[#DIV28M] FW: [CPDD] Action Required: WHO International Ketamine Rescheduling

Please see below for something that is likely of interest to Division 28 members.

William W. Stoops, Ph.D.
email: william.stoops@uky.edu
phone: (859) 257-5383
facsimile: (859) 257-7684

Associate Professor
University of Kentucky College of Medicine
Department of Behavioral Science
Department of Psychiatry
Center on Drug and Alcohol Research
University of Kentucky College of Arts and Sciences
Department of Psychology

Regulatory Knowledge and Support Core
University of Kentucky Center for Clinical and Translational Science

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From: College on Problems of Drug Dependence [CPDD@LISTS.VCU.EDU] on behalf of Connie Pollack [cayladati@GMAIL.COM]
Sent: Friday, October 09, 2015 10:46 AM
Subject: [CPDD] Action Required: WHO International Ketamine Rescheduling

Dear Member,

The NABR Update - Communicating Science Policy to the Biomedical Research Community since 1979
October 8, 2015

Action Required: WHO International Ketamine Rescheduling

The World Health Organization (WHO) is considering a change to the international scheduling of ketamine, proposed by China. YOUR ACTION IS NEEDED to ask the FDA to protect doctors' and veterinarians' access to this critical drug. Elevating international regulation of ketamine as a Schedule 1 drug could mean that it will be very difficult, if not impossible, for U.S. practitioners to use.
On October 5, the U.S. Food and Drug Administration (FDA) issued a request for comments regarding the abuse potential, actual abuse, medical usefulness, trafficking and impact of scheduling changes on the availability for medical use of 10 drug substances – including ketamine. The comments, DUE THURSDAY, OCTOBER 15, will be considered as FDA prepares a response to the WHO regarding the abuse liability and diversion of these drugs and will be provided to the 36th Expert Committee on Drug Dependence (ECDD), which will meet in Geneva November 16-20.
NABR has drafted a letter to the FDA that generally explains how critical ketamine is to veterinary and human medicine and how important it is that it remain accessible to biomedical research. We encourage you to use this template as a starting point to submit your own letter to the FDA. Below are the question(s) WHO has asked be addressed in your response:
• Ketamine use in clinical settings - when is ketamine the anesthetic, sedative or analgesic agent of choice for any of the following: emergency situations; conducting procedures with pediatric patients; short surgical procedures; long surgical procedures; surgery conducted outside a hospital without respiratory support facilities; and other.
• Veterinary therapeutic indications approved for ketamine (choices offered: anesthesia; pain management; sedation; no approved uses; other). 
• Current use of ketamine in medical or scientific research (including clinical trials). 
Comments can be filed at Regulations.gov. 


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