Prescription Drug Regulation, Cost, and Access: Current Controversies in Context

Instructor

Aaron Kesselheim

Professor of Medicine, Director of the Program On Regulation, Therapeutics, And Law, Brigham and Women's Hospital

Harvard University

Aaron S. Kesselheim MD JD MPH is a Professor of Medicine at Harvard Medical School and a faculty member in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital. Within the Division, Aaron created and leads the Program On Regulation, Therapeutics, And Law (PORTAL, www.PORTALresearch.org), an interdisciplinary research core focusing on intersections among prescription drugs and medical devices, patient health outcomes, and regulatory practices and the law. PORTAL is now among the most prolific independent academic centers focusing on these issues in the country (Twitter: @PORTAL_research, @akesselheim). Work by faculty members at PORTAL on this course has been supported by a grant from Arnold Ventures.

Author of over 350 publications in the peer-reviewed medical and health policy literatures, Aaron has testified before Congress on pharmaceutical policy, medical device regulation, generic drugs, and modernizing clinical trials, is a member of the FDA Peripheral and Central Nervous System Advisory Committee, and served on a National Academies of Science, Engineering and Medicine consensus committees on addressing the opioid epidemic and bioidentical hormone replacement. His work has also been funded by the Greenwall Faculty Scholar in Bioethics Program, the Commonwealth Fund, the Robert Wood Johnson Foundation, the Engelberg Foundation, the FDA, and AHRQ. Aaron is a core faculty member at the HMS Center for Bioethics, where he co-teaches a course on health policy, law, and bioethics and organizes a monthly policy and ethics seminar series. Aaron also serves as the Sidley Austin-Robert D. McLean Visiting Professor of Law at Yale Law School, where he teaches a yearly course on Food and Drug Administration Law. He is the editor-in-chief of the Journal of Law, Medicine, and Ethics and is a member of the Perspectives advisory board for the New England Journal of Medicine.

Instructor

Jonathan Darrow

Assistant Professor of Medicine, Program On Regulation, Therapeutics, And Law, Brigham and Women's Hospital

Harvard University

Jonathan J. Darrow joined the faculty of Harvard Medical School and the Program on Regulation, Therapeutics, and Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital in 2016, following service as Senior Law Clerk to a judge on the United States Court of Appeals for the Federal Circuit, the court that decides all patent appeals involving pharmaceuticals, biologics, and medical devices. He holds degrees in biological sciences / genetics, law, and business from Cornell, Duke, and Boston College, respectively, as well as a research doctorate in pharmaceutical policy and intellectual property theory from Harvard, where he also completed the LL.M. program. He has been qualified as a patent attorney since 2002. After admission to the California bar, Dr. Darrow worked on pharmaceutical litigation matters at Wiley Rein & Fielding in Washington , DC, served on the business law faculties of several universities, and explored the relationship between innovation policy and global health during stints at the World Trade Organization, the World Health Organization, and the World Intellectual Property Organization. He is a co-author of three textbooks, including Cyberlaw: Management & Entrepreneurship (2015) and The Legal and Ethical Environment of Business (2014). His scholarship on health policy and intellectual property has appeared in the British Medical Journal, the New England Journal of Medicine; the Journal of Law, Medicine & Ethics; the Stanford Technology Law Review; the Yale Journal of Health Policy Law & Ethics, and the Harvard Journal of Law & Technology, among many others, and he has testified before a committee of the Massachusetts legislature on an emerging issue of law and technology.

Instructor

Ameet Sarpatwari

Assistant Professor of Medicine, Assistant Director of the Program On Regulation, Therapeutics, And Law, Brigham and Women's Hospital

Harvard University

Ameet Sarpatwari is an Instructor in Medicine at Harvard Medical School, an Associate Epidemiologist at Brigham and Women’s Hospital, and Assistant Director of the Program On Regulation, Therapeutics, And Law (PORTAL) within the Division of Pharmacoepidemiology and Pharmacoeconomics. His research draws upon his interdisciplinary training as an epidemiologist and lawyer and focuses on the effects of laws and regulations on therapeutic development, approval, use, and related public health outcomes. Among other projects, he is currently examining the public health impact of risk evaluation and mitigation strategies, the comparative safety and effectiveness of authorized and non-authorized generics, and the effect of variation in state drug product selection laws on generic drug prescribing.

Dr. Sarpatwari completed his undergraduate studies at the University of Virginia, where he was a Jefferson Scholar. He studied epidemiology at the University of Cambridge, where his doctoral work centered on uncovering disease progression, treatment effectiveness, and co-morbid burden among adults patients with primary immune thrombocytopenia. He subsequently studied law at the University of Maryland as a John L. Thomas Leadership Scholar.

Dr. Sarpatwari is currently the Principal Investigator on a Greenwall Foundation Making a Difference in Real-World Bioethics Dilemmas grant and a Faculty Affiliate with the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Behavioral Insights Group at the Harvard Kennedy School. He teaches an annual course on Public Health Law at the Harvard T.H. Chan School of Public Health.