Accutane
Send Congressman Bart Stupak a Message at stupak.public.accutane@mail.house.gov.
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Accutane Hearing Held December 11, 2002
The Subcommittee on Oversight and Investigations of the House of Representatives Energy and Commerce Committee held a hearing on Wednesday, December 11, 2002, to investigate "Issues Relating to the Safety of Accutane". Witnesses included involved family members, Food and Drug Administration officials, national experts on Accutane-caused birth defects and the Chief Executive Officer of Hoffman-LaRoche, Inc.
Congressman Bart Stupak's Accutane Hearing Press Release
Congressman Bart Stupak's Opening Statement
House Committee on Energy and Commerce - Full Hearing Webcast
Table of Contents
- Stupak Response to FDA Advisory Panel Recommendations Regarding Mandatory Accutane Registry dated 2/27/04
- Stupak Statement to FDA Advisory Panel Hearing on Accutane SMART Voluntary Registry dated 2/27/04 (PDF - 8 pages)
- Congressman Bart Stupak's Statement, 10/5/00
- Background Information
- FDA Memorandum dated 2/23/98
- FDA "MedWatch" dated 2/26/98
- FDA's Warning Letter to Roche dated 3/5/98 (PDF - 4 pages)
- FDA's May 1, 2000 letter to Roche (PDF - 16 pages)
- Summary of Accutane Serious Adverse Events (PDF - 21 pages 35KB)
- Accutane Adverse Events Report
- Roche Delivers Different Labeling In Same Box
- Recommendations
- Detailed Chronology
- File an Adverse Event Report with FDA or call FDA @ 800-FDA-1088
- Correspondence
- Revised Informed Consent/Patient Agreement (PDF - 3 pages 144KB)
- Accutane Medication Guide (PDF - 6 pages 792KB)
- Other Accutane Links
- Accutane Safety and Risk Management Act
- Congressman Stupak Press Release (PDF - 1 page)
- Congressman Stupak Statement
- Background and Legislative Summary
- Side-by-Side of Legislation and Roche Plan (PDF - 1 page)
- Recommendations made by Members of Congress in 2000
- Accutane Serious Adverse Events 1998-2000 (PDF - 1 page)
- Serious Psychiatric and Childbirth Events (PDF - 2 pages)
- Adverse Event Data from the Last Quarter of 1999 (PDF - 1 page)
- Accutane Safety and Risk Management Act (PDF - 11 pages)
- March of Dimes Endorsement Letter (PDF - 1 page)
- Dr. Bremner Abstract on Study Showing Accutane's Affect on the Brain (PDF - 9 pages)
- Brain Scan from Dr. Bremner's Showing Accutane's Affect on the Brain (PowerPoint - 1 Slide)
- May 8, 2003 Letter - Stupak's Report To Chairman James C. Greenwood (PDF - 2 pages)
- FDA Commissioner Andrew von Eschenbach's Letter to Congressman Stupak (PDF - 2 pages)
- Stupak's Statement to FDA's Advisory Committee hearing on iPLEDGE dated 08-01-2007