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DEA abandons plan to prohibit more psychedelics, Colorado to vote on psychedelics in November, APA says science to support psychedelic treatment is “inadequate”
Plus: patent ping pong, and another wave of psilocybin bans in Oregon.
Happy Friday, and welcome back to The Microdose. Here’s the news of the week:
DEA abandons plan to prohibit more psychedelics. In early January, the U.S. Drug Enforcement Administration introduced a proposal to ban five unscheduled psychedelic tryptamines. Earlier this month, the agency announced that they’d hold a hearing about the proposal in late August after receiving multiple requests for the hearing, as well as nearly 600 comments.
In a surprising about-face, the DEA announced this week that they have withdrawn the proposal. Generally, the DEA hasn’t been particularly responsive to public feedback, Vincent Sliwoski writes in Harris Bricken’s Psychedelics Law Blog; the last time the agency withdrew a proposed rule was in 2016, when it reversed its decision to schedule kratom, a plant with both stimulant and sedative effects.
Psychedelics companies, researchers, and lawyers who challenged the proposed rule celebrated the news. Psychedelic start-up Tactogen published a statement applauding the DEA’s decision. “We hope the DEA will reconsider its practice of encumbering every psychedelic with the maximum possible regulatory restrictions,” they wrote.
APA says science is “inadequate” to support psychedelic treatment. This month, the American Psychiatric Association, the leading professional organization in psychiatry, released a position statement on the use of psychedelic and empathogenic agents for mental health conditions. “There is currently inadequate scientific evidence for endorsing the use of psychedelics to treat any psychiatric disorder except within the context of approved investigational studies,” the statement reads. The APA says they support ongoing research, but that “clinical treatments should be determined by scientific evidence in accordance with applicable regulatory standards and not by ballot initiatives or popular opinion.” The subtext isn’t subtle: the APA’s mention of ballot initiatives points directly towards efforts in places like Oregon and Colorado to make psychedelic-assisted therapy state-legal, and claims such efforts are premature.
The APA is an influential player in the psychiatry and mental health arenas. The organization, which represents some 37,000 members, issues position statements on major topics in the field. Such statements are often cited as scientific fact. Still, the APA’s positions are not without controversy, as when the organization opposed medical euthanasia and the medicinal use of cannabis.
There has never been a more exciting – or bewildering – time in the world of psychedelics. Don’t miss a beat.
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Patent ping pong. Since 2021, the U.S. Patent and Trademark Office (USPTO) and patent watchdog non-profit Freedom to Operate have been locked in a legal table tennis match — and this week, Freedom to Operate put the ball back in the USPTO’s court.
The volley concerns two patents the USPTO granted to mental health company Compass Pathways for what the company claims is a novel crystalline form of psilocybin. The USPTO granted the patents in March 2021. In December 2021, Freedom to Operate (FTO) challenged the patents by submitting petitions for post-grant reviews, presenting evidence that the patented form is not novel, and is not even a singular form. A month ago, the USPTO rejected FTO’s petitions for a post-grant review. And this week, Freedom to Operate announced that it has filed requests for reconsideration with the U.S. Patent Trial and Appeal Board (PTAB). Freedom to Operate alleges that PTAB made errors in its construal of Compass’s claims and that it inappropriately discounted expert testimony referenced in FTO’s petitions for post-grant review.
Based on the USPTO’s policies for handling a request for reconsideration, the office could decide to initiate a post-grant review after all or to uphold their previous decision. Celeste Alvarez, patent agent at Calyx Law, told The Microdose such requests are “very rarely granted” — only about 10% are successful. “To reverse a denial of institution, the petitioner must convince the Board that it abused its discretion — because of an erroneous interpretation of law, a factual finding not supported by substantial evidence, or an unreasonable judgment in weighing factors,” Alvarez says. In this particular case, Alvarez says, “unless the Board finds that additional briefing by Compass is needed, it will likely decide whether to grant or deny FTO’s request in about one month.”
The State of Psychedelics: Colorado to vote on psychedelics. This November, Colorado voters could weigh in on two psychedelics-related initiatives. Initiative 58 garnered the requisite 125,000 signatures last month to qualify for ballot inclusion, creates rules for establishing “regulated access” to psilocybin services in Colorado (which may later be expanded to include other so-called “natural medicines,” meaning psychedelic-containing plants). Initiative 61, which makes the possession, use, cultivation, and sharing of entheogenic plants and fungi state-legal, could also be added to the ballot as well; it has until August 8 to receive the requisite signatures, according to local news station Denver7.
The Latest in Oregon: Another wave of psilocybin bans. The list of Oregon counties and towns considering a ban on psilocybin services continues to grow. This week, commissioners in Jackson and Benton counties discussed potential bans, and the towns of Roseburg, Newberg, Philomath, and Sandy voted to include bans on voters’ November ballots. Corvallis City Council members also voted on a ban, but it was rejected with a 5-4 vote.
Two weeks ago, The Microdose reported on a public hearing in Deschutes County to discuss a ban on psilocybin services. In that meeting, county commissioners raised concerns that by the time Oregon Psilocybin Services releases their final rules, counties would not have enough time to consider the logistics of complying with those rules. Local officials in other counties and towns seem to have the same general concerns; Roseburg City Council’s ordinance mentions that the state’s rule-making is not yet complete, and that the city is “uncertain how the manufacture, delivery and administration of psilocybin at licensed psilocybin facilities will operate within the city.”
There are 36 counties in Oregon, and by The Microdose’s count, three counties have decided to put a ban to voters in November, with another 7 still considering similar resolutions. Additionally, 5 towns will include a psilocybin ban in the November vote, with at least two more considering, and just two — Corvallis and Ashland — that have decided against putting a ban to a vote. It’s likely we’ll see even more bans; municipalities have until August 19 to file a ballot title with their county clerk.
In a piece for The Intercept, journalist Mattha Busby reports on a May letter sent from the Substance Abuse and Mental Health Services Administration to congresswoman Madeleine Dean (D-Pennsylvania), which Busby calls “the clearest indication yet that top officials are preparing for the approval of psychedelic drugs.” In a statement published by MAPS, founder and executive director Rick Doblin praised the Biden administration “for taking psychedelic-assisted therapies, and their potential to treat life-threatening mental health conditions, seriously.”
WIRED profiles chemist Jason Wallach and the “high-stakes race to engineer new psychedelic drugs.”
You’re all caught up! Have a great weekend. Stay tuned on Monday for a new issue of 5 Questions.
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