WHAT IT IS: The Medical Marijuana and Cannabidiol Research Expansion Act (H.R. 8454) is legislation recently passed by Congress to address barriers to cannabis research. The Act recognizes that research on the impacts of cannabis is necessary – it is now legal for medical use in 39 states and Washington D.C. and adult use in 21 states and D.C. The Act will enable further studies to be conducted to more fully understand the impacts of cannabis on the human body. The Act will accomplish this by streamlining the application process for scientific marijuana studies and removing existing barriers for researchers that frequently slow the research process.
WHAT’S NEXT: The bill was signed into law by the President on December 2. While it is law, it will take quite some time for the provisions to be fully implemented. The federal agencies will need to implement the registration process and oversight. Universities will need to develop their own policies for the research including meeting the requirements under the legislation for acquisition and storing of cannabis to prevent diversion.
Overview
After unanimous consent from the Senate, President Biden signed into law the Medical Marijuana and Cannabidiol Research Expansion Act. The Act aims to streamline the application process for scientific studies of marijuana and eliminate barriers to cannabis research.
The legislation imposes a 60-day deadline on the U.S. Attorney General to approve a marijuana research or manufacturer application or to request additional information. It also streamlines efficiency for entities conducting research with large amounts of cannabis. Each year, an assessment must also be done on whether there is an adequate supply.
Additionally, the Act encourages the Food and Drug Administration (FDA) to develop medicines derived from cannabis and allows accredited research institutions with the proper Schedule I registration to cultivate, distribute, dispense, or possess their own marijuana for research purposes.
Under the Act, the Drug Enforcement Administration (DEA) is allowed to approve applications for manufacturers and distributors of cannabis for the commercial production of marijuana-derived drugs that have been approved by the FDA. The legislation also permits manufacturers to import cannabis and related materials that facilitate research into therapeutic uses.
Furthermore, the Act requires the Department of Health and Human Services (HHS) to assess the health benefits and health risks of marijuana, review policies that may be inhibiting authorized cannabis research, and offer suggestions for mitigating such barriers. More specifically, HHS is directed to work with the National Institutes of Health (NIH) on an analysis of the therapeutic potential of cannabis for conditions like epilepsy, the ways in which cannabis impacts the development of the adolescent brain, and how cannabis may affect a person’s ability to operate a motor vehicle.