On October 27, 1970, President Richard M. Nixon signed the Controlled Substances Act into law, relegating marijuana to Schedule I, a list of the most dangerous and medically useless drugs, where it continues to sit alongside heroin, LSD, and other toxic pharmaceuticals. More than half a century later, many of the federal restrictions on marijuana the law imposed may soon disappear, after the U.S. Department of Health and Human Services proposed that it be “rescheduled” to a lower tier, known as Schedule III, which regulates less deadly substances like ketamine, anabolic steroids, and testosterone.

The latest move follows decades of efforts to loosen federal limits on marijuana use. As early as 1972, the National Commission on Marihuana and Drug Abuse “urged Congress and the Nixon administration to deregulate marijuana because … it had medical value.” Today, despite the continuing federal ban, recreational marijuana is legal in 23 states, while 38 have legalized it for medicinal use.

Harvard Law Today spoke with Harvard Law School Professor Carmel Shachar J.D./M.P.H. ’10, a public health expert who serves as faculty director of the school’s Health Law and Policy Clinic. Until recently, she was executive director of Harvard’s Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, where she helped lead a project on psychedelics regulation and the law. Earlier this year, she and co-author Mason Marks, a law professor at the Florida State University, published a commentary in Nature titled “Drug scheduling limits access to essential medicines and should be reformed.” Shachar is optimistic that the latest push to reschedule marijuana will ultimately succeed and argues that the system that allowed it to languish on Schedule I for decades needs to be reformed.

Harvard Law Today: Why is marijuana, which is legal in many states and used regularly by tens of millions of Americans, a Schedule I controlled substance alongside drugs like heroin and LSD?

Carmel Shachar: Marijuana was put on the Schedule I list in the early 1970s when Congress first created the Controlled Substance Act, with very little medical or scientific evidence justifying why it was Scheduled I. And what we’ve seen, certainly since the 70s but even in the last decade or so, is a huge cultural shift in our understanding of marijuana. In some regards, the federal government’s approach at this point is more of an outlier than the norm. A lot of states have legalized marijuana. There’s a robust adult recreational use industry. And it’s very normalized and accepted that marijuana is a substance that has medicinal and social value. But under the current system, once a drug is scheduled, it tends to remain there.

HLT: In a paper you and your co-author, Mason Marks, wrote in Nature, you argued that Schedule I “is something of a regulatory black hole.” What did you mean by that?

Shachar: The current situation in which the U.S. Department of Health and Human Services [HHS] is moving to reschedule marijuana is really an anomaly. On paper, the Controlled Substances Act has several ways in which a substance can be rescheduled. To start, Congress could decide to reschedule a substance through legislation. Alternatively, the administration in power and regulatory agencies can initiate a rescheduling. Finally, people can petition for a rescheduling, and if the agency says no, they can take it to the courts.

What we’ve seen in the last several decades is a real resistance to using any of those pathways to rescheduling. There has been a lot congressional interest in moving marijuana off Schedule I. And it’s a real who’s who of congressional folks who tried to do it, including everyone from Ron and Rand Paul to Barney Frank and Cory Booker. The one thing they had in common was it just never succeeded. There have also been a lot of citizen petitions. The petition that got the furthest was rejected by the D.C. Circuit Court of Appeals, which said that it agreed with the HHS assertion that you would need formal clinical trial data to demonstrate marijuana has an accepted medical use.

HLT: So, why hasn’t anyone conducted the clinical trials?

Shachar: Requiring clinical trial data created a strange set of incentives and disincentives, because clinical trials are really expensive. And the players who have the money and expertise to do clinical trials are for-profit pharmaceutical companies. But they are unlikely to sink a lot of money into clinical trials for something that they can’t patent, which is the case with a naturally occurring substance like marijuana. So, we instead started to see these companies creating synthetic versions of naturally existing drugs. And today, there are some FDA approved, cannabis-derived synthetics that are not Schedule I. But naturally occurring marijuana is still among the most highly controlled substances.

HLT: You write that regulating natural and artificial cannabis differently results in disproportionate impacts on different communities. Can you explain why?

Shachar: A situation in which the naturally occurring substances are still Schedule I, but the synthetic patented pharmaceutical versions are not, does disadvantage certain groups, especially people of color. To begin with, we know that the war on drugs has disproportionately impacted communities of color. They’ve been over policed and there are a lot of people who are incarcerated as a legacy of those policies. Those communities are also less likely to have access to health insurance, physicians, and mental health providers. And so, you see people who are self-medicating, using marijuana, using naturally occurring psychedelics, who, because those drugs are scheduled, run the risk of being caught up in the criminal justice system. Whereas somebody from a less disadvantaged community is maybe going to their doctor, who is saying, “Hey, we have this new medication. You should try it.” And because it’s gone through the healthcare channels, they’re not open to criminal liability.

HLT: Given the number of states that have legalized access to marijuana, does it matter if the federal government reschedules it? Are the federal prohibitions even being enforced these days?

Shachar: The last few years have sort of been a status quo situation where the federal government doesn’t look too closely, and states do what they think is right. But as long as it’s Schedule I, all it takes is a change in presidential administration for that kind of uneasy status quo to evaporate. When Jeff Sessions was attorney general under [President] Trump, for instance, he was very anti-substance and anti-marijuana use, and he started pushing to crack down on marijuana use and distribution.

The marijuana industry also experiences several burdens. The biggest is that marijuana companies are prevented from claiming business deductions under the federal tax code. Another is that you can’t transport marijuana across state lines. A third is that, if you are prosecuted for possession of marijuana as a federal crime, the penalties are higher, because it’s Schedule I. Stepping it down to Schedule III would ease a lot of those burdens by enabling businesses to operate more normally from a tax perspective, allowing it to be transported across state lines, and reducing penalties for people prosecuted on the federal level for marijuana related crimes. And because it would be unlikely to get rescheduled back to Schedule I very easily, especially in the next several years, moving it to Schedule III would represent the federal government making a more permanent commitment to matching where many states are.

HLT: Would that make scientific research easier as well?

Shachar: Yes, it’s a lot easier to do medical research on Schedule III substances than Schedule I substances. So, we would see more research, which is good considering the higher rates of use, as well as the fact that there’s been a lot of innovation in marijuana growing. Today, if you want to do federally funded research, you have to work with the one lab that is licensed by the Drug Enforcement Administration to provide marijuana and other similar substances. But researchers have said that that lab grows an older strain of marijuana that doesn’t reflect a lot of what’s on the market today.

HLT: So, HHS has made the first move to reschedule marijuana. What happens next, and what’s the likelihood they will succeed?

Shachar: I’m very optimistic about them succeeding, but it’s certainly got many more steps until it’s a done deal. HHS has recommended that marijuana be downgraded from Schedule I to Schedule III. But the Drug Enforcement Administration manages Controlled Substances scheduling. The Controlled Substance Act requires the DEA to listen when HHS talks. So, I think the chances are good that DEA will hear what HHS has to say. But they’re going to have to go through the formal rulemaking process, which includes developing the proposed regulation, opening it to public comment, and holding a public hearing with the presentation of evidence.

HLT: Any chance of litigation?

Shachar: Yes. The U.S. is a signatory to the 1961 Single Convention on Narcotic Drugs. That treaty, which predates the Controlled Substances Act, requires signatories to treat cannabis like a controlled substance. A lot of other signatory nations have already acted to legalize marijuana, so I don’t think it would be an insurmountable burden. But somebody may bring litigation arguing that the U.S. is a signatory to this treaty, and it needs to stay in keeping with the treaty it signed.

HLT: Some advocates have argued that U.S. should legalize marijuana entirely. Is there a health and safety argument for continuing to regulate it as a controlled substance?

Shachar: I have heard physicians and scientists speak on both sides of this question. Many point out that we allow alcohol to be available with limited regulation and argue that it’s a little hypocritical to allow a bar on every corner, but to restrict access to marijuana. I have also talked with my colleagues at Harvard Medical School and the Harvard affiliated hospitals who say, “No, we know that long term use of marijuana has the chance of producing some undesired outcomes in the brain. And if we just treat it as a recreational thing without educating people or putting limits on it or keeping it reserved as a pharmaceutical to be used under medical supervision, then we may be doing more harm than good.”

I think there’s something to say for moderation in all cases. Whether marijuana really should look like a pharmaceutical that you use under the supervision of medical professionals, or, alternatively, we allow adults to make choices about their lives and we decide as a society that it’s a legitimate choice to say, “I want to spend part of my life a little stoned,” I think that’s a broader policy debate. But that’s a debate that we simply haven’t been able to have as long as marijuana was a Schedule I substance.

HLT: Moving beyond the question of marijuana, you titled your recent paper “Drug scheduling limits access to essential medicines and should be reformed?” What reforms would you like to see?

Shachar: I think knowledge is power. And the more research we have on substances to understand what their benefits and harms are, the better. The Controlled Substances Act is set up in a way that really chills research on these substances, whether they are Schedule I, II, or III. And because the courts have now said that clinical trial data, which is extremely expensive to produce, is needed to get a drug rescheduled, we’ve been caught in this chicken and egg situation. So, I would love to see a few things. The first is a new approach that is better able to incorporate cutting-edge medical research, because we’ve had medical research for a very long time showing that marijuana has medical uses and isn’t so dangerous that it needs to be a Schedule I substance. And second, I would like to see an avenue to make it more feasible to do research on naturally occurring substances which can’t be patented. Because we need to understand what people are putting in their bodies, whether those substances are legal or not.

HLT: Is there anything you’d like to add?

Shachar: I think this move to reschedule marijuana is, in some ways, a response to the approach taken in the 1970s and in some ways a response to the war on drugs, which came a little bit later. At the time, there was no real record of evidence to put marijuana on Schedule I, except that it happened during the Nixon years and there was a lot of cultural baggage associated with marijuana. It’s good that the Biden administration is addressing that. At the same time, I also think people should realize it’s not legalizing marijuana across the country. If you’re in a state where it’s still illegal, it’s still going to be illegal. But this will bring the federal government and the states that are more reflective of our current cultural norms into greater harmony. And I think that’s a good thing.

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