September 13, 2018
Members of the House Judiciary Committee voted today in favor of legislation (HR 5634: The Medical Cannabis Research Act of 2018) to facilitate federally-approved clinical trials assessing the efficacy of whole-plant cannabis. The vote marks the first time that lawmakers have ever decided in favor of easing existing federal restrictions which limit investigators ability to clinically study marijuana in a manner similar to other controlled substances.
“The federal hurdles in place that currently discourage clinicians from engaging in clinical cannabis research have long been onerous and irrational,” NORML Deputy Director Paul Armentano said. “It is high time that lawmakers recognize this problem and take action to amend it so that investigators may conduct the same sort of high-quality clinical research with cannabis that they do with other substances.”
Currently, federal regulations mandate that investigators participating in FDA-approved clinical trials involving cannabis must obtain marijuana from a single, federally-licensed source, the University of Mississippi. However, many of those familiar with their product have criticized its quality, opining that it possesses subpar potency, is often poorly manicured, and that it does not accurately reflect the wide variety of cannabis products and strains available to consumers.
As the result of a lawsuit, DEA Administrative Law Judge Mary Ellen Bittner in 2007 ruled that expanding the pool of federally licensed providers would be “in the public interest.” The agency ultimately rejected that decision. In 2016, the DEA publicly changed its stance and amended regulations in a manner to permit additional applicants to apply for federal licensure to grow marijuana. However, the United States Attorney General’s office has failed to take action on any pending 25 applications submitted following the 2016 rule change.
House Bill 6534, sponsored by Rep. Matt Gaetz (R-FL) and 40 cosponsors mandates the Attorney General to take action on these pending federal applications, and to approve at least two additional marijuana manufacturers within a year. The measure also explicitly permits the Veterans Affairs office to engage in clinical trials involving the cannabis plant.
While some Democrats on the Committee, as well as some drug policy reform organizations, expressed criticism with regard to a provision in the bill restricting applicants with a drug-related conviction, lawmakers indicated that they would consider revising this language prior to the bill receiving a vote on the House floor.
Armentano concluded: “While this vote marks a step forward, it must also be acknowledged that despite existing barriers to research, ample studies already exist to contradict cannabis’ federal, schedule I status as a substance without medical utility, lacking acceptable safety, and possessing a high potential of abuse. More clinical research is welcome, but unfortunately science has never driven marijuana policy. If it did, the United States would already have a very different policy in place.”