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The Drug Enforcement Administration (DEA) has again rejected a petition to reschedule psilocybin and a doctor\u2019s request for a federal waiver to obtain and administer the psychedelic to terminally ill patients, prompting a new set of legal challenges in federal court.<\/p>\n
Sunil Aggarwal, a Washington State-based palliative care specialist, has been fighting DEA for psilocybin access for over a year. But the agency has denied his petition to place the substance in a lower drug schedule, as well as the doctor\u2019s waiver request under federal \u201cRight to Try\u201d (RTT) law.<\/p>\n
The most recent rescheduling denial was handed down in a letter last month, with DEA saying that the Food and Drug Administration (FDA) has not authorized psilocybin as a medicine and so it must remain in Schedule I of the Controlled Substances Act (CSA).<\/p>\n
The letter doesn\u2019t directly address the key point of the rescheduling petition, which is that FDA has designated the psychedelic as a \u201cbreakthrough therapy\u201d for severe depression.<\/p>\n
Attorneys filed a challenge to the rescheduling petition denial in the U.S. Court of Appeals for the Ninth Circuit last week. Opening briefs are due from the petitioners in January 9 and the respondents by February 7.<\/p>\n
In a separate but related complaint, attorneys for Aggarwal petitioned the same court last month to review DEA\u2019s denial of a request for a federal waiver to allow the doctor to access psilocybin to treat anxiety and depression in his severely ill patients.<\/p>\n
Aggarwal, who serves as co-director of the Advanced Integrative Medical Science (AIMS), says federal RTT statute makes clear that seriously ill people qualify for investigational drugs, including psychedelics in Schedule I of the CSA.<\/p>\n
But DEA says that, because the RTT law only explicitly discusses exemptions under the Federal Food, Drug, and Cosmetic Act (FDCA), it doesn\u2019t have implications for the CSA. Plaintiffs contend that that\u2019s not the case, as CSA has a section that says DEA can\u2019t interpret the drug law in a way that conflicts with the FDCA.<\/p>\n
The agency previously rejected a RTT waiver request last year, which resulted in litigation in the same federal court. But\u00a0the court rejected the case on procedural grounds<\/a>\u00a0in February, with judges saying they could not reach the merits of the challenge because DEA hadn\u2019t made clear that its denial constituted a final rule that could be appealed.<\/p>\n Plaintiffs then\u00a0made repeated attempts to get DEA on record<\/a> about whether it had made a final rule. The agency didn\u2019t give a clear answer for months, but it finally confirmed that its decision was \u201cfinal\u201d in a letter that was dated in September and received by Aggarwal this month.<\/p>\n After receiving that confirmation, the petitioners pulled their earlier legal challenge and filed a new request for a review last week.<\/p>\n \u201cAs part of the team working to open access to psilocybin for therapeutic use, we are pleased to have elicited a prompt, clear and appealable denial of the psilocybin rescheduling petition,\u201d Kathryn Tucker, director of advocacy for the National Psychedelics Association who has been involved in the psilocybin litigation, told Marijuana Moment last week.<\/p>\n \u201cWe will take our very strong arguments that psilocybin does not belong on Schedule I into court and look forward to a successful outcome there,\u201d she said. \u201cThrough the RTT litigation and this new suit challenging the refusal to initiate rescheduling proceedings, we are pressing forward to open access, knowing that those with life-threatening conditions could be benefited with this therapy.\u201d<\/p>\n DEA is also facing increased political pressure from bipartisan lawmakers, who recently took an extra step to\u00a0provide additional congressional clarification<\/a>, filing companion bills in the House and Senate in July to reaffirm that the scope of RTT policy should include Schedule I drugs like psilocybin.<\/p>\n The legislation would make a technical amendment to the text of the existing statute, with the primary purpose of clarifying\u2014in the face of DEA objections\u2014that\u00a0RTT policy as signed into law by former President Donald Trump<\/a>\u00a0already means that patients with terminal health conditions can obtain and use investigational drugs that have undergone clinical trials, even if they\u2019re Schedule I controlled substances.<\/p>\n The bills were filed about six months after\u00a0bipartisan members of Congress sent a letter<\/a>, led by Rep. Earl Blumenauer (D-OR), requesting that DEA allow terminally ill patients to use psilocybin as an investigational treatment without the fear of federal prosecution.<\/p>\n In May, Sens. Cory Booker (D-NJ) and Brian Schatz (D-HI)\u00a0separately pushed top federal officials<\/a>\u00a0to provide an update on research into the therapeutic potential of psychedelics, arguing that ongoing federal prohibition has stymied studies.<\/p>\n \u2014 Booker posted a video last week where he talked about how psychedelics like psilocybin are strictly controlled under federal law as Schedule I drugs, which places \u201ca lot of limitations\u201d on them<\/a>.<\/p>\n \u201cBut at the same time, we\u2019re having massive breakthroughs in a lot of the research,\u201d he said, noting psilocybin and MDMA specifically \u201care showing incredible results for helping people with PTSD, with trauma, even with anxiety and depression.\u201d<\/p>\n Meanwhile, as part of their efforts to better understand DEA\u2019s administrative process, Aggarwal and his counsel have submitted several Freedom of Information Act (FOIA) requests for relevant documents. They\u2019ve previously accused the agency of using deliberate delay tactics in processing those requests\u2014the subject of another lawsuit<\/a>.<\/p>\n After asking for records related to both the RTT case\u00a0and a separate rescheduling petition<\/a> under FOIA law, the agency responded by designating the request as \u201ccommercial\u201d and asking for $11,740 up front to cover initial processing. Aggarwal and Tucker strongly contested the idea that there\u2019s a commercial motivation to the case, and they\u2019ve appealed the categorization, so far to no avail.<\/p>\n Activists\u2014including one of the plaintiffs in the RTT case, Erinn Baldeschwiler\u2014staged a demonstration outside of DEA headquarters<\/a>\u00a0in Virginia in May, demanding that the agency allow terminally ill patients to access psilocybin therapy.<\/p>\n In a procedural win for scientists and advocates, DEA recently retreated on\u00a0a proposed ban on psychedelic compounds<\/a>\u00a0that experts say have research value. The development came just one month after the agency\u00a0abandoned separate plans to place five tryptamine psychedelics in Schedule I<\/a>.<\/p>\n DEA faced significant criticism over the latter proposal,\u00a0receiving nearly 600 messages<\/a>\u00a0during a public comment period, with most opposing the rule change and requesting a hearing. The agency\u2019s own administrative court subsequently agreed that\u00a0there was a need to hold a hearing<\/a>\u00a0on the matter before the prohibition could be enacted\u2014but DEA pulled the proposal instead.<\/p>\n Separately, DEA recently said that it wants to more than double the amount of marijuana that can be legally manufactured for research<\/a> in 2023\u2014and it\u2019s also seeking to significantly increase the quota for the production of psychedelics like psilocyn, LSD and mescaline.<\/p>\n Read DEA\u2019s responses<\/a> to the petitions for a psilocybin rescheduling review and a RTT waiver below:\u00a0<\/strong><\/p>\n\n AOC Criticizes Biden\u2019s Exempting Undocumented Immigrants From Marijuana Pardon, Saying Democrats Must \u2018Step Up\u2019 To Win Latino Votes<\/a><\/p>\n<\/blockquote>\n\n Photo courtesy of Dick Culbert<\/a>.<\/em><\/p>\n The post DEA Faces New Legal Challenges Over Denying Psilocybin Rescheduling Petition And Doctor\u2019s Federal Waiver Request<\/a> appeared first on Marijuana Moment<\/a>.<\/p>\n
The Drug Enforcement Administration (DEA) has again rejected a petition to reschedule psilocybin and a doctor\u2019s request for a federal waiver to obtain and administer the psychedelic to terminally ill patients, prompting a new set of legal challenges in federal court. Sunil Aggarwal, a Washington State-based palliative care specialist, hasContinue Reading<\/a><\/span><\/p>\n","protected":false},"author":458,"featured_media":57706,"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\/57705"}],"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=57705"}],"version-history":[{"count":1,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/57705\/revisions"}],"predecessor-version":[{"id":57707,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/57705\/revisions\/57707"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media\/57706"}],"wp:attachment":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media?parent=57705"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/categories?post=57705"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/tags?post=57705"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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\nRead More: DEA Faces New Legal Challenges Over Denying Psilocybin Rescheduling Petition And Doctor\u2019s Federal Waiver Request<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"