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Senators Cory Booker (D-NJ), Rand Paul (R-KY) Reps Madeleine Dean (D-PA) and Nancy Mace (R-SC) filed a revised bill requesting an update on the federal scheduling of “breakthrough therapies” -an FDA designation for certain treatments involving psilocybin and MDMA- towards advancing R&D and improving access for those in need, reported Marijuana Moment.
While the bill’s original version included sections calling for a simpler registration process for researching Schedule I drugs, the new “Breakthrough Therapies Act” would amend the Controlled Substances Act (CSA) to move Schedule I drugs, either breakthrough therapies or those qualifying for a waiver under the Food, Drug & Cosmetic Act (FDCA), to Schedule II, thus facilitating their study as well as promoting drug development.
Though drugs moved to Schedule II under the new measure could be placed back in Schedule I if they no longer have accepted medical uses and if the head of the HHS recommends it to the attorney general.
Sen. Booker said recent studies have shown certain Schedule I substances such as MDMA and psilocybin “could offer major advancements in the treatment of depression, severe PTSD and addiction.” As such, the bill seeks to eliminate “unreasonably burdensome rules and regulations” delaying or preventing researchers from studying the substances as well as to provide access to ‘these promising therapies,’” or, as Sen. Paul and Rep. Mace called them, “compassionate medical use” for eligible patients urgently needing care, including veterans.
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Rep. Dean added that the state of both mental health and substance use disorders in the U.S, clearly calls for Congress to ensure access to treatment options. He said he hopes bipartisan legislation reduces barriers to better research and compassionate use, removes the stigma and “makes recovery possible for more people.”
Photo: Benzinga edit with photo by Cburnett on Wikimedia Commons and Octavio Hoyos on Shutterstock.
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Image and article originally from www.benzinga.com. Read the original article here.