FDA in the Twenty-First Century

The Challenges of Regulating Drugs and New Technologies

I Glenn Cohen editor Holly Fernandez Lynch editor

Format:Hardback

Publisher:Columbia University Press

Published:2nd Oct '15

Currently unavailable, and unfortunately no date known when it will be back

FDA in the Twenty-First Century cover

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. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.

Addresses perennial and new problems and the improvements the FDA can make to better serve the public good.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, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.

This book contains a concise historical account of FDA regulation and an insightful analysis of the major challenges the FDA faces over the next quarter century. The contributors, drawn from a variety of fields, are all authorities on the issues at hand. Although they do not share the same opinions, their disagreements make this essay collection remarkably balanced. Essential reading. -- Anup Malani, University of Chicago A truly magisterial collection, FDA in the Twenty-First Century is a must-read for academics, practitioners, and social scientists interested in the future of drug and device regulation. The book's contributors offer thoughtful and well-researched policy approaches on conundrums facing the FDA 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 the FDA-and society-as we confront the challenges of medical-product regulation in the twenty-first century. It should be read by regulators and the regulated alike, as well as by patients, policy makers, payers, physicians, pharmacists-anyone interested in human health. -- Daniel Troy, general counsel, GlaxoSmithKline PLC, and chief counsel of the FDA from 2001 to 2004 FDA in the Twenty-First Century lives up to its title. Drawing on the historical evolution of the FDA, this book lays out, in a clear and thoughtful manner, 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 and Drug Law Institute FDA in the Twenty-First Century does an excellent job of highlighting and explaining... it is a useful source for anyone interested in the nexus of modern medical bureaucracy. -- Devorah Goldman The Weekly Standard [These] essays provide an excellent survey of the growing challenges the FDA faces... Highly recommended. Choice Essential reading for anyone who wants to understand the powerful forces driving the FDA's evolution. -- Norman M. Goldfarb Journal of Clinical Research Best Practices This informative book is a valuable read for lawyers, policymakers, and anyone interested in public health. Harvard Law Review

ISBN: 9780231171182

Dimensions: unknown

Weight: unknown

568 pages