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96 Geo. L.J. 461 (2007-2008)
A Critical Examination of the FDA's Efforts to Preempt Failure-To-Warn Claims

handle is hein.journals/glj96 and id is 464 raw text is: A Critical Examination of the FDA's Efforts To Preempt Failure-To-Warn Claims DAVID A. KESSLER* AND DAVID C. VLADECK** TABLE OF CONTENTS INTRODUCTION .......................................... 462 A. EVOLUTION OF THE FDA'S NEW PREEMPTION POLICY ............. 462 B. THE IMPACT OF THE FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007 .......................... 467 I. BACKGROUND ................................................ 469 II. FDA DRUG APPROVAL .. ..................................... 470 Ill. FDA LABELING DETERMINATIONS ARE SUBJECT TO CONSTANT REEVALUATION AND REVISION, AND FAILURE-TO-WARN LITIGATION DOES NOT THREATEN To DISPLACE THE FDA's ROLE AS FINAL DECISION-MAKER REGARDING A DRUG'S LABEL ................... 475 A. PREEMPTION OF FAILURE-TO-WARN CLAIMS WOULD REMOVE INCENTIVES FOR DRUG MANUFACTURERS TO UPDATE LABELS .... 476 B. THE FDA'S JUSTIFICATIONS FOR PREEMPTION ARE LEGALLY FLAWED ....... ......................................... 481 IV. THE FDA's POST-APPROVAL MONrrORING SYSTEM CANNOT, BY ITSELF, ASSURE DRUG SAFETY, AND FAILURE-To-WARN LITIGATION PROVIDES AN IMPORTANT BACKSTOP ....................... 483 A. THE FDA FACES RESOURCE LIMITATIONS ................... 484 * David A. Kessler, M.D., is the dean and vice chancellor for medical affairs at University of California San Francisco (UCSF) School of Medicine. © 2008, David A. Kessler, M.D. Before joining UCSF in the fall of 2003, Dr. Kessler had been Dean of the Yale University School of Medicine since July 1997. Dr. Kessler served as Commissioner of the United States Food and Drug Administration from November 1990 until March 1997. He was appointed by President George H.W. Bush and reappointed by President William J. Clinton. ** David C. Vladeck is a professor of law at Georgetown University Law Center and Director of the Center on Health Regulation and Governance of the O'Neill Institute at Georgetown University Law Center. © 2008, David C. Vladeck. Prior to joining the Georgetown faculty, Professor Vladeck was an attorney with Public Citizen Litigation Group, where he engaged in preemption litigation, arguing in favor of preserving state law damage remedies. The authors are grateful to Timothy and Linda O'Neill for their sponsorship of the O'Neill Institute. They also wish to thank Lisa Heinzerling, William B. Schultz, and Catherine Sharkey for their thoughts on this Essay, and Katie Stewart, Meagan Winters, and Susannah Foster for their research and editorial assistance.

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