There Is No Excuse for Blocking Cannabis Research
If the federal government really wanted marijuana research to get done, it would have been done decades ago.
Senior officials in our nation’s public health agencies keep making excuses for the lack of serious scientific research in the United States into marijuana’s safety and effectiveness as medicine. Yesterday, for example, Marijuana Moment’s Kyle Jaeger reported on a recently published monograph prepared by high-ranking officials in NIH, NIDA, and FDA that cites a number of supposed barriers to this urgently needed scientific research, including
“the schedule I status of cannabis”
the “requirement that all approved projects obtain cannabis through NIDA”—aka the notorious NIDA Monopoly
the “complex and lengthy registration processes” applicable to growing and researching cannabis
the “schedule I classification of nonintoxicating cannabis components such as CBD”
These same government officials (and DEA and DOJ) consistently claim to be eager to get this research done. “Last week,” Jaeger reports, “DEA and NIDA both testified at a House Energy and Commerce subcommittee hearing in favor of a White House proposal to streamline the process.” And “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.’”
If the federal government really wanted this research to get done, it would have been done decades ago. More important, the federal government could get it done right now. Federal law permits the Attorney General on his motion or at the request of the Secretary of HHS to greenlight research with cannabis or any other schedule I substance today:
21 U.S.C. § 872(e). Section 822(d) of the Controlled Substances Act also permits the Attorney General to waive registration requirements that these same officials often cite as an obstacle to research:
Can anyone seriously dispute that doing so would be “consistent with the public health and safety” at this point? The Biden Administration finds a way to protect public health in other areas (e.g., the vaccine mandate) but not when it comes to marijuana. What gives?
The fact that federal officials continue to point to the NIDA Monopoly—the DEA policy that for fifty years required all marijuana to come from a single farm at the University of Mississippi under a contract with NIDA—as an excuse for blocking the laboratory door raises even more questions. The NIDA Monopoly is over. And contrary to popular belief, newly-licensed growers can supply any cannabis strain and any cannabis-derived product currently on the market. I explained all this here for anyone interested.
But let’s return to that House Energy and Commerce subcommittee hearing where “DEA and NIDA both testified … in favor of a White House proposal to streamline the process” and “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.’” There are two points here, and both are critical to understanding why it is so important that we reject the federal government’s excuses for blocking marijuana science.
First, many claim the Executive Branch’s position at the hearing demonstrates that the Biden Administration is ready to loosen schedule I restrictions. As I’ve already explained, however, the CSA already gives the Attorney General and HHS all the tools they need to do any kind of research with any substance it wants any time it wants—without new legislation. This is an area where the Executive Branch can act without Congress. The talk at the hearing was just that—talk.
Second, the most difficult thing to comprehend about that hearing is an issue nobody’s talking about: the federal government’s revelation of its disparate treatment of fentanyl-related-substances (FRS). As compared to marijuana, which has killed nobody, FRS have caused the deaths of over 100,000 people in the United States already in 2021. In a statement to the Committee, Dr. Douglas C. Throckmorton, FDA’s Deputy Director for Regulatory Programs, explains that
In the case of FRS, DEA issued a temporary order on February 6, 2018, controlling the entire FRS class (defined as all substances related to fentanyl that are within certain chemical structure parameters and that are not otherwise controlled and are not approved or exempted under the Federal Food, Drug, and Cosmetic Act) for a period of two years.
Congress has extended the order on three occasions, most recently extending the order through January 28, 2022.
On February 4, 2020, DEA asked HHS to conduct an eight-factor analysis on the FRS class and make a scheduling recommendation for the class.
Following careful evaluation, FDA concluded that such a finding is not possible for FRS as a class because (1) the class is vast in the number of hypothetical covered substances; (2) data on the pharmacological effect and epidemiological data showing harms and overdose deaths are available for fewer than 30 FRS substances; and (3) among the individual FRS for which pharmacological activity has been studied, FDA has identified examples of substances lacking in mu-opioid agonist activity, the presumed pharmacology that would lead to opioid-related harms.
Think about that. DEA wanted to put all FRS into schedule I, but FDA wouldn’t give its blessing. Like marijuana, these fentanyl-related-substances have not been approved by FDA for interstate marketing, so they do not meet DEA’s standard for having a “currently accepted medical use in treatment in the United States.” 21 U.S.C. 812(b)(1)(B). Worse, FRS is unquestionably more dangerous than marijuana. According to past practices, that should result in FRS being put into Schedule I. But instead, FDA concluded that the lack of data demonstrating that all FRS are deadly and some evidence that a few may not be as reason for keeping them all out of schedule I. Why did FDA keep pharmaceutical FRS out of schedule I while botanical marijuana remains in schedule I? The question answers itself.
Put simply, with marijuana, FDA and DEA are bending over backwards and contorting the law to maintain its schedule I status, which itself triggers the research restrictions those officials are complaining about. But FDA refused to permit DEA to put FRS in schedule I—even though they are objectively more dangerous and clearly have no “accepted medical use.”
There is a lot of smoke blowing.
The delays to marijuana research and the federal government’s disparate treatment of marijuana and far more danagerous substances like FRS are unacceptable. If you agree, please share this post widely.