AVMA, members push FDA to protect ketamine availability

Published on October 15, 2015
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Protecting access to critical drugsThe AVMA has submitted formal comments asking the U.S. Food and Drug Administration to work to protect veterinarians’ ability to continue using ketamine as needed to treat our patients, and we’d like to take this opportunity to thank all the member veterinarians who helped us in this effort.

We asked you last week to join your voices with ours in submitting comments on a very tight deadline set by the FDA, which is preparing comments to the World Health Organization (WHO) regarding the abuse liability and diversion of ketamine hydrochloride and nine other drugs. In response, more than 130 members submitted individual comments to the FDA and copied the AVMA in order to guide us as we crafted our own feedback. Members and non-members alike also shared the AVMA’s call to action and template letter on social media, and circulated them to members of other veterinary organizations.

We are awestruck and immensely grateful for your responses. The AVMA is recognized by local, state and federal governments as the collective voice of the entire veterinary profession, but your voices make ours stronger. Our work is both guided by and made more powerful with your input; together, we are able to more effectively advance our shared interests, values and goals.

Here are some of the key points we included in our comments to the FDA, which were submitted today (Thursday, Oct. 15):

  • Ketamine use is critical in veterinary medicine. Its availability to U.S. veterinarians must be protected in order for us to continue providing high-quality care to our patients.
  • Ketamine is a key component in veterinary medicine anesthetic protocols worldwide, and any regulatory action that limits its availability to the veterinary profession would gravely impact animal health and welfare.
  • Strict regulations and safeguards are in place in the United States to help prevent the illegal use of ketamine. U.S. veterinarians use the drug in accordance with these regulations.

Ketamine is not currently controlled internationally under either the Psychotropic Convention or the Single Convention on Narcotic Drugs. The WHO Expert Committee on Drug Dependence (ECDD) has reviewed ketamine several times and recommended each time that ketamine not be placed under international control. However, the committee plans to review ketamine again, along with a number of other drugs, at its upcoming 37th meeting in Geneva, Nov. 16-20.

The November review relates to a proposal pending before the U.N. Commission on Narcotic Drugs (CND) to control ketamine under Schedule IV of the 1971 Psychotropic Convention. Earlier this year, the AVMA became aware that China was proposing that ketamine be placed in Schedule I of the Psychotropic Convention. The AVMA advocated against this change, working with the World Veterinary Association and the World Medical Association, and the proposal was amended to suggest a Schedule IV designation. The CND then postponed consideration of that amended proposal, asking the WHO to gather more information.

The FDA last week issued a request for comments, due today, regarding the abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on the availability for medical use of ketamine and nine other drug substances. The agency said it would consider the comments in preparing a response to the WHO regarding the abuse liability and diversion of the 10 drugs, for the November meeting of the Expert Committee on Drug Dependence in Geneva.

Ketamine is currently a Schedule III drug in the United States under the Controlled Substance Act. The AVMA has received different opinions from the FDA and Drug Enforcement Administration on whether a more stringent international scheduling of ketamine would impact the U.S. classification.

If you would like to add your own voice to ask the FDA to protect veterinary access to ketamine, you can still do so – but all comments on the issue are due to the FDA no later than today, Oct. 15. We’ve created a template letter that you can quickly personalize and submit to the FDA. Detailed instructions for submitting comments either electronically or on paper can be found here:

https://www.federalregister.gov/articles/2015/10/05/2015-25201/international-drug-scheduling-convention-on-psychotropic-substances-single-convention-on-narcotic#h-6

Feel free to regulatorycommentsatavma [dot] org (subject: Ketamine) (copy us) on your comments to the FDA.