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New U.S. law promises to light up marijuana research

It just got easier for U.S. scientists to get their hands on some pot—for research, that is.

President Joe Biden today signed into law a bill that streamlines access to marijuana for medical research. The new law is expected to speed the issuance of government permits to scientists who want to study cannabis, whose medicinal promise has been widely touted but remains, with a few exceptions, unproven. It will also expedite applications from producers—including universities—that want to grow and distribute the drug for research. It also obliges the federal government to make sure an adequate, uninterrupted supply of marijuana is available to scientists.

“We will now be able to treat marijuana like we treat any other substance or pharmaceutical for which we hope there is potential benefit. We will be able to subject it to rigorous scientific trial,” says Representative Andy Harris (R–MD), a physician and former National Institutes of Health (NIH)–funded researcher who helped usher the bipartisan legislation through Congress.

“This is exciting,” says Ziva Cooper, the director of the Center for Cannabis and Cannabinoids at the University of California (UC), Los Angeles. “The bill is a significant step forward with respect to chipping away at the barriers” for research. Scientists are eager to study cannabis and its derivatives as potential treatments for cancer, chronic pain, post-traumatic stress disorder, and other conditions.

Other cannabis researchers welcomed the new law but said it doesn’t go far enough. In particular, they are disappointed it does not include a provision from an earlier draft of the legislation that would have allowed scientists to buy and study the marijuana available to consumers in the 37 states that have legalized its recreational or medical use.

“There’s no substitute for studying real-world products that our patients and recreational consumers are using,” says Staci Gruber, a neuroscientist who runs trials of cannabis and its compounds as potential treatments for several conditions at McLean Hospital in Massachusetts.

Cannabis is classified as a Schedule I drug—like heroin and LSD—under U.S. criminal law. That means both scientists and the growers who supply the drug for research must obtain permits from the Drug Enforcement Administration (DEA), and follow strict security rules for storing and handling the drug. But researchers have reported that it took DEA a year or more to respond to permit applications.  

The new law stipulates that within 60 days of receiving a researcher’s application, the agency has to approve it, request more information, or provide its reasons for denying it. If a researcher submits more information upon its request, DEA then has 30 days to make a decision. The law also makes it easier for researchers to amend their research protocols midstream, and ensures that DEA can’t demand stricter security measures for marijuana than for other Schedule I drugs.

“The great advance of this bill is it puts a deadline on the [DEA’s] response time,” says Larry Walker, a pharmacologist at the University of Mississippi who has applied for research registrations.

Walker is the former director of a University of Mississippi center that, for decades, was the sole DEA-registered grower permitted to supply cannabis to U.S. scientists. But researchers complained that the center’s pot was not nearly as potent as what is now commercially available to casual and medical users. Since last year, DEA has registered six more growers, all of them companies, to produce marijuana for research.

Those firms should be able to amply supply U.S. researchers indefinitely, says Steven Groff, the founder and chief medical officer of Groff North America in Pennsylvania. He says his firm already supplies smokable marijuana flower, vaping products, edibles, beverages, and soft chew tablets (a.k.a. gummies) to major research universities. And he dismisses complaints from scientists that DEA-registered companies can’t provide cannabis products that mirror products widely available in legal dispensaries. “That myth is over,” he contends. “We are going to be able to easily provide those materials now to researchers.”

Researchers can at least count on an ample supply going forward. The new law requires the attorney general to make an annual report to Congress on whether the DEA-controlled marijuana supply is uninterrupted and adequate for research needs, and to describe and remedy any shortfalls. And it orders NIH to produce a report within 1 year that addresses, among other things, the barriers to researching marijuana in states that have legalized it, and how those barriers can be overcome.

In the meantime, many researchers would like to see the federal government take additional steps to mainstream marijuana, in particular by removing its Schedule I classification. That listing suggests that marijuana is “uniquely harmful, and … medically unproven,” says Igor Grant, the director of the Center for Medicinal Cannabis Research at UC San Diego, even though the U.S. Food and Drug Administration has approved a number of cannabis-based therapies. “This [listing] remains a substantial obstacle, barrier, and burden to medical research,” Grant says.

In October, Biden ordered the attorney general to consider reclassifying cannabis. If it were moved down to Schedule II, pot would join a number of other approved drugs on that list, including morphine and Adderall, a treatment for attention deficit hyperactivity disorder.

Source: Science Mag