An Open Letter to Governor and Former DEA Administrator Asa Hutchinson

Dear Governor Hutchinson,

I read your press release criticizing President Biden for pardoning all federal cannabis possession convictions and requesting that the Attorney General and HHS Secretary initiate the administrative process to reconsider cannabis’s schedule I status under federal law. Your arguments—that President Biden “waved the flag of surrender in the fight to save lives from drug abuse” and “ignored the science that is behind the different categories of drugs—aren’t just wrong. They’re dangerous. I write to explain why that is so and in the hopes that you’ll join our efforts to pursue rational federal drug policy reform.

President Biden didn’t “surrender in the fight to save lives from drug abuse.”

When it comes to cannabis, the federal government gave up on enforcing the CSA provisions criminalizing cannabis-related activity years before the President Biden moved into the White House. As Justice Thomas explained recently in his statement regarding the denial of certioari in Standing Akimbo, LLC v. United Satates:

In 2009 and 2013, the Department of Justice issued memorandums outlining a policy against intruding on state legalization schemes or prosecuting certain individuals who comply with state law. In 2009, Congress enabled Washington D. C.’s government to decriminalize medical marijuana under local ordinance. Moreover, in every fiscal year since 2015, Congress has prohibited the Department of Justice from “spending funds to prevent states’ implementation of their own medical marijuana laws.” United States v. McIntosh, 833 F. 3d 1163, 1168, 1175–1177 (CA9 2016) (interpreting the rider to prevent expenditures on the prosecution of individuals who comply with state law).

141 S. Ct. 2236, 2237 (2021) (statement of Thomas, J., regarding denial of certiorari) (footnotes omitted).

The point here is that over the past couple decades the federal government has passively nurtured a multi-billion dollar cannabis market into existence through various non-enforcement policies (both formal and informal). For you to characterize President Biden’s pardons of a few of the lowest level cannabis convictions as the official surrender simply blinks reality.

The real “surrender”—or at least the first public one I’m aware of—in the fight for a federal cannabis policy that promotes public health and safety occurred on May 2, 1971. That’s when President Nixon was asked about the Shafer Commission and said “Even if the commission does recommend that [cannabis] be legalized, I will not follow that recommendation.” If you don’t know the details of the Shafer Commission Report, you’re missing a very important piece of the federal cannabis policy puzzle. Here are the basics.¹

When Congress passed the CSA in 1970, it placed cannabis in schedule I only tentatively. It did so not because of what science proved or even tended to prove about the plant but because of what it didn’t prove. At the time, cannabis had “no recognized therapeutic use” in treatment. Federal Drug Abuse and Drug Dependence Prevention, Treatment, and Rehabilitation Act of 1970, Hearings, 91st Cong., 2d Sess., on S. 3562 (Part 2) at 473 (1970). Whether that would change remained an open question.

The Assistant Secretary of the United States Department of Health, Education, and Welfare—HHS’s predecessor agency— recommended placing cannabis in schedule I “at least until the completion of certain studies.” Gonzales v. Raich, 545 U.S. 1, 14 (2005). Along with this preliminary classification, Congress established a “Commission on Marihuana and Drug Abuse,” Pub. L. No. 91-513 § 601, 84 Stat. 1236 (Oct. 27, 1970), and provided it $1 million to study the legal, scientific, and medical aspects of marijuana use, id. § 601 (d), (e). The Commission was to report back to Congress and the President within two years with “appropriate recommendations for legislation and administrative actions.” Id. § 601(2)(e).

Although the CSA left scheduling decisions up to the Attorney General, the architects of the plan apparently assumed that the Nixon Administration would follow the Commission’s recommendation if it concluded decriminalization was appropriate. As I’ll explain next, however, they were wrong about that.

President Nixon appointed Gov. Raymond P. Shafer of Pennsylvania, a former prosecutor with a “law-and-order” reputation, to run the commission. According to oval office tapes declassified in 2002, Nixon told Shafer he wanted a report that would blur the distinction between marijuana and hard drugs. As the Commission’s investigation was getting underway in May 1971, Nixon told his aide, “I want a goddamn strong statement about marijuana. Can I get that out of this sonofa-bitching, uh, domestic council? I mean one on marijuana that just tears the ass out of them.”

According to Nixon, and I kid you not, the "Jews" were to blame for the rising popularity of legalization. “Every one of the bastards that are out for legalizing marijuana is Jewish," Nixon complained. "What the Christ is the matter with the Jews, Bob, what is the matter with them? I suppose it’s because most of them are psychiatrists, you know, there’s so many, all the greatest psychiatrists are Jewish. By god, we are going to hit the marijuana thing, and I want to hit it right square in the puss. I want to find a way of putting more on that.”²

When Shafer eventually brought the Commission’s Report to the White House, it called for decriminalization of cannabis. True to his word (this time at least), Nixon “[did] not follow that recommendation.”³

That was the moment of public surrender. That was the moment that everyone paying attention knew U.S. cannabis policy under the CSA wasn’t about science or public health and safety.

President Biden isn’t “ignor[ing] the science that is behind the different categories of drugs.”

Again, cannabis’s scheduling isn’t based on science. It never was. The story of President Nixon taking a million dollars from American taxpayers to fund an extended investigation of cannabis’s legal, scientific, and medical uses only to ignore the results when they didn’t suit his anti-semitic political ends is proof enough of that. So I’ll focus here on demonstrating another point that is even more important:

Schedule I is anti-science and anti-public health and safety. In the case of cannabis, it does a better job of preventing scientific research than abuse and diversion.

Drugs end up in schedule I when DEA concludes that they have a high potential for abuse and no currently accepted medical use in treatment in the U.S.⁴ DEA has repeatedly concluded that to have a currently accepted medical use in treatment in the U.S., a drug must be FDA-approved for interstate marketing.⁵ And until a substance is approved by FDA for marketing, all use of that substance outside of strictly controlled research is, according to the federal government at least, "abuse." See, e.g., FDA Manual of Policies and Procedures, Center for Drug Evaluation and Research, 4200.3 Rev. 2 at 7 (defining “abuse” as “[t]he intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect”).

Thus, if people like using a substance before FDA approves it for interstate marketing—as is certainly the case with cannabis and virtually every other natural substance listed in schedule I—it is automatically a substance with a high potential for abuse and no currently accepted medical that belongs in schedule I. At that point, the only way to get the substance out of schedule I is to demonstrate that it has a currently accepted medical use in treatment in the U.S., which means getting FDA approval for interestate marketing. And that's where things get tricky for two reasons.

First, it is virtually impossible to research schedule I substances. Indeed, the only difference between schedule I and schedule II substances are that schedule II substances may be prescribed by a doctor and researched with far fewer regulatory hurdles. In testimony before the House Subcommittee on Health, Committee on Energy and Commerce, Dr. Nora Volkow, the Director of the National Institute on Drug Abuse (“NIDA”), recently described the extraordinary challenges researchers face when seeking to study schedule I substances, contrasting them with the dramatically more relaxed regulations that apply to substances in schedules II-V:

Even experienced researchers have reported that obtaining a new Schedule I registration [from DEA under 21 U.S.C. 823(f)], adding new substances to an existing registration, or getting approval for research protocol changes is time consuming. 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. This review is often in addition to other reviews of the proposed research and investigator, such as the federal grant review process, the FDA Investigational New Drug (IND) application review process, and Institutional Review Board and Institutional Animal Care and Use Committee reviews. Establishing the security infrastructure needed to conduct Schedule I research can be expensive and may need to be duplicated for each registrant working within a single research department. Researchers have also reported that there is a lack of clarity in some of the registration requirements and variability in their interpretation, which complicates and adds time to the process. For example, researchers report inconsistency in the guidance they have received on whether one individual can work under the registration of another, whether separate registrations are needed for each of an investigator’s research sites within the same campus, whether a manufacturing registration is needed to create final dosage formulations for research purposes, among other issues. Researchers have reported that sometimes these challenges impact Schedule I research and deter or prevent scientists from pursuing this critical work. 

A paper published by the National Library of Medicine in 2017, examined the problem of schedule I research barriers in the cannabis context specifically. After describing “[t]he substantial layers of bureaucracy that emerge from cannabis’s Schedule I categorization,” the authors explain that cannabis’s schedule I classification has stifled “research on the health effects of cannabis and cannabinoids . . . in the United States, leaving patients, health care professionals, and policy makers without the evidence they need to make sound decisions regarding the use of cannabis and cannabinoids.” Their conclusion is ominous (and obviously right): “This lack of evidence-based information on the health effects of cannabis and cannabinoids poses a public health risk.”

Second, getting FDA approval for interstate marketing requires around $1 billion in scientific research.⁶ Pharma companies are willing to that extraordinary price to bring drugs to market because once they get FDA approval, they also get years of market exclusivity. Without that temporary monopoly and various intellectual property rights, they’d never be able to recoup their investment and thus would never have an incentive to pay for the research in the first place. In other words, it makes sense to pay the price for FDA approval to bring a drug to market before there’s a market for the substance. With cannabis and other natural substances in schedule I, however, there’s already a booming interstate market for them. No drug company (or person, organization, or government) is willing to pay a billion dollars to prove a drug is safe and effective for marketing when it’s already on the market.

This creates a Kafkaesque nightmare loop for those seeking to establish the safety and efficacy of cannabis and other natural schedule I substances on the federal government’s terms. The more people use these substances across the country, the more urgency there is to study them. At the same time, however, because people are using the substances widely before the research has taken place, the government insists that everyone is abusing them, which under the government’s twisted “logic,” only reinforces the need to keep them in schedule I and not let anybody study them.

Not only is this situation frustrating and illogical, it is also downright dangerous. Making it harder to study the drugs people use most is insane. Those substances may be very dangerous, very helpful, or both. If they’re very dangerous, studying them would help educate the public about when, why, and to what extent that is so. It would also facilitate the innovation necessary to ameliorate their dangerous effects. If they’re helpful, we’ll never learn how, when, to what extent, for what purposes, under what conditions etc. without study them. And if they’re both very helpful and very dangerous (think fentanyl, opiates etc.), the urgent need for study increases in both directions.

Now tell me: How in god’s name is this ridiculous arrangement supposed to serve the public interest?

As bad as all this is for other substances, it’s especially dangerous in the cannabis context where the government’s non-enforcement policy encourages more and more people to use an ever-wider array of newfangled cannabis strains and products while simultaneously blocking the best and most competent scientists and research organizations from studying any of them. Left uncorrected, this will obviously have dire consequences for people young and old across the country, including the citizens of Arkansas. I therefore urge you to join me in the real fight to “save lives from drug abuse” by urging Congress to remove cannabis and other natural substances from schedule I immediately.

Thank you for your years of public service and for your time and attention to this letter, which I’m sure (or at least I hope) was an uncomfortable read for you. I’d love to discuss these issues with you if you’re interested. And if you think I’m wrong about any of this, I’d love to debate the issues with you anytime and anywhere. Next week in front of DEA headquarters sounds fun to me. What say you?

Respectfully,

Shane Pennington

P.S. Even if I haven’t persuaded you and you decide not to discuss/debate the issues with me, I do hope you’ll subscribe to OnDrugs and encourage your friends, family, and the people of Arkansas to do the same. Thanks!

1. Further detail on this episode available here.

2. Because this part is probably unbelievable if you’re encountering it for the first time, I encourage you to check out this transcript of a 2014 hearing of the House Subcommittee on Government Operations where all of this is quoted into the record.

3. There’s a whole lot more in those tapes and other records of the Nixon Administration. Suffice to say that the Jews weren’t the only targets of Nixon’s bigotry. If you want to know more, consult the links in notes 1 and 2 above and here and here (that’s just the tip of the iceberg—there’s a lot more). I warn you, though, it ain’t pretty.

4. See, e.g., 81 Fed. Reg. 53688 (Aug. 12, 2016) (“Congress established only one schedule, Schedule I, for drugs of abuse with ‘no currently accepted medical use in treatment in the United States’ and ‘lack of accepted safety for use . . . under medical supervision.’”) (quoting 21 U.S.C. 812(b)). Technically, there are two other ways for drugs to end up on schedule I: (1) Congress can put them there or (2) DEA can deem schedule I the most appropriate place for them to ensure U.S. treaty compliance (21 U.S.C. 811(d)(1)). Notice, though, that neither of these paths to schedule I is science-based either. Cannabis’s history proves that. Congress out and out said that cannabis's initial schedule I placement wasn't science based. That's why it placed it there tentatively pending the results of the Shafer Commission Report that Nixon subsequently ignored. And to the extent cannabis is in schedule I because of treaty commitments, that obviously isn't about science. After all, the U.S. is obligated to comply with the Single Convention whenever the WHO/UN subject a substance to control under the treaty regardless of what the science says.

5. Technically, DEA will also acknowledge that a drug not approved by FDA has a currently accepted medical use in treatment in the U.S. if it meets a five-part standard the agency itself created. See 57 Fed. Reg. 10499, 10504-06 (Mar. 26, 1992). That standard is designed to mimic FDA’s own standard for approving drugs for interstate marketing, however, and DEA has acknowledged that it won’t be moving cannabis out of schedule I without FDA approval. See, e.g., DEA Letter here at 25 (“In sum, DEA recognizes the possibility that drugs containing marijuana or its derivatives might, in the future, be proven to be safe and effective for the treatment of certain conditions and thus approved be by the United States Food and Drug Administration for marketing. Until then, we will continue to identify opportunities to assist researchers in this area while never losing sight of the need to protect the public.”) (emphases added).

6. According to the Bright Focus Foundation, "various sources" say that “it can cost more than $1 billion to bring one product to the market, including approximately $50-840 million to bring treatments through the stages of Basic Research/Drug Development and Pre-Clinical/Translational Research, and approximately $50-970 million to complete the Clinical Trials (Phases 1, 2, and 3).” Bright Focus cites: DiMasi, Joseph A., Ronald W. Hansen and Henry G. Grabowski (2003) “The Price of Innovation: New Estimates of Drug Development Costs,” Journal of Health Economics 22(2):151-85; Morgan, Steve, et al. “The cost of drug development: A systematic review” Health Policy 100 (2011) 4–17.