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U.S. set to allow more facilities to produce marijuana for research

Moving to end one university’s decadeslong monopoly on supplying marijuana for U.S. research, the Drug Enforcement Administration (DEA) said last Friday it will soon issue licenses to a number of growing facilities. Since 1968, only one operation, the University of Mississippi, has been licensed to supply marijuana to U.S. medical researchers who want to explore its value for treating conditions including post-traumatic stress disorder (PTSD) and chronic pain.

DEA announced on its website that it had sent a memorandum of agreement (MOA) to several manufacturers that had applied for licenses to grow cannabis for research studies. The memos come less 6 months after the agency published a final rule describing how exactly the program would work. And they mark a huge shift after years of delayed license applications. Although consuming marijuana is legal for medical purposes in 36 states and for recreational use in 17 states, consumption remains a criminal offense under federal law.

“We were euphoric. This is a victory for scientific freedom. It’s finally a chance to use real-world cannabis in our own studies and supply genetically diverse cannabis to scientists across the nation,” says Sue Sisley, the president and principal investigator at the Scottsdale Research Institute (SRI), which received one of Friday’s MOAs. In 2019, SRI sued DEA to force it to end years of delay in processing license applications. Two other applicants, the Biopharmaceutical Research Company and Steven Groff, a physician in York, Pennsylvania, also received memos from DEA, The Wall Street Journal reported.

 

 

Sisley, a physician who is also an adjunct professor at Humboldt State University, says the marijuana grown by the only currently licensed facility, the National Center for the Development of Natural Products at the University of Mississippi, is not pure or potent enough for research. Other researchers report no problems with the available cannabis, but say the change is nonetheless welcome because a single facility can’t supply the quantity or the diversity of research needs. “Older people are not going to smoke. …They will take a brownie, a gummy. New manufacturers could give us those products,” says Igor Grant, director of the Center for Medicinal Cannabis Research at the University of California, San Diego. "What’s needed is more product and more diversity.”

The move by DEA caps a saga that began in 2016 when then-President Barack Obama’s administration announced it would expand the number of growers allowed to produce marijuana. More than three dozen applied for licenses. But their applications languished throughout the administration of President Donald Trump.

Under the regulations published in December 2020, and the processes laid out in Friday’s memo, DEA will purchase the cannabis from growers and provide it to National Institutes of Health-funded and other researchers, although in some cases growers will supply small amounts directly to labs.

Some observers question the practicality of the scheme. It would be “a huge leap [for DEA to move] from the role of an enforcer of federal law regulating marijuana to being responsible for purchasing, possessing and directing marijuana in the research supply chain. How is this going to work?,” wrote Larry Houck, a lawyer with Hyman, Phelps & McNamara, in a post on the FDA Law Blog when DEA first proposed the new rules in March 2020.

Nonetheless, for cannabis researchers and their lawyers, the news was welcome. “An unlawful 50-year government monopoly that has blocked scientific research into the medical uses of cannabis [has] ended,” says Shane Pennington, a lawyer at Vincente Sederberg LLP, who represents SRI in two lawsuits it brought against the agency.

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