Sent via Electronic and U.S. Mail

October 13, 2015

James R. Hunter Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, rm. 1061 Rockville, MD 20852

Re: Docket No. FDA-2015-N-0045 for International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Ketamine; Phenazepam; Etizolam; 1-cyclohexyl-4-(1,2-diphenylethyl)-piperazine (MT-45); N-(1-Phenethylpiperidin- 4-yl)-N-phenylacetamide (Acetylfentanyl); α-Pyrrolidinovalerophenone (α-PVP); 4- Fluoroamphetamine (4-FA); para-Methyl-4-methylaminorex (4,4’-DMAR); para- Methoxymethylamphetamine (PMMA); 2-(ethylamino)-2-(3-methoxyphenyl)- cyclohexanone (Methoxetamine or MXE); Request for Comments

Dear Mr. Hunter:

This letter responds to the Food and Drug Administration’s (FDA) request for comments that appeared in the Federal Register on October 5, 2015, concerning International Drug Scheduling.

The Association of Public and Land-grant Universities (APLU) represents 237 public research universities, land-grant institutions, state university systems, and affiliated organizations. Many of our member institutions have veterinary and medical schools and nearly all our institutions have researchers and students who conduct biomedical research. On behalf of our institutional membership, APLU appreciates this opportunity to provide the FDA with comments.

APLU strongly objects to any attempt to alter the international regulation of ketamine that would result in increased difficulty for biomedical researchers to use this drug for legitimate and appropriate treatments.

The United States currently classifies ketamine as a Schedule III drug under the Controlled Substance Act (CSA). As such, strict regulations and safeguards are already in place to prevent its illegal use. As known to FDA, Schedule I drugs are defined as those with no currently acceptable medical use, a lack of accepted safety for use under medical supervision, and a high potential for abuse. Ketamine does not meet this definition, as it has important approved anesthetic uses in humans and animals, and it is already regulated appropriately and effectively by the CSA. Biomedical researchers regularly administer ketamine to sedate and provide analgesia for animals in their care. Restricting or eliminating access to this drug may unnecessarily halt countless pre-clinical research studies, many of which are federally-funded.

1307 New York Avenue, NW, Suite 400, Washington, DC 20005-4722  202.478.6040  fax 202.478.6046  www.aplu.org In contrast to the risk of restricting access to ketamine for its essential functions in legitimate and well-regulated biomedical research, stands the potential risk of abuse of the drug by unauthorized individuals. The World Health Organization reports that ketamine abuse in the United States and worldwide is uncommon, with less than 2% of the general population reporting that they had used ketamine at least once in their lifetime (WHO Critical Review Ketamine 2012). Elevating ketamine to a Schedule I drug with the accompanying restrictions of this classification is a disproportionate response to this risk, as it would unduly hamper U.S. biomedical research.

APLU appreciates this opportunity to provide FDA with these comments before the November 16-20 meeting of the World Health Organization’s 36th Expert Committee on Drug Dependence (ECDD).

Sincerely,

Peter McPherson