A House committee on Wednesday approved key piece of marijuana research legislation that, among other things, would allow scientists to finally study cannabis from state-legal dispensaries.
In general, the bill would accomplish two goals: First, it would establish a simplified registration process for researchers interested in studying cannabis, in part by reducing approval wait times, minimizing costly security requirements and eliminating additional layers of protocol review.
Second, it would expand the sources of research-grade cannabis that certified scientists would be able to obtain the products. That could resolve an issue identified by researchers and lawmakers, who complain that marijuana produced at the only existing federally authorized facility at the University of Mississippi is difficult to access and is chemically closer to hemp than cannabis available on the commercial market.
The Energy and Commerce Committee moved to advance the bipartisan Medical Marijuana Research Act in a voice vote. The next step for the legislation would be the House floor, thought it’s not clear at this point if or when Democratic leaders plan to take it up there.
Update: HR 3797 was favorably reported, as amended, to the House by a voice vote.
— Energy and Commerce Committee (@EnergyCommerce) September 9, 2020
Initially, the legislation simply stipulated that researchers could access marijuana from additional federally approved private manufacturers. But an amendment in the nature of a substitute that was released on Tuesday and approved by the committee, also via a voice vote, would also provide researchers with access to cannabis from state-legal businesses under certain circumstances.
“I believe there are signs that medical marijuana can be beneficial when used the proper setting for treatment of certain medical conditions,” Rep. Morgan Griffith (R-VA), who filed the substitute language, said. “But the truth is, we don’t really have enough research and we don’t really know what it’s about.”
“The problem is we don’t have enough research to convince people that we need to go forward with this as a medicinal product,” Griffith said, adding that he was appreciative that the U.S. Department of Health and Human Services (HHS) and Drug Enforcement Administration (DEA) for “their technical assistance in developing this amendment which adds clarity to the bill’s processes and definitions.”
“I believe that research can answer a lot of the questions we have about using marijuana as a legitimate medicinal tool in our doctors’ cabinets and in our cabinets,” he said.
Rep. Jan Schakowsky (D-IL) said during the hearing that while her home state of Illinois legalized marijuana and has seen strong sales, “the researchers at Northwestern University in my district—a leading research institution—have no way to access the cannabis sold at these dispensaries” and the university’s scientists “often face extreme difficulty in securing and maintaining cannabis and federal funding for the research that’s so important.”
The bill would “improve and increase the opportunity for very urgently needed medical marijuana research,” Rep. Debbie Dingell (D-MI), who cosponsored the bill amendment with Griffith, said.
“It’s time. We don’t have the data that we need and we need to get the data,” she said. “The federal framework for conducting research and gaining that objective, scientific data on the medicinal properties of marijuana is decades old.”
The congresswoman added that researchers currently “must contend with a very heavy-handed registration process, burdensome regulatory roadblocks that greatly limit our understanding of the health effects of marijuana or, quite frankly, let a researcher have access to what they need.”
“It’s high time we modernize our nation’s regulatory apparatus to facilitate legitimate medical research into the impacts of marijuana,” she said. “There are a lot of people who would benefit from the use of marijuana, but because they don’t have the research or they think that it’s illegal, they won’t.” One of those people, she said, was her late husband, former Rep. John Dingell (D-MI), who she encouraged to try cannabis but had declined because he felt there wasn’t enough research.
Chairman Frank Pallone (D-NJ) said that the legislation “takes us in the right direction by reducing barriers to cannabis research.”
“The bill and the changes included in the [amendment in the nature of a substitute] would create a less onerous registration process for those who want to advance cannabis research and encourage additional manufacturers and distributors to supply cannabis for purposes of research, making it easier for legitimate researchers to obtain products that better reflect the changing cannabis landscape,” he said.
In July, the House approved separate legislation that also called for letting researchers study marijuana purchased from businesses in state-legal markets instead of only letting them use government-grown cannabis. The intent of the provision, tucked into a 2,000-plus-page infrastructure bill, was to allow the interstate distribution of such products even to scientists in jurisdictions that have not yet legalized marijuana.
The revised research-focused proposal that advanced on Wednesday stipulates that nothing about the legislation precludes the HHS secretary from enforcing Food and Drug Administration restrictions on the method of administration of marijuana, the dosage or number of patients involved in approved studies. Originally, the bill said the Justice Department could not interfere in the production, distribution or sale of cannabis in compliance with the research guidance, but that was removed with the amendment.
The bill would also make it so there would be no limit on the number of entities that can be registered to cultivate marijuana for research purposes. Additionally, it would require HHS to submit a report to Congress within five years after enactment to overview the results of federal cannabis studies and recommend whether they warrant marijuana’s rescheduling under federal law.
“This proposed regulatory change is necessary and long overdue,” NORML Deputy Director Paul Armentano said in a press release. “In fact, NORML submitted comments to the US Federal Register in April explicitly calling for this change.”
“Rather than compelling scientists to access marijuana products of questionable quality manufactured by a limited number of federally licensed producers, federal regulators should allow investigators to access the cannabis and cannabis-infused products that are currently being produced in the legal marketplace by the multitude of state-sanctioned growers and retailers. Doing so will not only facilitate and expedite clinical cannabis research in the United States and provide important data regarding the safety and efficacy of real-world products, but it will also bring about a long overdue end to decades of DEA stonewalling and interference with respect to the advancement of our scientific understanding of the cannabis plant.”
This isn’t the only congressional marijuana vote that advocates are following. House leadership recently announced that there will be a floor vote on a comprehensive cannabis legalization bill later this month.
The more limited marijuana research bill is being led by the unlikely duo of pro-legalization Rep. Earl Blumenauer (D-OR) and prohibitionist Rep. Andy Harris (R-MD).
“As momentum grows in our effort to end the failed prohibition of cannabis, we also need to address failed drug laws like the ones that make it extremely difficult for researchers and doctors to study cannabis,” Blumenauer told Marijuana Moment. “With some form of cannabis legal in nearly every state, it’s inexcusable that the federal government is still blocking qualified researchers from advancing the scientific knowledge of cannabis.”
“The bipartisan support of our legislation in today’s committee markup is an important step in removing unnecessary barriers to medical cannabis research and ensuring that patients, clinicians, and consumers can fully understand the benefits and risks of cannabis,” he said.
During an Energy and Commerce Subcommittee on Health hearing in January—which was requested by four GOP lawmakers last year—federal health and drug officials, including from DEA, acknowledged that the current supply of cannabis for research purposes is inadequate and that scientists should be able to access a wider range of marijuana products.
In addition to the Blumenauer-Harris research legislation, the panel also examined several other marijuana reform bills during that earlier meeting, including two to federally legalize the plant.
DEA said four years ago that it would be taking steps to expand the number of federally authorized cannabis manufacturers, but it has not yet acted on applications.
Last year, scientists sued the agency, alleging that it had deliberately delayed approving additional marijuana manufacturers for research purposes despite its earlier pledge.
A court mandated that DEA take steps to make good on its promise, and that case was dropped after DEA provided a status update.
In March, DEA finally unveiled a revised rule change proposal that it said was necessary due to the high volume of applicants and to address potential complications related to international treaties to which the U.S. is a party.
The scientists behind the original case filed another suit against DEA, claiming that the agency used a “secret” document to justify its delay of approving manufacturer applications.
That was born out when the Justice Department Office of Legal Counsel document was released in April as part of a settlement in the case, revealing, among other things, that the agency feels that its current licensing structure for cannabis cultivation has been in violation of international treaties for decades.
But the bill marked up in committee on Wednesday stipulates that international treaty obligations “shall not be construed to prohibit, or impose additional restrictions upon, research involving marijuana, or the manufacture, distribution, or dispensing of marijuana, that is conducted in accordance with the Controlled Substances Act, this Act, and the amendments made by this Act.”
The legislation has drawn support from a broad array of organizations on both sides of the legalization debate, including Smart Approaches to Marijuana, American Psychological Association, Marijuana Policy Project and American Academy of Neurology.