Food and Drug Administration
September 9-10, 2003
Briefing Infomation
Disclaimer
The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
Table of Contents (PDF)
Tab 1. Memorandum Regarding Overview of the September 9 and 10 Meeting of the Anesthetic & Life Support Drugs Advisory Committee to Discuss Risk Management Plans for Extended-Release Opiate Analgesic Drug Products, Dr. Bob Rappaport, MD, FDA (PDF)
Tab 2. Draft Concept Paper, Risk Management Programs, FDA (PDF)
Tab 3. Abuse Liability and Drug Scheduling: The Role of the FDA, Dr. Deborah Leiderman, MD, FDA (PDF)
Tab 4. CSS Abuse Liability Analysis of Palladone (hydromorphone HCI) Extended Release Capsules (PDF)
Canadian Approved Label, Product Monograph, Palladone XL® Hydromorphone Hydrochloride Controlled Release Capsules (PDF)
Hydromorphone Hydrochloride Interactions (PDF)
Progress Report From the Clinical Pharmacology Section of the NIDA Addiction Research Center, Dr. Donald jasinski, MD, et. al., Nat'l Institute on Drug Abuse (PDF)
Tab 5. Substance Abuse and Mental Health Services Administration
Nonmedical Pain Reliever Use: Data From the National Survey on Drug Use and Health, (PDF)
Drug Abuse Warning Network (PDF)
Tab 6. Reference Documents and Literature
The Controlled Substances Act, Title II of the Comprehensive Drug Abuse Preveniton and Control Act of 1970 (PDF)
Public Policy of ASAM, Consensus Document, Definitions Related to the Use of Opiods for the Treatment of Pain, AAPM, APS, ASAM (PDF)
Model Guidelines for the Use of Controlled Substances for the Treatment of Pain, Federal State Medical Boards of the United States, Inc. (PDF)
Prescription Drug Abuse: FDA and SAMHSA Join Froces, Michelle Meadows (PDF)
Tab 7. Risk Management Programs
Acitq® (oral transmucosal fentanyl citrate), Anesta Corp. (PDF)
Subutex (buprenorphine HCI and Suboxone (buprenorphine HCI/naloxone), FDA (PDF)
Tab 8. Patient Package Inserts
Actiq (PDF)
Oxycontin (PDF)
Avinza (PDF)
Subutex and Suboxone (PDF)
Tab 9. Executive Summary, Prescription Monitoring Work Groups of the National Alliance for Model State Drug Laws (PDF)
Tab 10. Report to the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives - Prescription Drugs, State Monitoring Programs Provide Useful Tool to Reduce Diversion, GAO (PDF)
Tab 11. Recommendations For Prescription Monitoring Programs - Prescription Monitoring Work Group of the National Alliance for Model State Drug Laws (PDF)
Bibliography (HTM) (PDF) (Word)