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Bipartisan congressional lawmakers are applauding the Food and Drug Administration (FDA) for releasing first-ever draft guidance on psychedelics research<\/a>\u2014a development that they had requested through a new bill just days before the agency took the step.<\/p>\n Reps. Dan Crenshaw (R-TX), Mariannette Miller-Meeks (R-IA) and Ro Khanna (D-CA) filed the legislation this month. And while FDA didn\u2019t say that its decision to release the guidance was directly responsive to the measure, it\u2019s precisely the action that the first part of the bill addressed.<\/p>\n \u201cI\u2019m glad the FDA is taking this first step of issuing guidance for psychedelic clinical trials\u2014and listening to my bipartisan legislation with Reps. Miller-Meeks and Khanna,\u201d Crenshaw said in a press release on Thursday. \u201cIt\u2019s critical we get this right for the researchers doing this important scientific work.\u201d<\/p>\n \u201cWe need this guidance to expand clinical trial access so that we can push towards life-saving psychedelic therapies for our veterans, servicemembers, and people living with PTSD, traumatic brain injury, and substance abuse disorder,\u201d the congressman, a military veteran who has taken a leadership role on advancing psychedelics research, said.<\/p>\n FDA\u2019s draft guidance provides scientists with a framework to carry out research that could lead to the development of psychedelic medicines. A 60-day public comment period is open for interested parties to submit feedback on how final guidance should be shaped.<\/p>\n \u201cMany Veterans find guided use of psychedelics with assisted therapy as a way to successfully treat the excruciating, post-traumatic pain they face, with better outcomes and less medication side effects in pilot studies,\u201d Miller-Meeks said<\/a>. \u201cAs a physician, I know the importance of medical research and I am encouraged by the FDA\u2019s support and guidance regarding psychedelic clinical trials. This important step gives our Veterans another option and hope when they feel they\u2019ve run out of methods to cope.\u201d<\/p>\n Interest in psychedelics has grown exponentially over recent years as cities and states across the country have moved to promote research, remove criminal penalties and regulate access to substances such as psilocybin and MDMA\u2014both of which have already been designated by FDA as \u201cbreakthrough therapies.\u201d<\/p>\n The agency\u2019s draft guidance \u201cdescribes basic considerations throughout the drug development process including trial conduct, data collection, subject safety and new drug application requirements,\u201d FDA said.<\/p>\n Khanna, for his part, said that the agency\u2019s guidance \u201cis a critical step to help protect the well-being of veterans and those living with PTSD.\u201d<\/p>\n \u201cI\u2019m proud to cosponsor this bill to expand the body of research on psychedelic therapies in the hopes of improving the health of many Americans,\u201d he said.<\/p>\n \u2014 The lawmakers\u2019 bipartisan bill called\u00a0on the secretary of the U.S. Department of Health and Human Services (HHS), acting through the FDA commissioner, to \u201cissue for public comment draft guidance on considerations for conducting clinical trials for psychedelic assisted therapy, including how those seeking an investigational use exemption for such clinical trials should request interactive support by the Food and Drug Administration.\u201d<\/p>\n If enacted, it would have required FDA to produce that draft guidance within 180 days. But the agency was evidently prepared to release it much sooner. The bill would also mandate FDA to finalize its guidance 180 days after the draft document\u2019s publication, so lawmakers may still be interested in advancing the measure with that provision.<\/p>\n \u201cThere are open questions related to psychedelic-assisted therapy that need answers,\u201d Veterans Exploring Treatment Solutions (VETS) said. \u201cUnfortunately researching these compounds can be difficult due to administrative requirements related to scheduling status. We welcome efforts that reduce barriers to research and help pave the way for access to these lifesaving therapies.\u201d<\/p>\n On the same day that the legislation was introduced last week, Crenshaw discussed it at a House Energy & Commerce Committee hearing, where he talked about psychedelics as one possible \u201csolution\u201d to the country\u2019s substance misuse issues.<\/p>\n The congressman said that he was working on \u201cgetting clinical trial guidance for psychedelic therapies from the FDA,\u201d adding that \u201cthis therapy will be earth-shattering. It already has been already changed dozens of lives.\u201d<\/p>\n \u201cWe\u2019re not talking about 1960s LSD trips. This therapy is supervised by a medical practitioner [and] often occurs with repeat treatments in a controlled setting,\u201d he said. \u201cAnd when it comes to the efficacy of this therapy, the proof is in the data, in the testimonies\u2014but we need the FDA to issue clinical trial guidance for psychedelic assisted therapy so that the the industry can actually invest in this.\u201d<\/p>\n The FDA\u2019s Federal Register\u00a0filing\u00a0notes that a\u00a0public docket<\/a> has been made available for people to submit comments on the draft guidance.<\/p>\n The move is timely, as lawmakers and health officials have shown serious interest in quickly expanding research into psychedelics as studies have revealed their potential in the treatment of conditions such as severe depression, post-traumatic stress disorder and addiction.<\/p>\n Marijuana Moment asked HHS Secretary Xavier Becerra earlier this month about the department\u2019s current thinking around psychedelics policy<\/a>, and he said he needed to \u201cdefer\u201d to the expertise of the National Institute on Drug Abuse (NIDA), which also falls under his agency, \u201cbecause I want to make sure that I touch base with what they\u2019ve been doing on that.\u201d<\/p>\n This month, NIDA called for research into the\u00a0impact of evolving laws around psychedelics<\/a>, including the effects of allowing regulated access to substances like psilocybin.<\/p>\n NIDA separately announced in May that it is soliciting proposals\u00a0for a series of research initiatives<\/a>\u00a0meant to explore how psychedelics could be used to treat drug addiction, with plans to provide $1.5 million in funding to support relevant studies.<\/p>\n At a Senate committee hearing in May, NIDA Director Nora Volkow told members that there\u2019s emerging evidence that psychedelics carry \u201csignificant potential\u201d as therapeutic treatments for certain mental health conditions, and\u00a0it\u2019s a topic of \u201cgreat interest\u201d for researchers<\/a>.<\/p>\n Meanwhile, congressional lawmakers have also pushed for psychedelics reform.<\/p>\n For example, a powerful U.S. Senate panel has called on the U.S. Department of Veterans Affairs (VA) to\u00a0explore the therapeutic potential of psychedelics<\/a>.<\/p>\n On the House side, a congressional committee\u00a0recently approved a large-scale defense bill<\/a>\u00a0that includes GOP-led provisions to create a medical marijuana \u201cpilot program\u201d and require a study into the therapeutic potential of psychedelics for active duty military members under the U.S. Department of Defense (DOD).<\/p>\n About three in five American voters say psychedelics should be legalized for regulated, therapeutic use\u2014and nearly half believe possession should be decriminalized for personal use for any reason\u2014according to a national poll released this month<\/a>.<\/p>\n In a somewhat surprising twist, President Joe Biden\u2019s younger brother disclosed this week that the president is \u201cvery open-minded\u201d about the use of psychedelic medicines<\/a> to treat addiction.<\/p>\n How To Save Marijuana Social Equity Programs From The Supreme Court\u2019s Affirmative Action Ruling (Op-Ed)<\/a><\/p>\n<\/blockquote>\n\n Photo courtesy of Dick Culbert<\/a>.<\/em><\/p>\n The post Bipartisan Lawmakers Applaud FDA For Publishing Psychedelics Research Guidance, As They Requested In New Congressional Bill<\/a> appeared first on Marijuana Moment<\/a>.<\/p>\n
Bipartisan congressional lawmakers are applauding the Food and Drug Administration (FDA) for releasing first-ever draft guidance on psychedelics research\u2014a development that they had requested through a new bill just days before the agency took the step. Reps. Dan Crenshaw (R-TX), Mariannette Miller-Meeks (R-IA) and Ro Khanna (D-CA) filed the legislationContinue Reading<\/a><\/span><\/p>\n","protected":false},"author":458,"featured_media":66517,"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\/66516"}],"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=66516"}],"version-history":[{"count":1,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/66516\/revisions"}],"predecessor-version":[{"id":66518,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/posts\/66516\/revisions\/66518"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media\/66517"}],"wp:attachment":[{"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/media?parent=66516"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/categories?post=66516"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cannabiscultivatornews.com\/home\/index.php\/wp-json\/wp\/v2\/tags?post=66516"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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\nRead More: Bipartisan Lawmakers Applaud FDA For Publishing Psychedelics Research Guidance, As They Requested In New Congressional Bill<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"