Faculty Book Talk: I. Glenn Cohen and Holly Fernandez Lynch: FDA in the 21st Century: The Challenges of Regulating Drugs and New Technologies, Wednesday, October 28 at noon.

The Harvard Law School Library staff invites you to attend a book talk and panel discussion in celebration of Professor I. Glenn Cohen and Holly Fernandez Lynch’s recently published book, FDA in the 21st Century: The Challenges of Regulating Drugs and New Technologies (Columbia University Press).

Wednesday, October 28, 2015, 12:00 noon.
Harvard Law School Room WCC 2036 Milstein East C (Directions)
Sponsored by the Harvard Law School Library.
Lunch will be served.

FDA in the 21st Century


Ameet Sarpatwari

The talk will be moderated by Ameet Sarpatwari, Instructor in Medicine, Harvard Medical School, and Associate Epidemiologist, Brigham and Women’s Hospital.


Book talk panelists include:

Aaron Seth Kesselheim

Aaron Seth Kesselheim, Associate Professor, Harvard Medical School, and Director of the Program On Regulation Therapeutic And the Law (PORTAL), Brigham and Women’s Hospital.


Daniel Carpenter

Daniel Carpenter, Allie S. Freed Professor of Government, Harvard University, and Director of the Social Sciences program, Radcliffe Institute for Advanced Study, Harvard University.


I. Glenn Cohen is Professor of Law and Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics. He is one of the world’s leading experts on the intersection of bioethics (sometimes also called “medical ethics”) and the law, as well as health law. He also teaches civil procedure. Prof. Cohen’s current projects relate to health information technologies, mobile health, reproduction/reproductive technology, research ethics, rationing in law and medicine, health policy, FDA law and to medical tourism – the travel of patients who are residents of one country, the “home country,” to another country, the “destination country,” for medical treatment. His past work has included projects on end of life decision-making, FDA regulation and commodification.

He is the author of more than 70 articles and chapters and his award-winning work has appeared in leading legal (including the Stanford, Cornell, and Southern California Law Reviews), medical (including the New England Journal of Medicine, JAMA), bioethics (including the American Journal of Bioethics, the Hastings Center Report) and public health (the American Journal of Public Health) journals, as well as Op-Eds in the New York Times and Washington Post. Cohen is the editor of The Globalization of Health Care: Legal and Ethical Issues (Oxford University Press, 2013), the co-editor of Human Subjects Research Regulation: Perspectives on the Future (MIT Press, 2014, co-edited with Holly Lynch, introduction available here), and the author of Patients with Passports: Medical Tourism, Law, and Ethics (Oxford University Press, 2014).

Cohen was selected as a Radcliffe Institute Fellow for the 2012-2013 year and by the Greenwall Foundation to receive a Faculty Scholar Award in Bioethics. He is currently one of the key co-investigators on a multi-million Football Players Health Study at Harvard which is committed to improving the health of NFL players. He leads the Ethics and Law initiative as part of the multi-million dollar NIH funded Harvard Catalyst | The Harvard Clinical and Translational Science Center program. He is also one of three editors-in-chief of the Journal of Law and the Biosciences, a peer-reviewed journal published by Oxford University Press.

Holly Fernandez Lynch is Executive Director of the Petrie-Flom Center. As Executive Director, Holly is responsible for oversight of the Center’s sponsored research portfolio, event programming, fellowships, student engagement, and a range of other projects and collaborations. She is Co-Lead of the Law and Ethics Initiative of the Football Players Health Study at Harvard University, as well as Co-Lead of the Center’s Involvement with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst, Harvard’s Clinical and Translational Science Center. In addition, she is Co-Editor of the Center’s collaborative health policy blog, Bill of Health.

Holly’s scholarship focuses on law, bioethics, and health policy, in particular the regulation and ethical conduct of research with human subjects domestically and internationally, pharmaceutical development and regulatory policy, conflicts of conscience in health care, medical professionalism, conflicts of interest, and religion in health care. She published Conflicts of Conscience in Health Care: An Institutional Compromise in 2008 (MIT Press), and released a co-edited volume from MIT Press in 2014 called Human Subjects Research Regulation: Perspectives on the Future. She has served as Lecturer on Law at Harvard Law School, teaching a course on “Bioethics in the Courts,” as well as lecturer for Harvard Catalyst courses on “Introduction to Translational Medicine” and “Fundamentals of Clinical and Translational Research.” In 2014, Holly was appointed as a member of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), U.S. Department of Health and Human Services.



“In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good.

The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA’s successes and failures, contributors rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions in other countries.” — Columbia University Press

Recent Reviews:

“The book contains a concise historical account of FDA regulation and insightful analyses of the major challenges the FDA will face over the next quarter century. The contributors, drawn from a variety of fields, are all authorities on the issues at hand. Although they certainly do not share the same opinions, their disagreements make the book remarkably balanced. Essential reading.” — Anup Malani, University of Chicago

“A truly magisterial collection, FDA in the 21st Century is a must-read for academics, practitioners, and social scientists interested in the future of drug and device regulation. The contributors offer thoughtful and well-researched policy approaches on conundrums facing the FDA itself, and similar agencies around the world. Bravo!” — Frank Pasquale, University of Maryland, Carey School of Law

“This insightful and informative book draws on a variety of perspectives to chart a course for FDA — and society — as we confront the challenges of medical product regulation in the 21st Century. It should be read by regulators and the regulated alike, as well as by patients, policymakers, payers, physicians, pharmacists — indeed, by anyone interested in human health.” — Daniel Troy, General Counsel, GlaxoSmithKline PLC; Chief Counsel, FDA, 2001-2004

“FDA in the 21st Century lives up to its title. Drawing on the historical evolution of the FDA, this book lays out, in a clear and thoughtful manner, the key questions for the future. At a time when scientific opportunities are presenting at lightning speed, and the expectations of the public for transparency, personalized medicine, and safety have never been greater, this is an important book.” — Amy Rick, Food & Drug Law Institute

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