SEC Enforcement Activity: Public Companies and Subsidiaries

Jonathan P. Jarow

CEO and Founder, FDA Solutions LLC;
Former Chief Medical Officer, Office of Device Evaluation (CRDH),
Former Senior Medical Advisor to the Center Director (CDER),
Food and Drug Administration (FDA)

Jonathan Jarow is an expert on the FDA’s regulation of innovative pharmaceutical products and medical devices. A board-certified physician, he is the founder and CEO of FDA Solutions LLC, a consulting firm serving FDA-regulated companies.

Prior to founding FDA Solutions, Dr. Jarow spent almost ten years at the FDA in various leadership roles. He has been a primary clinical reviewer of investigational new drugs (INDs), new drug applications (NDAs), Biologics License Applications (BLAs), and Premarket Approvals (PMAs). In addition, he has led multidisciplinary professional staff in the development of high-priority FDA policies and programs. Dr. Jarow’s policy and implementation experience includes expedited drug development and approval pathways, drug recalls, rare diseases, human factor studies, software as a medical device, drug pricing, product labeling, and advertising and promotion.

Before joining the FDA, Dr. Jarow was Professor of Urology, Pathology, Radiology, and Biochemistry & Molecular Biology at Johns Hopkins University School of Medicine. He also served as clinical investigator for industry-sponsored clinical trials. Dr. Jarow’s clinical practice at Johns Hopkins focused on traditional and robotic surgery. Previously, he was associate professor of urology and obstetrics/gynecology at Wake Forest University’s Bowman Gray School of Medicine.

Dr. Jarow is the author of more than one hundred peer-reviewed publications. His research has appeared in the Journal of the American Medical Association (JAMA), the New England Journal of Medicine, and Nature Reviews Drug Discovery, among others.

Dr. Jarow has served as an expert witness and has extensive deposition and trial experience, including in federal, state, and international arbitration courts.

Alice Chen

Associate Professor,
Sol Price School of Public Policy;
Senior Fellow,
Leonard D. Schaeffer Center for Health Policy and Economics,
University of Southern California

Alice Chen specializes in health economics and labor economics. Professor Chen has expertise in a range of issues involving healthcare and pharmaceutical firms, including pharmaceutical competition and innovation, healthcare labor markets, and provider payment models.

Professor Chen has served as a consulting damages expert on life sciences matters, estimating the impact of allegedly false pharmaceutical marketing on prescription drug sales. In healthcare matters, she has offered written and deposition testimony on health insurance plan design in relation to class certification. She has testified at trial on statistical analyses of clinical trial data and regulatory drug approval. Professor Chen has also provided healthcare consulting services to pharmaceutical companies, including analyses of drug clinical trial data.

Professor Chen’s research has focused on improving the efficiency of healthcare markets, biologics and biosimilars innovation and competition, and the drivers and impacts of healthcare provider behavior. Her recent research analyzes the impact of Medicare policies on provider treatment decisions and healthcare outcomes and potential impacts of the Inflation Reduction Act on drug competition, pricing, and innovation. Professor Chen has presented her work before regulators at the Federal Trade Commission and the Congressional Budget Office.

Professor Chen has published articles in leading economics, health policy, and medical journals, including the American Economic Journal: Economic Policy, Health Affairs, JAMA Internal Medicine, and the Journal of Health Economics. Her research has also been cited in major media outlets, including Bloomberg, CBS News, Forbes, the New York Times, and the Washington Post.

At USC Price, Professor Chen teaches undergraduate- and graduate-level courses in health economics and health finance. The USC Health Administration Graduate Program has recognized her as Outstanding Faculty of the Year.

Donna L. Hoffman

Professor of Marketing,
Louis Rosenfeld Distinguished Scholar,
GW School of Business,
The George Washington University

Donna Hoffman is a world-renowned expert in online consumer experience and behavior, including how consumers react to information and disclosures in digital and online settings. Professor Hoffman is also a leading scholar on the impact of artificial intelligence (AI) and the Internet of Things (IoT) on consumer perceptions and behavior. She has extensive experience with survey methods and content analysis.

Professor Hoffman has testified in multiple matters, including in two federal trials. Her testimony in these matters included evaluating and opining on issues relating to online consumer behavior, digital marketing, and the role of internet search in the purchase decision process. Professor Hoffman has also applied her expertise to evaluate allegations of dark patterns in online user interfaces and their influence on user perceptions, decisions, and behavior. Some of her work in these contexts has involved data privacy issues.

Professor Hoffman cofounded and codirects the Center for the Connected Consumer, an academic research center dedicated to understanding consumer experiences with AI and smart devices that are connected to the internet.

Professor Hoffman’s research has appeared in top academic and managerial publications, such as Marketing Science, Management Science, the Journal of Marketing Research, the Journal of Marketing, the Journal of Consumer Research, and the Journal of Consumer Psychology. She currently serves on the editorial boards of leading academic publications in the marketing discipline, as well as serving as an associate editor at the Journal of Marketing. She coedited the book Beyond the Basics: Research-Based Rules for Internet Retailing Advantage and has coauthored numerous book chapters focused on consumer behavior in online environments.

One of the most highly cited scholars in the marketing field, Professor Hoffman has received many prestigious research awards. These include the Society for Consumer Psychology Fellow Award; the Robert B. Clarke Educator of the Year Award from Marketing EDGE (formerly the DMEF); the Sheth Foundation/Journal of Marketing Award for long-term contributions to the marketing discipline; and the William O’Dell/Journal of Marketing Research Award for long-term research impact.

Professor Hoffman has consulted to major corporations on electronic commerce and digital marketing strategy, including FedEx.com, Intel, Lands’ End/Sears, Microsoft, Procter & Gamble, and Walmart.com. She also served as a member of the Procter & Gamble Digital Advisory Board.