For the first time, the US Drug Enforcement Agency has waived some requirements for researchers discovering medical uses for marijuana. But critics say the move is only a minor step that fails to make it easier to win regulatory approval to conduct needed research.
Going forward, researchers can use a waiver to more readily obtain larger amounts of cannabidiol, or CBD, a particular constituent of marijuana, than was initially granted in their study protocols. Previously, researchers had to seek special permission from both the DEA and Food and Drug Administration if more CBD was needed in order to continue their clinical trials.
The DEA believes the move “will streamline the research process regarding CBD’s possible medicinal value and help foster ongoing scientific studies,” according to an agency statement. The change affects more than 70 researchers who are studying CBD for medical benefits, a DEA spokesman told us.
The policy change, however, stops short of reclassifying marijuana as a Schedule 2 controlled substance. Marijuana is currently a Schedule 1 drug, which are considered to have no “currently accepted medical use in the [United States], a lack of accepted safety for use under medical supervision, and a high potential for abuse.” Other drugs in this category include heroin, acid, and ecstasy.
Critics say the classification has deterred wider research into marijuana for legitimate medical uses.
Last year, for instance, the American Academy of Pediatrics issued a high-profile call for the DEA to reclassify marijuana so that more research can be conducted in the hopes of finding benefits for children. The influential medical society wants marijuana downgraded to a Schedule 2 drug, which are considered to still have a “high potential for abuse, which may lead to severe psychological or physical dependence,” but less so than Schedule 1 drugs.
One member of the AAP expert panel expressed mixed views on the change in DEA policy.
“I think it’s a very small step in the right direction,” said Dr. Seth Ammerman, a clinical professor in pediatrics at Stanford University and a member of the AAP national committee on substance abuse, who coauthored the policy statement. “If you look at the fine print, it’s still limiting research to those who have already gone through the process to do research in the first place.”
“It’s a minor change,” complained Paul Armentano, deputy director of NORML, an advocacy group that favors legalizing marijuana use. “The DEA has done nothing to speed the process for investigators who want to do clinical work with CBD. In order to do clinical work on a drug on the Schedule 1 list, an investigator still needs approval from the FDA, the DEA” and the National Institute on Drug Abuse.
Last year, the Epilepsy Foundation also called on the DEA to reschedule marijuana to enhance research. Following the legalization of marijuana in nearly two dozen states, there were reports that cannabis compounds were found to possibly reduce the frequency or severity of seizures.
But whether the Obama administration is willing to consider changing the scheduling is uncertain, given debate about the scientific evidence that would be needed to justify the move. We asked the DEA spokesman if a change is being considered and will update you accordingly. The FDA would have to collaborate on making such a decision and is conducting an analysis to determine whether marijuana should be downgraded on the Controlled Substances list.
One lawmaker, meanwhile, welcomed the DEA move.
“This is good news toward the progress on scientific research on cannabidiol,” Senator Chuck Grassley, a Republican from Iowa, said in a statement. He is on the Caucus on International Narcotics Control. “Right now, parents who are desperate to help their children live in uncertainty over cannabidiol. Federal agencies should do whatever they responsibly can to help research proceed so these families can get answers.”
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