Seriously ill patients would finally be allowed to use marijuana — and potentially MDMA and psilocybin — without violating federal law under a congressionally approved bill now heading to President Trump’s desk.
The bill, know as the “Right to Try Act,” would give certain patients access to drugs that have not yet received U.S. Food and Drug Administration approval for broad use. The House voted 250 – 169 to pass the legislation on Tuesday, and it cleared the Senate by unanimous consent last August.
In order to qualify under the new program, a drug must have completed a phase 1 clinical trial, be under active development, and meet certain other criteria:
“(2) the term ‘eligible investigational drug’ means an investigational drug (as such term is used in section 561)—
“(A) for which a Phase 1 clinical trial has been completed;
“(B) that has not been approved or licensed for any use under section 505 of this Act or section 351 of the Public Health Service Act;
“(C) (i) for which an application has been filed under section 505(b) of this Act or section 351(a) of the Public Health Service Act; or
“(ii) that is under investigation in a clinical trial that—
“(I) is intended to form the primary basis of a claim of effectiveness in support of approval or licensure under section 505 of this Act or section 351 of the Public Health Service Act; and
“(II) is the subject of an active investigational new drug application under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act, as applicable; and
“(D) the active development or production of which is ongoing and has not been discontinued by the manufacturer or placed on clinical hold under section 505(i); and
Marijuana meets all of those criteria, thanks to research on medical cannabis use by military veterans with post-traumatic stress disorder that is being funded by the Multidisciplinary Association for Psychedelic Studies (MAPS). That research is currently in Phase 2.
MDMA, commonly known as “ecstasy,” and psilocybin, the active ingredient in psychedelic mushrooms, have undergone Phase 1 and 2 clinical trials, with Phase 3 research on the way.
But while marijuana and potentially the other substances would be eligible for limited legal use under the new law once it is enacted, only patients who are seriously ill would be allowed to participate.
The legislation specifies that a qualifying patient must have been diagnosed with a life-threatening disease or condition, have exhausted approved treatment options and be unable to participate in the clinical trials themselves. A physician who is in good standing with a licensing board would then be able to certify the patient for access.
While the short title of the bill summarizes that it provides for the use of “unapproved medical products by patients diagnosed with a terminal illness in accordance with State law” (emphasis added), the legislative text itself provides no specific limitation concerning state laws. Thus, while patients who would otherwise qualify for medical cannabis access in their states would be clearly protected from federal harassment, it is somewhat of an open question as to whether the the use of psilocybin and MDMA, which are not legal for any use in any state, would be federally shielded.
That caveat aside, advocates are hopeful that the new law, when it is signed, could allow more patients to access substances that have until now only been available in limited clinical trials or through underground, unregulated therapy sessions.
“It seems passing Right to Try would grant people facing death across the country tremendous relief by allowing access to MDMA-therapy and psilocybin-therapy,” Natalie Lyla Ginsberg, MAPS’s policy and advocacy director, told Marijuana Moment in an email. “Both forms of psychedelic-therapy have been specifically researched as a treatment for anxiety associated with life-threatening illnesses, and have produced incredibly promising results, both for the patients and for their families and loved ones. We are hopeful Right to Try would inspire hospice centers to start integrating psychedelic therapy into their treatment.”
President Trump called on lawmakers to pass the legislation during his State of the Union address earlier this year.
“We also believe that patients with terminal conditions — terminal illness — should have access to experimental treatment immediately that could potentially save their lives,” he said. “People who are terminally ill should not have to go from country to country to seek a cure. I want to give them a chance right here at home. It is time for the Congress to give these wonderful, incredible Americans the right to try.”
The House previously passed a similar bill in March (after it failed during a prior attempt). Rather than seek to reconcile the differences between the two chambers’ proposals via a conference committee, a process that would require further Senate action that seems doubtful given broad Democratic opposition, House GOP leaders decided to simply pass the other chamber’s bill in order to get it to the president.
Majority Of Connecticut Residents Back Marijuana Legalization And Expungements, Poll Finds As Reform Bills Advance
As bills to legalize marijuana in Connecticut move through the legislature, a new poll finds that the reform has strong support among residents.
The survey from Sacred Heart University (SHU), released on Tuesday, found that about 66 percent of people in the state favor legalizing cannabis for adult use, while 27 percent are opposed.
If the policy change is enacted, 62 percent said those with prior marijuana convictions should have their records expunged.
Younger people and those who identify as Democrats were more likely to back ending prohibition, compared to those 65 and older or Republicans.
Further, the poll asked about perceived harms of cannabis, and 77 percent said they felt the plant carried “fewer effects” or comparable effects as alcohol. About 72 percent drew the same contrast between marijuana and other drugs such as heroin, amphetamines and prescription painkillers.
These figures are largely consistent with a previous poll that SHU conducted in February.
And like that prior survey, nearly half of Connecticut residents again expressed that they still believe that there are potential negative public safety implications of legalization, even if they support the policy. In this case, 48 percent said they agree that allowing recreational cannabis would lead to a “significant” increase in impaired driving.
Two in five respondents said they agree that marijuana is a gateway to other drugs. The poll involved interviews with 1,000 residents from March 23-31.
But while these figures largely align with the last SHU survey, one thing that has changed is that reform legislation has started to advance in the legislature, including a bill being backed by the governor.
The Judiciary Committee approved Gov. Ned Lamont’s (D) proposal, which was amended to more comprehensively address social equity issues, last week. That said, legislative leaders have indicated that the bill is fluid and will likely see additional revisions down the road.
A competing legalization measure from Rep. Robyn Porter (D) was approved in the Labor and Public Employees Committee last month.
One amendment that was adopted to the governor’s bill would provide for the free erasure of past marijuana convictions for possession or sales of up to four ounces of cannabis or six mature plants—a policy that is evidently backed by most residents in the state.
Lamont, who convened an informal work group in recent months to make recommendations on the policy change, initially described his legalization plan as a “comprehensive framework for the cultivation, manufacture, sale, possession, use, and taxation of cannabis that prioritizes public health, public safety, and social justice.”
For his part, House Speaker Matthew Ritter (D) said last month that “optimism abounds” as lawmakers work to merge proposals into a final legalization bill.
Majority Leader Jason Rojas (D) said “in principle, equity is important to both the administration and the legislature, and we’re going to work through those details.”
To that end, the majority leader said that working groups have been formed in the Democratic caucuses of the legislature to go through the governor’s proposal and the committee-approved reform bill.
In February, a Lamont administration official stressed during a hearing in the House Judiciary Committee that Lamont’s proposal it is “not a final bill,” and they want activists “at the table” to further inform the legislation.
The legislature has considered legalization proposals on several occasions in recent years, including a bill that Democrats introduced last year on the governor’s behalf. Those bills stalled, however.
Lamont reiterated his support for legalizing marijuana during his annual State of the State address in January, stating that he would be working with the legislature to advance the reform this session.
Ritter said in November that legalization in the state is “inevitable.” He added later that month that “I think it’s got a 50–50 chance of passing [in 2021], and I think you should have a vote regardless.” The governor said in an interview earlier this year that he puts the odds of his legislation passing at “60-40 percent chance.”
Should that effort fail, the speaker said he will move to put a constitutional question on the state’s 2022 ballot that would leave the matter to voters. Lamont made similar remarks last week.
The governor has compared the need for regional coordination on marijuana policy to the coronavirus response, stating that officials have “got to think regionally when it comes to how we deal with the pandemic—and I think we have to think regionally when it comes to marijuana, as well.”
He also said that legalization in Connecticut could potentially reduce the spread of COVID-19 by limiting out-of-state trips to purchase legal cannabis in neighboring states such as Massachusetts and New Jersey.
Photo courtesy of Mike Latimer.
Remembering Cannabis Legalization Pioneer Steve Fox
This post is a remembrance of longtime cannabis policy activist Steve Fox from his colleagues at VS Strategies and Vicente Sederberg LLP.
Dear Family, Friends, and Colleagues,
We are truly heartbroken to share news of the passing of our partner and dear friend Steve Fox. Steve served as managing partner of VS Strategies since co-founding it in 2013, and he was a leader at Vicente Sederberg LLP since its formation in 2010.
We welcome the celebration of Steve’s life through the sharing of thoughts and memories, and we ask for respect and privacy for his family, friends, and coworkers who are still reeling from this loss. We have also started a GoFundMe page to support Steve’s wife and daughters as they navigate their way through this extremely difficult time—https://www.gofundme.com/f/support-the-family-of-steve-fox
With wisdom beyond his years and a pioneering spirit, Steve was an “old soul” with a knack for seeing things in a new light. He was strongly principled, deeply empathic, and fiercely kind. And despite his usually soft-spoken and lighthearted demeanor, his opinions rarely went unheard and always carried significant weight.
His passion for politics and policy were exceeded only by his passion for people—his family, friends, and colleagues, as well as the multitude of strangers that he knew were being affected every day by politics and policy. He had a burning desire and uncanny ability to envision and effect positive change, both societally and in those closest to him. He was not just a remarkable human being, but a truly transformational leader.
Steve was always the first to volunteer and the last to seek credit. He was beyond generous with his time and patience, and perpetually understanding. He relished opportunities to provide counsel and guidance, and the feeling was mutual for those who received it. He was warmly regarded as a mentor by no fewer than a dozen current and former members of our firm, including all seven of us.
Steve was one of the first political professionals to enter the marijuana advocacy space. At a time when cannabis policy was just a blip on the political radar and most savvy up-and-comers were unwilling to dip a toe into the space, Steve dove in headfirst. While many viewed it as a losing cause that wasn’t worth the fight, he saw it as a cause worth fighting until it was won. And in working to legalize and regulate cannabis for medical and adult use, he found a way to fight simultaneously for several of his core values: To promote justice and compassion, to advance freedom and liberty, and to nurture and inspire the human spirit. Humbly righteous, judiciously aggressive, and relentlessly ethical, he was committed to doing the right thing, doing it the right way, and doing whatever it takes to get it done.
When he joined the Marijuana Policy Project in 2002, Steve was the only full-time cannabis lobbyist on Capitol Hill. He would remain at the forefront of the cannabis policy reform movement for nearly two decades, playing pivotal roles in several major victories at the federal and state levels.
Steve was a lead drafter of Colorado’s historic Amendment 64, which legalized cannabis for adult use, and he managed all aspects of the successful campaign behind its passage and implementation. He also conceptualized and co-founded Safer Alternative For Enjoyable Recreation (SAFER), which laid a lot of groundwork for the legalization effort and contributed to a seismic shift in the U.S. cannabis policy debate. In 2009, he co-authored the book “Marijuana Is Safer: So why are we driving people to drink?,” which is based on the SAFER strategy.
Steve was always thinking step ahead of the rest. Long before cannabis was legalized, he envisioned a legal, organized, and responsible cannabis industry. He played leading roles in conceptualizing and establishing several of the nation’s largest and most influential cannabis trade organizations, including the National Cannabis Industry Association, the Cannabis Trade Federation, and the U.S. Cannabis Council. He regularly led working group meetings and calls, and he was a frequent speaker at cannabis conferences.
Steve’s role in cannabis community cannot be overstated. He was a trailblazer in the movement to end prohibition, and he was an architect and caretaker of the legal industry that is quickly replacing it. He beat the path, built the shelter, and worked tirelessly to make it as welcoming, accessible and beneficial as possible. He always put the mission—the wellbeing of others and the betterment of society—ahead of himself.
No one was more reluctant to sing their own praises while being so deserving of a louder refrain.
In 2013, Steve received a highly esteemed award from the Drug Policy Alliance in recognition of his long-term spearheading of the Colorado legalization effort. With an audience of hundreds and the spotlight squarely on him, he used the better part of his brief acceptance speech to give recognition to the people and organizations who had supported and worked alongside him. He reserved only the final thought for his own personal message and dedication. It was to his parents, for raising him to believe in the Jewish philosophy “Tikkun olam”—to “repair or heal the world” through beneficial and constructive acts. That is what drove Steve to take on the cause of cannabis policy reform. And it was what drove Steve to be the person he was.
Tikkun olam. Mission accomplished, dear friend.
And the entire VSS and VS family
Biden’s Pick To Lead DEA Voiced Openness To State Medical Marijuana Program
President Joe Biden’s nominee to lead the Drug Enforcement Administration (DEA) previously described a New Jersey medical marijuana bill as “workable” while serving at the state’s attorney general.
Although the former top state prosecutor, Anne Milgram, doesn’t appear to have publicly detailed her personal views on cannabis reform, the limited comments she made over a decade ago signal that, at the very least, she’s open to allowing states to enact their own marijuana policies despite federal prohibition.
That’d be a big deal, as far as advocates are concerned. Having a DEA administrator who appears flexible with respect to state cannabis reform efforts would be a notable development given the role that the official plays in federal marijuana policy.
However, Milgram’s on-the-record remarks on the issue are admittedly minimal. In 2009, when the New Jersey legislature was considering a medical cannabis legalization bill, she called the proposal “workable,” according to a one-word quote included in an Associated Press report.
After the legislation was amended, a spokesperson for the then-attorney general said the change “tightens up the provisions…that could have become loopholes by people seeking to divert marijuana for illicit purposes.”
Biden announced Milgram as his pick to be the next DEA administrator on Monday, and now her nomination heads to the Senate. It is possible that she will be asked to elaborate on her views during a confirmation hearing before the Judiciary Committee.
Milgram’s prior statements are far from an explicit endorsement of medical cannabis legalization, but they do indicate that the nominee is not vociferously opposed to state-level reforms as has been the case for prior DEA administrators. And in combination with other Biden cabinet picks, that bodes well for advocates.
Attorney General Merrick Garland made clear during his oral and written testimony before the Senate, for example, that he does not feel the Justice Department should use its resources to go after people acting in compliance with state marijuana laws. That stands in contrast with President Donald Trump’s first selection for attorney general, Jeff Sessions, who rescinded Obama-era guidance deprioritizing prosecutions over state-legal cannabis activity.
The DEA, with authority delegated from the Department of Justice, plays an important role in determining the schedule status of marijuana and other drugs. If the agency’s administrator were to acknowledge the medical benefits of cannabis, it would deeply undermine its current classification in Schedule I, which is supposed to be reserved for substances with no therapeutic value.
That said, while the Justice Department and DEA play a key role in federal scheduling, a medical and scientific review by the Department of Health and Human Services (HHS) and the Food and Drug Administration is binding on the attorney general’s classification decision.
To that end, the former attorney general of California, Xavier Bacerra, was confirmed by the Senate to lead HHS, and he has a considerable record supporting cannabis reform and working to protect California’s legal program from federal interference.
Meanwhile, Biden has yet to nominate someone to run the federal Office of National Drug Control Policy (ONDCP), despite earlier reporting that a selection was imminent.
The presumed leading candidate to be White House drug czar—Rahul Gupta, the former chair of the West Virginia Medical Cannabis Advisory Board—has played a critical role in overseeing the implementation and expansion of a state medical marijuana program and has publicly recognized both the therapeutic and economic potential of cannabis reform.
But while any pro-reform appointment is notable in the new administration, the DEA administrator has played a historically antagonistic role opposing federal or state policy changes as they concern cannabis. And so Milgram would stand out as an especially significant pick to that end.
The nominee would be taking over the defense to a number of pending lawsuits from marijuana and psychedelics reform advocates and patients if confirmed.
For example, Seattle doctor hoping to expand access to psilocybin mushrooms for terminally ill cancer patients is taking DEA to court over the agency’s recent denial of an application to legally use the psychedelic in end-of-life treatment.
Scientists and veterans sued the federal agency last year, arguing that the legal basis DEA has used to justify keeping marijuana in Schedule I of the Controlled Substances Act is unconstitutional. They asked for a review of its decisions to reject rescheduling petitions in 2020, 2016 and 1992. DEA subsequently requested that the court dismiss that suit.
The agency has also been taken to court over delays in approving additional cannabis manufacturers for research purposes.
The Scottsdale Research Institute alleged that DEA has been deliberately using delay tactics to avoid approving cultivation applications. A court mandated that the agency take steps to make good on its promise, and that suit was dropped after DEA provided a status update.
In March 2020, 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.