Food and Drug Administration

Center for Drug Evaluation and Research

Versailles Ballroom, Holiday Inn, Bethesda, MD

Anesthetic & Life Support Drugs Advisory Committee

Meeting Agenda

September 9-10, 2003

                                                                                                                                     

                    Please note the agenda times listed are subject to                     

                                                                           change as the meeting progresses                                                         

September 9, 2003

 

8:00 a.m.                                        Call to Order and Opening Remarks

 

                                                                                    Introduction of Committee

 

                                                                        Conflict of Interest (COI) Statement

 

8:15 a.m.                                        Opening Remarks                

 

                                                                        Risk Management of Opiate Analgesics

                                                                                                              

    8:30 a.m.                                        FDA’s Role in the Risk Management of

                                                Opiate Analgesics

 

    8:45 a.m.                                        The Controlled Substances Act and Sponsor Presentation

                                                          Risk Management

 

    9:00 a.m.                                        The Drug Enforcement Agency’s Role in Risk Management of

                                                          Opiate Analgesics

 

    9:15 a.m.                                        Review of Current Medical Practice, Clinical Use

                                                          and Benefit of Opiate Analgesic Treatment

                                                         

    9:45 a.m.                                        Break

 

    10:00 a.m.                                       Opiate Use Data

 

                  10:15 a.m.                                       Misuse and Abuse of Opiate Analgesics in the

                                                                        Medical Setting

 

                  10:45 a.m.                                       Opiate Abuse Data

 

                  11:45 a.m.                                       Prescription Opiate Diversion

                                                                                               

                  12:15 p.m.                                      Lunch

 

                  1:15 p.m.                                        Open Public Hearing

 

                                                                        Existing Risk Management Plans

 

                  2:15 p.m.                                        Goals of Risk Management Plans/

                                                                        Non-Opiate Risk Management Plans

                                                                                                             

                  2:45 p.m.                                        Break

 

                  3:00 p.m.                                        Current Opioid Risk Management Plans

                                                                                                                

                  3:30 p.m.                                        Committee Discussion

 

                  5:00 p.m.                                        Adjournment

 

Food and Drug Administration

Center for Drug Evaluation and Research

Versailles Room, Holiday Inn, Bethesda, MD

Anesthetic & Life Support Drugs Advisory Committee

Meeting Agenda

       September 9-10, 2003                       

                               Please note the agenda times listed are subject to          

change as the meeting progresses

 

September 10, 2003                                                                                       

                                                                                                                                        

                       8:00 a.m.                                                     Call to Order and Opening Remarks

 

                                                                        Conflict of Interest Statement

 

                  8:45 a.m.                                        Sponsor Presentation (Purdue Pharma, L.P.)

                                                                             

                                                                                          Introductory Comments

                                                                       

                                                                        Palladone Risk Management Plans

                                                                       

                                                                        Concluding Remarks

                                                                                               

                  9:45 a.m.                                        Questions from the Committee

                                                                       

                  10: 00 a.m.                                      Abuse Liability

 

                  10:30 a.m.                                       Break

 

                  10:45 a.m,                                       Long Acting Opiates: Challenges and Risks

 

                  11:15 a.m.                                       FDA Presentation

 

                  12:15 p.m.                                      Open Public Hearing

 

                  12:45 p.m.                                      Lunch

                                                                         

                       1:45 p.m.                                        Committee Discussion

 

                  3:00 p.m                                          Break

 

                  5:00 p.m.                                        Adjournment