The following meeting notice was published in the Federal Register: The FDA Advisory Committee hearing on opioids, originally scheduled for mid June, has been postponed until September 13-14, 2001 from 8 AM to 5 PM both days at the University of Maryland Shady Grove Campus, Bldg 9630 Gudelsky Drive, in Rockville, MD.
On both days, the committee will discuss the medical use of opiate analgesics in various patient populations, including pediatric patients and patients with chronic nonmalignant pain, as well as the risk-to-benefit ratio of extending opiate treatment into these populations. It will also address concerns regarding the abuse potential, diversion and increasing incidence of addiction to opiate analgesics, especially to the modified release opiate analgesics.
The American Pain Foundation has serious concerns that the FDA may take action to address diversion and abuse of opioids which would have the unintended effect of restricting or inhibiting the legitimate prescribing and use of this class of drugs (see statement).
The entire meeting is open and the public is invited to attend without pre-registration. In addition, a portion of the meeting, the open-public hearing, is set aside so that the public may present relevant views to the committee.
IF YOU WISH TO SPEAK AT THE OPEN PUBLIC HEARING:
Please submit a statement of your position and how you can be contacted before the meeting. Email a statement of your position, name, address, fax and phone number to Kimberly Topper at firstname.lastname@example.org. The statements must be received by August 17, 2001. Presentations will be limited to 3-5 minutes. Any statement received after the deadline will be posted to the docket, but will not be sent to the committee nor will you be scheduled time to speak. The FDA does not pay for Open Public Hearing Speaker travel expenses.
IF YOU WISH TO SEND A STATEMENT FOR THE RECORD:
It is recommended that you send your statements via email to ensure prompt posting on the FDA's docket and distribution to committee members. If you wish to send in a statement to be posted, please go to: http://www.accessdata.fda.gov/scripts/oc/dockets/commentdocket.cfm . Select ; "Submit electronic comments" and follow the prompts. Letters will be posted under Docket Number 01N-0256 "Use of Opiate Analgesics in Various Patient Populations, including Pediatric Patients."
Letters/statements also may be mailed to:
Kimberly Topper; Food and Drug Administration, CDER,; Advisors and Consultants Staff, HFD-21; 5600 Fishers Lane; Rockville, MD 20857; email@example.com
Due to the overwhelming interest in this meeting and to time constraints, no statements will be read into the transcript by FDA staff. All statements received before the August 17th deadline will be available to the committee in advance.
MEETING INFORMATION AND COPIES OF MATERIALS SUBMITTED
For more information about this meeting and to obtain copies of meeting materials, please go to http://www.fda.gov/ohrms/dockets/ac/cder01.htm