Federally Approved Cannabis?
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Federally Approved Cannabis?

Pennsylvania-based Groff North America has begun growing DEA-approved cannabis for FDA clinical trials.

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March 9, 2022

Editor’s note: This article was updated March 11 to reflect that cannabis being grown under DEA approval is not readily available on the U.S. market but rather only to Schedule I research license holders.

Federally approved cannabis is now being grown in the private U.S. sector for scientific research, and one company is already selling it to other Schedule I researchers in a closed-loop system for Food and Drug Administration (FDA) clinical trials.

As one of a handful of companies to receive approval via memorandums of agreement (MOA) from the U.S. Drug Enforcement Administration (DEA) last year, Pennsylvania-based Groff North America began selling its legal cannabis last month for medical and scientific research purposes in that tightly defined system.  

New Mexico-based Bright Green Corp., Arizona-based Scottsdale Research Institute and California-based Biopharmaceutical Research Co. also were recipients of an MOA from the DEA.

Through DEA approval, Groff NA has acquired Schedule I registrations that allow the company to cultivate, extract and process federally legal cannabis in bulk manufacturing; produce precise dosed forms for clinical trials in FDA-approved drugs; import cannabis flower, genetics and extracts from anywhere in the world; and export cannabis flower and cannabis preparations to any of 150-plus signatory counties in the U.N.’s Single Convention on Narcotics, according to the company’s website.

In addition, the company can conduct its own research and analytical lab testing.

Dr. Steve Groff, the company’s founder and chairman, recently told Pittsburgh NPR that the DEA’s approval will unleash the American scientific community for cannabis research and development. 

“For the first time, real-world marijuana will be available to researchers throughout the country,” he said. “We’re working with some of the top institutions in America in providing new types of material that heretofore wasn’t available from Mississippi.”

Previously, since 1968, researchers had been restricted to accessing government-approved cannabis from one place: the University of Mississippi’s Research Institute of Pharmaceutical Sciences (RIPS). The federally funded program provided products to researchers through the National Institute of Drug Abuse (NIDA) for more than 50 years.

But as Cannabis Conference 2021 keynote speaker Dr. Sue Sisley pointed out in her session this past August in Las Vegas, the quality of government-funded cannabis was anything but representative of what’s available in the private sector. (The University of Mississippi recently launched its own nongovernment-funded cannabis research program).

Also, Sisley recently pointed out to Cannabis Business Times that active Schedule I research license holders for cannabis are few and far between—maybe 100 per year are issued in the U.S., she said.

A medical cannabis researcher and president of the Scottsdale Research Institute, Sisley has made cutting-edge discoveries for pain management and post-traumatic stress disorder, as well as a substitution therapy for opioids. But one barrier to her research was access to quality products.

Through her fight to grow her own cannabis for research, Sisley and two lawyers took on the DEA and Department of Justice through three federal lawsuits. They succeeded in securing a DEA Schedule I bulk manufacturer license—eliminating the 52-year government enforced research monopoly. The license paved way to cultivate cannabis flower for FDA-approved clinical trials.

Trailblazing that path, Sisley’s fight has led to the DEA now loosening its policies for others.

However, following its first federally sanctioned harvest, Groff NA was required to turn its crop over to the DEA before buying it back and selling it, NPR reported. That transfer happened Feb. 2.

While there are compliance costs associated with the DEA Schedule I registrations, Groff told NPR the new opportunities show promise.

“We see a number of opportunities to provide revenue, and then ultimately our long-term play is to be a pharmaceutical manufacturer of a number of cannabis-based drugs,” he said.

When Epidiolex, which contains CBD as an active ingredient, was approved by the FDA in June 2018 for the treatment of seizures associated with two rare forms of epilepsy, it became the first plant-derived cannabinoid prescription medicine. It took more than a decade and hundreds of millions of dollars for manufacturer GW Pharmaceuticals to receive that approval.

It could take even longer and more money to push cannabis-based drugs across the FDA-approval finish line because of side effects associated with the plant.  

Groff told NPR that he has roughly 10 business partners, ranging from larger universities to chemical companies.