505(b)(2) Approval Wraps Up; Oral Argument and a Decision are Patiently Awaited,
January 11, 2016
Any Given Patient for Any Given Indication: AbbVie Petitions FDA on Interchangeable Biosimilars,
December 28, 2015