Members of Congress are fast-tracking legislation, “The Medical Marijuana and Cannabidiol Research Expansion Act,” which seeks to facilitate cannabis-specific scientific research and potential drug development.
The House bill, which is scheduled for floor action this week, contains language that is similar to Senate Bill 253 — which Senate members unanimously passed in April. The Act provides the office of the US Attorney General with a 60-day timeline to either approve or deny the applications from scientists wishing to engage in clinical trials involving the use of cannabis by human subjects. (Protocols must first be reviewed and approved by both the Secretary of the US Department of Health and Human Services and by the National Institutes of Health prior to the AG’s authorization. Those agencies do not have an explicit timeline with which to complete their reviews.)
The Act also mandates the US Attorney General to solicit applications from those seeking to grow cannabis for either research purposes or for purposes of potential drug development, and it provides a timeline for the AG to approve those applicants.
Under current regulations, the US Drug Enforcement Administration is primarily tasked with reviewing and licensing marijuana cultivators, as well as granting Schedule I licenses to scientists wishing to study cannabis in clinical settings. In 2016, the agency announced that it would expand the pool of federally licensed growers beyond just the University of Mississippi (which was initially granted a federal cannabis cultivation license in 1968). In May 2021, the agency announced that it had reached agreements with a handful of third-party applicants to allow them to grow cannabis for use in federally approved clinical trials. However, the US National Institute on Drug Abuse has yet to officially partner with any of these entities and there is no explicit timeline as to when they will do so.
For decades, scientists wishing to work with marijuana have complained that it often takes years before their research protocols are approved by the DEA, and that the quality of cannabis provided by the University of Mississippi’s cultivation program is of inferior quality and that it is not representative of the products available in state-legal markets.
In response to those complaints, House members earlier this year passed legislation, HR 5657: The Medical Marijuana Research Act, permitting authorized scientists for the first time to access cannabis flowers and other products manufactured in accordance with state-approved marijuana programs. However, those explicit provisions were not included in the new bill that is being fast-tracked by both chambers.
NORML’s Deputy Director Paul Armentano criticized this omission. “Currently, the limited variety of cannabis cultivars accessible to federally licensed researchers does not represent the type or quality of cannabis products currently available in legal, statewide markets,” he said. “The fact that nearly one-half of US adults have legal access to these multitude of cannabis products, but our nation’s top scientists do not, is the height of absurdity and it is an indictment of the current system. This proposal misses the opportunity to change that reality.”
The Act also calls upon federal agencies, including HHS, to provide a report on the “potential therapeutic effects of cannabidiol or marijuana on serious medical conditions.” In past years, the US National Academy of Sciences, Engineering, and Medicine have compiled similar reports of this nature for Congress, though those reports garnered little attention.