Sen. Cory Booker (D-NJ) and Rand Paul (R-KY) filed a bill on Thursday that would require the Drug Enforcement Administration (DEA) to transfer breakthrough therapies like psilocybin and MDMA from Schedule I to II, while also removing research barriers for strictly controlled substances.<\/p>\n
The \u201cBreakthrough Therapies Act\u201d was filed on the same day that bipartisan House lawmakers announced the formation of a congressional psychedelics caucus<\/a> that\u2019s meant to promote the development of novel treatments derived from currently controlled entheogenic substances.<\/p>\n The new Senate legislation proposes to make a series of amendments to the federal Controlled Substances Act (CSA), including by creating a procedure through which current Schedule I drugs that are deemed breakthrough therapies by the Food and Drug Administration (FDA) or qualify for a waiver under the federal Food, Drug, and Cosmetic Act (FDCA) could be transferred to a lower schedule that would make them easier to study and promote drug development.<\/p>\n As soon as any drug receives a breakthrough therapy designation or qualifies for the FDCA waiver, that would trigger the administrative process for DEA to place it in Schedule II, which is reserved for drugs with \u201ccurrently accepted medical use with severe restrictions.\u201d<\/p>\n The other key components of the bill are largely borrowed from provisions of previous standalone legislation<\/a> that are meant to simplify and expedite research into Schedule I drugs, which would cover certain psychedelics, as well as marijuana and other controlled substances.<\/p>\n Scientists and lawmakers have consistently pointed out that the existing statutes on studying Schedule I controlled substances are excessively burdensome, limiting vital research.<\/p>\n To help resolve that, the Booker-Paul bill would make it so researchers with existing Schedule I or II registrations with DEA would be able to carry out studies into Schedule I drugs within 30 days of sending a notice to the attorney general. Scientists without such a registration on file would be able to petition DOJ for a registration and receive one within 45 days if they provide required information about their research project.<\/p>\n Additionally, rather than having each scientist involved in a Schedule I drug study obtain DEA registration, it would make it so multiple researchers at a given institution would be allowed to participate under a single registration. And a research institute with Schedule I studies taking place over multiple locations would only require one overall registration instead of needing to have a specific one for each site.<\/p>\n \u201cRecent studies suggest that some Schedule I substances such as MDMA and psilocybin could represent an enormous advancement for the treatment of severe post-traumatic stress disorder, depression and addiction,\u201d Booker said in a press release<\/a>. \u201cUnfortunately, regulatory red tape and a series of bureaucratic hurdles involved in studying Schedule I substances impedes critical research on these and other promising Schedule I compounds.\u201d<\/p>\n \u201cThis bill reduces these unreasonably burdensome rules and regulations that delay or prevent researchers from studying\u2014and patients from accessing\u2014this entire class of potential medicines,\u201d the senator, who posted a video late last month similarly touting the therapeutic benefits of psychedelics<\/a>, said.<\/p>\n Paul said that he\u2019s \u201cproud to co-lead this legislation with Sen. Booker that would streamline the registration process for breakthrough therapies currently restricted by outdated drug classifications.\u201d<\/p>\n \u201cThis bill will make it easier for researchers to conduct studies that can lead to breakthrough therapies to treat patients battling serious and life-threatening conditions,\u201d the senator said.<\/p>\n Booker and Paul previously introduced separate legislation in July<\/a> to clarify that federal \u201cRight to Try\u201d (RTT) laws give seriously ill patients access to Schedule I drugs, including marijuana and certain psychedelics.<\/p>\n Booker said last month that that the intent of that bill was to \u201copen up more avenues to take drugs that are now banned and make them accessible, especially for people that are suffering.\u201d<\/p>\n The earlier bill would make a technical amendment to the text of the existing statute, but the primary purpose is to clarify that RTT 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 This latest bipartisan legislation goes further that providing clarification, however.<\/p>\n \u201cWe urge Congress to swiftly pass the Breakthrough Therapies Act, which responsibly reduces the barriers to research and limited access of potentially life-saving treatments like MDMA- and psilocybin-assisted therapy,\u201d Martin Steele, a retired Marine and CEO of Reason for Hope, said of this latest legislation. \u201cVeterans should not be forced (nor should anyone else) to leave the country\u2014at great expense\u2014to access breakthrough therapies that can be safely provided and further studied in real-world settings here at home.\u201d<\/p>\n Meanwhile, Reps. Lou Correa (D-CA) and Jack Bergman (R-MI) announced on Thursday that they\u2019d formed what\u2019s being called the Congressional Psychedelics Advancing Clinical Treatments (PACT) Caucus, which will \u201cfocus on exploring psychedelic research to alleviate the U.S. mental health crisis.\u201d<\/p>\n These developments come amid a wave of local reform efforts\u2014and just one week after Colorado voters approved a historic ballot initiative<\/a>\u00a0to legalize the possession of certain entheogenic substances and create psilocybin \u201chealing centers\u201d in the state.<\/p>\n Correa has been one of the earliest advocates for psychedelics research in Congress,\u00a0supporting amendments to facilities studies<\/a>\u00a0into the substances and\u00a0requesting spending bill report language<\/a>\u00a0that was adopted earlier this year that calls for a Government Accountability Office (GAO) analysis on barriers to state, local and tribal programs for the psilocybin.<\/p>\n He said last year that psychedelics can \u201chelp veterans deal with those invisible wounds that they bring back from the battlefield\u2014PTSD and other mental issues that they bring back with them and carry with them on a day to day basis.\u201d<\/p>\n The psychedelic law reform movement started in earnest at the local level, beginning with Denver historic 2019 vote to decriminalize psilocybin mushrooms. Activists and lawmakers in cities across the U.S.\u2014from Seattle to Detroit\u2014have since followed suit.<\/p>\n State legislatures and governors have also approved measures meant to promote research into entheogenic plants and fungi in recent years, including those as ideologically distinct as Connecticut and Texas. And the conversation has increasingly picked up in the halls of Congress, too.<\/p>\n National Institute on Drug Abuse (NIDA) Director Nora Volkow has\u00a0long criticized the unique research barriers<\/a>\u00a0that are imposed on scientists interested in studying Schedule I drugs such as cannabis and psychedelics,\u00a0saying that she personally avoids taking on such projects<\/a>\u00a0given those difficulties.<\/p>\n She also said at the beginning of the year that\u00a0the \u201ctrain has left the station\u201d on psychedelics<\/a>, as people are going to keep using substances such as psilocybin\u2014especially as the reform movement expands and there\u2019s increased attention being drawn to the potential therapeutic benefits.<\/p>\n Advocates have been encouraged by the gradually growing interest in psychedelics policy and science issues within Congress.<\/p>\n Rep. Earl Blumenauer (D-OR) told Marijuana Moment late last month that\u00a0he \u201cabsolutely\u201d sees parallels between the movements<\/a>\u00a0to reform laws around psychedelics and marijuana. He also accurately predicted the Colorado voters would approve the psychedelics legalization initiative at the ballot last week.<\/p>\n The congressman is well known for his marijuana reform advocacy on Capitol Hill, serving as a co-chair of the Congressional Cannabis Caucus. But he\u2019s also become one of the most vocal members on psychedelics policy in recent years as his home state of Oregon has led the way in legalizing psilocybin services access and more broadly decriminalizing drug possession.<\/p>\n Blumenauer also recently\u00a0spoke about the therapeutic potential of psychedelics<\/a>\u00a0during a congressional committee markup, saying the substances hold \u201creal potential\u201d as alternative mental health therapies with \u201cless impact\u201d than traditional pharmaceuticals.<\/p>\n He suggested that psychedelics policy should be part of the larger conversation about health care improvements, noting his interest in giving terminally ill patients access to investigative drugs like psilocybin, for example.<\/p>\n At the beginning of this year, Blumenauer led a bipartisan letter requesting that\u00a0DEA allow terminally ill patients to use psilocybin<\/a> as an investigational treatment without the fear of federal prosecution under federal RTT law.<\/p>\n In July, the House voted in favor of\u00a0two psychedelics-related amendments to a defense bill<\/a>, including one that would require a study to investigate psilocybin and MDMA as alternatives to opioids for military service members and another that would authorize the defense secretary to provide grants for studies into several psychedelics for active duty service members with PTSD.<\/p>\n But while advocates are encouraged by these incremental developments amid the national psychedelics decriminalization movement, some lawmakers feel that Congress isn\u2019t keeping pace with the public and the science.<\/p>\n Rep. Jared Huffman (D-CA) told Marijuana Moment recently that he\u2019s done his research and believes that natural plants and fungi like psilocybin\u00a0can be a therapeutic \u201cgame changer,\u201d<\/a>\u00a0but he said that it\u2019s \u201cembarrassing\u201d how slow other federal lawmakers have been to evolve on the issue.<\/p>\n The U.S. Department of Health and Human Services (HHS) recently said that it is actively \u201cexploring\u201d the possibility of creating a task force to\u00a0investigate the therapeutic of certain psychedelics<\/a>\u00a0like psilocybin and MDMA in anticipation of federal approval of the substances for prescription use.<\/p>\n That came in response to letters from bipartisan congressional lawmakers, state legislators and military veterans, who implored the HHS secretary to to consider establishing an \u201cinteragency taskforce on the proper use and deployment of psychedelic medicine and therapy.\u201d<\/p>\n For its part, DEA said last month that it want to more than double the amount of marijuana that can be legally manufactured for research in 2023\u2014and it\u2019s also seeking to significantly increase the quota for the production of psychedelics<\/a>\u00a0like psilocyn, LSD and mescaline.<\/p>\n A top Canadian health official who heads up the country\u2019s efforts to combat addiction recently visited Colorado, Oregon and Washington State to learn about\u00a0their experiences implementing drug policy reform<\/a>\u00a0like broad decriminalization and harm reduction\u2014meeting with the governor of Oregon and psychedelics activists, among others, on a week-long tour.<\/p>\n Read the text<\/a> of the new Senate psychedelics and Schedule I research bill below:\u00a0<\/strong><\/p>\n\n Congressional Researchers Lay Out Six Key Limitations Of Biden\u2019s Marijuana Pardons<\/a><\/p>\n<\/blockquote>\n\n The post Cory Booker And Rand Paul File Bill To Reschedule Psychedelic Breakthrough Therapies And Remove Research Barriers<\/a> appeared first on Marijuana Moment<\/a>.<\/p>\n
Sen. Cory Booker (D-NJ) and Rand Paul (R-KY) filed a bill on Thursday that would require the Drug Enforcement Administration (DEA) to transfer breakthrough therapies like psilocybin and MDMA from Schedule I to II, while also removing research barriers for strictly controlled substances. The \u201cBreakthrough Therapies Act\u201d was filed onContinue Reading<\/a><\/span><\/p>\n","protected":false},"author":458,"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\/58167"}],"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=58167"}],"version-history":[{"count":1,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/58167\/revisions"}],"predecessor-version":[{"id":58168,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/58167\/revisions\/58168"}],"wp:attachment":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media?parent=58167"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/categories?post=58167"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/tags?post=58167"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\n
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\nRead More: Cory Booker And Rand Paul File Bill To Reschedule Psychedelic Breakthrough Therapies And Remove Research Barriers<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"