{"id":48549,"date":"2021-06-29T09:12:26","date_gmt":"2021-06-29T17:12:26","guid":{"rendered":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/2021\/06\/29\/dea-says-cancer-patients-request-for-medical-psilocybin-could-fuel-illegal-drug-market\/"},"modified":"2021-06-29T13:45:37","modified_gmt":"2021-06-29T21:45:37","slug":"dea-says-cancer-patients-request-for-medical-psilocybin-could-fuel-illegal-drug-market","status":"publish","type":"post","link":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/2021\/06\/29\/dea-says-cancer-patients-request-for-medical-psilocybin-could-fuel-illegal-drug-market\/","title":{"rendered":"DEA Says Cancer Patients\u2019 Request For Medical Psilocybin Could Fuel Illegal Drug Market"},"content":{"rendered":"<\/p>\n

The U.S. Drug Enforcement Administration (DEA) is asking a federal appeals court to throw out a lawsuit aimed at clearing a path to the therapeutic use of psilocybin, the main psychoactive compound in psychedelic mushrooms\u2014arguing that allowing limited medical access could boost the illegal drug trade.<\/span><\/p>\n

Two cancer patients and a Seattle-based physician specializing in end-of-life care sued the agency in March,\u00a0seeking legal access to psilocybin under state and federal right-to-try laws<\/a>, which allow patients with terminal conditions to try investigational medications that have not been approved for general use.<\/p>\n

DEA wants judges to dismiss or deny the case. In a brief filed on Friday in the U.S. Court of Appeals for the Ninth Circuit, Acting Assistant Attorney General Brian M. Boynton argues on behalf of the agency that the court lacks jurisdiction to hear the dispute and further contended that right-to-try laws don\u2019t actually let patients access drugs that are prohibited under the federal Controlled Substances Act (CSA).<\/p>\n

\u201cThe Right to Try Act exempts eligible investigational drugs from specifically identified requirements in the [U.S. Food, Drug and Cosmetics Act],\u201d DEA\u2019s brief says. \u201cThat exemption does not rescind the CSA or modify the restrictions that the law places on Schedule I substances.\u201d<\/p>\n

\u201cOn the petitioners\u2019 reading of the Right to Try Act,\u201d it argues, \u201cDEA would be powerless to prevent an unscrupulous doctor from obtaining Schedule I substances from an unregistered manufacturer.\u201d<\/p>\n

Allowing psilocybin to be dispensed under federal right-to-try laws would also fuel illicit drug sales, the agency claimed.<\/p>\n

\u201cThe persistent existence of the narcotics trade despite criminal enforcement efforts \u2018suggests that no small number of unscrupulous people will make use of [the Right to Try] exemptions to serve their commercial needs whenever it is feasible to do so,\u2019\u201d the agency brief says, quoting a prior Supreme Court case on marijuana. \u201cApplication of the CSA to restrict the use of psilocybin by patients with life-threatening conditions thus furthers the CSA\u2019s main objectives \u2018to conquer drug abuse and to control the legitimate and illegitimate traffic in controlled substances.\u2019\u201d<\/p>\n

Petitioners in the case\u2014the two patients, Dr. Sunil Aggarwal and the clinic where he works, the Advanced Integrative Medical Science (AIMS) Institute\u2014will have an opportunity to a reply in a brief due next month. Oral arguments in the case have been scheduled<\/a> for September 2.<\/p>\n

The case stems from a letter Aggarwal and AIMS wrote to DEA this past January asking for guidance on how to move forward on psilocybin under right-to-try laws.<\/p>\n

DEA replied 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 \u201cwould not be applicable to Dr. Aggarwal at this time.\u201d<\/p>\n

Lawyers for DEA argued in the new brief that the agency\u2019s decision is not reviewable and that the lawsuit should be dismissed.<\/p>\n

\u201cIf the petitioners believe that psilocybin should be moved to another schedule so that doctors may prescribe it as a therapeutic treatment, they are free to seek legislative action\u2026or to petition the agency for a rescheduling,\u201d the brief argues. \u201cBut nothing in the Right to Try Act disturbed the restrictions on Schedule I substances or Congress\u2019s judgment placing psilocybin in that category. DEA did not err in saying so.\u201d<\/p>\n

Last month, however, a bipartisan group of attorneys general from eight U.S. states and the District of Columbia sided with the cancer patients<\/a> in an amicus brief, noting the therapeutic potential of not only psilocybin but also also currently illegal drugs such as MDMA.<\/p>\n

\u201cHere, dying patients seek access to promising new treatments still in the investigative process\u2014access expressly permitted under both state and federal law\u2014to help them live in peace,\u201d the top state officials wrote.<\/p>\n

The brief likened the situation to one that arose in a 2006 Supreme Court decision,\u00a0Gonzales v. Oregon<\/em>, in which the court ruled that the Controlled Substances Act (CSA) didn\u2019t permit the U.S. attorney general to \u201cbar dispensing controlled substances for assisted suicide in the face of a state medical regime permitting such conduct.\u201d<\/p>\n

\u201cOnce again, the CSA blocks the way,\u201d the attorneys general wrote. \u201cFraming 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\u2019s requirements to permit therapeutic use for these patients.\u201d<\/p>\n

The states\u2019 filing 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.<\/p>\n

\u201cPsilocybin is likely not the last Schedule I controlled substance that could be eligible under state and federal RTT laws,\u201d it says. \u201cFor 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.\u201d<\/p>\n

Washington State adopted a right-to-try\u00a0law<\/a>\u00a0in 2017 and President Donald Trump signed the\u00a0federal Right to Try Act<\/a>\u00a0the following year. So far 41 state legislatures have adopted similar legislation, sometimes\u2014as in Washington\u2014unanimously.<\/p>\n

Other groups that have filed amici briefs<\/a> in the case include the Goldwater Institute<\/a>, 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>. A coalition of end-of-life caretakers<\/a> also filed a brief in support of petitioners, as did a group of law professors and bioethicists<\/a>.<\/p>\n

Aggarwal\u2019s 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\u00a0applying to state and federal regulators<\/a>\u00a0for approval to cultivate psilocybin mushrooms privately and use them in treatment.<\/p>\n

\u201cWe know that it\u2019s a naturally occurring substance that we can cultivate safely, we know how to dose it and there\u2019s really good reason to believe it can help,\u201d he told Marijuana Moment at the time.<\/p>\n

Aggarwal also sought psilocybin through commercial producers, but those manufacturers wouldn\u2019t supply the drug without DEA approval, said Kathryn Tucker of Emerge Law Group, lead attorney for the petitioners.<\/p>\n

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<\/a>, and in December the country\u2019s health minister said some therapists and health care professionals could also legally use the drug<\/a>.<\/p>\n

In Oregon, voters approved historic initiatives to\u00a0legalize psilocybin for therapeutic purposes<\/a>\u00a0and\u00a0decriminalize drugs more broadly<\/a>\u00a0in November.<\/p>\n

This isn\u2019t the first time DEA has found itself battling lawsuits over the criminalization of controlled substances that hold therapeutic value.<\/p>\n

Scientists and veterans sued the federal agency last year<\/a>, 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<\/a>.<\/p>\n

The agency has also been taken to court over delays in approving additional cannabis manufacturers for research purposes.<\/p>\n

The Scottsdale Research Institute alleged that DEA has been deliberately using delay tactics to avoid approving cultivation applications<\/a>. 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<\/a>.<\/p>\n

In March 2020, DEA finally unveiled a revised rule change proposal<\/a>\u00a0that 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.<\/p>\n

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.<\/p>\n

In addition to Oregon\u2019s 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 passed the Senate floor earlier this month<\/a>.<\/p>\n

That effort is just the latest as activists step up the push to enact psychedelics reform locally in cities and states across the country.<\/p>\n

A California bill to legalize possession of psychedelics\u00a0passed in the Senate earlier this month<\/a>. And it\u2019s since been referred to two Assembly committees.<\/p>\n

Texas and Connecticut enacted bills this year<\/a> study the potential therapeutic benefits<\/a> of psilocybin.<\/p>\n

A New York lawmaker introduced a bill this month that would require the state to establish an institute to similarly\u00a0research the medical value of psychedelics<\/a>.<\/p>\n

The Northampton, Massachusetts City Council\u00a0passed a resolution<\/a>\u00a0in April\u00a0to deprioritize enforcement of laws against the possession, use and distribution of a wide range of psychedelics such as psilocybin and ayahuasca. It\u2019s the third city in the state to advance the policy change, following\u00a0Somerville<\/a>\u00a0and\u00a0Cambridge<\/a>.<\/p>\n

These are some of the latest iterations of a national psychedelics reform movement that\u2019s spread rapidly since\u00a0Denver became the first city to decriminalize psilocybin mushrooms<\/a>\u00a0in 2019.<\/p>\n

Besides the cities in Massachusetts, four others\u2014Oakland<\/a>,\u00a0Santa Cruz<\/a>,\u00a0Ann Arbor<\/a>\u00a0and\u00a0Washington, D.C.<\/a>\u2014have also decriminalized possession of plant-and fungi-based psychedelics.<\/p>\n

Seattle lawmakers also recently sent a letter to members of a local task force focused on the opioid overdose epidemic, imploring the group to\u00a0investigate the therapeutic potential of psychedelics<\/a>\u00a0like ayahuasca and ibogaine in curbing addiction.<\/p>\n

In Oakland, the first city where a city council voted to broadly deprioritize criminalization of entheogenic substances, lawmakers\u00a0approved a follow-up resolution<\/a>\u00a0in 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.<\/p>\n

Read the full reply brief from Justice Department lawyers on behalf of DEA:<\/strong><\/em><\/p>\n

\n

DEA Psilocybin lawsuit<\/a> by Marijuana Moment<\/a><\/p>\n

\n

FDA Head Refuses To Say Whether Marijuana Is More Dangerous Than Tobacco<\/a><\/p>\n<\/blockquote>\n

\n

Photo courtesy of Wikimedia\/Workman<\/a><\/em><\/p>\n

The post DEA Says Cancer Patients\u2019 Request For Medical Psilocybin Could Fuel Illegal Drug Market<\/a> appeared first on Marijuana Moment<\/a>.<\/p>\n


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\nRead More: DEA Says Cancer Patients\u2019 Request For Medical Psilocybin Could Fuel Illegal Drug Market<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

The U.S. Drug Enforcement Administration (DEA) is asking a federal appeals court to throw out a lawsuit aimed at clearing a path to the therapeutic use of psilocybin, the main psychoactive compound in psychedelic mushrooms\u2014arguing that allowing limited medical access could boost the illegal drug trade. Two cancer patients andContinue Reading<\/a><\/span><\/p>\n","protected":false},"author":24,"featured_media":0,"comment_status":"false","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[18,81],"tags":[],"_links":{"self":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/48549"}],"collection":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/users\/24"}],"replies":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/comments?post=48549"}],"version-history":[{"count":1,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/48549\/revisions"}],"predecessor-version":[{"id":48550,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/48549\/revisions\/48550"}],"wp:attachment":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media?parent=48549"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/categories?post=48549"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/tags?post=48549"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}