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DEA Sued By Doctor Who Wants Permission To Give Psilocybin Mushrooms To Patients

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A Seattle doctor hoping to expand access to psilocybin mushrooms for terminally ill cancer patients is taking the U.S. Drug Enforcement Administration (DEA) to court over the agency’s recent denial of an application to legally use the psychedelic in end-of-life treatment.

Attorneys filed a lawsuit Monday in the U.S. Circuit Court of Appeals for the Ninth Circuit, arguing that DEA’s denial of the application was unfounded. They’re asking judges to throw out the decision and force the agency to “expeditiously reconsider and accommodate valid requests made from qualified health providers for the therapeutic use of the eligible investigation drug psilocybin.”

“It is a first-of-its-kind lawsuit,” lead attorney Kathyn Tucker said on a press call on Tuesday. “The case is about seeking to ensure that patients with serious, life-threatening illness are able to realize the promise of state and federal right-to-try laws and access psilocybin for therapeutic.”

The push to expand patient access began last year, when Dr. Sunil Aggarwal, who specializes in end-of-life care, began searching for a legal way to obtain psilocybin for treating patients. In November, he began applying to state and federal regulators for approval to cultivate psilocybin mushrooms 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,” Aggarwal told Marijuana Moment at the time.

Aggarwal’s team argues that psilocybin should be made available under state and federal right-to-try laws, relatively new policies that give patients with terminal conditions the opportunity to try investigational medications that have not been approved for general use. Washington state adopted a right-to-try law in 2017. President Donald Trump signed the federal Right to Try Act the following year. Dozens of other states have also passed right-to-try laws.

Aggarwal and the clinic where he works, the Advanced Integrative Medical Science (AIMS) Institute, wrote to DEA in January asking for guidance on how to move forward on psilocybin, which remains a Schedule I controlled substance, under right-to-try laws.

“What we hoped the DEA would be doing under right-to-try is creating a user-friendly approach to how clinicians like Dr. Aggarwal can navigate the system to obtain an eligible investigational drug for an eligible patient,” Tucker said on the press call.

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.”

In response, Aggarwal and the AIMS Institute filed their petition for review this week. At Tuesday’s press conference, he criticized DEA’s decision as an obstacle for terminally ill patients who simply want to improve their quality of life.

“This is absolutely unacceptable for their care, because they have this right under the law, and the law states that that medicines like this should be made available expeditiously for patients,” Aggarwal said. “I’m hoping that the judges who look at that will take into consideration the great potential [of psilocybin], the suffering of my patients, and the law and what their rights are.”

Tucker, the lead attorney in the suit, explained that psilocybin seems to fit the criteria listed in state and federal right-to-try laws, having completed a Phase I research trial and remaining under active investigation. “Psilocybin, hence, is what the right-to-try laws designate as an eligible investigational drug,” she said.

The team noted noted that 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.

One of the patients represented in the new lawsuit is Erinn Baldeschweiler, a mother of two who has been diagnosed with stage four metastatic breast cancer. Psilocybin, she believes, could help ease the emotional trauma of a terminal diagnosis.

“Whatever remaining time I have left,” Baldeschwiler said, “I want to have the highest quality of life.”

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.

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

A New York lawmaker filed a bill on Monday to decriminalize psychedelic mushrooms in the state, for example.

Six cities—OaklandSanta CruzAnn ArborWashington, D.C.Somerville and Cambridge—have decriminalized possession of a broader collection psychedelics since Denver became the first to deprioritize enforcement against psilocybin in 2019. Activists in Spokane, Washington have also recently submitted a similar reform proposal to local lawmakers.

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

Legislators in CaliforniaConnecticut, FloridaHawaiiKansasMissouriWashington State and Virginia are also considering psychedelics and drug policy reform bills for the 2021 session.

A Republican lawmaker in Iowa introduced a bill to remove psilocybin from the list of controlled substances, which received a subcommittee hearing last week but did not advance. He also filed another piece of legislation to let seriously ill patients use psychedelic mushrooms, LSD, DMT and other drugs.

Read the full psilocybin lawsuit against DEA and related correspondence below:

DEA Psilocybin Lawsuit by Marijuana Moment

New York Lawmaker Files Bill To Decriminalize Psilocybin Mushrooms

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

Another Poll Shows Majority Of Americans Support Marijuana Legalization And Expungements

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Another poll has found that a majority of Americans support legalizing marijuana and clearing the records of those with prior cannabis convictions.

This one—commissioned by CBS News and released on the unofficial marijuana holiday 4/20—shows that 55 percent of respondents said recreational cannabis should be legal in their own state, compared to 42 percent who said it should be illegal.

While still a sizable majority, that’s notably lower than several other recent surveys, including those released by Quinnipiac University and the Pew Research Center this month. Those polls found that 69 percent and 60 percent of Americans back broad legalization, respectively.

Unique to this poll, however, is that participants were also asked about related cannabis issues. For example, 59 percent of adults said that people with non-violent marijuana convictions in states that have legalized should have their records cleared, versus 37 percent who said the conviction shouldn’t be expunged.

Among those who were surveyed and live in a legal marijuana state, 60 percent said they favor the policy. And 53 percent of those living in states where prohibition is still on the books said cannabis should be legalized.

Via CBS News.

Twenty-three percent of respondents said legalizing cannabis would increase crime and 19 percent said it would decrease crime—but the majority (54 percent) said it would have “no effect.”

Via CBS News.

CBS also asked respondents whether they felt legalizing marijuana would lead people to use other drugs. Most people (45 percent) said the reform would have “not much effect” to that end, while 33 percent said they felt more people would seek out other substances and 17 percent said it would make people less likely to try other drugs.

Via CBS News.

Nearly half of Americans (48 percent) said legalization would boost local economies, while 14 percent said it would have a negative economic impact and 35 percent said it wouldn’t have much of an effect at all.

Via CBS News.

Interestingly, while most people backed legalization in the poll, 53 percent said that openly using marijuana socially is “unacceptable,” compared to 43 percent who said it was “acceptable”—perhaps more a reflection of respondents’ perception of other people’s views than their own.

The poll involved interviews with 1,004 adults from March 9-14 and has a margin of error of plus or minus 3.7 percentage points.

Despite this latest example of polling showing that Americans favor ending prohibition, President Joe Biden is still not on board with extending that policy to the federal level, as confirmed again by the White House press secretary on Tuesday.

While the president says he supports allowing states to set their own policies, he feels it should only be decriminalized and rescheduled federally and wants more research to be done if he’s to change his position on broader reform.

This poll comes at a time when there’s a concerted push in both chambers of Congress to seize the opportunity they have with Democratic control to pass legalization legislation.

Senate Majority Leader Chuck Schumer (D-NY), Senate Finance Committee Chairman Ron Wyden (D-OR) and Sen. Cory Booker (D-NJ) have been working on a bill on their side. The majority leader told Marijuana Moment on Monday that he’s working to push the president in a pro-legalization direction as they draft the measure.

Schumer said last week that the legislation will be introduced and placed on the floor “soon.”

On the House side, Judiciary Chairman Jerrold Nadler (D-NY) said recently that he plans to reintroduced his legalization bill, the Marijuana Opportunity, Reinvestment and Expungement (MORE) Act, which cleared the chamber last year but did not advance in the Senate under GOP control.

Biden Won’t Commit To Sign Marijuana Bill If Passed By Congress, Press Secretary Says

Photo courtesy of Mike Latimer.

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.
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New House Bills Would Make Cannabis Businesses Eligible For Federal Small-Business Aid

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Lawmakers in the U.S. House of Representatives have introduced three new bills to make state-legal marijuana businesses eligible for federal small business services, including loans, disaster relief and grant programs.

The package of legislation is aimed at establishing parity for cannabis businesses, which are currently prohibited from receiving federal aid due to marijuana still being classified as a Schedule I controlled substance. The country’s legal cannabis industry nevertheless now supports nearly 320,000 full-time jobs in the U.S., according to industry estimates.

The measures are largely similar to legislation introduced by the lawmakers in 2019, with some small changes.

One bill, sponsored by House Small Business Committee Chairwoman Nydia Velázquez (D-NY), would allow marijuana businesses to access resources from the federal Small Business Administration (SBA). The Ensuring Safe Capital Access for All Small Businesses Act of 2021, which had not been assigned a bill number as of Tuesday afternoon, would expand access to services such as microloans, disaster assistance and the agency’s loan guaranty program.

“With more and more states pursuing legalization, including my home state of New York, there are a growing number of legitimate small businesses that are excluded from critical SBA programs,” Velázquez said in a statement, noting that much of the cannabis industry consists of small businesses.

Compared to Velázquez’s 2019 bill, the new version adds clauses meant to expand the availability of services. While the 2019 bill applied to SBA itself, provisions in the new legislation also prevent SBA intermediaries, private lenders and state and local development companies from declining to work with businesses simply because of their marijuana-related work.

Another new section deals with debentures—certain unsecured loan certificates—and clarifies that SBA may not decline to purchase or guarantee a debenture just because of a business’s involvement in cannabis. Nor can other small business investment companies decline to provide assistance to the cannabis sector.

“This legislation will spark growth by extending affordable capital to small firms in the cannabis space,” she continued. “Simultaneously, the bill acknowledges the structural disadvantages facing entrepreneurs of color and seeks to level the playing field.”

Another newly refiled measure, H.R. 2649, sponsored by Rep. Dwight Evans (D-PA), would establish a U.S. Small Business Administration (SBA) grant program to provide funding to state and local governments to help them navigate the licensing process for cannabis businesses. The bill, which also removes marijuana from the Controlled Substances Act, specifies that the grant money should be used to benefit communities disproportionately impacted by the drug war.

“My bill would act as a poverty-buster and help homegrown small businesses, which are the backbone of our economy and our neighborhoods. We need to make sure that the booming legal cannabis industry does not become consolidated in the hands of a few big companies,” Evans said.


Marijuana Moment is already tracking more than 1,000 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.

A third bill, H.R. 2649, from Rep. Jared Golden (D-ME), would prohibit SBA partners that provide guidance and training services from denying help to businesses solely because of involvement in cannabis. The changes would affect providers such as SBA’s Small Business Development Centers, Women’s Business Centers and the Veterans Business Outreach Centers, among others.

“Our continued economic recovery depends on the health of American small businesses of all kinds. Especially in this environment, no Maine small business owner should be turned away from crucial SBA programs that could help them create jobs and lift up the economy,” said Rep. Golden. “My bill would help address this problem by providing small business owners directly or indirectly associated with the cannabis industry with access to the services and resources they need to get their small businesses off the ground and grow.”

Meanwhile, federal lawmakers have been making headway on other cannabis-related proposals. The House passed a cannabis banking bill on Monday, and broader legislation to legalize cannabis at the federal level is expected to be introduced soon.

The banking legislation would ensure that financial institutions can take on cannabis business clients without facing federal penalties. Fear of sanctions has kept many banks and credit unions from working with the industry, forcing marijuana firms to operate on a cash basis that makes them targets of crime and creates complications for financial regulators. The full House passed the bill on a 321–101 vote.

“Even if you are opposed to the legalization of cannabis, you should support this bill,” sponsor Rep. Ed Perlmutter (D-CO) said on the House floor. “The fact is that people in states and localities across the country are voting to approve some level of cannabis use, and we need these cannabis businesses and employees to have access to checking accounts, payroll accounts, lines of credit, credit cards and more.

Other Democrats, including Senate Majority Leader Chuck Schumer (D-NY), Senate Finance Committee Chairman Ron Wyden (D-OR) and Sen. Cory Booker (D-NJ) are working on legislation that would end federal cannabis prohibition completely.

Schumer said last week that the long-awaited proposal would be introduced “shortly” and placed on the floor “soon.” Schumer has so far declined to discuss the bill’s specifics, though he’s stressed that it will prioritize small businesses and people most historically impacted by the drug war.

In an interview with Marijuana Moment this week, Schumer worried that passage of the House banking bill could actually undermine broader congressional cannabis reform this year.

On the House side, Judiciary Chairman Jerrold Nadler (D-NY) said recently that he plans to reintroduced his own legalization bill, the Marijuana Opportunity, Reinvestment and Expungement (MORE) Act, which cleared the House in a landmark vote last year but did not advance in GOP-controlled the Senate.

Meanwhile, support for legalization among U.S. voters continues to grow. More than 9 in 10 Americans (91 percent) now support legalizing cannabis for either medical or adult use, according to a Pew Research Center poll released on Friday. Sixty percent of respondents said that cannabis should be legal for both medical and adult use. Thirty-one percent said it should be legalized for therapeutic purposes only, while just eight percent said it should continue to be criminalized across the board.

A majority of those in every age, race and political demographic included in the poll said they feel marijuana should be legal in some form, although many Republicans remain wary of adult-use legalization. Seventy-two percent of Democrats favored both medical and adult-use legalization compared to only 47 percent of Republicans.

Among the minority in opposition to federal legalization: President Joe Biden (D). White House Press Secretary Jen Psaki said last month that the president’s position on the issue “has not changed,” meaning he still opposes the reform. on Tuesday, Psaki refused to say whether Biden would sign or veto a cannabis legalization bill if passed by Congress.

The president instead backs modestly rescheduling the plant, decriminalizing possession, legalizing medical cannabis, expunging prior marijuana records and letting states set their own policies.

Read the full text of the new legislation below:

Ensuring Safe Capital Access for All Small Businesses Act of 2021 by Marijuana Moment on Scribd

Ensuring Access to Counseli… by Marijuana Moment

Homegrown Act by Marijuana Moment on Scribd

Schumer Worries Senate Marijuana Banking Vote Could Undermine Broader Legalization Push

 

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Biden Won’t Commit To Sign Marijuana Bill If Passed By Congress, Press Secretary Says

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White House Press Secretary Jen Psaki on Tuesday declined to say whether President Joe Biden would sign or veto a bill to federally legalize marijuana if it arrives on his desk, noting that his cannabis policy position is at odds with broader proposals that congressional Democratic leaders are working on.

She was also asked about his stance on marijuana banking reform, the disconnect between public opinion favoring legalization and the president’s opposition and whether Biden plans to revisit clemency applications for those facing federal sentences over cannabis.

The noncommittal response to the legalization question comes on the unofficial cannabis holiday 4/20—a day that has seen a wide range of politicians, including Senate Majority Leader Chuck Schumer (D-NY), voice support for comprehensive marijuana reform.

Psaki was pressed on the Senate leader’s remarks and asked whether Biden would support legislation to end federal cannabis prohibition if Congress approved it.

“The president supports leaving decisions regarding legalization for recreational use up to the states, rescheduling cannabis as a Schedule II drug so researchers can study its positive and negative impacts and, at the federal level, he supports decriminalizing marijuana use and automatically expunging any prior criminal records,” she said. “He also supports legalizing medicinal marijuana so that’s his point of view on the issue.”

Biden’s positions to that end are well known, but an outstanding question has been whether his opposition to adult-use legalization is so strong that he would reject a reform proposal such as those currently being drafted in the House and Senate.

Asked directly what action the president would take if a federal legalization bill was sent to his desk, Psaki signaled that he wouldn’t be inclined to sign it, stating “I just have outlined what his position is, which isn’t the same as what the House and Senate have proposed, but they have not yet passed a bill.”

The reporter followed up to ask about a separate cannabis pledge Biden made as a presidential candidate, when he said people incarcerated in federal prisons over non-violent marijuana offenses should be released.

Psaki said that would be addressed if cannabis was rescheduled to Schedule II—a dubious claim given that there are still serious penalties for offenses involving substances in that category as well. She also didn’t provide any insight into whether the president is proactively pushing for the modest scheduling change.

Later in the briefing, the press secretary was asked where Biden stands on legislation to protect banks that service state-legal marijuana businesses from being penalized by federal regulators. The House approved the Secure and Fair Enforcement (SAFE) Banking Act along bipartisan lines on Monday.

She said it was a “good question,” but she wasn’t sure and told the reporter she would follow up with a response later.

When pushed on Biden’s opposition to the legalization in the face of mounting, majority support among Americans, Psaki said that while he’s in favor of decriminalization and legalizing medical marijuana, he wants more research on the “positive and negative effects” of adult-use legalization.

“He’ll look at the research once that’s concluded,” she said. “Of course we understand the movement that’s happening toward it. I’m speaking for what his position is and what long, consistently has been his position. He wants to decriminalize, but again, he’ll look at the research of the positive and negative impacts.”

The press conference ended with a final question about cannabis policy—specifically whether the Biden administration plans to revisit requests for clemency for federal cannabis convictions. The reporter cited the case of Luke Scarmazzo, who was sentenced to 22 years in federal prison for operating a state-legal medical cannabis business in California, as an example.

“Given, as you’ve noted in the briefing, the president’s support for decriminalization, support for expunging exactly these types of offenses, are there any plans to revisit some of those bids for clemency?” the reporter asked.

“Well, I would just take it as an opportunity to reiterate that the president supports legalizing medicinal marijuana,” Psaki said. “It sounds like this would have been applicable in this case, and of course decriminalizing marijuana use and automatically expunging any prior criminal records. In terms of individual cases, I can’t get ahead of those obviously.”

These question come, of course, on 4/20. But they also come at a time when there’s a concerted push in both chambers of Congress to seize the opportunity they have with Democratic control to pass legalization legislation.

Schumer, Senate Finance Committee Chairman Ron Wyden (D-OR) and Sen. Cory Booker (D-NJ) have been working on a bill on their side. The majority leader told Marijuana Moment on Monday that he’s working to push the president in a pro-legalization direction as they draft the measure.

Schumer said last week that the legislation will be introduced and placed on the floor “soon.”

On the House side, Judiciary Chairman Jerrold Nadler (D-NY) said recently that he plans to reintroduced his legalization bill, the Marijuana Opportunity, Reinvestment and Expungement (MORE) Act, which cleared the chamber last year but did not advance in the Senate under GOP control.

Schumer Worries Senate Marijuana Banking Vote Could Undermine Broader Legalization Push

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.
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