A new bill introduced in the United States Senate seeks to radically alter federal jurisdiction over the manufacture, distribution, sale and use of medical marijuana.
The Compassionate Access, Research Expansion and Respect States (CARERS) Act of 2015, introduced this week by Senators Rand Paul (R-KY), Cory Booker (D-NJ) and Kirsten Gillibrand (D-NY), is a bill to “extend the principle of federalism to State drug policy, provide access to medical marijuana and enable research into the medicinal properties of marijuana.”
The most important part of the CARERS Act effectively allows states to opt out of the Controlled Substances Act with respect to medical marijuana laws – both legitimizing current state medical marijuana policy under federal law and future state action. Section 2 of this bill states that:
Notwithstanding any other provision of law, the provisions of [the Controlled Substances Act] relating to marihuana shall not apply to any person acting in compliance with State law relating to the production, possession, distribution, dispensation, administration, laboratory testing or delivery of medical marihuana.
It is important here to note that this bill addresses the Controlled Substances Act (CSA) and not the Federal Food, Drug and Cosmetic Act – meaning, in effect, that while it eliminates the enforcement authority of the Drug Enforcement Administration (DEA) with respect to state medical marijuana programs, it does nothing to address the jurisdiction and enforcement authority of the Food and Drug Administration (FDA).
Nonetheless, this single provision of the CARERS Act would result in a profound and historic change in federal drug laws. It allows state law to supersede or replace federal law regarding criminal penalties and enforcement authorized by the Controlled Substances Act.
The bill makes other changes to the CSA. Marijuana would be reclassified from Schedule I to Schedule II, effectively recognizing that it has accepted medical use in the United States.
Also, cannabidiol (CBD), a non-psychoactive ingredient produced by cannabis plants with medical use in the treatment of seizures and other ailments, would be exempt from marijuana’s CSA schedule. The bill would remove marijuana grown to produce CBD, with less than .3 percent THC, from the CSA. This provision would expedite the availability of CBD throughout the United States.
Additional provisions of the CARERS Act would allow marijuana-related businesses operating in accordance with state law to have access to the nation’s financial system. Current federal law prohibits banks from accepting deposits of proceeds from the sale of controlled substances, meaning that medical marijuana businesses currently have nowhere to deposit their funds. While the Justice Department has issued guidelines assuring financial institutions they will not be prosecuted for accepting such deposits, these guidelines represent prosecutorial discretion and do not have the force of law.
So, for example, under the CARERS Act:
A depository institution that provides financial services to a marijuana-related legitimate business shall not be subject to a criminal penalty under any Federal law solely for providing those services or for further investing any income derived from such services.
The Act also seeks to expand research on marijuana’s medical use by simplifying the approval process for research and requiring the government to issue at least three licenses for the production of marijuana for research purposes. Currently proposals to conduct research on marijuana’s medical use are subjected to elaborate scrutiny by the National Institute on Drug Abuse (NIDA), whose professional mission is to study drug abuse rather than medical use, and marijuana grown for research purposes has been limited to a single operation at the University of Mississippi.
The final provision of the CARERS Act provides for military veterans to have access to cannabis in states with medical marijuana programs. Specifically, the bill allows healthcare providers in the Department of Veteran Affairs to provide the recommendations needed for veterans to participate in state medical marijuana programs without jeopardizing their access to treatment and services under federal law.
The proposed bill goes a long way toward addressing the conflict between state and federal law regarding the manufacture, distribution, sale and use of marijuana for medical reasons. Its chances for passage are a different matter. And like any piece of legislation such chances are subject to both partisan priorities as well as the different political environments in the Senate and the House of Representatives. But as a matter of policy this bill isolates and addresses several, but not all, key issues related to medical marijuana legislation passed by the states.
While not comprehensive, it prioritizes many important issues and presents straightforward remedies in the context of the long-accepted political doctrine of federalism – allowing individual states to innovate new public policies according to local needs and local political values. This bill will focus debate and advance the process of holding legislators accountable with respect to public opinion and practical solutions.
There are, however, additional issues of great importance that are not addressed by this bill. They fall into two categories. First, federalism may be a necessary device to advance the medical marijuana issue but it is not a sufficient policy to address the need of providing access to medical marijuana on a national basis. Second, this act does not address the use of medical marijuana in places without state medical laws and it does nothing about the clash between such laws and the jurisdiction and regulations enforced by the Food and Drug Administration (FDA).
For a drug to be sold as medicine in the United States it must be approved by the Food and Drug Administration. This approval requires three phases of controlled studies, involving animal studies, small-scale human studies and large-scale studies. The animal studies establish that the drug produces specific effects, the small-scale studies prove these effects in human subjects and the large-scale studies verify the effects and also indicate the range and scope of possible side effects of the drug. The CARERS Act makes FDA approval feasible by way of its provisions expediting research. Meanwhile, regardless of the provisions of the Controlled Substances Act, medicine in the United States is not medicine unless the FDA certifies it as such.
The controlled studies required for FDA approval of a drug are an expensive process and usually result in a proprietary and patented pharmacological product. Whether this is a viable model for making marijuana available for therapeutic use in the United States is a matter for discussion and debate. In many respects state-level medical marijuana programs make such a model impractical and have rendered it, in this context, obsolete. However, in this area there is a clash between state and federal law and it is a clash that is not addressed by the CARERS Act.
While CARERS would produce many positive outcomes, it is not a comprehensive remedy to address conflicts between state and federal laws regarding the medical use of marijuana. Nor would it end federal attempts, or federal capacity, to circumvent, interfere and otherwise obstruct state medical marijuana programs in the future. In this regard it would shift the agent of such obstruction from the Drug Enforcement Administration to the Food and Drug Administration.
The CARERS Act is good policy and over time will also be seen as good politics. This legislation enhances the durability of state medical marijuana programs. This is good for many patients and as such is good for the country.
However, this legislation benefits patients in states that have authorized medical marijuana. It is not enough. Patients in all states deserve to have access to medical marijuana. Hopefully this legislation will pass Congress, be signed by the president and will encourage more states to provide medical access to cannabis. An even better result is that passage of this legislation and a review of its implementation will encourage Congress to consider and pass more comprehensive legislation to provide access to medical cannabis throughout the United States.