Lawyers for Dr. Sunil Aggarwal filed the federal petition almost immediately following a decision Monday by the U.S. Court of Appeals for the Ninth Circuit<\/a> that dismissed on procedural grounds a lawsuit Aggarwal and two of his terminally ill cancer patients filed against DEA last year<\/a>. In that case, plaintiffs argued they should be allowed legal access to psilocybin under state and federal right-to-try laws, which are intended to let patients with terminal conditions try investigational medications that have not been approved for general use.<\/p>\n Congress and 41 states have passed right-to-try laws.<\/p>\n As part of the suit, attorneys general from eight U.S. states and the District of Columbia filed a friend-of-the-court brief<\/a> in support of the patients, noting the therapeutic potential of not only psilocybin but also other currently illegal drugs, including 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 amicus brief said.<\/p>\n Separately, a bipartisan group of members of Congress sent a letter last month urging DEA to let terminally ill patients have access to psilocybin<\/a>. The agency, lawmakers said, is \u201cobstructing access to psilocybin for therapeutic use consistent with the letter and intent Right to Try (RTT) laws.\u201d<\/p>\n \u201cResearch demonstrates that psilocybin provides immediate, substantial and sustained relief from debilitating anxiety and depression in individuals with terminal illnesses,\u201d they wrote. \u201cWe strongly believe that our constituents suffering such illnesses should have access to this investigational drug should they decide to pursue such a course of treatment.\u201d<\/p>\n Psilocybin is currently listed under the federal Controlled Substances Act as a Schedule I drug, a category reserved for substances with a high potential for abuse, no currently accepted medical use in the United States and no accepted safety standards for use of the drug under medical supervision. The petition<\/a> argues that\u2019s a poor fit.<\/p>\n Beyond a growing body of research indicating its therapeutic promise, it says, psilocybin is also an \u201celigible investigational drug\u201d under federal law and \u201cnumerous FDA-approved clinical trials and studies\u201d have shown the substance to be safe for use under medical supervision. More than half a century of research, the petition adds, indicates psilocybin has a low potential for abuse compared even to substances in Schedule II, which includes fentanyl, cocaine, amphetamines and opium.<\/p>\n \u201cAlthough psilocybin should be rescheduled as a matter of law, it is also good policy,\u201d the petition says. \u201cRescheduling psilocybin will not<\/em> make the substance widely available as a prescription medicine or as a drug of abuse.\u201d<\/p>\n Reclassifying psilocybin as a Schedule II drug would open a very limited window for patients to legally access and use psilocybin, at least at first. As the petition acknowledges, the U.S. Food and Drug Administration (FDA) has not approved any drug containing psilocybin, and DEA registration would be required to produce and handle the substance even for research purposes. It describes practical controls around Schedule II substances as \u201cnearly identical to schedule I controls.\u201d<\/p>\n \u201cWhile rescheduling alone would not<\/em> make psilocybin available as prescription medicine in interstate commerce, it would give the federal regulators maximum flexibility to work with<\/em> state governments, as opposed to silently against<\/em> them,\u201d the petition says. \u201cFor example, the federal government could create limited pilot programs to be administered in a state or allow state programs to organically grow with federal oversight or guidance.\u201d<\/p>\n The change would also open a clear path for patients like Aggarwal\u2019s to legally access psilocybin \u201cas contemplated by state and federal Right to Try laws, with DEA supervision but without the need for a waiver or exception from DEA.\u201d<\/p>\n While the petition is aimed at rescheduling psilocybin federally, lawyers for Aggarwal have also said they\u2019ll file an individual request for waiver with DEA on behalf of his patients. That move is designed to force DEA to issue a formal decision on psilocybin, which could later be challenged in court, attorney Kathryn Tucker said in a statement earlier this week. The Ninth Circuit panel that rejected Aggarwal\u2019s suit on Monday ruled that an earlier statement by DEA\u2014telling the doctor there was no legal way for his patients to access psilocybin\u2014wasn\u2019t subject to court review.<\/p>\n \u201cGiven that the interests of terminally ill patients are at stake, where the advance of illness makes time short, there is an urgency for DEA\u2019s action,\u201d Tucker said in the statement. \u201cWe hope congressional interest in this matter will continue, and possibly include Congressional Oversight Hearings.\u201d<\/p>\n As Aggarwal\u2019s petition points out, the legal landscape around psilocybin at the state level is already shifting: \u201cLocal jurisdictions are decriminalizing and legalizing psilocybin use,\u201d it says, noting Oregon\u2019s 2020 initiative that legalized therapeutic psilocybin services as well as ongoing reform efforts in states such as Washington, Connecticut, New York and Texas.<\/p>\n \u201cIt is imperative that scientists be able to examine the risks and dangers of real-world psilocybin being used in these jurisdictions in real-time,\u201d the petition says. \u201cBy rescheduling psilocybin, DEA can relieve some of these burdens and participate in the process as a regulator.\u201d<\/p>\n Both progressive and more conservative states are exploring psilocybin as a possible therapy. On Thursday, a House committee in Utah approved a bill that would study the therapeutic potential of psilocybin<\/a> and other psychedelic drugs and consider possible regulations for their lawful use.<\/p>\n Washington State lawmakers had been considering a bill to legalize what the legislation calls \u201csupported psilocybin experiences\u201d<\/a> for adults 21 and older, but that bill failed to pass out of committee by a deadline this week. Aggarwal told Marijuana Moment in a statement shortly after the bill was introduced, that the bill had \u201ctoo many details to comment on\u201d but was a step in the right direction.<\/p>\n Seattle recently became the largest U.S. city to decriminalize psychedelics<\/a> following a City Council resolution in October.<\/p>\n Washington lawmakers last legislative session considered a bill that would have removed all penalties<\/a> for possession of relatively small, \u201cpersonal use\u201d amounts of drugs and instead invested in treatment and recovery services. While that legislation died in committee, lawmakers from both parties acknowledged at the time that the state\u2019s drug control apparatus was broken.<\/p>\n Shortly thereafter, the state Supreme Court overturned Washington\u2019s felony law against drug possession completely<\/a>, sending lawmakers scrambling to replace the law. Ultimately they approved a modest reform, reducing the state\u2019s felony charge for drug possession to a misdemeanor<\/a> and earmarking more money for treatment. But the law\u2019s criminal penalties will expire in 2023, an effort to encourage lawmakers to revisit the policy.<\/p>\n Since Denver in 2019 became the first U.S. city to decriminalize psilocybin mushrooms, a number of states and municipalities have made similar changes.<\/p>\n Oregon voters passed a pair of initiatives in 2020 to legalize psilocybin therapy<\/a> and decriminalize possession of all drugs<\/a>, and Washington, D.C. voters approved a ballot measure that year to deprioritize enforcement of laws criminalizing psychedelics<\/a>.<\/p>\n Other states have passed more moderate measures, for example Connecticut, which last year passed a law requiring the state to carry out a study into the therapeutic potential of psychedelics<\/a>. Texas also adopted a law last year to study the benefits of psychedelics for military veterans<\/a>.<\/p>\n California made a push to legalize psychedelics possession last year, but that measure was put on pause. The bill\u2019s sponsor, however, says he has plans to move it across the finish line<\/a> this year.<\/p>\n Lawmakers in other large states, including Florida<\/a> and New York<\/a> have recently filed psychedelics reform bills.<\/p>\n In terms of right-to-try laws, meanwhile, a new Republican-led bill in Missouri would expand that state\u2019s existing right-to-try law to allow residents with serious illnesses access psychedelic drugs such as psilocybin<\/a>, ibogaine and LSD.<\/p>\n Utah Lawmakers Vote To Study Benefits Of Psychedelics In Treating Mental Health Disorders<\/a><\/p>\n<\/blockquote>\n Photo courtesy of Wikimedia\/Workman<\/a>.<\/em><\/p>\n\n
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