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8 States Side With Cancer Patients In Psilocybin Lawsuit Against DEA

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A bipartisan group of attorneys general from eight U.S. states and the District of Columbia has sided with cancer patients in a lawsuit against the federal Drug Enforcement Administration (DEA) that seeks legal access to psilocybin, a compound found in psychedelic mushrooms, for end-of-life care.

The patients and Seattle-based palliative care physician Dr. Sunil Aggarwal sued DEA in March after the agency denied their application to legally use a synthetic form of the drug under state and federal right-to-try (RTT) laws, which give patients with terminal conditions the opportunity to try investigational medications that have not been approved for general use.

In a friend of the court brief filed late last week in the U.S. Court of Appeals for the Ninth Circuit, the state attorneys general say DEA’s rejection of the patients’ application was an overreach of the agency’s power. Noting the therapeutic potential of not only psilocybin but also MDMA, the brief urges the court to rule in the patients’ favor.

“Here, dying patients seek access to promising new treatments still in the investigative process—access expressly permitted under both state and federal law—to help them live in peace,” says the brief, filed Friday by Washington State Attorney General Bob Ferguson (D) and joined by Mark Brnovich (R) of Arizona, Kathleen Jennings (D) of Delaware, Karl Racine (D) of Washington, D.C., Kwame Raoul (D) of Illinois, Dana Nessel (D) of Michigan, Keith Ellison (DFL) of Minnesota, David Yost (R) of Ohio and Ellen Rosenblum (D) of Oregon.

The brief likens the situation to one that arose in a 2006 Supreme Court decision, Gonzales v. Oregon, in which the court ruled that the Controlled Substances Act (CSA) didn’t permit the U.S. attorney general to “bar dispensing controlled substances for assisted suicide in the face of a state medical regime permitting such conduct.”

“Once again, the CSA blocks the way,” the attorneys general wrote. “Framing its effort to undermine democratic processes at the state and federal levels as an act of administrative restraint, DEA claims it lacks the authority to waive the CSA’s requirements to permit therapeutic use for these patients.”

The states’ filing stops short of saying the patients are eligible to use psilocybin under Washington’s state law, noting that that by law that decision should be made “by the patient with a terminal illness in consultation with the patient’s health care provider.” But it also suggests that psilocybin is among an emerging class of Schedule I controlled substances under the CSA that may indeed qualify as an investigational drug.

“The States understand that psilocybin treatment of terminally ill patients meets the basic requirement that an ‘investigational drug’ be one that has successfully completed Phase I clinical trials and is now in a subsequent phase of trials,” it says.

“Psilocybin is likely not the last Schedule I controlled substance that could be eligible under state and federal RTT laws,” the brief continues. “For example, the Schedule I substance methylenedioxy-methylamphetamine (MDMA) is the subject of ongoing studies to evaluate the possible efficacy in the treatment of anxiety associated with life-threatening illnesses.”

Washington State adopted a right-to-try law in 2017 and President Donald Trump signed the federal Right to Try Act the following year. So far 41 state legislatures have adopted similar legislation, sometimes—as in Washington—unanimously.

At the crux of the states’ argument is that DEA lacks the authority to nullify state right-to-try laws on the grounds that eligible drugs are forbidden under the federal CSA. “DEA’s refusal to recognize accommodation for state RTT laws in the face of the clear intent of Congress poses a threat to state sovereignty,” the amicus brief says. “This threat is especially acute because it comes from a federal executive agency rather than Congress itself.”

Among organizations filing separate amici briefs in the case on Friday were the Goldwater Institute, a conservative libertarian think tank that has been a leader in drafting and sponsoring state and federal right-to-try legislation, and the ACLU of Washington. A coalition of end-of-life caretakers also filed a brief in support of petitioners, as did a group of law professors and bioethicists.

Dr. Aggarwal’s effort to secure access to psilocybin for his patients began in earnest after state and federal RTT legislation became law. He started looking for legal ways to obtain and use psilocybin in end-of-life treatment, and last November began applying to state and federal regulators for approval to cultivate psilocybin mushrooms privately and use them in treatment.

“We know that it’s a naturally occurring substance that we can cultivate safely, we know how to dose it and there’s really good reason to believe it can help,” he told Marijuana Moment at the time.

Aggarwal also sought psilocybin through commercial producers, but those manufacturers wouldn’t supply the drug without DEA approval, said Kathryn Tucker of Emerge Law Group, lead attorney for the petitioners.

“In the face of an absolute barrier to DEA permission, this lawsuit was filed,” she told Marijuana Moment during a press call on Monday.

Tucker described the states’ brief in the case as “quite a remarkable filing.”

“When you read the states’ amicus, it’s pretty clear that the states come out and say that, yes, certainly there’s going to be a population of patients eligible and that it appears that psilocybin meets the requirements to be deemed an eligible investigational drug,” she said. “And interestingly, the states’ brief goes further and the states say psilocybin is not the only drug that could be at issue here.”

This past January, Aggarwal and the clinic where he works, the Advanced Integrative Medical Science (AIMS) Institute, wrote to DEA asking for guidance on how to move forward on psilocybin under right-to-try laws.

Instead DEA rejected the application, replying in a February 12 letter that the agency lacks the authority to waive the federal Controlled Substances Act, despite what the federal Right to Try Act says. The only way to dispense psilocybin legally, the agency added, would be to apply for a federal research permit, which “would not be applicable to Dr. Aggarwal at this time.”

Patients, Aggarwal and the AIMS Institute filed an opening brief in their lawsuit earlier this month. A brief from the U.S. Department of Justice is due June 21, and reply briefs are expected through the summer. Oral argument in the case could begin as soon as September, Tucker said Monday.

Health regulators in Canada have already extended legal exemptions to certain patients seeking to use psilocybin in end-of-life care. Officials there granted the first such exemption in August of last year, and in December the country’s health minister said some therapists and health care professionals could also legally use the drug.

In Oregon, voters approved historic initiatives to legalize psilocybin for therapeutic purposes and decriminalize drugs more broadly in November.

This isn’t the first time DEA has found itself battling lawsuits over the criminalization of controlled substances that hold therapeutic value.

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.

The new psychedelics-related litigation is unique, however, and reflects the growing public interest in loosening laws governing plant- and fungi-based materials, particularly for medical use.

In addition to Oregon’s already enacted policy change, a number of jurisdictions have recently considered or adopted legislation to roll back penalties around psychedelics. A California bill that would legalize the possession of many psychedelics cleared a major procedural hurdle last week and now proceeds to the Senate floor.

That effort is just the latest as activists step up the push to enact psychedelics reform locally in cities and states across the country.

The Northampton, Massachusetts City Council passed a resolution earlier this month to deprioritize enforcement of laws against the possession, use and distribution of a wide range of psychedelics such as psilocybin and ayahuasca. It’s the third city in the state to advance the policy change, following Somerville and Cambridge.

These are some of the latest iterations of a national psychedelics reform movement that’s spread rapidly since Denver became the first city to decriminalize psilocybin mushrooms in 2019.

Besides the cities in Massachusetts, four others—Oakland, Santa Cruz, Ann Arbor and Washington, D.C.—have also decriminalized possession of plant-and fungi-based psychedelics.

In Oakland, the first city where a city council voted to broadly deprioritize criminalization of entheogenic substances, lawmakers approved a follow-up resolution in December that calls for the policy change to be adopted statewide and for local jurisdictions to be allowed to permit healing ceremonies where people could use psychedelics.

Read the full amicus brief from attorneys general representing eight US states and Washington, DC:

State Amici In Psilocybin Case by Marijuana Moment

California Bill To Legalize Possession Of Psychedelics Heads To Senate Floor After Committee Action

Photo courtesy of Wikimedia/Mushroom Observer

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.

Ben Adlin is a Seattle-based writer and editor. He has covered cannabis as a journalist since 2011, most recently as a senior news editor for Leafly.

Politics

California Senator Previews Next Steps For Psychedelics Bill And Says It’s A Step Toward Decriminalizing All Drugs

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A California senator sponsoring a bill to legalize possession of psychedelics in the state says the proposal is a step toward eventually decriminalizing all drugs.

“We want to get there,” he said in a recent meeting with activists and researchers, though he added that it’s possible the broader reform would need to be decided by voters.

Sen. Scott Wiener (D) made the comments last week in a chat hosted by the Psychedelic and Entheogen Academic Council (PEAC), discussing next steps for his psychedelics legislation after it passed in the Senate earlier this month. He said advancing the measure in the Assembly will be “very challenging” due to a number of factors, but he sees progress in the legislature.

It’s also unclear where Gov. Gavin Newsom (D) stands on the reform, he said—though the governor has long been an outspoken opponent of the war on drugs.

“This is the first time that this idea has ever been introduced in the legislature,” Wiener said. “It’s a brand new idea” that “many of my colleagues have never interacted with.”

The bill originally included record sealing and resentencing provisions for people previously convicted of psychedelics possession offenses, but that language was removed in its last committee stop prior to the Senate floor vote as part of an amendment from the sponsor.

Wiener said the reasoning behind that deletion was that the policy “ended up generating a huge price tag” based on a fiscal analysis, but it could be addressed in separate legislation if the main bill passes.

Since clearing the Senate, SB 519 has been referred to two Assembly committees—Public Safety and Health—but the clock is ticking to move it this session. The senator said it must be heard by the panels by July 15, and then it would go the the Appropriations Committee, which would need to take action by late August.

If all goes well, Wiener told the PEAC members that a floor vote in the Assembly would happen in early September. Should the chamber approve it, the bill would go back to the Senate for concurrence on any amendments (or otherwise go right to Newson’s desk). The governor would need to receive the bill by September 10, and then he would have 30 days to act on it.

Assembly passage is far from a given, however. There are “rivalries” and “tensions” between the two chambers, Wiener said, despite the fact that they’re controlled by the same party.

Colleagues in the same chamber might be more willing to “give you a benefit of the doubt in helping you move forward bills,” he said. What’s more, members in the Assembly go up for reelection more frequently than in the Senate, making them less inclined to back novel legislation like the psychedelics proposal.

The senator said one possible amendment that could be expected in the Assembly would be to remove ketamine from the list of psychedelics that would be included in the reform.

“There are disagreements within the psychedelic world on it,” he said. “It might come out. My view as you keep things in until you have to make a give, and that’s one that we could potentially give on. You don’t want to spontaneously give on things without getting some ability to move the bill forward as a result.”

Mescaline, a psychoactive compound derived from peyote and other cacti, is another controversial psychedelic.

It was specifically excluded from the bill’s reform provisions in peyote-derived form, but the possession of the compound would be allowed if it comes from other plants such as “the Bolivian Torch Cactus, San Pedro Cactus, or Peruvian Torch Cactus.”

That decision on the peyote exclusion was informed by native groups who have strongly pushed back against decriminalizing the cacti for conservationist reasons and because of its sacred value for their communities.

If enacted into law, the bill would remove criminal penalties for possessing or sharing numerous psychedelics—including psilocybin mushrooms, DMT, ibogaine, LSD and MDMA—for adults 21 and older.


Marijuana Moment is already tracking more than 1,100 cannabis, psychedelics and drug policy bills in state legislatures and Congress this year. Patreon supporters pledging at least $25/month get access to our interactive maps, charts and hearing calendar so they don’t miss any developments.

Learn more about our marijuana bill tracker and become a supporter on Patreon to get access.

The state Department of Public Health would be required to establish a working group “to study and make recommendations regarding possible regulatory systems that California could adopt to promote safe and equitable access to certain substances in permitted legal contexts.” Those recommendations would be due by January 1, 2024.

For psilocybin specifically, the legislation would repeal provisions in California statute that prohibit the cultivation or transportation of “any spores or mycelium capable of producing mushrooms or other material” that contain the psychoactive ingredient.

But this bill, Wiener emphasized at the beginning of the meeting, is ultimately an incremental step to ending the drug war.

“My view is we should be decriminalizing possession and use of all drugs—and we want to get there,” he said. “This is a step just like cannabis [legalization] was a step. And ultimately we may need to go to the voters for the broader drug decriminalization like Oregon.

For the time being, however, the senator encouraged PEAC members in San Francisco, where lawmakers are more amenable to psychedelics reform, to reach out to people in other areas of the state to apply pressure on their representatives.

Meanwhile, a group of California activists announced plans earlier this year to put an initiative to legalize the use and retail sale of psilocybin on the state’s 2022 ballot. That group, Decriminalize California, said that it would first work to convince lawmakers to pursue reform and then take the issue directly to the people if the legislature fails to act.

The psychedelics effort in the California legislature, which Wiener first previewed back in November, comes as activists are stepping up the push to enact psychedelics reform locally in cities in the state and across the country. The bill notes those efforts in an explanation of the proposal.

The Northampton, Massachusetts City Council passed a resolution in April to deprioritize enforcement of laws against the possession, use and distribution of a wide range of psychedelics such as psilocybin and ayahuasca. It’s the third city in the state to advance the policy change, following Somerville and Cambridge.

These are some of the latest iterations of a national psychedelics reform movement that’s spread rapidly since Denver became the first city to decriminalize psilocybin mushrooms in 2019.

Besides the cities in Massachusetts, four others—Oakland, Santa Cruz, Ann Arbor and Washington, D.C.—have also decriminalized possession of plant-and fungi-based psychedelics.

In Oregon, November’s election saw the passage of a historic initiatives to legalize psilocybin mushrooms for therapeutic purposes and more broadly decriminalize possession of all drugs.

The governor of Connecticut signed legislation last week that includes language requiring the state to carry out a study into the therapeutic potential of psilocybin mushrooms.

Texas lawmakers also recently sent their governor a bill to require the state study the medical benefits of psychedelics for military veterans.

A New York lawmaker introduced a bill this month that would require the state to establish an institute to similarly research the medical value of psychedelics.

In Oakland, the first city where a city council voted to broadly deprioritize criminalization of entheogenic substances, lawmakers approved a follow-up resolution in December that calls for the policy change to be adopted statewide and for local jurisdictions to be allowed to permit healing ceremonies where people could use psychedelics.

After Ann Arbor legislators passed a decriminalization resolution last year, a county prosecutor recently announced that his office will not be pursuing charges over possessing entheogenic plants and fungi—“regardless of the amount at issue.”

The Aspen, Colorado City Council discussed the therapeutic potential of psychedelics like psilocybin and proposals to decriminalize such substances at a meeting last month. But members said, as it stands, enacting a reform would be more better handled at the state level while entheogens remain strictly federally controlled.

Seattle lawmakers also recently sent a letter to members of a local task force focused on the opioid overdose epidemic, imploring the group to investigate the therapeutic potential of psychedelics like ayahuasca and ibogaine in curbing addiction.

Texas Governor Signs Medical Marijuana Expansion Bill

Photo courtesy of Wikimedia/Mushroom Observer.

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New Jersey Attorney General Cracks Down On ‘Gift’ Marijuana Schemes Involving Overpriced Snacks

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The attorney general of New Jersey on Tuesday sent warning letters to companies that are effectively circumventing the state’s marijuana laws by “gifting” cannabis in exchange for non-marijuana-related purchases such as overpriced cookies, brownies and stickers.

Gifting is lawful between adults 21 and older under New Jersey’s adult-use cannabis law, but a number of businesses are allegedly taking advantage of that policy by giving away “free” cannabis products to those who purchase other items like snacks and baked goods.

No retail marijuana businesses have been licensed since the state enacted recreational legalization earlier this year, which followed voter approval of a reform initiative during the November 2020 election. Licensing regulations still need to be developed before adult-use shops can open.

“In legalizing adult-use cannabis in New Jersey, the Legislature made it clear they were creating a regulated market with restrictions on how that market operates,” Attorney General Gurbir Grewal said in a press release. “Instead of waiting for those regulations to be established, some vendors have decided to move forward on their own, in ways that the law does not allow.”

“Today we’re making it clear that we will not permit these entities to undermine the regulated cannabis marketplace the Legislature created or to compete unfairly with properly licensed cannabis businesses,” he said.

Four Sky High Munchies, Slumped Kitchen LLC, NJGreenDirect.com LLC and West Winds Wellness were targeted with cease and desist letters, which state that the cannabis gifts that they’re offering appear to be central to their business transactions. The non-cannabis items are generally overpriced, the press release notes.

New Jersey’s legalization law establishes the Cannabis Regulatory Commission (CRC) to oversee the market and create licensing rules. CRC Chairperson Dianna Houenou said that the division “is committed to establishing a safe marketplace of cannabis products.”

“Those trying to preempt the rules and transfer unregulated and untested marijuana items jeopardize public health and undermine confidence in the forthcoming regulated cannabis industry,” she said.

“We will not allow vendors to misrepresent what they’re selling,” Kaitlin Caruso, acting director of the state’s Division of Consumer Affairs, said. “Under our consumer protection laws, vendors are subject to fines and penalties for making false or misleading statements about what they’re selling. We have warned these companies about our concerns, and to stop conduct that could violate our laws.”

New Jersey’s attorney general has been proactive about cannabis reform implementation since the legalization bill was enacted.

The day after Gov. Phil Murphy (D) signed bills to legalize and decriminalize marijuana, Grewal directed prosecutors to drop cases for cannabis-related offenses and issued separate guidance for police on how to proceed under the updated laws.

The attorney general also encouraged prosecutorial discretion for marijuana cases in earlier memos prior to the bill’s signing.

Federal Marijuana Trafficking Cases Drop Again In 2020 As More States Legalize

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Texas Governor Signs Medical Marijuana Expansion Bill

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Texas Gov. Greg Abbott (R) signed a bill to modestly expand the state’s limited medical marijuana program on Tuesday.

The legislation adds cancer and post-traumatic stress disorder to the list of conditions that qualify patients to legally access cannabis. It also doubles the amount of THC concentration that is allowed, from 0.5 percent to one percent.

As originally passed in the House, the bill would have also included chronic pain as a qualifying condition, but that was removed by the Senate and was not re-added in a conference committee. The House-approved version also increased the THC limit to five percent, but that too was watered down in the Senate.

Abbott has not yet commented on a separate piece of drug policy reform legislation that the legislature also passed to require the state to study the therapeutic potential of psychedelics like psilocybin and MDMA.

Abbott first announced he would sign the cannabis bill in a Twitter post last week.

Separate bills to reduce penalties for possessing cannabis concentrates, revise the state’s hemp program and broadly decriminalize marijuana possession also advanced this year—but they did not make it over the finish line by the session’s end.

Partly because of those failures, a newly formed progressive coalition that’s being led by two former congressional candidates said last week that it plans to take cannabis and other issues directly to voters by putting reform measures on local ballots across the state.

Abbott did not sign additional legislation to clarify that a positive marijuana test alone is not sufficient criteria for removing a child from their home. But he didn’t veto it, either, and it was enacted without the his signature last month and takes effect on September 1, 2021.

Connecticut Senate Approves Marijuana Legalization Bill In Special Session

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