Hyman Phelps and McNamara
 
Kurt R. Karst
Director
Photo of Kurt R. Karst

(202) 737-7544
kkarst@hpm.com

Practice Areas
Prescription Drugs and Biologics
Corporate Transactions
Enforcement
OTC Drugs and Cosmetics
Training Programs

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

Bar Admissions
District of Columbia
Maryland

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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.


Related Experience
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.

Enforcement
• Advises clients on marketing and unapproved drug enforcement issues.

Articles / Publications    -    see more articles
FDA Amendments Act - HPM Issues Detailed Summary and Analysis,  October 2007

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,  June 2006


Speaking Engagements    -    see more speaking engagements
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

ACI: FDA Boot Camp,  September 18 - 19, 2014  Hatch-Waxman and BPCIA Overview. Co-chair for the conference

Hatch Waxman Boot Camp ,  June 9-10, 2014

Summit on Biosimilars: The Definitive Forum on the Legal, Regulatory, Patent, and Commercial Realities of Biosimilars,  June 4-6, 2014

FDLI Webinar Doing Business with India: Latest Developments in Pharmaceutical Regulation,  June 3, 2014  Panel member


Blog Posts    -    see more blog entries
FDA Law Blog's 30 For 30 Hatch-Waxman 30th Anniversary Trivia: The Answers,  September 23, 2014
Happy Anniversary Hatch-Waxman! Our 30 For 30 Trivia,  September 22, 2014
FAST Generics Act Would Amend the FDC Act to Address REMS/Restricted Access Programs and Biostudy Sample Availability,  September 18, 2014
Thou Shalt Not: FDA Issues Two Guidances on ANDA Refuse-to-Receive Issues on the Eve of GDUFA Public Meeting,  September 17, 2014
Court Upends FDAs Clinical Superiority Requirement for Granting Orphan Drug Exclusivity; Decision Leaves a Lot of Questions to Be Answered,  September 11, 2014