A bipartisan coalition of senators has reintroduced a bill that’s meant to promote research into marijuana.
The Cannabidiol and Marihuana Research Expansion Act, which unanimously passed the Senate in identical form last year, would streamline the application process for researchers who want to study the plant and to encourage the Food and Drug Administration (FDA) to develop cannabis-derived medicines.
It would also clarify that physicians are allowed to discuss the risks and benefits of marijuana with patients and require the U.S. Department of Health and Human Services (HHS) to submit a report on those potential health benefits, as well one on barriers to cannabis research and how to overcome those obstacles.
Sens. Dianne Feinstein (D-CA), Brian Schatz (D-HI) and Chuck Grassley (R-IA) are the lead sponsors of the bill.
“Because of restrictive regulations, we still do not understand exactly how medical marijuana can be used to safely treat a variety of conditions where it may be far more useful than current treatments,” Feinstein said in a press release. “This bill, which passed the Senate unanimously last year, would streamline the research process to allow FDA-approved marijuana-derived medications to be used to treat serious medical conditions. Millions may ultimately benefit from a new, safe treatment for conditions like intractable epilepsy once this bill becomes law.”
Restrictive rules on research mean we don't know how medical marijuana could be used to effectively treat any number of conditions. Our bill will streamline the research process to help develop new, safe marijuana-derived medications.https://t.co/HVukrHoBRD
— Senator Dianne Feinstein (@SenFeinstein) February 8, 2021
In general, the first section of the bill concerns the application process for institutions seeking federal authorization to research marijuana. The U.S. attorney general would be given a 60-day deadline to either approve a given application or request supplemental information from the applicant. It would also create an expedited pathway for researchers who request larger quantities of Schedule I drugs.
The second major section of the bill is about FDA approval of marijuana-derived drugs. One way to encourage such developments is through allowing “accredited medical and osteopathic schools, practitioners, research institutions, and manufacturers with a Schedule I registration” to cultivate their own cannabis for research purposes, a summary says.
The Drug Enforcement Administration would get a mandate to approve applications to be manufacturers of marijuana-derived, FDA-approved drugs under the bill. Manufacturers would also be allowed to import cannabis materials to facilitate research into the plant’s therapeutic potential.
Finally, a fourth section would require HHS to look at the health benefits and risks of marijuana as well as policies that are inhibiting research into cannabis that’s grown in legal states and provide recommendations on overcoming those barriers.
A separate piece of cannabis research legislation cleared the House last year. A major difference in the respective bills is that the House-passed measure contained provisions that would allow scientists to obtain cannabis from state-legal dispensaries for research purposes. That was designed to help them avoid depending on marijuana that’s produced at the only federally authorized manufacturing facility at the University of Mississippi.
“I’ve been a strong supporter of this legislation since it was first introduced in 2016,” Grassley said of his chamber’s bill. “During my time in the Senate, I’ve heard directly from constituents who want safe and effective treatment options for their families, which could include options derived from the marijuana plant.”
“This bipartisan bill is critical to better understanding the marijuana plant and its potential benefits and negative side effects,” he said. “It will empower the FDA to analyze CBD and medical marijuana products in a safe and responsible way so that the American public can decide whether to utilize them in the future based on sound scientific data. This is a smart step forward in addressing this current schedule I drug.”
Schatz said that the “medical community agrees that we need more research to learn about marijuana’s potential health benefits, but our federal laws today are standing in the way of that inquiry” and the group’s bill “will remove excessive barriers that make it difficult for researchers to study the effectiveness and safety of marijuana, and hopefully, give patients more treatment options.”
The bill’s other original cosponsors include Sens. Dick Durbin (D-IL), Thom Tillis (R-NC), Tim Kaine (D-VA), Joni Ernst (R-IA), Kevin Cramer (R-ND) and Amy Klobuchar (D-MN).
Ahead of the Senate vote late last year, Feinstein filed a floor amendment in the nature of a substitute to add requirements for researchers who want to increase the quantity of cannabis they’re using for studies.
The amendment also stipulated that it “shall not be a violation of the Controlled Substances Act (CSA) for a State-licensed physician to discuss” the risk and benefits of marijuana and cannabis-derived products with patients. As introduced, the more broadly stated that it “shall not be unlawful” for doctors to have such conversations. It’s not clear why the language was revised to more narrowly protect physicians from penalties under the CSA alone.
Another revised provision of the legislation clarifies that the definition of cannabidiol is “derived from marihuana that has a delta–9 tetrahydrocannabinol level that is greater than 0.3 percent,” whereas the initial bill didn’t include the “delta-9” qualifier ahead of THC.
Those changes were included in the reintroduced bill.
The proposal has been endorsed by mainstream medical organizations like American Academy of Pediatrics, American Medical Association, American Psychological Association and American Society of Addiction Medicine, as well as pro-legalization groups such as Americans for Safe Access, Multidisciplinary Association of Psychedelic Studies and NORML.
“I have heard from many parents and adults who have turned to CBD and these individuals have seen positive results,” Feinstein said in remarks for the Congressional Record about the new bill. “Despite this, however, many are also concerned about the lack of science-based information related to proper delivery mechanisms, dosing, or potential interactions that CBD or marijuana may have with other medications. Some also worry because these products aren’t well regulated or factory sealed, and often are labeled incorrectly. Additional research will increase our ability to adequately address these concerns.”
This is the fourth piece of cannabis legislation to be introduced in the 117th Congress.
A bipartisan group of lawmakers reintroduced a bill on Thursday that would allow hemp and CBD derived from the crop to be marketed and sold as dietary supplements.
A Republican congressman filed one bill to move cannabis from Schedule I to Schedule III of the Controlled Substances Act and another to prevent the U.S. Department of Veterans Affairs from denying veterans benefits solely because they use medical marijuana in compliance with state law.
Read the reintroduced Senate marijuana research bill below:
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.