Publication: Protecting the Ignorant, the Unthinking and the Credulous: Are the FDA's Efforts to Accelerate the Drug Approval Process Compromising Public Safety?
Open/View Files
Date
2000
Authors
Published Version
Published Version
Journal Title
Journal ISSN
Volume Title
Publisher
The Harvard community has made this article openly available. Please share how this access benefits you.
Citation
Protecting the Ignorant, the Unthinking and the Credulous: Are the FDA's Efforts to Accelerate the Drug Approval Process Compromising Public Safety? (2000 Third Year Paper)
Research Data
Abstract
Recently, five approved prescription drugs were recalled in a one-year period after the Food and Drug Administration (FDA or the agency) deemed them to be too unsafe for patient use. Notorious among them was fenfluramine (Pondimin), the "fen" half of "fen-phen," a drug used to promote weight loss in patients. The list also includes Seldane, a popular antihistamine as well as Redux, Posicor, and the pain medication Duract. All had side effects not detected in clinical trials. This unusually high rate of withdrawals in such a short period of time sparked the most recent round of debate over the ever-controversial topic of the FDA drug approval process.
Description
Other Available Sources
Keywords
Food and Drug Law, FDA, recall, approval, access, safety, drugs
Terms of Use
This article is made available under the terms and conditions applicable to Other Posted Material (LAA), as set forth at Terms of Service