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[caption id="attachment_14184" align="alignright" width="300"] Use our template letter to personalize your own comments to the FDA for more impact.[/caption]
Update 10/13: We've been notified by AVMA members that they've been unable to submit comments electronically via the regulations.gov site. We've contacted the FDA to inquire about this problem. In the meantime, comments can still be mailed to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Update for clarification, 10/8: Ketamine is not controlled internationally under either the Psychotropic Convention or the Single Convention on Narcotic Drugs. The WHO Expert Committee on Drug Dependence reviewed ketamine at its 34th, 35th, and 36th meetings. On March 13, 2015, the UN Commission on Narcotic Drugs decided by consensus to postpone the consideration of a revised proposal concerning the recommendation to place ketamine in Schedule IV of the Psychotropic Convention and to request additional information from the WHO. The original proposal brought to the March meeting of the UN Commission on Narcotic Drugs by China was to place ketamine in Schedule I, and we have been given different opinions by FDA and DEA on whether a more stringent international scheduling of ketamine would impact the US’s classification. Hence AVMA’s concern and continued engagement and advocacy on this issue.
It appears that the World Health Organization (WHO) may be considering another proposed change to the international scheduling of ketamine, and the AVMA is seeking your help in asking the FDA to protect veterinarians' access to this critical drug.
In April, we informed you that the WHO had received a proposal from China to regulate ketamine hydrochloride as a Schedule 1 drug. The AVMA, in cooperation with the World Veterinary Association and the World Medical Association, fiercely advocated against this change, because international regulation of ketamine as a Schedule 1 drug could mean that it would no longer be available to U.S. practitioners. As a result of those advocacy efforts, ketamine was not rescheduled at that time.
But this week, on Oct. 5, the 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 will be considered as FDA prepares a response to the WHO regarding the abuse liability and diversion of these drugs.
The AVMA is drafting a letter to the FDA that will outline how critical ketamine use is in veterinary medicine and how important it is that it remain available to U.S. veterinarians as we treat our patients. But our voice is made stronger when it is joined by the voices of individual members. So we’re requesting your help during this urgent time to reinforce our message.
Will you consider writing to the FDA yourself to explain how critical ketamine is in veterinary medicine and why it must remain available to veterinarians? We’ve created a template letter that will allow you to personalize your response to make more impact. Comments are due to the FDA by Oct. 15 – next week – and the FDA’s comments will be provided to the 36th Expert Committee on Drug Dependence (ECDD), which will meet in Geneva Nov. 16-20.
Among the information requested by WHO is the following:
- 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)
Please submit your comments by Oct. 15 to the FDA regarding your professional use of ketamine and its importance to patient care. Detailed instructions for submitting comments either electronically or on paper can be found here:
Feel free to regulatorycommentsavma [dot] org (copy us) on your comments to the FDA, as this can also help guide us as we write the AVMA’s response. We will post our own letter with comments to the FDA on our website as soon as it’s completed.
Thank you in advance for helping us protect veterinarians’ ability to continue using ketamine to treat patients. Your voice will make ours even more powerful and effective in advocating on behalf of our member veterinarians and our patients.