Cannabis Research

A Law That Facilitates Cannabis Research Exemplifies the Modesty of the Reforms We Can Expect From Congress

Making it easier for scientists to study marijuana is a far cry from the liberalization that most Americans want.


President Joe Biden last week signed into law what Marijuana Moment describes as "the first piece of standalone federal cannabis reform legislation" ever enacted in the United States. That is probably the most impressive thing you can say about the new law, which aims to make it somewhat easier for scientists to study a drug that is still prohibited for all other purposes under federal law.

The legislation, which received broad bipartisan support in the House and Senate, suggests how far the national conversation about cannabis has progressed since California became the first state to approve its medical use in 1996. At the same time, the bill's modest scope shows how much distance remains between federal law and the marijuana policies that three-quarters of the states have adopted.

H.R. 8454, a.k.a. the Medical Marijuana and Cannabidiol Research Expansion Act, passed the Senate by unanimous consent in March and passed the House by a vote of 325–95 in July. It is aimed at reducing some of the bureaucratic barriers to marijuana research.

Those barriers can be formidable. When the Multidisciplinary Association for Psychedelic Studies (MAPS) proposed a study of marijuana as a treatment for post-traumatic stress disorder, for example, it had little trouble obtaining permission from the Food and Drug Administration (FDA), which approved the application about five months after receiving it in November 2010. But MAPS got a lot more pushback from the U.S. Public Health Service (PHS), whose approval also was required at the time, and the researchers did not receive the marijuana they needed, which was available only from the National Institute on Drug Abuse (NIDA), until August 2016, nearly six years after the FDA application.

Some of the obstacles that MAPS encountered have been addressed since then. The Obama administration cut the PHS out of the process in 2015, and the Drug Enforcement Administration (DEA) began licensing additional suppliers of marijuana for research last year. H.R. 8454 prohibits the Department of Health and Human Services (HHS) from reinstituting an additional, cannabis-specific layer of bureaucratic review, and it requires faster DEA action on applications from manufacturers and researchers.

For half a century, the production of marijuana for research was limited to a single grower operating under a contract with NIDA. Researchers had long objected to that arrangement, complaining about the quality and variety of the marijuana supplied by NIDA as well as the agency's involvement in the approval process. In 2016, after resisting efforts to end NIDA's marijuana monopoly for years, the DEA said it was finally ready to license additional producers. But that did not happen until last year, thanks to a combination of legal objections from the Justice Department and the Trump administration's foot dragging.

The DEA finalized regulations for marijuana production in December 2020, and five months later it announced that several applicants "appear to meet the legal requirements." Since then, it has approved seven "bulk manufacturer marihuana growers." Under H.R. 8454, the DEA has 60 days to approve an application to produce marijuana or request supplemental information. It is required to act on the application within 30 days of receiving any additional information it requests.

Those same requirements will apply to researchers seeking DEA approval for marijuana studies. The law also eliminates a requirement that the DEA approve subsequent research protocol revisions, as long as the type, quantity, and handling of marijuana does not change. If there are such changes, the DEA has 30 days to object, and then only if it thinks "additional security measures are needed to safeguard against diversion or abuse."

More generally, H.R. 8454 requires the DEA to annually "assess whether there is an adequate and uninterrupted supply of marijuana, including of specific strains, for research purposes." And it instructs HHS, "in coordination with the National Institutes of Health and relevant federal agencies, to report on the therapeutic potential of marijuana for various conditions such as epilepsy, as well as the impact on adolescent brains and on the ability to operate a motor vehicle."

In an interview with Science, University of Mississippi pharmacologist Larry Walker described the law's limits on the DEA's response time, which previously could extend to a year or longer, as a "great advance." Ziva Cooper, director of UCLA's Center for Cannabis and Cannabinoids, called the law "exciting" and "a significant step forward with respect to chipping away at the barriers" to marijuana research. But let's not get too excited.

Although Biden has instructed HHS Secretary Xavier Becerra and Attorney General Merrick Garland to review marijuana's classification under the Controlled Substances Act, H.R. 8454 does not address that issue. Marijuana is still listed in Schedule I, a category supposedly reserved for drugs with a high abuse potential and no accepted medical use that cannot be used safely even under a doctor's supervision. Marijuana's Schedule I status triggers special requirements for storing and handling it.

Nor does H.R. 8454 allow researchers to use marijuana sold by state-licensed dispensaries, which would be more representative of the cannabis Americans actually consume. "There's no substitute for studying real-world products that our patients and recreational consumers are using," Staci Gruber, a neuroscientist at McLean Hospital in Massachusetts, told Science.

Shane Pennington, an attorney at the Denver-based cannabis law firm Vicente Sederberg, raises several additional concerns in a July 26 Substack essay. Pennington says H.R. 8454 gives the DEA "unbridled authority to avoid licensing any marijuana manufacturers at all simply by refusing to place a notice in the federal register seeking more applications." He adds that the DEA's deadlines for processing applications have no teeth because the law does not specify any consequences for missing them and because the agency can "avoid triggering any of the deadlines…simply by refusing to accept any particular application as 'complete.'"

Pennington also notes that H.R. 8454 creates a new requirement for DEA registration of researchers studying CBD and other cannabis derivatives that contain minimal or no THC. "By imposing registration requirements on these otherwise-non-controlled substances," he writes, "this bill dramatically increases barriers to cannabis research."

Even aside from those specific shortcomings, support for H.R. 8454 should not be confused with support for broader changes to federal law. Rep. Andy Harris (R–Md.), an original co-sponsor of the bill, is an arch prohibitionist who has devoted much time and energy to obstructing voter-approved legalization in Washington, D.C., where recreational use has been allowed since 2014 but nonmedical sales remain illegal.

"We will now be able to treat marijuana like we treat any other substance or pharmaceutical for which we hope there is potential benefit," Harris said. "We will be able to subject it to rigorous scientific trial." When nine out of 10 Americans already think marijuana should be available as a medicine, that stance looks more like a delaying tactic than a concession to public opinion.

Still, H.R. 8454 reflects how the national debate about marijuana has changed since the 1990s. One provision in particular is uncontroversial today but would have raised the hackles of Democrats as well as Republicans back when state-approved medical marijuana was a novelty. The law says "it shall not be a violation of the Controlled Substances Act" for physicians to discuss the risks and benefits of medical marijuana with their patients.

That principle has been well established since the Clinton administration unsuccessfully tried to punish doctors for such conversations by prosecuting them, excluding them from Medicare and Medicaid, or revoking the DEA registrations that allow them to prescribe controlled substances. In 2002, the U.S. Court of Appeals for the 9th Circuit upheld an injunction that blocked those threats on First Amendment grounds. The Supreme Court declined to hear the government's appeal.

In the current context, the controversy at the center of that case is hard to fathom. But when voters in California and Arizona approved medical marijuana ballot initiatives in 1996, the Clinton administration viewed that development as such a grave threat to pot prohibition that it justified a heavy-handed, constitutionally dubious response. The New York Times editorialized that the administration "has little choice but to insist that Federal drug statutes be enforced." Given that imperative, the Times said, the federal government's "aggressive campaign to combat the state initiatives, including criminal prosecution of doctors who prescribe marijuana…makes sense."

Drug warriors were right to worry. Medical marijuana did in fact pave the way for broader legalization, which the Times itself finally endorsed in 2014. Today 37 states allow medical use, and 21 of them also allow recreational use. The latter policy, which was supported by a quarter of Americans in 1995, is now favored by more than two-thirds. Yet Congress has responded to those realities with nothing more than piecemeal reforms that fall far short of what a large majority of voters say they want. H.R. 8454 is emblematic of that situation.

[This article has been updated with Shane Pennington's criticism of H.R. 8454.]