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The Drug Enforcement Administration (DEA) has formally requested that federal health officials conduct a medical scientific review on psilocybin in response to a long-pending rescheduling petition.<\/p>\n
After initially denying advocates\u2019 request to authorize a review into the psychedelic, last week DEA forwarded the request to move psilocybin from Schedule I to Schedule II of the Controlled Substances Act (CSA) to the U.S. Department of Health and Human Services (HHS) for consideration.<\/p>\n
The August 11 transmittal follows an intensive legal back-and-forth between DEA and the petitioners, led by Washington State-based doctor Sunil Aggarwal, who has sought approval to administer psilocybin for end-of-life care of his patients.<\/p>\n
The U.S. Court of Appeals for the Ninth Circuit rejected separate arguments from lawyers for Aggarwal and his clinic, the Advanced Integrated Medical Science (AIMS) Institute, in February\u2014ruling\u00a0that the Drug Enforcement Administration (DEA) provided a reasonable explanation<\/a> in denying the doctor\u2019s request for review.<\/p>\n 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\u00a0win permission from regulators under state and federal right-to-try laws<\/a>.<\/p>\n While the federal appellate court\u2019s earlier ruling last October technically went against DEA<\/a>, the court did not send the rescheduling petition to the Food and Drug Administration (FDA) for review, as lawyers for the doctor had requested.<\/p>\n But now DEA has taken a key step in the rescheduling process, submitting the request to HHS, which is headed up by Secretary Robert F. Kennedy Jr., who has advocated for broader access of psychedelic medicine for people with serious mental health conditions.<\/p>\n Given FDA\u2019s prior designation of psilocybin as a \u201cbreakthrough therapy,\u201d in addition to the \u201cabundant clinical trial results supporting rescheduling,\u201d AIMS contends that \u201cHHS and FDA are in position to quickly provide DEA an evaluation and scheduling recommendation before sending the matter back to DEA to begin the formal rulemaking process required to reschedule.\u201d<\/p>\n \u201cPatients approaching death through terminal illness and Veterans at risk of suicide due to PTSD will be among those benefitted by rescheduling,\u201d a media advisory from AIM\u2019s legal team says. \u201cAs soon as psilocybin moves off schedule I, access via Right to Try will be possible for these populations.\u201d<\/p>\n \u201cLeadership in this Administration\u2019s federal agencies, including HHS Secretary Robert F. Kennedy Jr., FDA Commissioner Marty Makary, and VA Commissioner Doug Collins, have spoken publicly about their desire and intention to open a path to access to psychedelic therapies, including US Health and Human Services secretary.\u201d<\/p>\n Aggarwal said in a social media post that \u201cit took us 3.5 years from time of filing to clear this step.\u201d<\/p>\n \u201cHere\u2019s hoping to swift review and smooth sailing from here on out,\u201d he said<\/a>.<\/p>\n\n When DEA rebuffed Aggarwal\u2019s 2020 rescheduling petition, the doctor filed suit. And in early 2022, a federal appellate panel dismissed the lawsuit, opining that the court lacked jurisdiction<\/a>\u00a0because DEA\u2019s rejection of Aggarwal\u2019s administrative request didn\u2019t constitute a reviewable agency action.<\/p>\n The panel heard oral arguments in the case in August of last year. Lawyers for Aggarwal and AIMS argued that RTT laws should open a path to legal use of psilocybin and other controlled substances. But attorneys for DEA contended in an April filing<\/a>\u00a0that the federal RTT law,\u00a0signed into law in 2018 by President Donald Trump<\/a>, \u201cdoes not provide any exemptions\u201d from CSA restrictions.<\/p>\n \u2014 Meanwhile, a federal judge recently ruled against Utah state and county officials in a lawsuit<\/a> challenging their prosecution of a Provo City-based religious group that uses the psychedelic fungi as sacrament.<\/p>\n This comes about three months after U.S. District Judge Jill N. Parrish granted Singularism\u2019s motion for a temporary injunction and\u00a0ordered police to return psilocybin that was seized<\/a>\u00a0last year as part of a raid at its spiritual center.<\/p>\n As HHS considers the rescheduling petition for psilocybin, the Trump administration is separately looking at a proposal to move cannabis to Schedule III of the CSA. While there are mixed opinions within MAGA circles on the reform<\/a>, the president said last week that a decision is imminent.<\/p>\n The post DEA Advances Psilocybin Rescheduling Petition To Federal Health Officials Following Years-Long Legal Challenge<\/a> appeared first on Marijuana Moment<\/a>.<\/p>\n
The Drug Enforcement Administration (DEA) has formally requested that federal health officials conduct a medical scientific review on psilocybin in response to a long-pending rescheduling petition. After initially denying advocates\u2019 request to authorize a review into the psychedelic, last week DEA forwarded the request to move psilocybin from Schedule IContinue Reading<\/a><\/span><\/p>\n","protected":false},"author":458,"featured_media":82866,"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\/82865"}],"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\/458"}],"replies":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/comments?post=82865"}],"version-history":[{"count":1,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/82865\/revisions"}],"predecessor-version":[{"id":82867,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/82865\/revisions\/82867"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media\/82866"}],"wp:attachment":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media?parent=82865"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/categories?post=82865"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/tags?post=82865"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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\nRead More: DEA Advances Psilocybin Rescheduling Petition To Federal Health Officials Following Years-Long Legal Challenge<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"