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* Politics * Science & Health * Culture * Business * Video * Newsletter * Subscribe * Remove Ads * Bill Tracking * About * Login Instructions * All 2024 Cannabis Bills * Bill Hearing Calendar * About Marijuana Moment * Support Marijuana Moment * Subscribe To Newsletter Connect with us * * * MARIJUANA MOMENT IN CASE ON PSILOCYBIN ACCESS FOR CANCER PATIENTS, DEA SAYS FEDERAL RIGHT TO TRY LAW ‘DOES NOT PROVIDE ANY EXEMPTIONS’ FROM CONTROLLED SUBSTANCE ACT * Politics * In Case On Psilocybin Access For Cancer Patients, DEA Says Federal Right To Try Law ‘Does Not Provide Any Exemptions’ From Controlled Substance Act * Second California Senate Committee Approves Bill To Legalize Psychedelic Service Centers * 4/20 Events At South Dakota’s Medical Marijuana Dispensaries Double As Petition Drives For Full Legalization * Missouri Attorney General Opens Investigation Into Intoxicating Hemp Products * Bipartisan Congressional Lawmakers Tell VA To Prepare Plan For MDMA-Assisted Therapy As FDA Considers Approving The Psychedelic * Science & Health * State Marijuana Legalization Linked To Fewer Immigrant Deportations, Study Finds * CBD Is A ‘Powerful And Promising’ Treatment For Crack Use Disorder—With Fewer Side Effects Than Conventional Therapies, Study Finds * Marijuana Legalization Reduces Likelihood Of Teen Use, Study Published By American Medical Association Finds * Medical Marijuana Patient Enrollment Grew 610% Since 2016, Showing ‘Increasing Cultural Acceptance Of Cannabis,’ Federal Study Finds * Use Of Psilocybin For Mental Health Treatment ‘Not Associated’ With Risk Of Paranoia, American Medical Association Study Finds * Culture * Brands And Advocacy Groups—From ACLU To KFC—Launch 4/20 Promotions To Mark The Marijuana Holiday * Former Minnesota Gov. Jesse Ventura Promotes New Cannabis Brand Ahead Of 4/20 That He’d ‘Offer To You’ On Governor’s Mansion Visit * Colorado Amendment Addresses Concerns On Banning Social Media Marijuana Posts, But Questions On Psychedelics And Other Drugs Remain * Former Minnesota Governor Jesse Ventura Launches His Own Cannabis Brand, Fulfilling A ‘Lifelong Dream’ * Marijuana Rolling Paper Company Seeks Content Creator To ‘Get Paid To Smoke Weed’ For $70,420 Salary * Business * Legal Marijuana Purchases In Michigan Spiked In March, Reaching A New Record High * The Legal Marijuana Industry Now Supports More Than 440,000 Full-Time Jobs, Up 5% From Last Year, Report Finds * Missouri Warns Marijuana License Applicants Of ‘Predatory Practices’ Around Social Equity Status * Missouri Marijuana Worker Union Dispute Could Have Major Implications For National Labor Law * New Mexico Retailers Set A New Marijuana Sales Record In March * Video * Hawaii Senate Rejects Marijuana Decrim Expansion Bill, While Expungements Legislation Heads To Governor * Vermont Senate Panels Advance Safe Drug Consumption Site Bill After Narrowing Scope To A Single Burlington Facility * Joe Biden And Kamala Harris Tweet About Marijuana At Exactly 4:20 On 4/20 * Ahead Of 4/20 White House Says Biden Has Been ‘Very Clear’ In Supporting Marijuana Decriminalization, But Admin Is Awaiting DOJ Rescheduling Action * New Hampshire Lawmakers Weigh Medical Marijuana Expansion Bills Amid Recreational Legalization Debate * Newsletter * Progressives plan cannabis votes under Democratic majority (Newsletter: April 23, 2024) * Biden celebrates 4/20 with cannabis reform push (Newsletter: April 22, 2024) * Senate cannabis expungements bill (Newsletter: April 19, 2024) * Schumer & lawmakers talk cannabis as 4/20 approaches (Newsletter: April 18, 2024) * Congressional cannabis & psychedelics votes (Newsletter: April 17, 2024) * Subscribe * Remove Ads * Bill Tracking * About * Login Instructions * All 2024 Cannabis Bills * Bill Hearing Calendar * About Marijuana Moment * Support Marijuana Moment * Subscribe To Newsletter POLITICS IN CASE ON PSILOCYBIN ACCESS FOR CANCER PATIENTS, DEA SAYS FEDERAL RIGHT TO TRY LAW ‘DOES NOT PROVIDE ANY EXEMPTIONS’ FROM CONTROLLED SUBSTANCE ACT Published 6 seconds ago on April 23, 2024 By Ben Adlin The Drug Enforcement Administration (DEA) is arguing that a federal law giving seriously ill people the “right to try” investigational drugs doesn’t apply to controlled substances like psychedelics. The agency’s claim comes in a new brief in a lawsuit filed by a Washington State doctor seeking to legally use psilocybin to treat cancer patients in end-of-life care. “Because substances in Schedule I are deemed to have no accepted medical use in under the CSA,” DEA contends, referring to the federal Controlled Substances Act (CSA), “the law does not provide for any registration that would permit such drugs to be dispensed in the course of professional practice.” DEA filed the brief late last week in U.S. Circuit Court of Appeals for the Ninth Circuit, in response to the latest legal challenge from Dr. Sunil Aggarwal and the Advanced Integrative Medical Science (AIMS) Institute. Aggarwal and AIMS have spent years pursuing various legal and regulatory pathways to allow the clinic to use psilocybin in palliative care. Marijuana Consumers Have "Significantly Decreased Odds" Of Cognitive Decline Marijuana Consumers Have "Significantly Decreased Odds" Of Cognitive Decline A recent study suggests that marijuana users have lower chances of experiencing subjective cognitive decline (SCD) compared to non-users. The study indicated that people who consume cannabis for recreational or medical purposes reported less confusion and memory loss compared to non-users. This finding holds significance as previous research has linked subjective decline to increased risk of dementia later in life. However, the study reveals that the impact of THC on cognitive function may be more complex than commonly assumed. Individuals using marijuana for medical purposes or both medical and recreational purposes also showed “decreased odds of SCD, although not significant”. Past studies have highlighted negative associations between heavy cannabis use and mental performance. The authors highlight that cognitive effects are influenced by factors like purpose of use, extending beyond consumption frequency. The study proposes several theories explaining the association between cannabis use and reduced cognitive decline. These include the potential benefits of marijuana in improving sleep quality and alleviating stress. “Several studies have found that cannabis use might enhance sleep quality, expedite sleep onset, and reduce sleep disturbances. Non-medical cannabis use could have contributed to the observed decrease in SCD due to its potential benefit on sleep quality,” the new paper says. More Videos 0 seconds of 1 minute, 37 secondsVolume 0% Press shift question mark to access a list of keyboard shortcuts Keyboard ShortcutsEnabledDisabled Play/PauseSPACE Increase Volume↑ Decrease Volume↓ Seek Forward→ Seek Backward← Captions On/Offc Fullscreen/Exit Fullscreenf Mute/Unmutem Decrease Caption Size- Increase Caption Size+ or = Seek %0-9 Next Up Cannabis May Be “Viable Alternative” Treatment For Dogs With Common Skin Disease 01:23 facebook twitter Email pinterest Linkhttps://cdn.jwplayer.com/previews/xlU8CGIt Copied Live 00:00 01:48 01:37 The clinic generally argues that the CSA must accommodate a path to legally accessing psilocybin under state and federal right to try (RTT) laws, which are intended to 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, and then-President Donald Trump (R) signed the federal Right to Try Act the following year. Dozens of other states have also enacted right to try policies. In the years since, AIMS has presented DEA with multiple proposals in order either to legally cultivate or otherwise obtain psilocybin to treat patients under RTT. The agency has denied them all. “DEA has rejected each request,” the clinic argued in its opening brief earlier this year, “but has never addressed the arguments that Dr. Aggarwal has raised in support of them.” “If DEA wants to disclaim authority to grant Dr. Aggarwal access to psilocybin under the CSA and RTT,” AIMS contined, “it must provide a reasoned explanation for how that decision comports with the CSA and the agency’s own precedent.” Eight U.S. states as well as Washington, D.C. have filed a friend of the court brief in support of AIMS’s effort to use psilocybin under state and federal RTT laws. But in its response this week, DEA asserts that the federal RTT Act doesn’t affect CSA’s prohibition of certain drugs. “The Right to Try Act does not provide anyone with a right to dispense or receive controlled substances,” the new brief says. Rather, the primary function of the federal law was “to relieve qualifying individuals from regulatory requirements that would otherwise be imposed on eligible investigational drugs under the” federal Food, Drug and Cosmetics Act (FDCA), DEA argues. “As DEA explained, the Right to Try Act does not ‘provide any exemptions from the CSA or its implementing regulations. And it does not ‘give the DEA authority to waive CSA requirements,'” the government’s brief says. “Indeed, the Right to Try Act does not even mention the CSA or controlled substances at all.” If Aggarwal wants to give psilocybin to patients, DEA contends he would need to be a registered researcher conducting an approved project—which DEA says are matters handled by different federal agencies. “The only registration that would permit a physician to dispense a schedule I controlled substance is registration as a researcher conducting an approved research project,” its brief says. “DEA cannot issue such a registration unless the Secretary of Health and Human Services, acting through FDA, determines that the research protocol is meritorious and the applicant is qualified and competent to conduct it.” DEA’s brief criticizes the AIMS lawsuit’s interpretation of the law as “a fundamental misunderstanding” and “a tortuous account of the interaction between the two statutes”—RTT and FDCA. Such a reading, it says, “would vest authority in DEA to allow physicians to provide patients with schedule I substances for therapeutic purposes, notwithstanding Congress’s determination that the drugs lack accepted medical use or safety under medical supervision.” “Petitioners’ posited tensions between the CSA and the FDCA are without basis,” the agency’s brief says. “While the subject matter of the two statutes overlaps somewhat (because they both deal with drugs), each statute establishes its own requirements and prohibitions, and DEA and FDA have complementary spheres of authority… But that does not mean that one agency has superseded or interfered with the other’s statutory regime.” A 2022 amendment to the federal RTT Act created a separate registration process to facilitate cannabis research, DEA noted in its brief, but “this new process still requires that new research projects be ‘reviewed and allowed…by the Secretary of Health and Human Services.'” “Thus,” the filing says, “even when Congress has acted specifically to enhance research of a Schedule I drug, it has made researcher registration conditional on approval by the Secretary.” Shortly after the lawsuit was filed, Washington State and eight other jurisdictions—Delaware, Illinois, Michigan, Minnesota, Nevada, Oregon, Pennsylvania and Washington, D.C.—filed an amicus brief in support of the clinic’s position, arguing that CSA doesn’t prohibit the use of controlled substances under RTT. Many of the same states filed an amicus brief in a related 2021 case involving Aggarwal. “The CSA was intended to combat drug trafficking and abuse,” says the latest filing, led by the office of Washington State Attorney General Bob Ferguson (D). “It is easy to make sense of both the CSA and the later, more specific RTT Act,” it suggests: “neither law facilitates traffic in illicit substances, both laws emphasize the primacy of states in the regulation of medical practice, and the RTT Act includes broad immunity from liability.” “It is irrelevant whether a Schedule I substance has a ‘currently accepted medical use’ under the CSA in the context of uses authorized by the RTT Act,” the states’ brief says. “The RTT Act’s purpose is to provide a unique, targeted exemption from such requirements.” Aggarwal and AIMS have been working since at least 2020 to find a way to legally obtain psilocybin for patients in palliative care, initially seeking to win permission from regulators under state and federal RTT laws. When DEA rebuffed that request, Aggarwal sued. But in early 2022, a federal appellate panel dismissed the lawsuit, opining that the court lacked jurisdiction because DEA’s rejection of Aggarwal’s administrative request didn’t constitute a reviewable agency action. The current Ninth Circuit cases stems from Aggarwal’s responses to that ruling. In February 2022, the doctor filed a formal petition with DEA to reschedule psilocybin from Schedule I to Schedule II under the federal Controlled Substances Act (CSA)—the denial of which is a reviewable action. He also applied for the regulatory waiver to obtain psilocybin. DEA denied Aggarwal’s petition in September 2022 and rejected the waiver request the next month. The doctor’s Ninth Circuit cases challenge both decisions. As Aggarwal’s efforts have made its way through the courts, a number of studies have strengthened the case for psilocybin’s legitimate medical use. In response, Congress late last year sent a defense bill to President Joe Biden (D) that contains provisions to fund studies into the therapeutic use of psychedelics such as psilocybin and MDMA for military service members. A recent clinical trial published by the American Medical Association, meanwhile, found that psilocybin “displayed strong and persistent antidepressant effects” in people with bipolar II disorder, “with no signal of worsening mood instability or increased suicidality.” In September of last year, researchers at Johns Hopkins and Ohio State universities published a report that linked psilocybin use with “persisting reductions” in depression, anxiety and alcohol misuse, as well as increases in emotional regulation, spiritual wellbeing and extraversion. Those results were “highly consistent with a growing body of clinical trial, behavioral pharmacology, and epidemiological data on psilocybin,” authors of the study said. “Overall, these data provide an important window into the current resurgence of public interest in classic psychedelics and the outcomes of contemporaneous increases in naturalistic psilocybin use.” Last August, a separate study from the American Medical Association (AMA) found that people with major depression experienced “clinically significant sustained reduction” in their symptoms after just one dose of psilocybin. And a survey by Canadian researchers published in October said psilocybin use can help ease psychological distress in people who had adverse experiences as children. Researchers said psilocybin appeared to offer “particularly strong benefits to those with more severe childhood adversity.” Canada, for its part, allowed four cancer patients in 2020 to become the nation’s first people in decades to legally possess psilocybin after being granted permission by the country’s health minister to use the substance for end-of-life care. Later that year, some healthcare professionals also gained the ability to legally possess and use psilocybin themselves. A survey published earlier this year found that roughly 8 in 10 Canadians believe psilocybin is “a reasonable choice” for end-of-life care. Read the DEA response brief in AIMS v. DEA below: > Second California Senate Committee Approves Bill To Legalize Psychedelic > Service Centers Photo courtesy of Wikimedia/Workman. 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. Related Topics:featured Don't Miss Second California Senate Committee Approves Bill To Legalize Psychedelic Service Centers Ben Adlin Ben Adlin, a senior editor at Marijuana Moment, has been covering cannabis and other drug policy issues professionally since 2011. He was previously a senior news editor at Leafly, an associate editor at the Los Angeles Daily Journal and a Coro Fellow in Public Affairs. He lives in Washington State. YOU MAY LIKE Second California Senate Committee Approves Bill To Legalize Psychedelic Service Centers State Marijuana Legalization Linked To Fewer Immigrant Deportations, Study Finds 4/20 Events At South Dakota’s Medical Marijuana Dispensaries Double As Petition Drives For Full Legalization Missouri Attorney General Opens Investigation Into Intoxicating Hemp Products Bipartisan Congressional Lawmakers Tell VA To Prepare Plan For MDMA-Assisted Therapy As FDA Considers Approving The Psychedelic DEA Shouldn’t Be In Charge Of Marijuana Rescheduling Decision, Jesse Ventura Says Advertisement MARIJUANA NEWS IN YOUR INBOX Get our daily newsletter. Email address: Leave this field empty if you're human: SUPPORT MARIJUANA MOMENT * * * * About Marijuana Moment * Subscribe * Sponsorship and Advertising * Privacy Policy All the cannabis news you need, all in one place. 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