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
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
FDA Boot Camp , November 10-11, 2015
Kurt Karst is speaking on the "Hatch Waxman and BPCIA Overview" on March 11, 2015
RDD Europe 2015, May 5-8, 2015
FDA's Orange Book and ANDA's: Questioning the Policies and Precedents Surrounding RLD Patent Listings.
Kurt Karst is speaking at the FDA Boot Camp on March 11, 2014, March 10-11, 2015
Kurt Hatch-Waxman and BPCIA Overview
Respiratory Drug Delivery Asia 2014; Goa, India , November 12-14, 2014
Jumping Legal Hurdles with the US FDA: The Generic Inhaler Challenge
Paragraph IV Disputes Master Symposium, September 30 - October 1st, 2014
New Exclusivity Challenges for Brand Names and Generics: Exploring Their Implications for Paragraph IV Challenges
see more blog entries
Mallinckrodt Sues FDA After Agency Downgrades Therapeutic Equivalence Rating for Generic CONCERTA,
November 19, 2014
Ranbaxy Sues FDA Over Stripped Tentative Approvals for Generic VALCYTE and NEXIUM and Lost Exclusivity,
November 17, 2014
One Down, One to Go: FDA Strips Ranbaxy of 180-Day Exclusivity for Generic VALCYTE; Is Generic NEXIUM Next?,
November 6, 2014
Courtroom Drama Over NEUPOGEN Biosimilar Spills Over to FDA With the First Petition Accompanied by a 505(q) Certification,
November 5, 2014
FDA Appeals Depomed Orphan Drug Case,
November 4, 2014