A bipartisan marijuana research bill that’s scheduled for a House committee vote on Wednesday is poised to be amended to allow scientists to access cannabis products directly from state-legal markets for research purposes.
The Energy and Commerce Committee announced last week that members would be marking up the Medical Marijuana Research Act. But one day before the vote, an amendment in the nature of a substitute was released that contains several notable changes.
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.
Initially, the legislation simply stipulated that researchers could access marijuana from additional federally approved private manufacturers. But the new proposed bipartisan amendment would provide researchers with access to cannabis from state-legal businesses under certain circumstances.
Under the substitute bill, the secretary of the U.S. Department of Health and Human Services (HHS) would have to “offer to qualified marijuana researchers marijuana products available through State authorized marijuana programs that are consistent with the guidance” outlined in the legislation. That requirement would only be enforced until the agency determined that the existing number of manufacturers could “ensure a sufficient supply of marijuana intended for medical research.”
The amended bill would give HHS 180 days to “issue guidance related to the use of marijuana from State authorized marijuana programs, including necessary quality or production standards for marijuana intended for use in medical research.”
The bill could also be changed under the amendment in the nature of a substitute to remove a section of the original bill that stipulated the Justice Department could not interfere in the production, distribution or sale of cannabis in compliance with the research guidance. A new provision 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.
The rest of the changes in the substitute version are generally technical and conforming in nature.
Of the proposed revisions, the provision that would allow researchers to access marijuana from state-legal dispensaries is the most significant—and could potentially lend to disagreement among some committee members. That said, the substitute was introduced in a bipartisan fashion, with Reps. Debbie Dingell (D-MI) and Morgan Griffith (R-VA) carrying it.
“NORML supports the adoption of amended language pertaining to the use of cannabis produced under state-licensed programs for FDA-approved clinical research,” Paul Armentano, deputy director of NORML, told Marijuana Moment. “In fact, NORML has previously submitted comments to the U.S. Federal Register explicitly demanding this regulatory change.”
“Rather than compelling scientists to access marijuana products of questionable quality manufactured by a limited number of federally licensed producers, NORML believes that 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 would 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 would 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.”
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 research bill set for committee action on Wednesday 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 the Department of Health and Human Services 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.
The upcoming markup 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). It will be subject to further amendments during the committee markup.
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 the Drug Enforcement Administration (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 looked at several other marijuana reform bills during that 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 scheduled for committee action next week 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.
Read the proposed marijuana research bill below: