“The release of this framework is absolutely monumental and is the biggest, the most meaningful, and material progress made in federal cannabis policy in decades,” says George Hodgin, CEO of the Biopharmaceutical Research Company, one of the applicants. “It opens up a path for traditional drug development in the United States,” whereby researchers can conduct clinical trials and seek approval from the Food and Drug Administration (FDA) for marijuana-based therapies.
Not everyone shares Hodgin’s optimism. Federal rulemaking can take years because it involves soliciting and responding to public comments, not to mention potential litigation over the decision, says Shane Pennington, an attorney at Yetter Coleman LLP, a Houston law firm representing one of the applicants, the Scottsdale Research Institute (SRI). “DEA basically has … found a way to put this on the back burner a lot longer.”
DEA says the proposed rules, published 23 March in the Federal Register, are necessary to comply with federal law and international treaties. One of the most notable stipulations is that DEA would take possession of all marijuana (and any byproducts) from the new growers shortly after harvest and hold the exclusive right to distribute it. The agency says these measures are necessary to comply with the Single Convention on Narcotic Drugs, a 1961 treaty aimed at combatting drug trafficking.
The only marijuana that can be legally used for research in the United States is grown at the University of Mississippi, Oxford, under a contract with the National Institute on Drug Abuse (NIDA), an arrangement that has been in place for more than 50 years. But interest in the potential medical benefits of cannabis has grown in recent years, along with the number of Americans using the drug in states where it’s legal, and some researchers have become frustrated at being limited to this single source.
The NIDA cannabis doesn’t come close to representing the potency, quality, and diversity of what’s readily available in states with legal markets, says Sue Sisley, president and principal investigator of SRI, which recently completed a DEA-approved clinical trial of marijuana to treat post-traumatic stress disorder (PTSD) in military veterans. “When you’re talking about trying to develop cannabis into a medicine, [NIDA’s] product is fundamentally inadequate.”
In August 2016, DEA announced it would consider applications from other growers. Prospective growers (see a partial list here) included universities, research institutes, biotech startups, and companies that produce cannabis products in states where they are legal. But a few months later, President Donald Trump was elected and appointed Jeff Sessions, a longtime marijuana critic, as attorney general, a position that put him indirectly in charge of DEA. Applicants waited and wondered what was happening with their applications. “We heard nothing but crickets for 3 years,” Hodgin says, “despite multiple attempts at outreach through Congress and through direct outreach.”
Frustrated by the delays, SRI filed a lawsuit against DEA in June 2019 seeking to compel it to respond to the applications. In response, DEA said it would evaluate the pending applications—but only after proposing rules for administering the growing program. The reaction among applicants was mixed: Some were cautiously optimistic; others interpreted the move as a stall tactic.
Releasing the proposed rules last week “underscores the federal government’s support for scientific and medical research with marijuana and its chemical constituents,” DEA said in a statement. The agency noted it has registered 595 researchers to conduct marijuana studies—up from 371 in 2017—and increased the production quota for marijuana from 472 to 3200 kilograms in the same time period.
The notion that DEA would take possession and distribute cannabis grown for research constitutes a “huge leap” for the agency, according to Larry Houck, a pharmaceutical industry consultant and former investigator and policy adviser for DEA, from its established role of enforcing federal marijuana law. In a 26 March post on FDA Law Blog, Houck outlines several regulatory questions and concerns. “Can DEA be both a participant and regulator of the same activities?” he asks.
Sisley and her legal team see this stipulation as an unnecessary roadblock. She notes that DEA already has a mechanism for allowing manufacture and distribution of other tightly regulated drugs for clinical research, including MDMA, LSD, and psilocybin, each of which has been studied as a potential treatment for conditions such as PTSD and depression. “What we’re saying is [cannabis] shouldn’t be any different,” she says.
Other countries, including Canada and Australia, have licensed growers for research cannabis without taking possession of the drug, Sisley says. “All of them have looked at the [Single Convention] language and decided that this treaty was never designed to block research.”
The new rules may immediately eliminate several applicants from contention. A requirement that growers have never broken federal law, if enforced, would be a stumbling block for companies that already produce or distribute marijuana in states where it is legal. (Although it hasn’t been an enforcement priority for DEA, growing, selling, and even possessing cannabis is still a violation of federal law, even in states that have legalized it.)
Sisley says SRI complies with federal law and has not yet grown any marijuana, but she says the requirement would exclude experienced growers who already produce high-quality cannabis. “They would be ideal participants,” she says. “We’re trying to actually replicate what people are using in the real world.”
Hodgin, too, says his company has been careful to stay on the good side of federal law, and he’s unfazed by the prospect of DEA taking possession of his company’s crops if its application to grow is approved. He hasn’t heard from DEA since the proposed rules were announced, however. “We are ready and eager for the next steps from them, and we’re ready to move forward as soon as they are.”