martes, 4 de abril de 2017

FDA Law Blog: Is it Scheduling or Rescheduling? DEA Issues Interim Rule on Oral Solutions of Dronabinol

FDA Law Blog: Is it Scheduling or Rescheduling? DEA Issues Interim Rule on Oral Solutions of Dronabinol

Posted: 04 Apr 2017 01:18 AM PDT
By John A. Gilbert, Jr. –

On March 23, 2017, DEA issued an Interim final rule “placing FDA-approved products of oral solutions containing dronabinol in schedule II of the CSA.” Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral solutions Containing Dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] in Schedule II, 82 Fed. Reg. 14815 (Mar. 23, 2017) (“Interim final rule”). The action was based on FDA’s recent approval for marketing of Syndros, a drug product consisting of dronabinol in an oral solution. The action is effective as of publication; however, comments and/or a request for hearing may be filed by April 24, 2017.

As a result of the Interim final rule, Syndros, or any FDA-approved oral solution of dronabinol, will be controlled in Schedule II. DEA and HHS found that dronabinol has a high potential for abuse and for physical dependence requiring placement in Schedule II. The rule also distinguished Syndros from the only other FDA-approved dronabinol formulation, Marinol. In 1999, Marinol was rescheduled from Schedule II to III based on evidence that its formulation in a capsule in sesame oil would limit its abuse potential. Schedules of Controlled Substances: Rescheduling of the Food and Drug Administration Approved Product Containing Synthetic Dronabinol [(-)-D9-(trans)-Tetrahydrocannabinol] in Sesame Oil and Encapsulated in Soft Gelatin Capsules From Schedule II to Schedule III, 64 Fed. Reg. 35928 (July 2, 1999). In particular, HHS and DEA found that the sesame oil concentration would limit the ability to alter the concentration of the drug and affect its route of administration. In the present rule, both HHS and DEA noted that oral solutions of dronabinol can be manipulated to allow concentrations to be smoked, vaped or some other route of administration. 82 Fed. Reg. at 14817.   Thus, both agencies found that Syndros should be controlled in Schedule II rather than Schedule III because it has a greater abuse potential then Marinol.

While the control of Syndros in Schedule II was not unexpected for the reasons cited above, DEA’s interpretation of the recent amendment to the Controlled Substance Act (“CSA”) scheduling provisions raises other issues.  

First, DEA declined to act on the HHS recommendation to reschedule all forms of dronabinol from Schedule I to Schedule II. As required under the CSA, 21 USC § 811(b), (c) and (f), on December 28, 2016, HHS provided DEA with its “eight-factor” analysis recommending to reschedule Syndros and dronabinol oral solutions from Schedule I to Schedule II. Id. at 14816.  HHS also recommended that all dronabinol formulations be rescheduled to Schedule II as well. However, DEA specifically declined to consider the HHS recommendation that all dronabinol products should be rescheduled to Schedule II. Instead, DEA limited the current Interim final rule to only FDA-approved products containing dronabinol in an oral solution. DEA characterized the HHS recommendation related to rescheduling of all forms of dronabinol as “outside the scope of the final rule.” Id. Nevertheless, HHS is now on record as recommending that DEA reschedule all formulations of dronabinol to Schedule II. It remains to be seen whether DEA believes it must now consider this recommendation in as separate rulemaking.

Second, DEA’s Interim final rule states that this action is a scheduling action while the HHS written recommendation viewed this as a rescheduling action. HHS recommended rescheduling of dronabinol and oral solutions containing dronabinol. However, DEA’s Interim final rule refers to the placement of oral solutions of dronabinol (Syndros) into Schedule II. DEA states that its legal authority for issuing the Interim final rule derives from the Improving Regulatory Transparency for New Medical Therapies Act, which requires DEA to initiate a scheduling action for new FDA-approved drugs within 90 days (see our previous post here). This requirement is codified at 21 U.S.C. § 811(j). DEA further states that the purpose of this law is to expedite scheduling of newly approved drugs that are currently in Schedule I or not controlled. In a footnote, the Agency stated that “in DEA’s view,” this law does not apply to the reformulation of a drug containing a substance already controlled in Schedule II-V. Id. at 14816, fan 1.

DEA takes a very narrow interpretation of the recent amendment to the CSA. The amended scheduling statute was intended to expedite the scheduling process but by referring to it as “expedited scheduling” DEA implies that it should be limited. However, the plain language of the law does not limit the 90 day scheduling requirement to drugs in Schedule I or drugs not currently scheduled. The law states that requirement to issue an interim rule not later than 90 days after transmission of the HHS recommendation shall apply to drugs with an abuse potential for which a new-drug application has been submitted to HHS, 21 USC § 811(f), and for which HHS recommends that DEA control such drug in schedules II-V, 21 U.S.C. § 811(j). Moreover, this section of the law specifically refers to § 811(a) which applies to actions to “transfer between such schedules”, or “ remove” a drug from any schedule. Thus, the statute does not support the apparent narrow scope of DEA’s interpretation for controlling a drug.

DEA’s characterization of this action as a drug “scheduling” and narrow interpretation of the 90 day requirement does not impact the “expedited” scheduling of Syndros. However, if DEA maintains this position, new drugs approved by FDA where HHS recommends rescheduling or descheduling, will not be subject to the 90 day rule which could mean scheduling delays of months if not years.

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