Pharmaceutical Regulation, Compliance & Policy, Part 3: A Close Look at Generic Drugs – FDA Watch
In this third part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with Sara Koblitz, Director at HPM; Kurt Karst, Director at HPM; and Karin Hessler, General Counsel at the Association for Accessible Medicines. Together, they discuss the biggest hurdles that the generic industry needs to overcome in today’s regulatory environment; the effect of pressure on industry to continue lowering drug prices; how the Hatch-Waxman Act has played out over the past 40 years; how the act can be used to address drug shortages; incentives for companies to develop follow-on products to avoid shortages; how tariffs are impacting generic drug manufacturing overseas; and much more.
This episode and the rest of our series do not include the usual Headlines and Resources Links segments.
About Our Guests
Sara Koblitz
Sara W. Koblitz advises FDA-regulated clients on a range of issues with a particular focus on Hatch-Waxman patent and exclusivity, biosimilars, and the Orange Book. She helps drug and device manufacturers in various stages of product development and guides clients through the applicable regulatory requirements with respect to applications and submissions, device classification, potential exclusivities, promotional issues, and post-marketing requirements. Koblitz also counsels cosmetics, food, and dietary supplement clients, with experience regarding genetically-modified foods, medical foods, food labeling, and dietary supplement claims and substantiation.
Koblitz has authored several Citizen Petitions and has worked extensively with litigators and experts in preparation for depositions and trial. She has worked with companies of all sizes, from start-ups to fortune 500 companies. Koblitz also has experience in export control and other areas of regulatory law.
Prior to joining Hyman Phelps & McNamara, Koblitz practiced at a major intellectual property firm, where she counseled clients on the Hatch-Waxman Act and other areas of FDA regulation. Prior to that she worked on general FDA regulatory matters at an AmLaw 100 firm. While in law school, Koblitz clerked at the FDA Office of Policy and the Humane Society of the United States.
Kurt 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, Karst often leads the response to new rules and regulations, sharing his interpretation with the broader legal community.
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. 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.
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, Karst lobbied for F. Hoffmann-La Roche Inc. In 1995, he was awarded a Fulbright Scholarship for post-graduate studies in Germany.
Karin Hessler
Karin Hessler is the Chief Legal and Intellectual Property Officer for the Association for Accessible Medicines (AAM). She serves as a critical advisor in all aspects of advocacy, policy and internal operations. She also leads the AAM team on tariffs and trade, litigation, intellectual property and internal governance work.
Before joining AAM in March 2019, Hessler was a partner at Wiley Rein LLP, where she represented clients on intellectual property matters, with a special focus on patent litigation in the biotechnology and medical device industries. She has played a lead role in all phases of numerous Hatch-Waxman litigations, including expert discovery, fact discovery, claim construction, trials, regulatory analysis and settlement negotiations. Karin has significant experience in FDA regulatory issues as well as IPR process.
Hessler received her J.D. from NYU School of Law, an M.A. in biochemistry from Duke, and her B.S. in biochemistry from Lafayette College.
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