July 24, 2003


Dear Pain Management Advocate:


In response to your request to be informed regarding regulatory and other matters related to pain management advocacy, the following meeting might be of interest to you and/or your constituency.  The FDA Anesthetic and Life Support Drugs Advisory Committee has scheduled a meeting to discuss Risk Management Plans for opiate analgesic drug products with particular attention to modified-release products.  The announcement is listed below for your reference.  The schedule and contact information is as follows:

DATE AND TIME:  The meeting will be held on September 9 and 10, 2003 from 8 a.m. to 5 p.m.

LOCATION:  Holiday Inn, Versailles Ballrooms, 8120 Wisconsin Avenue, Bethesda, MD

CONTACT: Johanna Clifford, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, Rm. 1093, 5630 Fishers Lane), Rockville, MD 20857.

Telephone: 301-827-7001; Fax: 301-827-6772

Email: clifford@cder.fda.gov

Electronic comments should be submitted to http://www.fda.gov/dockets/ecomments.  Select “2003N-0294 Opiate Risk Management” and follow the prompts to submit your statement.  Written comments should be submitted to the Dockets Management Branch, HFA-305, Food and Drug Administration, Rm.1061, 5630 Fishers Lane, Rockville, MD 20852.

AGENDA: See attached schedule for the details of the agenda for each day.

PROCEDURE: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.  Written submissions may be made to the contact person by September 2, 2003.   Oral presentations from the public will be scheduled between approximately 11:30 A.M. and noon on both days.  Those interested in making formal oral presentations should notify the contact person before September 2, 2003, and submit a brief statement summarizing the general nature of the evidence or arguments to be presented, the names and addresses of proposed participants, and an indication of the approximate length of time requested to make their presentation.


For additional information, you can visit the FDA website at http://www.fda.gov/cder and click on Advisory Committee.  Follow the prompts to the September Calendar. You may also call the FDA Advisory Committee Information line at (800) 741-8138 or, in the Washington, DC area, at (301) 443-0572.  The FDA Anesthetic and Life Support Drugs Advisory Committee has code number 12529.




Patient Advocacy