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Accutane

Send Congressman Bart Stupak a Message at stupak.public.accutane@mail.house.gov.
Please include your name, home address, zip code and phone number.

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

  1. Stupak Response to FDA Advisory Panel Recommendations Regarding Mandatory Accutane Registry dated 2/27/04
  2. Stupak Statement to FDA Advisory Panel Hearing on Accutane SMART Voluntary Registry dated 2/27/04 (PDF - 8 pages)
  3. Congressman Bart Stupak's Statement, 10/5/00
  4. Background Information
  5. FDA Memorandum dated 2/23/98
  6. FDA "MedWatch" dated 2/26/98
  7. FDA's Warning Letter to Roche dated 3/5/98 (PDF - 4 pages)
  8. FDA's May 1, 2000 letter to Roche (PDF - 16 pages)
  9. Summary of Accutane Serious Adverse Events (PDF - 21 pages 35KB)
  10. Accutane Adverse Events Report
  11. Roche Delivers Different Labeling In Same Box
  12. Recommendations
  13. Detailed Chronology
  14. File an Adverse Event Report with FDA or call FDA @ 800-FDA-1088
  15. Correspondence
  16. Revised Informed Consent/Patient Agreement (PDF - 3 pages 144KB)
  17. Accutane Medication Guide (PDF - 6 pages 792KB)
  18. Other Accutane Links
  19. Accutane Safety and Risk Management Act
  20. Dr. Bremner Abstract on Study Showing Accutane's Affect on the Brain (PDF - 9 pages)
  21. Brain Scan from Dr. Bremner's Showing Accutane's Affect on the Brain (PowerPoint - 1 Slide)
  22. May 8, 2003 Letter - Stupak's Report To Chairman James C. Greenwood (PDF - 2 pages)
  23. FDA Commissioner Andrew von Eschenbach's Letter to Congressman Stupak (PDF - 2 pages)
  24. Stupak's Statement to FDA's Advisory Committee hearing on iPLEDGE dated 08-01-2007