The U.S. Drug Enforcement Administration (DEA) recently rehired an agent that was fired almost five years ago after the agent tested positive for tetrahydrocannabinol during a drug screening. Anthony Armour, the agent in question, was terminated in 2019 by the federal agency.
In 2023, Armour filed a suit against the agency in the Federal Circuit’s Court of Appeals, arguing that the DEA had no grounds to fire him without any evidence that he’d intended to break the law. In his suit, Armour asserted that he was using what he thought to be a hemp product that was federally legal as an alternative to opioids to manage chronic pain.
His attorney, Matt Zorn, also argued that the DEA had no policy on CBD at the time of his client’s termination, which came roughly one year after the 2018 Farm Bill federally legalized hemp and its derivatives. It should be noted that in 2021, the DEA did revise its policy for job applicants, including a section inquiring about prior use of CBD and hemp before federal legalization in its questionnaire.
Last week, the court process ended in Armour’s favor, with the agency agreeing to reinstate him with restored pension eligibility as well as back pay. The Department of Justice, through the lawsuit, acknowledged that during his tenure, the plaintiff was an outstanding agent. The department then highlighted that despite this, his careless conduct in CBD consumption did justify his firing by the DEA.
In an interview, Armour stated that he was excited to return to work at the federal agency and hoped to finish his career by aiding the DEA in its mission to remove dangerous drugs from the streets. He also hopes that marijuana will be legalized, given scientific evidence that supports the drug’s legalization.
This settlement agreement comes just as the DEA concludes a review into the scheduling of cannabis under a directive issued by President Joseph Biden in 2022. While the Department of Health and Human Services did recommend that marijuana be moved to Schedule III, the DEA has yet to give its final decision on the matter.
The issue on classification was brought up in Armour’s case, with the primary query being whether marijuana rescheduling would prevent the Drug and Enforcement Administration from enforcing its employment penalty.
The agency still defines an illegal substance as any drug under Schedule I or II of the Controlled Substances Act that cannot be prescribed.
As the scheduling review process nears its end, cannabis companies such as Tilray Brands Inc. (NASDAQ: TLRY) (TSX: TLRY) will be hoping for an outcome that eases many of the hoops that they have been compelled to jump through in order to operate their state-legal businesses within the broader federal regulations, which aren’t so accommodating.
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Last week, the Virginia Rehabilitation and Social Services Senate Committee passed a proposal to legalize commercial cannabis sales by a 10 to 5 vote. The bill, SB 448, introduced by Senator Aaron Rouse, aims to initiate the licensing of recreational cannabis businesses starting this July. However, retail licenses would not be accessible until next year.
Subject to voter approval, the measure gives local governments the authority to potentially outlaw commercial marijuana operations.
SB 448 will move on to the Senate’s justice committee next week. Subsequently, it will undergo evaluation in the finance committee, where a crucial deadline of Feb. 5, 2024, looms to keep it in contention. There’s also a crossover date of Feb. 13, 2024, that requires the senate to forward the bill to the house, which is also considering a marijuana sales measure of its own.
During a senate marijuana subcommittee hearing, Rouse’s bill prevailed over an opposing proposal from Senator Adam Ebbin, SB 423. Ebbin’s proposal, which aimed to accelerate adult-use marijuana sales through already-existing dispensaries, was rejected due to worries about possible market dominance by well-established companies.
SB 448 outlines licensing for five business categories, including testing laboratories, cultivators, retailers, manufacturers and transporters. The entities would fall under the regulatory purview of the state’s existing CCA.
Legislators have refrained from debating the bill’s tax components or criminal justice legislation effects thus far, delegating those discussions to the senate’s fiscal and judicial committees.
One amendment suggested during last week’s session is a definition of cultivator size measurement. Cannabis advocates suggest replacing the bill’s maximum of 2,000 plants for the largest cultivators with a cap on canopy square area. However, Rouse objected to this change, claiming that plant counts are simpler to monitor and give small companies greater flexibility.
The subcommittee meeting included a significant amount of debate on social-justice provisions, which emphasized priority licensing for veterans, hemp producers and people from low-income and over-policed communities. Changes that were covered in previous subcommittee sessions included doing away with a clause that prohibited legislators from working in the marijuana industry and forbidding law enforcement from being involved in the business. Additional changes addressed issues such as fairness standards for veterans, testing licensing restrictions to prevent lab shopping and concerns for those impacted by the drug war.
Additionally, the proposal addresses the qualifying standards for marijuana company licenses, prohibiting those with felonies or other convictions involving moral conduct from applying for seven years. There were requests to shorten this exclusion period during the subcommittee meeting.
The legislation arrives against the backdrop of Virginia’s existing legal framework, where recreational cannabis possession, use and personal cultivation are already permitted. Originally a Democrat-controlled legislation from 2021, the framework ran into difficulties due to GOP control over the governor’s office and the house later in the year. The unlicensed market has since expanded as a result of the lack of a newly adopted regulatory framework.
Even if Democrats took back control of both chambers of Congress in November, it is still difficult to pass laws on marijuana sales. There are challenges in reaching a consensus among Democrats and possible resistance from Virginia Governor Glenn Youngkin. Gov. Youngkin has voiced his distaste for cannabis reform and highlighted particular issues, such as labor union regulations for cannabis-related enterprises. Although he first seemed receptive to the notion of commercial sales, more subsequent remarks appear to indicate a change in perspective.
The entire cannabis industry, including sector players such as SNDL Inc. (NASDAQ: SNDL), hope that the launch of adult-use cannabis sales in Virginia happens on schedule so that the residents who aspire to consume this substance can find legal sources to access it.
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CNW420 spotlights the latest developments in the rapidly evolving cannabis industry through the release of two informative articles each business day. Our concise, informative content serves as a gateway for investors interested in the legalized cannabis sector and provides updates on how regulatory developments may impact financial markets. Articles are released each business day at 4:20 a.m. and 4:20 p.m. Eastern – our tribute to the time synonymous with cannabis culture. If marijuana and the burgeoning industry surrounding it are on your radar, CNW420 is for you! Check back daily to stay up-to-date on the latest milestones in the fast -changing world of cannabis.
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Money is pouring into the fledgling psychedelic medicine industry, with dozens of startup companies vying to be among the first to sell mind-expanding drugs for depression, addiction and other mental health conditions.
While psychedelics are still illegal under federal law, companies are jostling to try and patent key ingredients found in magic mushrooms, ayahuasca and other substances that have been used underground for decades or — in some cases — for millennia by indigenous cultures.
Wall Street’s sudden exuberance for hallucinogens has rankled longtime advocates and philanthropists, who dreamed of making low-cost psychedelics widely available for mental health and personal growth. Instead, many now see a very different future for drugs like psilocybin and LSD: as expensive, specialty medications controlled by a handful of biotech companies.
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“It’s disappointing,” said Carey Turnbull, an investor and philanthropist who sits on the board of several psychedelic nonprofits. “All the air is getting sucked out of the room by these for-profit companies who say, ‘Wow, this stuff is awesome, if I could patent it I’d make a fortune.’”
Since 2010, Turnbull and his wife have donated millions to fund psychedelic research at New York University, Yale and other top academic centers.
Promising results from those studies have sparked a wave of popular interest in psychedelics, amplified by books, documentaries and articles touting their potential to reshape care for mental illness, trauma and end-of-life care.
But in recent years, Turnbull has pivoted to challenging what he and other advocates consider frivolous patents filed by companies entering the field.
Most psychedelic startups are backed by venture capitalists or tech investors looking for the next industry “disruptor.” Behind one of the biggest companies, Atai Life Sciences, is PayPal billionaire Peter Thiel, whose enthusiasm for psychedelics is shared by many in Silicon Valley.
About 50 such companies now trade on public stock exchanges, including developers of psychedelic drugs, retreats and training programs. Some analysts project the industry could grow to over $10 billion within the decade.
But recently investors have pulled back, amid reminders of the stark challenges of converting illegal drugs into money-making medicines.
Atai laid off 30 per cent of its staff last March after its depression treatment failed in a key study. Stocks are down 80 per cent to 90 per cent from their highs across the industry with several smaller companies restructuring or declaring bankruptcy.
“They’re in this hype cycle, but then the reality of running a biotech company catches up with you,” said Chris Yetter of Dumont Global, which trades in cannabis and psychedelic companies. “You do drug trials and some of them succeed and some fail and every quarter your cash drains away.”
The cash crunch recently forced fundamental changes at the field’s leading nonprofit, the Multidisciplinary Association for Psychedelic Studies.
For more than 30 years, MAPS’ efforts have been funded almost entirely by donations from wealthy individuals, including billionaires like New York Mets owner Steven Cohen and Republican political donor Rebekah Mercer. On principle, MAPS has never patented its work.
The group’s pharmaceutical arm, the MAPS Public Benefit Corp., is expected to win U.S. approval this year for the first psychedelic medicine accepted for review by the Food and Drug Administration: MDMA, or ecstasy, to help treat post-traumatic stress disorder.
But as investment opportunities have multiplied, charitable donations have dried up. The group was recently forced to take on private investors to continue funding the drug company, which changed its name to Lykos Therapeutics.
“We’re a victim of our own success,” said MAPS founder Rick Doblin. “It’s heartbreaking because I had hoped to go the whole way with philanthropy, but I was unable to raise the mega millions to do that.”
Psychedelics never fit the business model of the traditional blockbuster drug: an exclusive, patent-protected medicine that patients take regularly for years.
None of the psychedelics currently being studied are new. Synthetic drugs like LSD and ecstasy have been off patent for decades. Naturally occurring substances like psilocybin, found in certain mushrooms, can’t be patented by themselves.
And then there’s the challenge of administering drugs that bring about intense, disorienting visions and experiences. All the drugs vying for FDA approval will have to be given under professional supervision, typically during several therapy sessions lasting about six to eight hours each.
All those hours and professional fees will drive up costs, which many analysts say could range from $5,000 to $10,000 for one course of treatment.
Psychedelic executives say the only way to defer those costs is to conduct large, rigorous clinical studies needed for FDA approval, which could compel insurers to pay for psychedelics. But funding those studies requires raising tens of millions from investors, who typically only back drugmakers with strong patents.
“The only way you’re going to bring about that broad and equitable access is with robust intellectual property,” said Kabir Nath, CEO of Compass Pathways, which is studying laboratory-made psilocybin for depression, anorexia and other disorders.
Compass is among the most aggressive companies in terms of trying to patent its technology, with dozens of applications filed with the U.S. Patent and Trademark Office.
One submission describes the “soft furniture” and “muted colors” that would decorate rooms where patients take psilocybin. Another patent lays claim to a specific, microscopic structure found in Compass’ synthetic psilocybin, which the company claims is uniquely suited for mass production.
The company’s efforts have drawn ridicule from some researchers, who note that as early as the 1970s, psychedelic therapists had codified the settings and techniques described in Compass patents.
“It just seems like a blatant power grab,” said Frederick Barrett, a neuroscientist who directs Johns Hopkins University’s psychedelic center.
But attempts to challenge the patents on Compass’ synthetic psilocybin have been unsuccessful, despite years of work by Turnbull’s patent watchdog group, Freedom to Operate.
Other companies are taking more creative approaches to patenting psychedelics, such as reformulating them as dissolvable lozenges or films — or combining LSD and ecstasy into a combination pill. Skeptics note that that approach, dubbed “candyflipping,” has been used recreationally for decades.
One of the more intriguing reformulation efforts involves trying to shorten the duration of the psychedelic experience, or even do away with it entirely, while retaining the psychological benefits for patients.
The rush to innovate worries some psychiatrists who point to the many fundamental questions about psychedelics that remain unanswered, including exactly how they affect the brain and how long their benefits might last.
As companies develop more psychedelic derivatives and combinations, deciphering their strengths and weaknesses will become more challenging, says Dr. Jeffrey Lieberman of Columbia University. Unless researchers can clearly demonstrate their benefits, they risk another backlash like the 1970 federal ban that wiped out psychedelic research for decades.
“Psychedelics could have tremendous benefit for treating a number of illnesses,” Lieberman said. “But if we mess it up and rush the process, these drugs are going to get banned again and you lose that opportunity.”
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group.
Several Canadian biotechnology companies are poised to make a killing in the Australian market after the county’s Therapeutic Goods Administration (TGA) allowed psychiatrists to prescribe MDMA and psilocybin in 2023. The TGA regulates therapeutic goods such as medical devices and prescription drugs in Australia. It approved the prescription of psilocybin, the main psychoactive agent in magic mushrooms, and MDMA by changing their classification in Australia’s Poisons Scheme.
The TGA’s changes to the Poisons Scheme mean that the two psychedelics are considered Schedule 8 Controlled Drugs for specific uses. However, psilocybin and MDMA will remain in Schedule 9 (Prohibited Substances), which largely restricts their supply to clinical trials. That said, the approval means that Australian psychiatrists with special authorization can now prescribe MDMA to treat post-traumatic stress disorder (PTSD) and psilocybin for treatment-resistant depression. With the nation preparing its Authorized Prescriber Scheme for psychedelics-based medicines, the nascent psychedelic market is completely ripe for the taking.
Biotechnology companies from Canada are set to reap big from Australia’s psychedelic segment by supplying the industry with standardized and safe good manufacturing practice-grade substances. The Authorized Prescriber Scheme is still in its infancy and recently reached a major milestone after Monarch Mental Health Group cofounder Ted Cassidy became the first physician to prescribe MDMA-assisted therapy to treat a female patient with PTSD.
Several Canada-based biotech companies with a focus on psychedelics have already completed the logistical and regulatory steps required to facilitate the export of controlled substances such as MDMA and psilocybin to Australia. Now that they have overcome the significant legal and logistical challenges involved, these Canadian companies are ready to begin shipping MDMA and psilocybin to Australia.
British Columbia-based Filament Health Corp. recently made its first export of PEX010, a botanical psilocybin drug candidate, to Perth-based Reset Mind Sciences. Filament has plenty of experience supplying drugs to specialized programs such as the Authorized Prescriber Scheme. The British-Columbia-based biotech company supplied Canada’s Special Access Program with nonmarketed drugs that aren’t available for retail sale for patients with severe or life-threatening conditions for several years.
Reset Mind Sciences will use Filament’s product for research purposes. It is currently looking to secure a GMP license application to manufacture botanically sourced psilocybin products for human consumption.
Toronto-based PharmAla Biotech is also working to supply MDMA and psilocybin to Australia’s psychedelics space. In late 2023, the company announced the completion of its first psilocybin and MDMA shipment to Australian partner Vitura Health Limited. In addition, Optimi Health Corp from Garibaldi Highlands, British Columbia, has partnered with mental-health charity and psychedelic-assisted therapy training provider Mind Medicine Australia to supply psychedelics under the Authorized Prescriber Scheme.
The opening of more international markets is likely to provide impetus to psychedelic drug developers such as Compass Pathways PLC (NASDAQ: CMPS) to speed up their R&D efforts in order to tap the growing market for drugs based on hallucinogens.
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PsychedelicNewsWire (“PNW”) is a specialized communications platform with a focus on all aspects of psychedelics and the latest developments and advances in the psychedelics sector. It is one of 60+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, PNW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, PNW brings its clients unparalleled recognition and brand awareness. PNW is where breaking news, insightful content and actionable information converge.
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1st Detect, a wholly owned subsidiary of mass spectrometry company Astrotech, is offering its breakthrough TRACER 1000(TM) Explosive Trace Detector (“ETD”) in markets that accept ECAC certification
The TRACER 1000(TM) ETD is designed to outperform ETDs currently used at airports, cargo and other secured facilities, as well as at borders
Astrotech is working to position its product as the next-generation solution for the ETD market at a time when many of the existing IMS-based ETDs are due for replacement
Keenly watching the developments in the field of explosives and narcotics detection at airports is Astrotech (NASDAQ: ASTC), a mass spectrometry company that, through its wholly owned subsidiary, 1st Detect, has developed and rolled out the breakthrough TRACER 1000(TM) Explosive Trace Detector (“ETD”). The world’s first mass spectrometry-based ETD certified by the European Civil Aviation Conference (“ECAC”), the TRACER 1000(TM) is designed to outperform the ETDs currently used at aviation checkpoints as well as borders, cargo facilities, and other secured points around the world.
It is powered by the Astrotech Mass Spectrometer (“AMS”) Technology that is inexpensive, smaller, and easier to use when compared to traditional mass spectrometers. The AMS Technology works under ultra-high vacuum, which eliminates competing molecules, resulting in higher resolution and fewer false alarms.
Normally, ETDs are used at the secondary screening stage at airports. They aid in additional examination of passengers following the detection of something on their person during primary screening. An ETD is designed to assess and analyze samples taken by wiping a passenger’s hands, clothes, or belongings with a swab that is subsequently inserted into the detector.
Astrotech nonetheless believes that ETD customers are unsatisfied with the currently deployed ETD technology, which is driven by ion mobility spectrometry (“IMS”). “The company further believes that some IMS-based ETDs have issues with false positives, as they often misidentify personal care products and other common household chemicals as explosives, causing facility shutdowns, unnecessary delays, frustrations, and significant wasted security resources. In addition, there are hundreds of different types of explosives, but IMS-based ETDs have a very limited threat detection library reserved only for those few explosives of largest concern,” wrote Astrotech in its most recent Form 10-K annual filing (https://cnw.fm/6awj0).
Against this backdrop and as many of the tens of thousands of IMS instruments deployed in the field near their end of life and need replacement, Astrotech is working to position its TRACER 1000(TM) product as the next-generation solution for the ETD market. “Based on our near-zero false alarm rate, we believe that the TRACER 1000(TM) improves checkpoint efficiency and passenger throughput by reducing the need for time-consuming and invasive secondary screenings that cost airports millions in lost merchandise and food sales,” said Thomas B. Pickens III, Chairman and CEO of 1st Detect, in a May 2023 news release announcing a significant purchased order for its next-generation solution (https://cnw.fm/EHKRI).
Astrotech is currently offering the TRACER 1000(TM) to countries that accept ECAC certification while awaiting Transportation Security Administration (“TSA”) certification. Last year, the company received a 17-unit order to deploy the TRACER 1000(TM) ETDs in Europe and another significant purchase order for seven detectors to be deployed in a European airport in Romania (https://cnw.fm/q0tBT).
NOTE TO INVESTORS: The latest news and updates relating to ASTC are available in the company’s newsroom at https://cnw.fm/ASTC
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CannabisNewsWire (“CNW”) is a specialized communications platform with a focus on cannabis news and the cannabis sector. It is one of 60+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, CNW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, CNW brings its clients unparalleled recognition and brand awareness. CNW is where breaking news, insightful content and actionable information converge.
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