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Appeals Court Hears Arguments on Psilocybin Rescheduling Battle

The DEA denied a petition for rescheduling in September 2022.
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The Ninth Circuit Court of Appeals heard arguments on Friday in a federal lawsuit that has the potential to move magic mushrooms from Schedule 1 to Schedule 2 on the list of controlled substances – thus making psilocybin legal for medical use.

Though it’s not clear when the appellate court may issue a ruling, the plaintiffs – Seattle-based psychedelics research and treatment clinic Advanced Integrative Medical Science Institute and its founder, Dr. Sunil Aggarwal – are challenging a finding by the U.S. Drug Enforcement Administration that denied a petition requesting the rescheduling.

Aggarwal wants to be able to prescribe psilocybin to patients battling depression, so he petitioned the DEA to move the drug to Schedule 2. The DEA denied the request in September 2022, asserting that the petition didn’t satisfy a five-factor test the agency uses to determine whether rescheduling is appropriate.

That test was at the heart of the recent legal argument before the Ninth Circuit, Law360 reported. The assessment, according to Law360, considers:

  • Whether there’s any “currently accepted medical use.”
  • The drug’s chemistry and reproducibility.
  • Evidence of efficacy.
  • Adequacy of safety studies.
  • The degree to which this evidence is available to and accepted by experts.

“The rescheduling petition here did not so much as attempt to address the five elements of the test, let alone attempt to satisfy them,” a DEA lawyer argued to the court, adding that because the U.S. Food and Drug Administration has not yet approved any psilocybin-based medicines that the petition was essentially putting the cart before the horse.

Matt Zorn, an attorney for Aggarwal, argued to the appellate court that the DEA’s position reflects its desire to control and regulate medicine in the U.S., and asserted that there’s little more that the plaintiffs could have done aside from submitting a host of evidence – as they already have – supporting the thesis that psilocybin can be of serious value to patients battling depression.

“If this court doesn’t direct DEA to send this petition [to the FDA], DEA will have effectively rewritten this statute so that it can front-run petitions — meritorious petitions like the one that we submitted — make up the law, and deny them without ever getting HHS’ opinion on them,” Zorn asserted.

Zorn said the DEA didn’t even consider the medical evidence that Aggarwal submitted to the agency, and asked the court to order DEA to forward the petition and evidence to the FDA for analysis.

“The correct result in this case is to hold DEA’s denial of the rescheduling petition at issue to be unlawful, to set it aside and to direct DEA to send the petition to FDA to get its recommendations, as the statute prescribes,” Zorn said.

Aggarwal isn’t fighting the suit alone; amicus briefs in support of his rescheduling position have been submitted to the Ninth Circuit by NORML, End of Life Washington, EvergreenHealth, A Sacred Passing, Pancreatic Cancer North America and the Global Wellness Institute, The Paper reported in March.

The post Appeals Court Hears Arguments on Psilocybin Rescheduling Battle appeared first on Green Market Report.

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