The Medical Marijuana Research Act (H.R. 5657)

A mixed bag that fails to address the biggest obstacle to research.

Sponsored by Reps. Earl Blumenauer (D-OR) and Andy Harris (R-MD), the Medical Marijuana Research Act (H.R. 5657) purports to facilitate cannabis research by, for example, allowing scientists to study cannabis products from state-legal dispensaries. I go over the bill carefully below, one section at a time, but here’s my big-picture take:

The Good: This bill is much, much better than the Cannabidiol and Marihuana Research Expansion Act (S. 253), which I ranted about in this essay. Of course, that’s not saying much. It includes many seemingly well-intentioned changes, including, for example, deadlines for processing applications, requiring FDA and DEA to establish a process for researchers to get their hands on and (presumably) study the dispensary products people are actually using, and removing some of the red tape that makes it so hard to do study cannabis at the federal level now.

The Bad: On closer inspection, however, many of of the changes the bill calls for would be ineffectual in practice. Only one of the deadlines, for example, would be enforceable in court. The rest may as well not be there at all. And even those the few changes that would be helpful in theory won’t make any difference in practice because the bill provides no funding for research.

The Bottom Line: Supposed regulatory barriers are not blocking research today. Lack of funding is. With the fall of the NIDA monopoly, we now have more than enough DEA-licensed growers to meet national demand for research cannabis many times over. And as I’ve explained elsewhere, those growers can already supply researchers with the cannabis strains and products people are using under state-legal regimes.

Even if the deadlines in the bill were enforceable (and again, with one exception, they’re not), it would take years before any actual research would get done under the plan it envisions. That’s unacceptable. President Biden says that the opioid abuse and overdose epidemics are urgent national emergencies. He says that the Administration is leaving no stone unturned in its quest to address them.

If that were true, though, the Administration would be tripping over itself to fund serious clinical research with cannabis (and psychedelics). After all, Biden’s chief Science Advisor, Dr. Francis Collins, and the Director of NIDA, Dr. Nora Volkow, are on record—in the New England Journal of Medicine no less—touting cannabis as “America’s Exit Drug” because of its promise as a powerful weapon in America’s existential fight against opioids/fentanyl analogues/etc. And that was in 2017.

Yet here we are, half a decade later, and we still haven’t gotten around to doing the basic science that all these lawmakers and elected officials claim is so important. That’s inexcusable.

The Details, Section By Section

The rest of this essay provides a summary of each section’s key provisions (and by “key” here, I mean the ones I find interesting and/or important). When I have comments on a particular provision, they appear in bold directly following the relevant summary. If you see “***” before any of my comments, that means I think the point is especially important and worthy of your (and Congress’s) attention.

Section 1. SHORT TITLE.

This section announces the bill’s “short title”: the “Medical Marijuana Research Act.”

Section 2. FACILITATING MARIJUANA RESEARCH.

This section requires the Secretary of HHS (who would delegate responsibility over these matters to FDA) to continue running the NIDA drug supply program and work with the Attorney General (who would delegate responsibility to DEA) to establish and run a “specialized process” to enable marijuana manufacturers and distributors to supply DEA-registered researchers with the cannabis strains and products people are using across the country under state-legal regimes.

It would require FDA and DEA to meet not later than 60 days after enactment to start developing this “specialized process” and to have the process up and running within 1 year.

***Shane’s Comments: This 60-day deadline is toothless. When a statute includes a deadline for an agency to act but fails to include consequences for the agency’s noncompliance, courts will not enforce the deadline against the agency. See, e.g., Transportation Div. v. Fed. R.R. Admin., 10 F.4th 869, 874 (D.C. Cir. 2021) (“[I]f a statute does not specify a consequence for noncompliance with statutory timing provisions, the federal courts will not in the ordinary course impose their own coercive sanction.”) (quoting Barnhardt v. Peabody Coal, 537 U.S. 149, 159 (2003)).

Section 2(c) woud require FDA within 180 days of enactment to issue “guidance related to marijuana from State-authorized marijuana programs for research.”

Shane’s Comments: The 180-day deadline is toothless for the reason just explained. Also, hard to understand why Congress would call for FDA guidance regarding dispensary cannabis/cannabis products. For one thing, guidance is non-binding. For another, it is hard to imagine what FDA might say in the guidance. Would be useful for Congress to provide some guidance of its own about what sort of substance it wants the guidance to have.

Section 2(d) would require DEA to register applicants seeking to research marijuana if (1) the applicant is registered to dispense or research any controlled substance in any schedule and (2) there is no state-law obstacle to registration. Only applicants seeking to do FDA clinical trials would need an FDA-approved protocol to get registered as a marijuana researcher.

DEA would be required to grant or deny applications within 60 days of receipt. If it denies an application, it would be required to explain the denial in writing.

Shane’s Comments: The 60-day deadline is toothless and unenforceable. See earlier comments. Unclear whether DEA must issue the denial and explanation within 60 days or just the denial. If you give an agency a deadline to issue a denail but then give it infinite time to provide an explanation, you should expect the denial might arrive within 60 days but the explanation definitely won’t. Of course, because this deadline is toothless anyway, the agency will be free to ignore it with impunity in any case. Strongly recommend adding consequences for violation and clarifying that the denial and the explanation must arrive within 60 days.

DEA would only be permitted to deny an application meeting the requirements described earlier if it determined that registering the applicant would be “inconsistent with the public interest,” a determination that DEA would have to make based on four factors:

1. the applicant’s experience in dispensing or researching controlled substances;

2. the applicant’s “conviction record” under federal or state law relating to the manufacture, distribution, or dispensing of controlled substances;

3. compliance with state/local controlled substances laws; and

4. “[s]uch other conduct which may threaten the public health and safety.”

***Shane’s Comments: DEA interprets “conviction record” elsewhere in 21 U.S.C. 823 to include non-compliance. So, for example, 21 U.S.C. 823(a)(4), which requires DEA to consider an applicant’s “prior conviction record of applicant under Federal and State laws relating to the manufacture, distribution, or dispensing of such substances,” when deciding whether granting an application to manufacture schedule I substances would be consistent with the public interest. DEA interprets that factor to include non-compliance with federal laws even when that non-compliance doesn’t result in a conviction. This is one of the ways DEA excludes those who have participated in the state-legal cannabis industry from obtaining DEA registration. It violates the plain language of the statute, and Congress should take this opportunity to remind DEA that “conviction record” means “conviction record” (particularly when other factors listed focus on compliance with particular laws).

DEA would not be permitted to impose security measures on applicants conducting marijuana research beyond those applicable to “applicants conducting research on other controlled substances in schedule II that have a similar risk of diversion and abuse.

***Shane’s Comments: How on earth is DEA supposed to decide what schedule II substances have a “similar risk of diversion and abuse” to cannabis? Congress should spell out what it means here. Otherwise, this is legislative roulette.

Sec. 3. MANUFACTURE AND DISTRIBUTION OF MARIJUANA FOR USE IN LEGITIMATE RESEARCH

Section 3 would require DEA to register applicants to manufacture/distribute marijuana intended for eventual use in research unless doing so would be inconsistent with the public interest based on four considerations:

1. maintenance of effective controls against diversion;

2. compliance with applicable state and local laws;

3. prior conviction record of the applicant under federal or state law relating to the manufacture, distribution, or dispensing of controlled substances; and

4. such other conduct which may threaten the public health and safety.

***Shane’s Comments: See comments above regarding DEA’s indefensible interpretation of “prior conviction record.”

The bill would clarify that there’s no limit on the number of manufacturers and distributors of marijuana DEA may register.

The bill would require DEA to approve or deny any such application within 60 days. And in the case of denial, the bill would require DEA to explain the basis for its decision within that same time frame. The bill also makes clear that if DEA fails to grant or deny the application within that timeframe, “the request [for registration] is deemed approved.”

Shane’s Comments: Finally! A statutory deadline with teeth! Because this 60-day deadline assigns consequences for DEA’s non-compliance, it would be enforceable in court. Congress should amend the other deadlines in the bill to have comparable language to ensure they’re actually enforceable.

Sec. 4. TERMINATION OF INTERDISCIPLINARY REVIEW PROCESS FOR NON-NIH-FUNDED QUALIFIED MARIJUANA RESEARCHERS

This section prohits FDA from imposing an IRB-review requirement on researchers seeking to conduct non-human, non-federally-funded research.

Shane’s Comments: About time.

Sec. 5. CONSIDERATION OF RESULTS OF RESEARCH

This section requires FDA to review existing marijuana research and submit a report to Congress on the results of the research as well as a recommendation regarding whether marijuana should be rescheduled (if it hasn’t been rescheduled already). In making the scheduling recommendation, the bill instructs Congress to consider the eight factors listed in 21 U.S.C. 811(c)—the same factors that govern scheduling decisions today. Finally, the bill requires FDA to do all this either (1) whenever FDA approves a drug containing marijuana for interstate marketing under the FFDCA or (2) not later than 5 years from the date the bill is enacted.

***Shane’s Comments: Requiring DEA to apply the 8 factors in section 811(c) is not advisable. Instead, Congress should ask FDA why widespread state acceptance of marijuana’s medical use ought not be taken as incontrovertible evidence that marijuana has a currently accepted medical use in treatment in the U.S. It should further clarify that in making that assessment, FDA should ignore DEA’s view of the question. I’d love to hear FDA, DEA, or anybody attempt to explain how a federal agency can maintain that marijuana does not have a currently accepted medical use in treatment in the U.S. when state law and doctors across the country say otherwise. FDA used to acknowledge that state acceptance of a substance’s medical utility ought to constitute proof of currently accepted medical use in treatment in the U.S. Congress should ask when it changed its mind and why.

Also, the fact that Congress is contemplating waiting five years before returning to the question of marijuana’s proper scheduling under the CSA should be a startling wakeup call for anyone who thinks we’re on the right track with cannabis policy reform at the federal level.

Sec. 6. PRODUCTION QUOTAS FOR MARIJUANA GROWN FOR LEGITIMATE, SCIENTIFIC RESEARCH.

This section would amend 21 U.S.C. 826 to limit the statute’s quota requirement to apply only to marijuana production and distribution under the provisions of the bill.

Shane’s Comments: I’m not sure what the point of this provision is. If it’s to relieve state-legal operators of the CSA’s quota requirements, I suppose that’s fine. It would add to the already long list of U.S. violations of the Single Convention, but that’s a problem Congress could address fairly easily. As it stands, DEA doesn’t even attempt to impose the quota requirement on state-level operators, so again, I’m not sure I’m understanding the import of this one. If you get it, please let me know.

Sec. 7. ARTICLE 28 OF THE SINGLE CONVENTION ON NARCOTIC DRUGS

This section establishes a rule of construction applicable to Article 28 of the Single Convention, which says:

Article 23, in turn, provides:

Section 7 of the bill would prohibit construing Article 28 to prohibit or restrict the manufacture, distribution, dispensing, or researching of marijuana as envisioned in the bill and the CSA.

***Shane’s Comments: A pro bono lawsuit Matt and I brought revealed a secret OLC Opinion declaring that U.S. marijuana policy under the NIDA monopoly violated these particular provisions for over half a century. Perhaps this language is designed to address that issue. If so, it falls just short of solving the problem, as I explain below.

U.S. courts will not construe subsequent legislation to abrogate longstanding U.S. treaty obligations absent a clear statement in the subsequent statute demonstrating Congress’s intent. The Supreme Court and the D.C. Circuit, for example, have held that “neither a treaty nor an executive agreement will be considered ‘abrogated or modified by a later statute unless such purpose on the part of  Congress has been clearly expressed.’” Roeder v. Islamic Republic of Iran (“Roeder I”), 333 F.3d 228, 237 (D.C. Cir. 2003) (quoting Trans World Airlines v. Franklin Mint Corp., 466 U.S. 243, 252 (1984)). “[S]ome affirmative expression of congressional intent to abrogate the United States’ international obligations is required” before a court may find that a statute abrogates a prior treaty commitment. Weinberger v. Rossi, 456 U.S. 25, 32 (1982). “Legislative silence is not sufficient to abrogate a treaty,” Trans World Airlines, 466 U.S. at 252, and thus “[a]n ambiguous statute cannot supersede an international agreement if an alternative reading is fairly possible.” Roeder v. Islamic Republic of Iran (“Roeder II”), 646 F.3d 56, 61 (D.C. Cir. 2011) (citing Fund for Animals, Inc. v. Kempthorne, 472 F.3d 872, 879 (D.C. Cir. 2006)); see also Murray v. The Charming Betsy, 2 Cranch 64, 118 (1804) (“[A]n act of congress ought never to be construed to violate the law of nations, if any other possible construction remains ….”); Comm. of U.S. Citizens Living in Nicaragua v. Reagan, 859 F.2d 929, 936-37 (D.C. Cir. 1988) (“[U]nless Congress makes clear its intent to abrogate a treaty, a court will not lightly infer such intent but will strive to harmonize the conflicting enactments.”).

This clear statement rule ensures that “‘the legislature has in fact faced, and intended to bring into issue, the critical matters involved in the judicial decision.’” Roeder I, 333 F.3d at 238 (quoting Gregory v. Ashcroft, 501 U.S. 452, 461 (1991)). The Supreme Court and the D.C. Circuit have repeatedly reaffirmed the importance of this rule and have refused to find that a later-in-time statute repealed a prior treaty or agreement in the absence of an affirmative indication that Congress intended to override the United States’ international commitments. See, e.g., Trans World Airlines, 466 U.S. at 252 (Par Value Modification Acts did not render prior air carriage treaty unenforceable); Weinberger, 456 U.S. at 33 (statute prohibiting employment discrimination against United States citizens on overseas military bases did not invalidate executive agreements allowing for preferential hiring of local nationals); McCulloch v. Sociedad Nacional de Marineros de Honduras, 372 U.S. 10, 20 (1963) (National Labor Relations Act did not abrogate longstanding policy of allowing the internal affairs of foreign-flagged ships to be governed by the laws of the flag state); Roeder II, 646 F.3d at 61-62 (statute waiving Iran’s sovereign immunity against suit by former hostages not sufficient to abrogate the Algiers Accords, in which the United States agreed to bar such claims); Roeder I, 333 F.3d at 236-37 (same).

Because the bill’s language is not such a clear statement, it would not effectively displace U.S. obligations under the Single Convention. The good news is that Congress can cure the problem through a very simple amendment adding a provision along these lines: “to the extent that the United States’ obligations under any international agreement or treaty, including but not limited to the Single Convention on Narcotic Drugs of 1961, interferes with or impedes the implementation or execution of any provision of this Act, it is the intent of Congress to abrogate that international agreement or treaty to that extent.”

Sec. 8. DEFINITIONS

Defines a couple of terms.