The Drug Enforcement Administration (DEA) and National Institute On Drug Abuse (NIDA) say they are in favor of a White House proposal to streamline the process of researching Schedule I drugs like marijuana and certain psychedelics.
The agencies testified at a House Energy and Commerce subcommittee hearing on Thursday, expressing support for the Office of National Drug Control Policy (ONDCP) research plan. While the focus of the meeting was mostly on a controversial move to strictly classify fentanyl-related substances, the Biden administration proposal’s research components would also help address concerns within the scientific community about the difficulty of studying other Schedule I drugs.
DEA said in written testimony that “expanding access to Schedule I research is a critical part of DEA’s mission to protect public safety and health.”
“It is critical that the scientific and medical community study Schedule I substances, as some may turn out to have therapeutic value,” DEA Principal Deputy Administrator Louis Milione said. “DEA supports the administration’s legislative proposal’s expansion of access to Schedule I research. DEA looks forward to continuing to work with the research community and our interagency partners to facilitate Schedule I research.”
In general, what the administration is proposing is to align the research requirements for Schedule I drugs with those of less-restricted Schedule II drugs. Scientists and lawmakers have consistently pointed out that the existing rules for studying Schedule I controlled substances are excessively burdensome, limiting vital research.
Rather than having each scientist involved in a Schedule I drug study obtain DEA registration, ONDCP wants to make it so multiple researchers at a given institution would be allowed to participate under a single registration. The administration also proposed a policy change where a research institute with studies taking place over multiple locations would only require one overall registration instead of needing to have a specific one for each site.
Another change would allow certain researchers to move ahead with conducting their studies after submitting a notification to the Department of Justice instead of waiting for officials to affirmatively sign off on their proposals. ONDCP’s plan would also waive the requirement for additional inspections at research sites in some circumstances and allow researchers to manufacture small amounts of drugs without obtaining separate registrations. The latter component would not allow cultivation of marijuana, however.
“Even experienced researchers have reported that obtaining a new Schedule I registration, adding new substances to an existing registration, or getting approval for research protocol changes is time consuming,” NIDA Director Nora Volkow said in her testimony. “Unlike for Schedule II through V substances, new and amended Schedule I applications are referred by the DEA to the HHS for a review of the protocol and a determination of the qualifications and competency of the investigator.”
“Researchers have reported that sometimes these challenges impact Schedule I research and deter or prevent scientists from pursuing this critical work,” she said.
In an interview last week, Vokow said that even she—the top federal official overseeing drug research—is personally reluctant to conduct studies on Schedule I substances like marijuana because of the “cumbersome” rules that scientists face when investigating them.
When ONDCP first announced its proposed Schedule I policy changes in September, some experts tempered expectations about the practical effects of aligning Schedule I and Schedule II applications. The difference is largely a matter of extra paperwork for the more restrictive category, they contend.
Regardless, several lawmakers who attended Thursday’s subcommittee hearing expressed enthusiasm about the prospects of these policy changes.
“I’m particularly interested in eroding existing barriers of federal law that limit researchers at academic medical centers from studying Schedule I substances,” Rep. Doris Matsui (D-CA) said. “So I’m grateful that our research agencies are working to find effective solutions.”
Rep. Tony Cárdenas (D-CA) also weighed in, saying that “we all agree that the current scheduling classification system has made it very difficult for scientists to research the effects of scheduled compounds, which may have medicinal properties.”
“For example, we know that compounds in marijuana have legitimate and beneficial medical uses, despite it being Schedule I,” he said. “So I’m encouraged to see that efforts are being made to allow researchers to study the effects of various compounds. In this proposal.”
ONDCP’s intent to streamline research into Schedule I drugs has been notable and seems to be part of a theme that developed within the administration.
For example, DEA has repeatedly proposed significant increases in the production of marijuana, psilocybin and other psychedelics for research purposes, with the intent of aiding in the development of new federally approved therapeutic medications.
NIDA’s Volkow told Marijuana Moment in a recent interview that she was encouraged by DEA’s prior proposed increase in drug production quota. She also said that studies demonstrating the therapeutic benefits of psychedelics could be leading more people to experiment with substances like psilocybin.
But while the production developments are promising, advocates are still frustrated that these plants and fungi remain in the strictest drug category in the first place, especially considering the existing research that shows their medical value for certain conditions.
There has been at least one recent development in the fight to modernize marijuana research. President Joe Biden signed a massive infrastructure bill last month that includes provisions aimed at allowing researchers to study the actual cannabis that consumers are purchasing from state-legal dispensaries instead of having to use only government-grown cannabis.
But that’s just one of numerous research barriers that scientists have identified. A report that NIDA recently submitted to Congress stressed that the Schedule I status of controlled substances like marijuana is preventing or discouraging research into their potential risks and benefits.
A federal appeals court recently dismissed a petition to require the DEA to reevaluate cannabis’s scheduling under the Controlled Substances Act. However, one judge did say in a concurring opinion that the agency may soon be forced to consider a policy change anyway based on a misinterpretation of the therapeutic value of marijuana.
Meanwhile, DEA has given hemp businesses that sell delta-8 THC products a boost, with representatives making comments recently signaling that, at the federal level at least, it’s not a controlled substance at this time.
Separately, the Washington State attorney general’s office and lawyers representing cancer patients recently urged a federal appeals panel to push for a DEA policy change to allow people in end-of-life care to access psilocybin under state and federal right-to-try laws.
Photo courtesy of Brian Shamblen.