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. FDAs 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 Agencys 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