FDA Law Blog: Still Not Ready for Prime Time: DEA Denies Joint Petitions to Reschedule Marijuana

FDA Law Blog: Still Not Ready for Prime Time: DEA Denies Joint Petitions to Reschedule Marijuana

Still Not Ready for Prime Time: DEA Denies Joint Petitions to Reschedule Marijuana Posted: 25 Aug 2016 02:21 AM PDT By John A. Gilbert, Jr. & Larry K. Houck – We previously summarized (here and here) the Drug Enforcement Administration’s (“DEA’s”) recent actions related to marijuana and reviewed DEA’s notice that it will expand the number of marijuana cultivators for research. Today we analyze DEA’s denial of several recent petitions to reschedule marijuana. On August 12, 2016, DEA issued a final rule denying two petitions to reschedule marijuana. As discussed in more detail below, while both the Department of Health and Human Services (“HHS”) and DEA raised concerns about the abuse potential of marijuana, the critical basis for this decision remains the same, neither HHS nor DEA found that marijuana has a currently accepted medical use in the United States. It is worth noting that a growing majority of states have passed legislation authorizing use of marijuana for medicinal purposes or limited use of low-THC oil (e.g., cannabidiol or “CBD”) for medical purposes. In addition, several jurisdictions, including Connecticut, the District of Columbia, Iowa and Oregon, have rescheduled marijuana for medical use. This is in addition to several states and the District of Columbia which have authorized some use of marijuana for recreational use. Thus, the issue remains under either state or federal law as to a finding of currently accepted medical use in the United States. DEA received a petition from Bryan Krumm, a private citizen in New Mexico in 2009 (“Krumm Petition”), and the second from the then-governors of Rhode Island and Washington in 2011 (“Governor’s Petition”).  Denial of Petition To Initiate Proceedings to Reschedule Marijuana, 81 Fed. Reg. 53,767 (Aug. 12, 2016); Denial of Petition To Initiate Proceedings to Reschedule Marijuana, 81 Fed. Reg. 53,688 (Aug. 12, 2016) [hereinafter Denial of Petitions]. The Krumm Petition requested DEA to remove marijuana from schedule I of the Controlled Substances Act (“CSA”), asserting that: Marijuana has accepted medical use in the United States; Studies have shown that smoked marijuana has proven safety and efficacy; Marijuana is safe for use under medical supervision; and Marijuana does not have the abuse potential for placement in schedule. Id. at 53,767. The Governor’s Petition requested removal of marijuana and “related items” from schedule I and reschedule as “medical cannabis” in schedule II because cannabis has an accepted medical use in the United States; is safe for use under medical supervision; and for medical purposes has a relatively low potential for abuse, especially in comparison with other schedule II drugs. Id. at 53,688. Neither petition appeared to provide adequate detailed scientific or medical support for the fact that marijuana has an acceptable medical use in the United States. Rather both made anecdotal references to use of marijuana in certain types of treatment. As a threshold matter, DEA asserted that marijuana or cannabis could only be rescheduled to schedule II in order for the U.S. to comply with its obligations under international treaties. Next, DEA explained that while schedule I drugs have “no currently accepted medical use in treatment in the United States” and “a lack of accepted safety for use of the drug . . . under medical supervision,” schedule II drugs have “currently accepted medical use in treatment in the United States.” Id. at 53,689, 53,768. Thus, DEA found that any action to reschedule marijuana turns on whether marijuana has a currently accepted medical use in treatment in the U.S. Id. As we have noted before, the federal CSA requires that DEA make certain findings before initiating any action to reschedule a drug. Placement of a drug in one of the four schedules (II-V) where there has been a finding of accepted medical use relative to its potential for abuse and potential for psychological or physical dependence. Moreover, prior to initiating rescheduling proceedings, 21 U.S.C. § 811(b) requires DEA to seek an opinion from HHS and determine whether the “scheduling recommendation, scientific and medical evaluation, and ‘all other relevant data’ constitute substantial evidence that the drug should be rescheduled as proposed.” Id. at 53,739, 53,820. HHS’ recommendations are binding on DEA as to scientific and medical matters. 21 U.S.C. § 811(b); Denial of Petitions at 53,739, 53,820. This analysis is commonly known as the “eight factor analysis.” The eight factors include: The drug’s actual or relative potential for abuse; The drug’s scientific evidence of its pharmacologic effect, if known; The state of current scientific knowledge regarding the drug; The drug’s history and current pattern of abuse; The drug’s scope, duration, and significance of abuse; The risk, if any, to public health; The drug’s psychic or physiological dependence liability and Whether the drug is an immediate precursor of a controlled substance. 21 U.S.C. § 811(c). DEA requested a scientific and medical evaluation and scheduling recommendation from HHS as required. Denial of Petitionsat 53,739, 53,820. HHS concluded, upon considering the eight factors, that marijuana meets the scheduling criteria for remaining in schedule I. Denial of Petitions at 53,688, 53,767. Most important, HHS found that marijuana does not have a currently accepted medical use in the United States. This scientific and medical finding is binding on DEA. Thus, while DEA also made specific findings relative to these factors, in effect, DEA’s hands are tied in that without a finding from HHS that marijuana does have an accepted medical use, DEA will have to deny any petition to reschedule the drug. It is worth taking a closer look at the factors that HHS and DEA believe still indicate that marijuana does not have a currently accepted medical use in the United States. Both DEA and HHS assert that a drug is considered to have a currently accepted medical use in treatment in the United States for purposes of the CSA if it is the subject of an approved new drug application (“NDA”) under the federal Food, Drug and Cosmetic Act (21 U.S.C. § 355). Denial of Petitions at 53,740, 53,821. FDA has not approved an NDA for marijuana for any indication. Id.In the alternative, DEA established a five part test in a 1992 marijuana rescheduling petition denial to determine whether a drug has a currently accepted medical use in the U.S. Id; Marijuana Scheduling Petition; Denial of Petition; Remand, 57 Fed. Reg. 10,499, 10,504-06 (Mar. 26, 1992). Under the DEA test, a drug is considered to have a currently accepted medical use only if it meets all five elements. Denial of Petitions at 53,740, 53,821. Those elements are: The drug’s chemistry is known and reproducible; There are adequate safety studies; There are adequate and well-controlled studies proving efficacy; The drug is accepted by qualified experts; and The scientific evidence is widely available. In the denying the petitions, DEA reviewed these five factors and found that marijuana did not meet this alternative test establishing a currently accepted medical use in the United States. DEA found that under Factor 1, chemical constituents including tetrahydrocabinnol (“THC”) and other cannabinoids vary significantly in different marijuana strains “chemical composition among different marijuana samples is not reproducible.” Id. at 53,761, 53,840. DEA notes, however, that chemistry may be consistent enough to derive standardized doses if a specific cannabis strain is processed under controlled conditions. Id.DEA also asserted that there are no adequate marijuana safety studies for use in specific, recognized conditions, nor are there adequate, well-controlled studies that determine marijuana’s efficacy. Id. Also, there is no consensus of expert opinions about the medical utility of marijuana for treating specific disorders. Id. Lastly, DEA stated that there is a lack of currently available data on marijuana that sufficiently addresses its chemistry, toxicology, and effectiveness. Id. In addition, the agency noted there is a lack of scientific evidence about marijuana’s chemistry to a specific cannabis strain that could be formulated into standardized and reproducible doses. Id. DEA, thus applying the five-part test, found that marijuana meets none of the five elements. While denying the petitions for initiating proceedings to reschedule marijuana, the DEA’s findings offer a potential roadmap for future rescheduling petitions. Any future petitions would do well to limit the rescheduling request to a particular strain or strains from which standardized doses can be processed for a specific disorder. The strain should have been subjected to safety and efficacy studies for use in specific, recognized conditions. Petitioners should elicit expert opinions about the medical utility of the marijuana strain for treating those specific disorders. In addition, petitioners should provide data that sufficiently addresses the chemistry, toxicology, and effectiveness of that specific marijuana strain. In summary, the key to any future rescheduling of marijuana remains a finding, specifically by HHS, and supported by DEA, that marijuana does have an accepted medical use in the United States. DEA stated in its notice to allow additional cultivators of marijuana for research that it might take a negative inference if an entity previously conducted activities in violation of federal law. We are left wondering how this position would play out if marijuana is eventually rescheduled and whether DEA will similarly scrutinize an applicant’s experience in conducting authorized activities in states where marijuana has been legalized for medical use. This would include practitioners, pharmacies, cultivators, distributors, researchers and testing facilities, all of whom are licensed and required to comply with regulatory requirements under state law. Some of these entities, including many practitioners who prescribe or authorize marijuana for authorized indications, are current DEA registrants.