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.
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.
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:
Photo courtesy of Wikimedia/Mushroom Observer
Pennsylvania Senators Will Consider DUI Protections For Medical Marijuana Patients At Hearing
A Pennsylvania Senate committee is set to take up a bill next week that would protect medical marijuana patients from being prosecuted under the state’s “zero tolerance” DUI laws.
The legislation, sponsored by Sen. Camera Bartolotta (R), would amend state statute to require proof of active impairment before a registered patient can be prosecuted for driving under the influence. The current lack of specific protections for the state’s roughly 368,000 patients puts them in legal jeopardy when on the road, supporters say.
The #PASenate Transportation Committee will hold a hearing on 9/21 with a focus on my #SB167, which would remove DUI penalties for legal medicinal cannabis use. @SenLangerholc @PASenateGOP Details ⤵️https://t.co/cSd2Cpdky9 pic.twitter.com/av3mxvAuCk
— Senator Bartolotta (@senbartolotta) September 16, 2021
Bartolotta first introduced an earlier version of the bill in June 2020. She said at the time that the state needs to “ensure that the legal use of this medicine does not give rise to a criminal conviction.”
Months after the standalone reform legislation was introduced, the Pennsylvania House approved a separate amendment that would enact the policy change.
Pennsylvania legalized medical marijuana in 2016, with the first dispensaries in the state opening in 2018. But the state’s zero-tolerance DUI law still doesn’t reflect those changes. Because it criminalizes the presence of any THC or its metabolites in a driver’s blood—which can be detected for weeks after a person’s last use—the law puts virtually all medical marijuana patients at risk, even if it’s been days since their last use and they show no signs of impairment.
Bartolotta’s bill would require officers to prove a registered patient was actually impaired on the road.
Marijuana Moment is already tracking more than 1,200 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.
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“Unimpaired patients currently face the risk of being arrested, prosecuted and convicted for using medicinal marijuana that has no bearing on their ability to drive a vehicle,” the senator wrote in a cosponsorship memo late last year. “Given the very serious consequences of a DUI conviction, my legislation will provide critical protections for medicinal cannabis patients by ensuring responsible use of their legal medicine does not give rise to a criminal conviction.”
Several legal cannabis states have enacted per se THC limits in blood, similar to blood alcohol requirements. However, evidence isn’t clear on the relationship between THC concentrations in blood and impairment.
A study published in 2019, for example, concluded that those who drive at the legal THC limit—which is typically between two to five nanograms of THC per milliliter of blood—were not statistically more likely to be involved in an accident compared to people who haven’t used marijuana.
Separately, the Congressional Research Service in 2019 determined that while “marijuana consumption can affect a person’s response times and motor performance… studies of the impact of marijuana consumption on a driver’s risk of being involved in a crash have produced conflicting results, with some studies finding little or no increased risk of a crash from marijuana usage.”
Outside of this bill, Pennsylvania lawmakers have continued to pursue adult-use legalization in the state. Earlier this year, two legislators circulated a memo to build support for a comprehensive reform bill they plan to introduce, for example.
A bipartisan Senate duo is also in the process of crafting legislation to legalize cannabis across the commonwealth. They announced some details of the proposal earlier this year, but the bill has yet to be formally introduced.
Outside the legislature, Gov. Tom Wolf (D) said earlier this year that marijuana legalization was a priority as he negotiated the annual budget with lawmakers. However, his formal spending request didn’t contain legislative language to actually accomplish the cannabis policy change.
Wolf, who signed a medical cannabis expansion bill in June, has repeatedly called for legalization and pressured the Republican-controlled legislature to pursue the reform since coming out in favor of the policy in 2019. Shortly after he did that, a lawmaker filed a separate bill to legalize marijuana through a state-run model.
Lt. Gov. John Fetterman (D), who is running for U.S. Senate, previously led a listening tour across the state to solicit public input on legalization. He’s credited that effort with helping to move the governor toward embracing comprehensive reform. The lieutenant governor even festooned his Capitol office with marijuana-themed decor in contravention of a state law passed by the GOP-led legislature.
Fetterman has also been actively involved in encouraging the governor to exercise his clemency power for cannabis cases while the legislature moves to advance reform.
In May, Wolf pardoned a doctor who was arrested, prosecuted and jailed for growing marijuana that he used to provide relief for his dying wife. That marks his 96th pardon for people with cannabis convictions through the Expedited Review Program for Non-Violent Marijuana-Related Offenses that’s being run by the Board of Pardons.
Overall, legalization is popular among Pennsylvania voters, with 58 percent of residents saying they favor ending cannabis prohibition in a survey released in April.
Another poll released in May found that a majority of voters in the state also support decriminalizing all currently illicit drugs.
Photo courtesy of Mike Latimer.
80 Top Law Enforcement Officials, Including A Biden Nominee, Urge SCOTUS To Hear Safe Injection Drug Case
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—have filed a brief urging the Supreme Court to take up a case on the legality of establishing a safe injection facility where people can use illicit drugs in a medically supervised environment.
The nonprofit organization Safehouse was set to launch a safe consumption site in Philadelphia before being blocked by a legal challenge from the Trump administration, and it filed a petition with the nation’s highest court last month to hear the case. Now the group of law enforcement officials associated with Fair and Just Prosecution are calling on the Supreme Court to act in an amicus brief.
“Amici have an interest in this litigation because overdose prevention sites (OPSs) are among the harm reduction and public health interventions that have proven effective in preventing fatal overdoses and diverting people from unnecessary and counterproductive interactions with the justice system,” they wrote. “Amici, many of whom are currently or were previously responsible for enforcing the nation’s drug laws, also believe that the Controlled Substances Act cannot be construed to prohibit operation of a facility designed to address the most acute aspects of this public health emergency.”
“As law enforcement and criminal justice leaders, amici’s objective is to maintain public safety; saving lives and promoting health is as central to that mission as preventing and prosecuting crime.”
Read the full brief: https://t.co/e4Sv6oba4b
— Fair and Just Prosecution (@fjp_org) September 17, 2021
If the court agrees to hear the dispute, advocates will be looking toward the Biden Justice Department and whether it will continue the federal government’s opposition to allowing supervised injection facilities. It would be a precedent-setting case that could steer policy for years to come, meaning Safehouse is taking a significant risk by pursuing the appeal of its loss in a lower court before the majority of conservative justices.
“Failing to address the loss of life resulting from drug overdoses—and criminalizing a community-based public health organization working to save lives—will further erode trust in the justice system,” the new brief states. “If there were ever a time to demonstrate that our government values the dignity of human life, that time is now.”
While President Joe Biden hasn’t weighed in directly on safe consumption sites, there’s been a theme within his administration of embracing the general concept of harm reduction for drugs. The White House Office of National Drug Control Policy (ONDCP), for example, said that “promoting harm-reduction efforts” is a first-year priority. In an overview of its objectives, the office said it intends to expand “access to evidence-based treatment,” enhance “evidence-based harm reduction efforts” and promote “access to recovery support services.”
These goals theoretically align with those of Safehouse, which wants to give people with substance use disorders a facility where medical professionals can intervene in the event of an overdose and provide people with the resources to seek recovery.
Among the signatories on the amicus brief are a former deputy assistant attorney general under Obama, district attorneys of Baltimore, Cook County, Dallas County, Los Angeles County, Manhattan, Philadelphia, San Francisco County and Seattle and the former attorneys general of Ohio, Vermont and Virginia.
But one signatory who especially stands out is Rachael Rollins, the district attorney of Suffolk County, Massachusetts who is Biden’s nominee for U.S. attorney of Massachusetts.
“As an elected prosecutor, I have a responsibility to protect every member of my community, which requires moving away from criminal justice responses to substance use disorder,” Rollins said in a press release. “Instead, we must embrace proven public health strategies as potential solutions. Lives depend on it.”
Philadelphia District Attorney Larry Krasner said the drug war “has taken too many lives already, and criminalization has only exacerbated this devastating toll.” He added: “We need a new way forward that allows communities to address the overdose crisis with harm reduction approaches proven to save lives and improve community safety.”
“Our nation’s failed war on drugs has taken too many lives…and criminalization has only exacerbated this devastating toll. We need a new way forward that allows communities to address the overdose crisis with harm reduction approaches proven to save lives." –@DA_LarryKrasner
— Fair and Just Prosecution (@fjp_org) September 17, 2021
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.
Safehouse won a battle in a federal district court in 2019 to proceed with the facilities. But in January, the U.S. Court of Appeals for the Third Circuit overturned the decision, ruling that permitting such facilities would violate a 1980s-era federal statute that bars organizations from running operations “for the purpose of unlawfully… using controlled substances.” That law was passed while Biden served in the Senate and helped push punitive drug policies that have had lasting consequences.
“As current and former criminal justice leaders, amici have seen first-hand how the classic ‘war on drugs’ approach to drug control—with its almost exclusive focus on aggressive criminal law enforcement—has exacerbated the overdose epidemic,” the pro-reform prosecutors and cops wrote in the new brief. “This experience confirms that no jurisdiction can arrest its way out of this public health problem. Fatal overdoses are a symptom of substance use disorder, a medical condition requiring a medical response.”
“Distorting federal drug laws to prohibit an [overdose prevention site] or to prosecute its sponsors would further undermine trust in the justice system and faith in the fair and sensible application of our drug laws. Interpreting federal criminal law to bar empirically validated harm reduction measures would make no one safer; it would only impede cooperation between law enforcement and the communities they serve.”
In its original petition to the Supreme Court in the current safe injection site case, Safehouse argued that the justices should “grant review to determine whether” federal statute really does prohibit “non-commercial, non-profit social service agencies…from establishing an overdose-prevention site that includes medically supervised consumption.”
“This question is a matter of life or death for thousands of Philadelphians and many thousands more throughout the country,” it said. “Tragically, while respondents have been pursuing this declaratory judgment against Safehouse, more than 3,200 people died in Philadelphia of drug overdoses—many of which could have been prevented if medical care had been immediately available through supervised consumption services.”
Safehouse also pointed out that Xavier Bacerra, the Biden administration’s secretary of health and human services, was among eight top state law enforcement officials who filed an earlier amicus brief in support of the organization’s safe injection site plan when he served as California’s attorney general.
The organization put the gravity of the case in no uncertain terms, painting a picture of how its proposed facility can save lives.
“When breathing stops, even a brief delay while waiting for medical help to arrive may result in an otherwise preventable overdose death or irreversible injury,” the petition says. “As a result, every second counts when responding to an opioid overdose; as more time elapses, the greater the risk of serious injury and death. Ensuring proximity to medical care and opioid reversal agents like the drug Naloxone at the time of consumption is therefore a critical component of efforts to prevent fatal opioid overdose.”
“Intervention by this Court is warranted to make clear that the federal law does not criminalize this essential public health and medical intervention designed to save lives from preventable overdose death,” it continues.
Safehouse argued that the appeals court’s interpretation of the law “eviscerates the intended boundaries of the statute and would criminalize the operation of legitimate businesses, charities, families, and good Samaritans that serve and reside with those suffering from addiction.”
If the Supreme Court were to take up the case and rule in favor of Safehouse, it could embolden 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.
At the same time that Safehouse is turning to the Supreme Court, it also announced recently that it will be returning the the federal district court that gave it an initial 2019 victory in support of establishing a safe injection facility before it was overturned in the appeals court.
The organization is making the unique argument that the federal government’s decision to block it from providing the service violates religious freedom by subjecting participants “to criminal penalties for exercising their sincerely held religious beliefs that they have an obligation to do everything possible to preserve life and to provide shelter and care to the vulnerable, including those suffering from addiction.”
In 2018, a congressional subcommittee approved legislation to specifically prohibit Washington D.C. from using local tax dollars to help open safe consumption facilities. But that provision was not enacted and has not been reintroduced since.
A 2020 study found that people “who reported using supervised injection facilities on an at least weekly basis had a reduced risk of dying compared to those who reported less than weekly or no use of this health service.”
Read the amicus brief from the prosecutors on the Safehouse safe injection site case below:
Photo courtesy of Jernej Furman.
Former GOP Congressman Who Actually Supported Marijuana Reform Enters The Cannabis Industry
Lately it’s come to seem as if most of the former politicians who’ve entered the marijuana industry were unhelpful or downright hostile to legalization when they were in office. But on Friday, a cannabis company announced an addition to its board who disrupts that narrative: a former Republican congressman who has a consistent legislative record of cosponsoring and voting for marijuana reform measures.
The multi-state cannabis businesses Red White & Bloom Brands Inc. (RWB) is bringing on former Rep. Ryan Costello (R-PA) to help it navigate the complicated regulatory space, drawing on his experience in Congress as the company works to expand.
Costello certainly isn’t the only Republican lawmaker who’s made the transition from Capitol Hill to the cannabis market. But he is a rare example of a politician who actually embraced enacting marijuana policy changes while he was in power before standing to profit from the industry. The congressman cosponsored a variety of bills—including ones to shield states that legalize cannabis from federal interference—and supported several reform amendments.
“I’m looking forward to utilizing my 15+ years of service in government, the legal profession, and my familiarity with cannabis policy to be a strategic resource for RWB as it positions itself as a true market leading house of brands in the permitted U.S. marketplace,” Costello said in a press release.
This breaks with a trend that has increasingly frustrated advocates, where it seems the people most inclined to benefit from legalization are those who stood in the way in Congress. The best-known example of that is former GOP House Speaker John Boehner (R-OH), who’s faced criticism from activists over his anti-legalization record while in office before joining the board of marijuana company Acreage Holdings.
While Costello left Congress in 2019 prior to the historic House vote on a standalone bill to federally deschedule cannabis, there are plenty of examples of him supporting more modest reform proposals during his congressional tenure.
He was a cosponsor of legislation to protect state marijuana markets from federal intervention, promote cannabis research, support military veterans’ access to medical marijuana, protect banks that service state-legal cannabis businesses and legalize industrial hemp.
The congressman also voted in favor of floor amendments to shield all state marijuana programs from Justice Department intervention, allow Department of Veterans Affairs doctors to recommend medical cannabis and end hemp prohibition.
In that respect, he was a rare GOP lawmaker. While the issue is increasingly bipartisan among the public, that hasn’t been reflected in Congress. And now Costello is in a position to leverage his legislative experience to advance a marijuana business’s interests.
It’s an exception to the trend.
For example, Tom Price, the former U.S. Department of Health and Human Services (HHS) head under President Donald Trump, is serving as a member of the board of directors for a medical marijuana business in Georgia after he refused to take action to reclassify cannabis under federal law when he had the power to do so. Price consistently voted against marijuana reform measures while serving in Congress.
Former Rep. Steve Buyer (R-IN), who also has a long track record of opposing marijuana legalization efforts, joined a Canadian cannabis company’s board in 2019.
Earlier this month, a New York-based lobbying firm that’s headed by a former Republican U.S. senator announced that it is launching a practice focused on serving cannabis businesses. That former senator, Alfonse D’Amato, racked up a record of supporting the war on drugs while in office.
There is at least one other former GOP congressman who entered the cannabis space with a legislative record supporting marijuana reform. Former Rep. Dana Rohrabacher (R-CA), who championed cannabis reform while in Congress, became an advisory board member for a marijuana company after being voted out of office in 2018.
Separately, President Joe Biden’s pick to head up federal drug policy worked for a major marijuana business last year, according to his financial disclosure reports.
Photo courtesy of WeedPornDaily.