Posted: 09 Apr 2019 06:38 PM PDT
We sometimes use the term “act of Congress” when referring to something that is difficult or requires large effort to achieve. But, as nothing else has worked, a real act of Congress may be required to compel the Drug Enforcement Administration (“DEA”) to issue marijuana manufacturer registrations for research. To that end, Representative Matt Gaetz (R.-FL) introduced H.R. 601, the Medical Cannabis Research Act of 2019.
In August 2016 DEA expressed its full support to expand research “into the potential medical utility of marijuana and its chemical constituents” (see our previous post here). Acknowledging increased interest in research with cannabinoids including cannabidiol (“CBD”), and based upon discussions with the National Institutes of Drug Abuse and the Food and Drug Administration (“FDA”), DEA “concluded that the best way to satisfy the current researcher demand for a variety of strains of marijuana and cannabinoid extracts is to increase the number of federally-authorized marijuana growers.” Id. DEA announced that it would consider additional applications for registration to grow and cultivate marijuana for research.
DEA has received twenty-six applications for registration to manufacturer marijuana in the two and a half years since the agency began accepting them. To date, the DEA has not published a Federal Register final rule granting any such registrations. It is worth noting that DEA has continued to grant importer registrations for marijuana. See, e.g., Importer of Controlled Substances Application: Sanyal Biotechnology LLC, 83 Fed. Reg. 12,407 (Mar. 21, 2018); Importer of Controlled Substances Registration, 83 Fed. Reg. 27,632 (June 13, 2018).
During this same period, FDA approved Epidiolex, an oral CBD solution for the treatment of certain seizures. Subsequently, DEA scheduled Epidiolex and other FDA-approved drugs containing CBD derived from cannabis with no more than 0.1 percent tetrahydrocannabinols (“THC”) in Schedule V of the Controlled Substances Act (“CSA”) (see our previous post here). It appears that neither FDA nor DEA believed there was any abuse potential of CBD with less than .01 percent THC, however, DEA scheduled this CBD formulation to comport with the import and export provisions of the Single Convention on Narcotic Drugs, 1961. CBD is still controlled under the relevant international drug control treaties.
Then in December, Congress enacted the Farm Bill, removing “hemp” from the CSA definition of “marijuana” and excluding THC contained in “hemp” from scheduling under the CSA. 7 U.S.C. § 1639o; 21 U.S.C. § 802(16). “Hemp” is defined as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”
It is also worth noting that in December, DEA doubled the adjusted 2019 aggregate production quotas for marijuana from 2018 to 1,140,216 grams or 2,500 pounds. At that time DEA noted that it “continues to review applications” for bulk manufacturer registrations “necessary to produce an adequate and uninterrupted supply” of marijuana.
Congressional efforts to prod then-Attorney General Sessions and DEA to issue the registrations were unsuccessful. Letters from federal lawmakers dated July 25, 2018 and August 31, 2018 had no effect.
Finally, in January, Representative Gaetz introduced the bipartisan Medical Cannabis Research Act of 2019, a revision of a bill with the same goals introduced in the last Congress and which would amend 21 U.S.C. § 823. The current bill, which would require the Attorney General to continue assessing the required adequate, uninterrupted cannabis supply for legitimate research annually. Medical Cannabis Research Act of 2019, H.R. 601, 115th Cong. (2019). Unlike the 2018 bill, the current bill would require the Attorney General through DEA to issue registrations to at least three applicants to manufacture cannabis for legitimate research purposes within a year, and to register at least four applicants in subsequent years. (The 2018 bill would have required at least two and three applicants, respectively, in initial and subsequent years). Registered manufacturers would be limited to supplying cannabis to DEA-registered Schedule I researchers for “use in preclinical research or in a clinical investigation pursuant to an investigational new drug exemption” under section 505(i) of the Food, Drug and Cosmetic Act. In addition, registered manufacturers must:
The Medical Cannabis Research Act of 2019 if enacted as written will not change the legal status of marijuana nor affect CSA provisions regulating cannabis manufacturers for other than research purposes, including commercial drug product development by the private sector.
Requiring DEA to grant a certain number of registrations is problematic in that it appears contrary to the CSA wherein DEA is only required to grant a registration if the applicant is qualified. While we would assume that a number of the current applicants should be able to meet the CSA requirements, this is not a given. In lieu of requiring DEA to issue a certain number of marijuana manufacturer registrations each year, the bill would require DEA to grant or deny the registrations, or request additional information, within one year of receiving an application.
Congressman Gaetz stated: “[c]urrently, all federally-approved studies of medical cannabis get their product from one source, and it is extremely subpar . . . [it] is weak and often moldy . . . federally grown cannabis is scarce; there is not enough product.”
It is time that DEA and DOJ make good on their announcement to issue additional registrations for marijuana manufacturers. Manufacturer compliance with CSA recordkeeping and security requirements minimize risk of diversion. It is unfortunate that it may require an act of Congress to facilitate legitimate medical research with cannabis, but American patients and the public are worthy.
In August 2016 DEA expressed its full support to expand research “into the potential medical utility of marijuana and its chemical constituents” (see our previous post here). Acknowledging increased interest in research with cannabinoids including cannabidiol (“CBD”), and based upon discussions with the National Institutes of Drug Abuse and the Food and Drug Administration (“FDA”), DEA “concluded that the best way to satisfy the current researcher demand for a variety of strains of marijuana and cannabinoid extracts is to increase the number of federally-authorized marijuana growers.” Id. DEA announced that it would consider additional applications for registration to grow and cultivate marijuana for research.
DEA has received twenty-six applications for registration to manufacturer marijuana in the two and a half years since the agency began accepting them. To date, the DEA has not published a Federal Register final rule granting any such registrations. It is worth noting that DEA has continued to grant importer registrations for marijuana. See, e.g., Importer of Controlled Substances Application: Sanyal Biotechnology LLC, 83 Fed. Reg. 12,407 (Mar. 21, 2018); Importer of Controlled Substances Registration, 83 Fed. Reg. 27,632 (June 13, 2018).
During this same period, FDA approved Epidiolex, an oral CBD solution for the treatment of certain seizures. Subsequently, DEA scheduled Epidiolex and other FDA-approved drugs containing CBD derived from cannabis with no more than 0.1 percent tetrahydrocannabinols (“THC”) in Schedule V of the Controlled Substances Act (“CSA”) (see our previous post here). It appears that neither FDA nor DEA believed there was any abuse potential of CBD with less than .01 percent THC, however, DEA scheduled this CBD formulation to comport with the import and export provisions of the Single Convention on Narcotic Drugs, 1961. CBD is still controlled under the relevant international drug control treaties.
Then in December, Congress enacted the Farm Bill, removing “hemp” from the CSA definition of “marijuana” and excluding THC contained in “hemp” from scheduling under the CSA. 7 U.S.C. § 1639o; 21 U.S.C. § 802(16). “Hemp” is defined as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”
It is also worth noting that in December, DEA doubled the adjusted 2019 aggregate production quotas for marijuana from 2018 to 1,140,216 grams or 2,500 pounds. At that time DEA noted that it “continues to review applications” for bulk manufacturer registrations “necessary to produce an adequate and uninterrupted supply” of marijuana.
Congressional efforts to prod then-Attorney General Sessions and DEA to issue the registrations were unsuccessful. Letters from federal lawmakers dated July 25, 2018 and August 31, 2018 had no effect.
Finally, in January, Representative Gaetz introduced the bipartisan Medical Cannabis Research Act of 2019, a revision of a bill with the same goals introduced in the last Congress and which would amend 21 U.S.C. § 823. The current bill, which would require the Attorney General to continue assessing the required adequate, uninterrupted cannabis supply for legitimate research annually. Medical Cannabis Research Act of 2019, H.R. 601, 115th Cong. (2019). Unlike the 2018 bill, the current bill would require the Attorney General through DEA to issue registrations to at least three applicants to manufacture cannabis for legitimate research purposes within a year, and to register at least four applicants in subsequent years. (The 2018 bill would have required at least two and three applicants, respectively, in initial and subsequent years). Registered manufacturers would be limited to supplying cannabis to DEA-registered Schedule I researchers for “use in preclinical research or in a clinical investigation pursuant to an investigational new drug exemption” under section 505(i) of the Food, Drug and Cosmetic Act. In addition, registered manufacturers must:
- “[H]ave established and begun operating a process to store and handle” Schedule I substances to include required security;
- Be able to provide at least ten unique plant cultivars and “scale up” production to produce cannabis to supply forecasted demand;
- Be able to test for and isolate at least twelve cannabinoids for “producing specific products for specific studies by compounding pharmacists or others, labeling, and chemical consistency;”
- Be licensed by the state where they conduct operations; and
- Provide a written explanation of how its manufacture of cannabis “would augment the nation’s supply of cannabis for legitimate research purposes.”
The Medical Cannabis Research Act of 2019 if enacted as written will not change the legal status of marijuana nor affect CSA provisions regulating cannabis manufacturers for other than research purposes, including commercial drug product development by the private sector.
Requiring DEA to grant a certain number of registrations is problematic in that it appears contrary to the CSA wherein DEA is only required to grant a registration if the applicant is qualified. While we would assume that a number of the current applicants should be able to meet the CSA requirements, this is not a given. In lieu of requiring DEA to issue a certain number of marijuana manufacturer registrations each year, the bill would require DEA to grant or deny the registrations, or request additional information, within one year of receiving an application.
Congressman Gaetz stated: “[c]urrently, all federally-approved studies of medical cannabis get their product from one source, and it is extremely subpar . . . [it] is weak and often moldy . . . federally grown cannabis is scarce; there is not enough product.”
It is time that DEA and DOJ make good on their announcement to issue additional registrations for marijuana manufacturers. Manufacturer compliance with CSA recordkeeping and security requirements minimize risk of diversion. It is unfortunate that it may require an act of Congress to facilitate legitimate medical research with cannabis, but American patients and the public are worthy.
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