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eBook details

• Title: Prescription for a Cure: Does the FDA's Draft Guidance Adequately Manage Advisory Committee Members' Conflicts of Interest?
• Author : Stanford Law & Policy Review
• Release Date : January 22, 2008
• Genre: Law,Books,Professional & Technical,
• Pages : * pages
• Size : 151 KB

Description

INTRODUCTION On November 16, 1999, the Gastrointestinal Drugs Advisory Committee of the Food and Drug Administration (FDA) recommended prompt approval of the drug Lotronex, used to treat women with irritable bowel syndrome. (1) Among the participants on the advisory committee was a paid consultant of the drug manufacturer, Glaxo, who had participated in the investigation of the drug for the company. (2) At the meeting, he acknowledged concerns about evidence that the drug caused some people to develop ischemic colitis, (3) but rather than delay approval of the drug he suggested "monitor[ing] it very carefully," with the expectation that complications would not prove too injurious. (4) The committee ultimately recommended approving the drug without further testing, and the FDA followed the committee's advice and formally approved Lotronex in February 2000. (5) Just nine months later, Glaxo withdrew the drug from the U.S. market after forty-nine patients taking Lotronex developed ischemic colitis and five died. (6) These and other similar events led to criticism of the FDA's handling of conflicts of interest from many fronts. (7)

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