Where to Go from Here? The FDA RIF and Its Impact on the Medical Products Industry
June 25, 2025 | 2:00PM–3:30PM ET | Live Webinar
The FDA RIF and Its Impact on the
Medical Products Industry
Overview
June 25, 2025 | 2:00PM – 3:30PM ET | Live Webinar
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Speakers
E. Cartier Esham
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CEO and Founder, Esham Strategies, LLC
Biography
CARTIER ESHAM, is the CEO of Esham Strategies, a strategic consultancy firm in D.C. that works to empower thought leadership, disrupt the status quo and advance innovative health policy solutions. She also represents the Alliance for a Stronger FDA and serves as the organization’s Executive Director.
Prior to launching her own firm, she served as the serves as the Chief Scientific Officer at the Biotechnology Innovation Organization (BIO) where she managed and directed BIO’s policy development, advocacy, research and educational initiatives for BIO’s emerging companies team, the science and regulatory team, the infectious disease team, the industry analysis and research team, and the membership team.
Dr. Esham has over 20 years of health policy experience. Prior to joining BIO, Dr. Esham was a Vice President and Director of Research at Dutko Worldwide, a private consulting firm in Washington D.C., where she worked on a variety of environmental, education, science, technology, and health care related issues on the federal, state, and local levels. Dr. Esham has a Ph.D. in Microbiology from the University of Georgia, a master’s degree in Marine Biology from the University of North Carolina at Wilmington and a bachelor’s degree from the University of Kentucky.
Megan Elise Howard
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Associate, Covington & Burling LLP
Biography
MEGAN HOWARD is an Associate in the Food, Drug, & Device Group at Covington & Burling, where she provides strategic advice on a wide range of complex legal and regulatory issues involving FDA oversight. Her practice focuses on issues related to clinical trials, approvals of drug and biological products, and medical product shortages. Prior to joining Covington & Burling, Megan spent nearly nine years working in various capacities in the Office of the Commissioner at the FDA. Megan began her FDA career as a 2014 Presidential Management Fellow (PMF) in the Office of Legislation and completed her PMF rotation with Ranking Member Patty Murray’s Health Policy Office on the Senate Health, Education, Labor, and Pensions Committee. Megan later served as the FDA Detailee to Chairman Frank Pallone’s professional staff on the House Energy & Commerce Committee, and a Senior Advisor to the Deputy Commissioner of the Office of Policy, Legislation, and International Affairs. Megan received her BA in political science and MPA in public policy from the Ohio State University, and her JD from Georgetown University Law Center.
Danielle C. Humphrey
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VP Compliance Officer & Chief Regulatory Counsel, Becton Dickinson (BD)
Biography
DANIELLE HUMPHREY joined Becton, Dickinson and Company (BD) in November 2019 as Associate General Counsel, Regulatory Law and Compliance Officer for Life Sciences. She now serves as VP, Compliance Officer and Chief Regulatory Counsel, and a member of the Law Group’s Leadership Team. Danielle leads a group of Regulatory attorneys focusing on medical device regulatory, environmental, global trade, and U.S. government contracting matters. She is responsible for the oversight and effective implementation of the BD compliance program in the Life Sciences and Medical Segments and provides legal advice and strategic counsel on a wide range of regulatory matters. She is a core member of BD’s legal team helping drive the company’s mission, protecting the Company, and serving as a trusted advisor and strategic leader within the legal department and company. She provides tactical support and serves as a strategic legal partner to BD’s Regulatory, Quality, Medical Affairs, Sales and Marketing, and Product Development teams.
Prior to joining BD, Danielle was Counsel at Hogan, Lovells US LLP, where she advised clients on the U.S. Food and Drug Administration’s (FDA) regulation of medical devices and combination products. Danielle’s legal practice focused on analyzing complex legal challenges and developing innovative regulatory strategies to drive submissions and compliance, advertising and promotion, government and internal investigations, and corporate transactions. Danielle also brings legal and industry experience from her time as Assistant General Counsel for Wal-Mart, where she provided counsel to Wal-Mart and Sam’s Club regarding health and wellness related innovations, business ventures and regulatory compliance.
Danielle currently serves as a Board Member for the CAO Research Foundation. This foundation is a non-profit organization whose mission is to improve patient’s lives through collaborative support of orthopaedic and muscular skeletal research.
Danielle earned a Sc.B. with honors in Psychology from Brown University, and her J.D. from the Duke University School of Law. Danielle currently lives in Mountain Lakes, NJ with her husband and three children.
Kurt R. Karst
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Director, Hyman, Phelps & McNamara, P.C.
Biography
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.
Moderated By Rachel Turow
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Of Counsel, Skadden, Arps, Slate, Meagher & Flom LLP
Biography
RACHEL TUROW is Lead Counsel, FDA Regulatory at Walmart. Turow has over 17 years of experience as an FDA regulatory lawyer, with expertise in healthcare and pharmaceutical industries. She also spent five years at the FDA. She and her team provide regulatory legal advice to Walmart’s business on OTC drugs, dietary supplements, medical devices, and food safety as well as counsel on other regulatory issues affecting these products as they arise. Prior to joining Walmart, Rachel was Associate General Counsel, Regulatory Law & Policy; and Head of U.S. Regulatory Policy at Teva Pharmaceuticals where she focused on legal and policy issues affecting the approval and uptake of innovative medicines, generic drugs, and biosimilars. She also served as Director of Regulatory Policy for Novo Nordisk, a leading global healthcare company, where she strategically responded to FDA policy and regulatory issues related to the company’s pipeline of products. During her five years at the FDA, Rachel focused on drug and medical device regulation. She served as Special Assistant to the Center Director at the Center for Devices and Radiological Health, and as Regulatory Counsel at the Office of Regulatory Policy in the Center for Drug Evaluation and Research. At the start of her career, Rachel was a corporate lawyer at United Therapeutics. She holds a degree in Human Biology from Stanford University and earned her Juris Doctor and a Master of Public Heath from the University of Michigan. She lives in McLean, Virginia, with her husband and three children.
