Washington, DC: Members of the US House Judiciary Committee last week voted in favor of legislation, HR 5634: The Medical Cannabis Research Act of 2018, to facilitate FDA-approved clinical trials involving whole-plant cannabis. The Act mandates the federal government to license multiple providers of research-grade marijuana, among other changes.
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 measure now awaits further action on the House floor.
Under current US policy, investigators can only administer cannabis provided by the University of Mississippi during the course of an FDA-approved trial. 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.
In 2016, the US Drug Enforcement Administration amended its regulations to permit additional applicants to seek federal licensure to grow marijuana for use in clinical research. However, to date, neither the DEA nor the Justice Department have taken action on over two-dozen pending applications. Passage of HR 5634 would mandate federal agencies approve at least two new applicants within a year’s time.
This week, clinical investigators with the Center for Medicinal Cannabis Research at the University of California, San Diego received federal permission to import cannabis products manufactured in Canada for use in human trials. The products, which are high in cannabidiol and low in THC, are unavailable from the University of Mississippi program, which currently provides only six distinct cannabis strains – none of which contain more than 0.08 percent CBD.
For more information, contact Paul Armentano, NORML Deputy Director, at: firstname.lastname@example.org or NORML Political Director, Justin Strekal, at (202) 483-5500. Read NORML’s op-ed on the pending legislation, “The federal government must stop stifling medical marijuana research.”