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.
This bipartisan legislation would make long-overdue improvements to the Fed Govt’s policies on marijuana research. It would advance the work of scientists and provide more reliable information about any benefits and harmful consequences that result from medicinal marijuana use.
— Morgan Griffith (@RepMGriffith) September 9, 2020
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.
Virginia Has Sealed 64,000 Marijuana Distribution Charges Since Legalization Took Effect This Summer
“These aren’t just numbers and there are families attached.”
By Ned Oliver, Virginia Mercury
Virginia has sealed records documenting more than 64,000 misdemeanor marijuana distribution charges since the state legalized the drug in July.
The figure came out Thursday during a meeting of the legislature’s Cannabis Oversight Commission.
Officials said the records were scrubbed from the state’s criminal record database, which is used by employers like school boards, state agencies and local governments to screen employees.
The state had already sealed 333,000 records detailing charges of simple possession last year after the state reduced the offense to a civil infraction on par with a traffic offense, said Shawn G. Talmadge, the Deputy Secretary of Public Safety and Homeland Security.
Lawmakers directed the state to expand that effort when they voted to broadly legalize recreational use of marijuana earlier this year.
The legislature also agreed to a broader expungement reform that will automatically seal other misdemeanor charges, including underage possession of alcohol, use of a fake ID, petit larceny, trespassing and disorderly conduct. Talmadge said those charges will remain in the system until the state finishes updating the software it uses to track criminal records.
“As of right now, the process is proceeding,” he said.
The Virginia Joint Commission on Cannabis Oversight is meeting now. You can find the agenda and links to livestream and to provide public comment at https://t.co/f1wsPn7SV7
— Jennifer McClellan (@JennMcClellanVA) October 14, 2021
Members of the oversight commission also heard from two advocates who urged them to move fast to address people currently imprisoned for marijuana offenses—a category of people the legalization legislation passed this year did not address.
Chelsea Higgs Wise, the leader of the advocacy group Marijuana Justice, and Gracie Burger, with the Last Prisoner Project, said Department of Corrections data suggests there are currently 10 people being held solely on serious marijuana charges.
They said it remains unknown how many more are being held because of marijuana related probation violations.
“These aren’t just numbers and there are families attached,” Burger said.
DEA Proposes Dramatic Increase In Marijuana And Psychedelic Production In 2022, Calling For 6,300 Percent More MDMA Alone
The Drug Enforcement Administration (DEA) is proposing a dramatic increase in the legal production of marijuana and psychedelics like psilocybin, LSD, MDMA and DMT to be used in research next year.
In a notice scheduled to be published in the Federal Register on Monday, the agency said there’s been a “significant increase in the use of schedule I hallucinogenic controlled substances for research and clinical trial purposes,” and it wants authorized manufacturers to meet that growing demand.
DEA had already massively upped its proposed 2021 quota for cannabis and psilocybin last month, but now it’s calling for significantly larger quantities of research-grade marijuana and a broader array of psychedelics to be manufactured in 2022.
It wants to double the amount of marijuana extracts, psilocybin and psilocyn, quadruple mescaline and quintuple DMT. What especially stands out in the notice is MDMA. The agency is proposing an enormous 6,300 percent boost in the production of that drug—from just 50 grams in 2021 to 3,200 grams in the coming year—as research into its therapeutic potential continues to expand.
LSD would see a 1,150 percent increase, up to 500 grams of the potent psychedelic.
Marijuana itself would get a 60 percent boost under DEA’s proposal, up to 3.2 million grams in 2022 from the 2 million grams last year.
Here’s a visualization of the proposed quota increase from 2021 to 2022 for marijuana and cannabis extracts:
For all other THC, psilocybin, psilocyn and MDMA:
And for other psychedelic substances like LSD, mescaline and DMT:
DEA said in the Federal Register notice that it has been receiving and approving additional applications to “grow, synthesize, extract, and manufacture dosage forms containing specific schedule I hallucinogenic substances for clinical trial purposes” to achieve these ambitious quotas.
“DEA supports regulated research with schedule I controlled substances, as evidenced by increases proposed for 2022 as compared with aggregate production quotas for these substances in 2021,” the agency said, adding that it working “diligently” to process and approve marijuana manufacturers applications in particular, as there’s currently only one farm at the University of Mississippi that’s permitted to cultivate the plant for research.
“Based on the increase in research and clinical trial applications, DEA has proposed increases in 3,4- Methylenedioxyamphetamine (MDA), 3,4-Methylenedioxymethamphetamine (MDMA), 5-Methoxy-N,N-dimethyltryptamine, Dimethyltryptamine, Lysergic acid diethylamide (LSD), Marihuana, Marihuana Extract, Mescaline, Psilocybin, Psilocyn, and All Other Tetrahydrocannabinols to support manufacturing activities related to the increased level of research and clinical trials with these schedule I controlled substances.”
Here are the exact numbers for the proposed 2021 and 2022 quotas:
|All other tetrahydrocannabinol||1,000||2,000|
A 30-day public comment period will be open after the notice is formally published on Monday.
It’s difficult to overstate just how significant the proposed 2022 increases are, but it’s certainly true that scientific and public interest in marijuana and psychedelics has rapidly increased, with early clinical trials signaling that such substances show significant therapeutic potential.
National Institute on Drug Abuse (NIDA) Director Nora Volkow told Marijuana Moment in a recent interview that she was encouraged by DEA’s previous proposed increase in drug production quota. She also said that studies demonstrating the therapeutic benefits of psychedelics could be leading more people to experiment with substances like psilocybin.
Advocates and experts remain frustrated that these plants and fungi remain in the strictest federal drug category in the first place, especially considering the existing research that shows their medical value for certain conditions.
A federal appeals court in August dismissed a petition to require the DEA to reevaluate cannabis’s scheduling under the Controlled Substances Act. However, one judge did say in a concurring opinion that the agency may soon be forced to consider a policy change anyway based on a misinterpretation of the therapeutic value of marijuana.
Separately, the Washington State attorney general’s office and lawyers representing cancer patients recently urged a federal appeals panel to push for a DEA policy change to allow people in end-of-life care to access psilocybin under state and federal right-to-try laws.
Image element courtesy of Kristie Gianopulos.
Supreme Court Won’t Hear Case On Legalizing Safe Drug Consumption Sites, But Activists Are Undeterred
The U.S. Supreme Court (SCOTUS) has rejected a request to hear a case on the legality of establishing safe injection sites where people can use illicit drugs in a medically supervised environment.
The justices announced on Tuesday that they decided against taking up the case raised by the nonprofit Safehouse, despite the pleas of attorneys general from 10 states and D.C. who recently filed amici briefs urging the court’s involvement.
Representatives from 14 cities and counties, as well as the mayor of Philadelphia, which is at the center of the current case, also filed briefs in support of the case in recent days.
Safehouse was set to launch a safe consumption site in Philadelphia before being blocked by a legal challenge from the Trump administration. It filed a petition with the nation’s highest court in August to hear the case.
But while the Supreme Court declined to take action—and the Biden administration passed up its voluntary opportunity to weigh in at this stage, which may well have influenced the justices’ decision—activists say the battle will continue at a lower federal court level, where the administration will have to file briefs revealing its position on the issue.
Disappointed but not surprised U.S. Supreme Court declined to hear our case. We’re pursuing our claims in federal court. As that litigation proceeds, Biden administration will have to take a position, which it avoided by waiving its right to respond to our Supreme Court petition.
— Safehouse (@SafehousePhilly) October 13, 2021
“We were disappointed that the government chose not to respond to our petition,” Safehouse Vice President Ronda Goldfein told Filter. “They said, ‘We’re going to waive our right to respond,’ [and] the Supreme Court declined to review our case. Ordinarily that sounds like the end of the road—but in our case we are still pursuing our claims in a different venue.”
That venue will be the the federal district court in Philadelphia, where activists plan to submit multiple arguments related to religious freedom and interstate commerce protections. The Biden administration will be compelled to file a response in that court by November 5.
“If they don’t respond, they lose,” Goldfein said.
A coalition of 80 current and former prosecutors and law enforcement officials—including one who is President Joe Biden’s pick for U.S. attorney of Massachusetts—previously filed a brief urging the Supreme Court to take up Safehouse’s safe injection case.
Fair and Justice Prosecution, the group that coordinated the amicus brief, also organized a tour of Portugal for 20 top prosecutors in 2019 so they could learn about the successful implementation of the country’s drug decriminalization law.
If the Supreme Court were to have taken the case and rule in favor of Safehouse, it could have emboldened advocates and lawmakers across the country to pursue the harm reduction policy.
The governor of Rhode Island signed a bill in July to establish a safe consumption site pilot program where people could test and use currently illicit drugs in a medically supervised environment. It became the first state in the country to legalize the harm reduction centers. It’s not clear whether the Department of Justice will seek to intervene to prevent the opening of such facilities in that state.
Massachusetts lawmakers advanced similar legislation last year, but it was not ultimately enacted.
A similar harm reduction bill in California, sponsored by Sen. Scott Wiener (D), was approved in the state Senate in April, but further action has been delayed until 2022.