A Critical Examination of the FDA's Efforts To Preempt Failure-To-Warn Claims

Kessler and Vladeck highlight what they believe are the two most problematic aspects of the FDA's pro-preemption position that do not stand out in more comprehensive treatments of the issue. The first point is that the FDA's pro-preemption arguments are based on a reading of the FDCA that...

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Bibliographic Details
Published inThe Georgetown law journal Vol. 96; no. 2; p. 461
Main Authors Kessler, David A, Vladeck, David C
Format Journal Article
LanguageEnglish
Published Washington Georgetown University Law Center 01.01.2008
Subjects
Descriptive labeling
FDA approval
Litigation
Pharmaceutical industry
Preemption
Prescription drugs
Safety
Side effects
State laws
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Summary:Kessler and Vladeck highlight what they believe are the two most problematic aspects of the FDA's pro-preemption position that do not stand out in more comprehensive treatments of the issue. The first point is that the FDA's pro-preemption arguments are based on a reading of the FDCA that understates the ability of drug manufacturers to change labeling unilaterally to respond to newly discovered risks, or to seek labeling changes from the FDA. While, the second concern is that the FDA's pro-preemption arguments are based on unrealistic assessment of the agency's practical ability--once it has approved the marketing of a drug--to detect unforeseen adverse effects of the drug and to take prompt and effective remedial action.
ISSN:0016-8092