lunes, 17 de octubre de 2016

FDA Law Blog: Ut Oh ... Not So Fast ... DEA Withdraws Notice of Intent to Place Opioids Mitragynine and 7-Hydroxymitragynine – the Main Active Constituents of the Plant Kratom – in CSA’s Schedule I

FDA Law Blog: Ut Oh ... Not So Fast ... DEA Withdraws Notice of Intent to Place Opioids Mitragynine and 7-Hydroxymitragynine – the Main Active Constituents of the Plant Kratom – in CSA’s Schedule I



Posted: 13 Oct 2016 07:07 AM PDT
By Karla L. Palmer –

In a move unprecedented in recent memory, on October 13, 2016, DEA published a Withdrawal of Notice of Intent to Temporarily Place Mitragynine and 7- Hydroxymitragynine (i.e., kratom) in schedule I of the Controlled Substances Act.

As background, a little over a month ago, on August 31, 2016, DEA’s Administrator issued a notice of intent to temporarily schedule in schedule I of the Controlled Substances Act (CSA) the opioids mitragynine and 7-hydroxymitragynine. These opioids are the main active constituents of the plant kratom.  DEA took this action based on the Administrator’s finding that placement of these opioids into CSA’s schedule I was “necessary to avoid an imminent hazard to the public safety.”  Thus, any final order would impose administrative, civil, and criminal sanctions and regulatory controls applicable to schedule I controlled substances on the manufacture, distribution, possession, importation, and exportation of, and research and conduct of instructional activities of these substances

As DEA’s August 31st Notice of Intent stated, 21 U.S.C. § 811(h)(4), requires the Administrator to notify the Secretary of HHS of his intention to temporarily place a substance into schedule I of the CSA. The Administrator transmitted notice of his intent to place mitragynine and 7-hydroxymitragynine in schedule I on a temporary basis to the Assistant Secretary on May 6, 2016.  The Assistant Secretary responded on May 18, 2016, advising that, based on FDA’s review, there are “currently no investigational new drug applications or approved new drug applications” for mitragynine and 7-hydroxymitragynine. The Assistant Secretary also stated that HHS did not object to the temporary placement of mitragynine and 7-hydroxymitragynine in schedule I of the CSA.   DEA noted neither substance is currently listed in any CSA schedule, and there were no approved new drug applications or investigational new drug applications for the substances.

Importantly, to temporarily schedule a substance in schedule I, because of its “imminent hazard to the public safety,” the Administrator must consider only three of the eight statutory factors typically required for scheduling a controlled substance under 21 U.S.C. § 811(c): the substance's history and current pattern of abuse; the scope, duration and significance of abuse; and what, if any, risk there is to the public health. 21 U.S.C. §

811(h)(3). Consideration of these factors includes actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution. Id. § 811(h)(3). Temporary scheduling is only permitted for schedule I substances: those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. Id. § 812(b)(1).  Thus, considering the history and current pattern of abuse, the scope, duration and significance of abuse; and risk to the public health, as addressed in the Notice, DEA published its Notice of Intent concerning the substances, stating that after 30 days it could publish a final rule temporarily scheduling the substances for a period of up to two years.  DEA noted also that, although it believed the Notice was not subject to APA notice and comment requirements, the Administrator would “take into consideration any comments submitted by the Assistant Secretary with regard to the proposed temporary scheduling order.”

Although we are unsure yet whether the Assistant Secretary submitted comments, DEA stated in its October 13th Notice of Withdrawal of Intent that it had “received numerous comments from members of the public challenging the scheduling action and requesting the  Agency consider those comments and accompanying information before taking further action.  A check of the docket (DEA-442) did not reveal that any comments had been publicly posted, although DEA stated in its withdrawal notice it is reviewing comments it received by email and mail, and those comments do not need to be resubmitted.

A simple Google search of “Kratom,” however, shows a glimpse of the widespread and significant public outcry resulting from DEA’s emergency scheduling attempt. Others reported last week that DEA faced pressure from industry and Capitol Hill, including letters to DEA signed by several members of Congress requesting DEA to permit adequate time for stakeholders to comment or otherwise weigh in on the propriety of DEA’s temporary scheduling decision.

DEA’s Notice of Intent to Withdraw states the Agency will now receive from FDA its scientific and medical evaluation, and scheduling recommendation for the substances. See 21 U.S.C. § 811(b).  (DEA noted it previously requested FDA’s evaluation (which FDA is required to provide within a reasonable time under § 811)).  Not only do we look forward to reading FDA’s scientific and medical evaluation, and scheduling recommendation, but we also assume the public will file numerous comments addressing both the propriety of DEA’s decision and of kratom use generally.  DEA has established a comment period for docket number DEA-442, which will remain open until December 1, 2016.