FDA in the Twenty-First Century : : The Challenges of Regulating Drugs and New Technologies / / ed. by Holly Fernandez Lynch, I. Glenn Cohen.

• Superior document: Title is part of eBook package: De Gruyter Columbia University Press Complete eBook-Package 2014-2015
• MitwirkendeR: Barnes, Mark,; Bierer, Barbara,; Boyd, Marie,; Carpenter, Daniel,; Charo, R. Alta,; Cohen, I. Glenn,; Copeland, Katrice Bridges,; Cortez, Nathan,; Devine, Jennifer,; Digilova, Alla,; English, Andrew,; Evans, Barbara J.,; Gibson, Shannon,; Grabowski, Henry,; Greene, Jeremy,; Greenwood, Kate,; Grossman, Lewis A.,; Hutt, Peter Barton,; Kahn, Jonathan,; Kesselheim, Aaron S.,; Klasmeier, Coleen,; Lemmens, Trudo,; Levitt, Geoffrey,; Li, Rebecca,; Lietzan, Erika,; Lynch, Holly Fernandez,; Mello, Michelle M.,; Miller, Frances H.,; Moffitt, Susan,; O’Leary, Patrick,; Parasidis, Efthimios,; Pham-Kanter, Genevieve,; Pike, Elizabeth R.,; Price, W. Nicholson,; Rai, Arti,; Redish, Martin H.,; Riley, Margaret Foster,; Robertson, Christopher,; Roin, Benjamin N.,; Rosenberg, David,; Ruger, Theodore W.,; Sklamberg, Howard,; Spector-Bagdady, Kayte,; Yan, Huaou,
• HerausgeberIn: Cohen, I. Glenn,; Lynch, Holly Fernandez,
• Place / Publishing House: New York, NY : : Columbia University Press, , [2015]; ©2015
• Year of Publication: 2015
• Language: English
• Physical Description: 1 online resource (568 p.)

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.

Table of Contents

Frontmatter -- Contents -- Acknowledgments -- Introduction -- Chapter One. Historical Themes and Developments at FDA Over the Past Fifty Years -- PART ONE. FDA in a Changing World -- Introduction -- Chapter Two. A Global and Innovative Regulatory Environment for the U.S. FDA -- Chapter Three. FDA and the Rise of the Empowered Patient -- Chapter Four. After the FDA -- Chapter Five. The Future of Prospective Medicine Under the Food and Drug Administration Amendments Act of 2007 -- PART TWO. Preserving Public Trust and Demanding Accountability -- Introduction -- Chapter Six. Global Trends Toward Transparency in Participant-Level Clinical Trials Data -- Chapter Seven. Conflicts of Interest in FDA Advisory Committees -- Chapter Eight. The Crime of Being in Charge -- Chapter Nine. Recalibrating Enforcement in the Biomedical Industry -- PART THREE. Protecting the Public Within Constitutional Limits -- Introduction -- Chapter Ten. Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection -- Chapter Eleven. The FDCA as the Test for Truth of Promotional Claims -- Chapter Twelve. Why FDA’s Ban on Off-Label Promotion Violates the First Amendment -- PART FOUR. Timing Is Everything -- Introduction -- Chapter Thirteen. Speed Versus Safety in Drug Development -- Chapter Fourteen. Overcoming “Premarket Syndrome” -- Chapter Fifteen. FDA’s Public Health Imperative -- PART FIVE. Old and New Issues in Drug Regulation -- Introduction -- Chapter Sixteen. The Drug Efficacy Study and Its Manifold Legacies -- Chapter Seventeen. Drug Safety Communication -- Chapter Eighteen. Innovation Policy Failures in the Manufacturing of Drugs -- PART SIX. Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars -- Introduction -- Chapter Nineteen. From “Recycled Molecule” to Orphan Drug -- Chapter Twenty. FDA, Negotiated Rulemaking, and Generics -- Chapter Twenty-One. The “Follow-On” Challenge -- Chapter Twenty-Two. FDA Regulation of Biosimilars -- PART SEVEN. New Wine in Old Bottles -- Introduction -- Chapter Twenty-Three. Analog Agency in a Digital World -- Chapter Twenty-Four. Twenty-First-Century Technology with Twentieth-Century Baggage -- Chapter Twenty-Five. Device-ive Maneuvers -- Chapter Twenty-Six. A New Regulatory Function for E-Prescriptions -- Chapter Twenty-Seven. Race and the FDA -- Contributors -- Index