Representative Morgan Griffith (R-VA) has introduced two bills that would remove federal roadblocks to marihuana and cannabidiol (“CBD”) access by patients for legitimate medical purposes in states that allow such access. (We use the spelling of “marihuana” that appears in the federal Controlled Substances Act (“CSA”) and the bills). Congressman Griffith sponsored the “Legitimate Use of Medicinal Marihuana Act,” H.R. 714, and reaching across the aisle, co-sponsored the “Compassionate Access Act,” H.R. 715, with Earl Blumenauer (D-OR). The Oregon representative has advocated to remove marihuana from control under the CSA. An accompanying press release notes that the current bills “would alleviate” CSA blockage of measures that permit the use of marihuana for treating cancer and glaucoma passed by Virginia, Congressman Griffith’s state, in 1979.
The Compassionate Access Act (“CAA”) and the Legitimate Use of Medicinal Marihuana Act (“LUMMA”) are the latest proposals to change Federal law and authorize the medical use of marihuana. We note that most recently in November, voters in Arkansas, Florida and North Dakota approved marihuana for medical use, joining a growing majority of states that authorize the use of marihuana or low-THC oil (“CBD”) for medical purposes. These bills are also a response to the Drug Enforcement Administration’s (“DEA’s”) August 2016 denial of two petitions to reschedule marihuana wherein DEA and the Department of Health and Human Services (“HHS”) have maintained the status quo, that is, that marihuana lacks a currently accepted medical use in treatment in the United States. We posted a blog on the petition denials on August 24, 2016.
In short, both bills as drafted appear to conflict with existing administrative and statutory requirements, particularly, the requirement that marihuana (or any other controlled substance) cannot be rescheduled from Schedule I without a finding of currently accepted medical use.
A drug can be scheduled, rescheduled or de-scheduled through administrative rulemaking or Congress can take such action by legislation. The CAA appears to mandate that HHS and DEA administratively reschedule the drug, and the LUMMA, would reschedule the drug by legislation. However, both approaches as drafted, have some serious faults. First, the CAA would require that HHS and DEA conduct administrative rescheduling but arrive at a specific result whether or not supported by the scientific and medical evaluation that is required under such action. Second, the LUMMA would reschedule marihuana by legislation but does not specifically find that Congress has determined that marihuana has a currently accepted medical use in the United States. Thus, the LUMMA would run afoul of the existing statutory criteria for placing drug in Schedule II-V. Congress has legislatively scheduled drugs in the past, e.g., anabolic steroids, however we are unaware of any case where Congress has rescheduled a drug from Schedule I into another schedule which would authorize its legitimate medical use.
The following is a brief summary of the proposed bills:
The Compassionate Access Act
The CAA would require HHS within 180 days, in consultation with the Institute of Medicine of the National Academy of Sciences, to recommend that DEA reschedule marihuana from Schedule I to another schedule. And DEA, “taking into consideration” HHS’ recommendation, would have one year to issue a final rule rescheduling marihuana. The CAA would also remove CBD from the CSA’s definition of marihuana and separately define it as a derivative from marihuana or synthetically formulated with 0.3 percent delta-9-tetrahydrocannabinol (“THC”). DEA considers all extracts of marihuana including CBD to be Schedule I substances.
The CAA mandate that HHS recommend rescheduling, and that DEA reschedule it, appears to disregard the existing CSA requirement that HHS and DEA conduct a medical and scientific evaluation, the “eight factor analysis.” The CAA’s removal of CBD containing trace amounts of THC from the definition marihuana seems more reasonable considering that consumption of CBD reportedly does not produce psychoactive effects and thus lacks potential for abuse, a key criteria for placement in any schedule.
In addition, the CAA would prohibit the CSA and the Federal Food, Drug and Cosmetic Act (“FDCA”) from restricting activities in states that have authorized marihuana and CBD activities for medical use, including:
- “[T]he prescription of marihuana;”
- “[A]uthorized patients” to obtain, possess, transport and use marihuana;
- Caregivers to obtain, possess and transport marihuana for authorized patients;
- Parents or guardians to obtain, possess and transport marihuana for minors;
- Production, processing, manufacturing and distributing marihuana;
- Pharmacies and health care providers dispensing marihuana; and
- Laboratories testing safety, quality and efficacy of marihuana.
However, the CAA does not specifically amend the CSA nor create a statutory scheme to resolve the internal conflicts with existing provisions of the CSA. So, unless, marihuana was rescheduled, these requirements would be inconsistent with the law and regulations. The CAA would lift the same CSA prohibitions that apply to CBD activities in those states where authorized.
Lastly, the CAA mandates that the Attorney General “delegate responsibility . . . for control over access to marihuana for research into its potential medicinal uses to an agency of the executive branch that is not focused on researching the addictive properties of substances.” The goal is for the agency assuming such responsibility is to ensure the availability of an adequate supply of marihuana for medicinal research.
We are unsure how the Attorney General would delegate authority provided by the CSA to ensure access to marihuana for research to another agency outside the Department of Justice. However, that said, this provision may not be as necessary as intended given that DEA has now abrogated its long-held policy of limiting marihuana cultivation for research to a single grower. DEA recognizes the need to increase the number of marihuana cultivators for product development, explaining that the prior monopoly was for federally-funded and academic research. DEA’s decision to issue additional marihuana manufacturer registrations for supplying researchers may make the provision requiring delegation of responsibility over access to marihuana for research unnecessary.
The Legitimate Use of Medicinal Marihuana Act
The LUMMA mirrors the CAA in certain respects, but there are some notable differences. For example, while the CAA would require administrative rescheduling of marihuana to any schedule other than Schedule I, the LUMMA would move marihuana specifically to Schedule II.
While it is necessary to resolve the current myriad of conflicting state marihuana and CBD approvals with federal restrictions, these bills are not the vehicles to do it.
The CAA was introduced and referred to the House Committee on Energy and Commerce and the House Judiciary Committee on January 27th. The LUMMA was introduced on the same day and referred to the House Committee on Energy and Commerce.