New legislation being filed this week by a bipartisan coalition of Republicans and Democrats — including the chair of the powerful House Judiciary Committee — would remove several key federal roadblocks to research on marijuana.
“Not later than 1 year after the date of enactment of the Medical Cannabis Research Act of 2018…the Attorney General shall register…at least 2 applicants to manufacture cannabis for legitimate research purposes,” reads the text of a bill obtained by Marijuana Moment that is slated to be introduced on Thursday with the support of Judiciary Chairman Bob Goodlatte (R-VA).
In subsequent years, the attorney general would be required to license at least three additional cannabis manufacturers annually.
For decades, all cannabis used for studies in the U.S. has been grown at a single farm at the University of Mississippi. Researchers have long argued that it is difficult to access cannabis from the facility, and that the product is often of low quality.
In 2016, the Drug Enforcement Administration enacted a new policy intended to license more research cultivators, and he agency has reportedly since received at least 25 applications to participate in the new program. But it has not yet acted on any of them and, according to the Washington Post, that is because top Justice Department officials have stepped in to prevent DEA from approving any proposals.
The new legislation would force the attorney general’s hand.
A fact sheet circulated by the office of Congressman Matt Gaetz (R-FL), the lead sponsor of the bill, says that the existing cannabis research supply is “extremely subpar.”
“It is weak and often moldy, which can cause illness. In addition to being subpar, federally-grown cannabis is scarce; there is not enough product,” the document says.
The new bill would also create a “safe harbor” from federal law for universities and other research institutions that want to study marijuana. And it would clarify that doctors with the U.S. Department of Veterans Affairs are allowed to refer military veterans to studies on cannabis’s medical benefits.
Bloomberg first reported that Goodlatte was supporting the bill.
On Tuesday night, Gaetz and other lawmakers took to the House floor to voice support for marijuana law reform.
“Even though VA doctors/staff are not prohibited from sharing information about federally-approved cannabis clinical trials with patients, many VA offices believe mentioning these trials is illegal,” Gaetz’s fact sheet says. “This legislation codifies that healthcare providers at the VA are authorized to provide information about federally-approved cannabis clinical trials, and they are also allowed to fill out forms for veterans to participate in these trials.”
Besides Goodlatte, other initial cosponsors include Steve Cohen (D-TN), Alcee Hastings (D-FL), Darren Soto (D-FL), Dana Rohrabacher (R-FL), Karen Handel (R-GA), Earl Blumenauer (D-OR), Scott Taylor (R-VA), Carlos Curbelo (R-FL), Dina Titus(D-NV), Tom McClintock (R-CA), Ileana Ros-Lehtinen (R-FL), Darrell Issa (R-CA) and Barbara Lee (D-CA).
See below for the full section-by-section bill analysis circulated by Gaetz’s office:
Section 1: Title
Section 2: INCREASING THE NUMBER OF FEDERALLY-REGISTERED MANUFACTURERS OF CANNABIS FOR LEGITIMATE RESEARCH PURPOSES
PROBLEM: Currently, all federally-approved studies of medical cannabis get their product from one source, and it is extremely subpar. It is weak and often moldy, which can cause illness.
SOLUTION: this section requires there to be at least three federally-approved manufacturers of cannabis for legitimate research purposes.
The license to be a federally-approved manufacturer would be one year, with the (rare) exception of producers who wish to initiate a multi-year study or clinical trial.
Manufacturers would have to pass stringent background checks and meet a strict set of criteria, including growing at least ten different strains, and being able to test for at least 12 different cannabinoids. We must ensure that federally-approved growers are safe, will not run out of product, and are prepared to meet the needs of current and future researchers.
The strict standards set forth for medical cannabis manufacturers are not applied to other, non-research-based cannabis businesses. Keeping “research cannabis” separate means this legislation does not interfere with federal laws, state laws, or law enforcement. This bill makes no changes to the legal status of cannabis.
By ending the current monopoly on research-grade medical cannabis, and by improving choice among growers, research will be easier and better.
In addition to being subpar, federally-grown cannabis is scarce; there is not enough product. This section requires the Attorney General to annually assess whether there is an adequate and uninterrupted supply of research-grade cannabis.
Even though the DOJ is required to process new applicants for growing cannabis, they have dragged their feet, and a huge backlog of applications has built up. This section requires DOJ/DEA to act on any application to manufacture cannabis within one calendar year.
Some institutions (like universities) want to research cannabis, but cannot do so because cannabis research threatens their federal funding. This section includes “safe harbor” for researchers and institutions studying cannabis, and for patients in federally-approved medical cannabis clinical trials.
Section 3: PROVISION BY DEPARTMENT OF VETERANS AFFAIRS HEALTH CARE PROVIDERS OF INFORMATION REGARDING VETERAN PARTICIPATION IN FEDERALLY-APPROVED CANNABIS CLINICAL TRIALS
PROBLEM: even though VA doctors/staff are not prohibited from sharing information about federally-approved cannabis clinical trials with patients, many VA offices believe mentioning these trials is illegal.
SOLUTION: this section codifies that healthcare providers at the VA are authorized to provide information about federally-approved cannabis clinical trials, and they are also allowed to fill out forms for veterans to participate in these trials.
This section also clarifies that VA employees are allowed to receive information about cannabis clinical trials from researchers.
Finally, this section says that VA researchers (who are eligible to research Schedule 1 substances) may do research on cannabis.
This section provides clarity to VA employees, and allows VA researchers to study cannabis.
This bill is not a pathway to legalization, nor does it change the legal status of cannabis. It simply makes it easier to conduct federally-approved research. Many people say that we can’t change cannabis laws without doing more research. Fair enough. This legislation simply makes cannabis research safer, better, and more accessible.
Congressional Bill Filed To Protect Marijuana Consumers From Losing Public Housing
A congresswoman on Thursday reintroduced a bill that would allow people living in federally assisted housing to use marijuana in compliance with state law without fear of losing their homes.
As it stands, people living in public housing are prohibited from using controlled substances in those facilities regardless of state law, and landlords are able to evict such individuals. But the bill from Rep. Eleanor Holmes Norton (D-DC) would change that.
It would provide protections for people living in public housing or Section 8 housing from being displaced simply for using cannabis in states that have legalized it for medical or recreational purposes.
“Individuals living in federally assisted housing should not be denied admission, or fear eviction, for using a legal product,” Norton said on Thursday. “Adult use and/or medical marijuana is currently legal in 36 states and the District of Columbia, and over 90 percent of Americans support legalized medical marijuana.”
The legislation would also require the head of the Department of Housing and Urban Development (HUD) to enact regulations that restrict smoking marijuana at these properties in the same way that tobacco is handled.
“HUD, like DOJ, should not be allowed to enforce federal marijuana laws where states have taken action to legalize marijuana,” the congresswoman said, referring to a congressionally approved rider that prevents the Department of Justice from interfering with state medical cannabis laws.
Norton filed earlier versions of the Marijuana in Federally Assisted Housing Parity Act in 2018 and 2019, but they did not receive hearings or votes.
In 2018, a Trump administration official said that she was working to resolve conflicting federal and state marijuana laws as it applies to residency in federally-subsidized housing, but it’s not clear what came of that effort.
Rep. Alexandria Ocasio-Cortez (D-NY) also raised the issue during a committee hearing in 2019, pressing former HUD Secretary Ben Carson on policies that cause public housing residents and their families to be evicted for committing low-level offenses such as marijuana possession.
She pointed to two specific HUD policies: the “one strike” rule, which allows property managers to evict people living in federally assisted housing if they engage in illicit drug use or other crimes, and the “no fault” rule, which stipulates that public housing residents can be evicted due to illicit drug use by other members of their household or guests—even if the resident was unaware of the activity.
Ocasio-Cortez and then-Sen. Kamala Harris (D-CA) also filed legislation that year that would protect people with low-level drug convictions from being denied access to or being evicted from public housing.
Sen. Jeff Merkley (D-OR) also introduced an affordable housing bill last year that included a provision to prevent landlords from evicting people over manufacturing marijuana extracts if they have a license to do so.
Read the text of the marijuana housing legislation below:
Photo courtesy of Martin Alonso.
FDA Clears Researchers To Study MDMA Use By Therapists Being Trained In Psychedelic Medicine
The Food and Drug Administration (FDA) has already authorized clinical trials into the therapeutic potential of MDMA for patients with post-traumatic stress disorders—but now it’s given the green light to a psychedelics research institute to expand its studies by administering the substance to certain therapists.
Volunteer therapists who are being trained to treat people with PTSD will be able to participate in the Phase 1 trials to gain personal experience with the treatment option. This is a complementary research project that comes as the Multidisciplinary Association for Psychedelic Studies (MAPS) is in the process of conducting Phase 3 trials involving people with the disorder.
The development comes months after Canadian regulators announced that certain therapists would be allowed to take psilocybin in order to gain a better understanding of the psychedelic when treating patients.
MAPS sought permission to proceed with the therapist-specific trials in 2019, but FDA placed them on a 20-month hold because of concerns about the merits, risks and credentials of investigators. MAPS appealed that hold, providing evidence about the study’s scientific value and ability of its staff, and FDA cleared them on Tuesday.
— MAPS (@MAPS) May 13, 2021
The organization “chose to dispute” FDA’s hold not just because of the impact it had on the planned studies, “but in an attempt to resolve an ongoing issue with the FDA regarding investigator qualifications across studies,” it said in a press release on Wednesday.
“While the term ‘dispute’ may seem adversarial, this process can actually strengthen the relationship and trust between us and our review Division and ensures the Division has support on this project from the [FDA] Office of Neuroscience,” MAPS Public Benefit Corporation (PBC) CEO Amy Emerson said. “This decision demonstrates how our strategic, data-driven strategy in challenging the FDA rulings can be successful.”
Now MAPS is able to launch the Phase 1 clinical trials into MDMA-assisted therapy for therapists.
It will be designed to “measure development of self-compassion, professional quality of life, and professional burnout among clinicians delivering the treatment to patients,” the association said.
Getting personal experience with the substance “is widely considered to be an important element in preparation and training to deliver psychedelic-assisted therapies.”
This will “support the goals of the MDMA Therapy Training Program to provide comprehensive training to future providers,” and it “builds capacity to deliver quality, accessible care to patients, pending approval of MDMA-assisted therapy as a legal prescription treatment,” MAPS PBC Director and Head of Training and Supervision Shannon Carlin said.
FDA first granted MAPS’s request for an emergency use authorization for MDMA in PTSD in 2017. The organization expects to complete its Phase 3 trails in 2022.
The scientific expansion move also comes as the psychedelics decriminalization movement continues to build in the U.S.
Missouri Regulators Derail Medical Marijuana Business Ownership Disclosure Effort With Veto Threat
Missouri regulators say they feel requiring medical marijuana business license ownership disclosures under a House-approved amendment could be unconstitutional, and they may urge the governor to veto the legislation.
By Jason Hancock, Missouri Independent
An effort by lawmakers to require disclosure of ownership information for businesses granted medical marijuana licenses was derailed on Thursday, when state regulators suggested a possible gubernatorial veto.
On Tuesday, the Missouri House voted to require the Department of Health and Senior Services provide legislative oversight committees with records regarding who owns the businesses licensed to grow, transport and sell medical marijuana.
The provision was added as an amendment to another bill pertaining to nonprofit organizations.
Its sponsor, Rep. Peter Merideth, D-St. Louis, said DHSS’s decision to deem ownership records confidential has caused problems in providing oversight of the program. He pointed to recent analysis by The Independent and The Missourian of the 192 dispensary licenses issued by the state that found several instances where a single entity was connected to more than five dispensary licenses.
The state constitution prohibits the state from issuing more than five dispensary licenses to any entity under substantially common control, ownership or management.
On Thursday, a conference committee met to work out differences in the underlying bill between the House and Senate.
Sen. Eric Burlison, a Republican from Battlefield and the bill’s sponsor, called the medical marijuana amendment an “awesome idea. I think it’s awesome.”
However, he said opposition from the department puts the entire bill in jeopardy.
“The department came to me,” he said, “and said they felt that this was unconstitutional.”
DHSS has justified withholding information from public disclosure by pointing to a portion of the medical marijuana constitutional amendment adopted by voters in 2018 that says the department shall “maintain the confidentiality of reports or other information obtained from an applicant or licensee containing any individualized data, information, or records related to the licensee or its operation… .”
Alex Tuttle, a lobbyist for DHSS, said if the bill were to pass with the medical marijuana amendment still attached, the department may recommend Gov. Mike Parson veto it.
The threat of a veto proved persuasive, as several members of the conference committee expressed apprehension about the idea of the amendment sinking the entire bill.
Merideth said the department’s conclusion is incorrect. And besides, he said, the amendment is narrowly tailored so that the information wouldn’t be made public. It would only be turned over to legislative oversight committees.
Rep. Jered Taylor, R-Republic, chairman of the special committee on government oversight, said the amendment is essential to ensure state regulators “are following the constitution, that they’re doing what they’re supposed to be doing.”
The medical marijuana program has faced intense scrutiny in the two years since it was created by voters.
A House committee spent months looking into widespread reports of irregularities in how license applications were scored and allegations of conflicts of interest within DHSS and a private company hired to score applications.
In November 2019, DHSS received a grand jury subpoena, which was issued by the United States District Court for the Western District. It demanded the agency turn over all records pertaining to four medical marijuana license applications.
The copy of the subpoena that was made public redacted the identity of the four applicants at the request of the FBI. Lyndall Fraker, director of medical marijuana regulation, later said during a deposition that the subpoena wasn’t directed at the department but rather was connected to an FBI investigation center in Independence.
More recently, Parson faced criticism for a fundraiser with medical marijuana business owners for his political action committee, Uniting Missouri.
The group reported raising $45,000 in large donations from the fundraiser. More than half of that money came from a PAC connected to Steve Tilley, a lobbyist with numerous medical marijuana clients who has been under FBI scrutiny for more than a year.