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Bipartisan Lawmakers Push FDA To Speed Up Approval Of Psychedelic Therapies

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A bipartisan coalition of 32 members of Congress is urging federal health officials to speed up ongoing reviews of psychedelic therapies.

“For many people, current treatment options are insufficient, deepening an already urgent public health crisis,” wrote lawmakers, Reps. Jack Bergman (R-MI) and Lou Correa (D-CA), chair of the Congressional Psychedelics Advancing Therapies Caucus, in a letter to the head of the Food and Drug Administration (FDA). “As members of the House of Representatives, we have heard from countless veterans, clinicians and families seeking evidence-based alternatives.”

The letter to FDA Commissioner Marty Makary says lawmakers are “encouraged” by his recent statement that psychedelic treatments are “a top priority for this FDA and this administration.”

The FDA and the Department of Health and Human Services (HHS) announced steps last month that they say will help “expediting” therapeutic access to psychedelics for patients suffering from serious mental health conditions.

That movement a President Donald Trump signed an executive order on psychedelics.

The lawmakers’ new letter said they want the FDA to conduct “expeditious and rapid review of promising treatments,” especially those that address urgent unmet needs in PTSD, traumatic brain injury and other neuropsychiatric conditions, but “understand and respect the agency’s role in ensuring that new treatments meet rigorous safety and efficacy standards.”

They said recent developments, including the public release of documents related to the denial of MDMA-assisted therapy approval during the Biden administration, “highlight the complexity of evaluating innovative treatment modalities and underscore the need for clear and consistent expectations for this emerging field.”

Members of Parliament have several questions for Makary to answer:

  • Specific Protocol Assessment (SPA): How does FDA communicate and apply other data concerns beyond clearly defined primary endpoints and control conditions when pivotal trials are conducted in a SPA? Are improvements being made to anticipate regulatory expectations for therapies in developing areas?
  • Methodological standards and interagency coordination: What steps FDA is taking to clarify methodological expectations for entactogen- and psychedelic-assisted clinical trials—including strategies to mitigate functional illusion and expectancy effects—and how the agency is coordinating with federal partners, such as the US Department of Veterans Affairs, to meet urgent research needs in populations such as the US Department of Veterans Affairs. Veterans with PTSD.
  • Review integrity and subject matter expertise: How does the FDA ensure that reviews of entactogenic and psychedelic-assisted therapies are conducted by qualified experts with relevant experience? What steps are there in the evaluation process to ensure consistency, objectivity and independence?
  • Timeline for final guidance: What is the timeline for finalizing the FDA’s June 2023 guidance on accelerated clinical trials of new therapeutics, including entactogen- and psychedelic-assisted therapies?

They are also encouraging clarification in any new FDA guidance on:

  • Strategies to mitigate functional desistance and expectancy bias;
  • Adverse event monitoring and security reporting rules;
  • Provider training, licensing and participant protections;
  • The evolving role of psychotherapy alongside pharmacological intervention;
  • Generalizability of findings to different patient populations; and
  • Consistency of regulatory expectations for entactogenic and psychedelic drug development programs.

“We remain committed to ensuring that veterans and others with treatment-resistant mental health conditions have access to safe, evidence-based care,” the lawmakers said. he wrote. “We respectfully urge the FDA to continue its evaluation of entactogen- and psychedelic-assisted therapies with transparency, urgency, and scientific rigor while the agency fulfills its statutory responsibilities.”

In addition to Bergman and Correa, other lawmakers who signed the letter include: Dan Crenshaw (R-TX), Morgan Luttrell (R-TX), Pete Sessions (R-TX), Alexandria Ocasio-Cortez (D-NY), Nancy Mace (R-SC), Mark Pocan (D-WI), Mariannette Miller-Meeks (R-WI Orden) and Derrick Van Orden (R-WI).

Robert F. Kennedy Jr. HHS Secretary said recently The Trump administration is “very eager” to create a pathway to access psychedelic therapy and that senior officials at federal agencies want to “get it out to the public as soon as possible.”

In an interview with the Joe Rogan Experience in February, Kennedy said he was confident “we’re going to get it,” with plans to develop and finalize rules that would allow patients with conditions like post-traumatic stress disorder (PTSD) and depression to access psychedelic substances like psilocybin and MDMA in a “very controlled environment.”

“Everyone at my agency … is very eager to get a rule that will allow these types of studies and allow access to these products in therapeutic settings, particularly for military personnel who have sustained these injuries,” the HHS secretary said. “We are working on that process now. We are all working and trying to make it happen.”

“I think we’ll make it,” he said.

Last June, Kennedy said that his agency “Fully committed” to expanding research into the benefits of psychedelic therapy. and, along with the head of the FDA, aims to give military veterans legal access to these substances “within 12 months.”

Veterans Affairs Secretary Doug Collins also announced in April that he had an “eye-opening” conversation with Kennedy. On the therapeutic potential of psychedelic medicine. And he said he’s open to the government issuing vouchers to cover the costs of psychedelic therapy for veterans who receive services outside the VA while Congress considers avenues for access.

Bipartisan members of Congress introduced legislation this session to provide $30 million in annual funding. establish psychedelic-focused “centers of excellence” at the US Department of Veterans Affairs (VA) facility where veterans can receive new treatments containing substances such as psilocybin, MDMA and ibogaine.

A US Senate committee held a hearing last month on a bipartisan bill Promote research into the therapeutic potential of psychedelics by creating a new office at the VA this would help develop innovative treatments for serious mental health conditions and review the scheduling status of drugs such as psilocybin, ibogaine and MDMA.

Former US House Speaker Newt Gingrich (R-GA) said ibogaine represents ‘amazing breakthrough’ in nation’s current ‘patient care system’ this has left people with serious mental health conditions without access to promising alternative treatments.

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MMJDaily will be back August 10th

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Even the best growers need a dark cycle. MMJDaily is shutting down for the annual two-week summer break. There will be no newsletter in your inbox or new articles on the website for the next two weeks, but we will be back on August 10th. Thank you, as always, for following and supporting our work. Rest…

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Adding Hemp To Dog Food Improves Digestive Health, New Study Shows

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A new study has found that adding hemp oil or a hemp seed byproduct to dog food can improve digestive health without negatively affecting the overall microbial system.

Research published in the journal Veterinary Sciences suggests that some types of hemp derivatives can be safely included as ingredients in dog food. However, the effects appear to depend in part on whether the cannabis is added as an oil or fiber supplement.

For the study, researchers at Kasetsart University in Thailand divided 24 mixed-breed dogs into three groups: one fed food with an 11 percent concentration of a high-fiber hemp seed byproduct, one received food containing 2 percent hemp seeds, and a third received a control diet without hemp.

The dogs were fed the diets for 90 days. The researchers compared the stool samples before the experiment and after 30 and 90 days. Genetic sequencing was used to track changes in gut bacterial composition and diversity.

Dogs fed hemp seed oil-infused food experienced a greater increase in microbial species richness.

“Hemp seeds modulate the canine microbiome without disrupting the ecological stability of the specific formulation, contributing to beneficial health effects in canine nutrition.”

The diet was also associated with increased levels of “beneficial” bacteria from the Lactobacillaceae family, and the fiber-rich hemp seed byproduct Actinobacteriota.

“Hemp seed derivatives altered the microbial composition by promoting beneficial bacteria that promoted gut health in dogs in a formulation-dependent manner,” the authors wrote, and the results “provide evidence for their inclusion as a functional ingredient in dog food.”

Despite the differences between the diets, 19 key bacterial collections were present throughout to analyze. And by day 90, the microbial composition also seemed to stabilize, indicating that the dietary supplements did not significantly disrupt the dogs’ intestinal systems.

Overall, the findings suggest that hemp seed ingredients can be safely incorporated into dog food while protecting gut health by promoting beneficial bacteria, the study authors said.

This is one of the latest studies on cannabis and its effects on dogs.


It’s Marijuana Time tracking hundreds of cannabis, psychedelic and drug policy bills in state legislatures and Congress this year. Patreon supporters by pledging at least $25/month, you’ll get access to our interactive maps, charts, and audio calendars so you never miss a development.


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For example, a systematic review of the scientific literature determined that studies “consistently show” this CBD is a potential “anti-cancer agent” in various types of cancer—and this effect applies to both dogs and humans.

The National Animal Supplement Council (NASC) sponsored a study in 2024 said that CBD is “safe for long-term use” in dogs—This is a significant finding given the emerging research that cannabis can effectively treat anxiety and certain skin conditions in dogs.

Another 2024 case study found this Cannabis appears to be a “viable alternative” treatment option for dogs suffer from a common skin disease, especially if they suffer from the adverse side effects of conventional steroid therapies.

Meanwhile, previous research suggests that Giving dogs a dose of CBD can help reverse the ill effects of accidental THC consumptionaccording to a study by the authors titled “First report of treatment of THC toxicosis in dogs with administration of CBD.”

Another study published in 2024 found that Dogs receiving daily doses of CBD see “significant reductions” in stress and anxiety related to car trips.

Other studies have demonstrated the benefits of CBD, such as the frequency of seizures among dogs receiving the cannabinoid is reduced. Moreover, a study published in 2018 found this dogs with arthritis see improvements with CBD treatment.

As for other animals, it was discovered by the US Department of Agriculture (USDA) in 2013 Cows fed hempseed cake maintain very low concentrations of THC and CBD in their bodies, indicating that meat products from hemp-fed cows are safe for human consumption.

Another federally funded study published in 2022 found this Feeding hemp to cows reduces stress.

It has also been studied by researchers How CBD affects stress and pain in horses.

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Ora Pharm affirms uninterrupted access to Helius products

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Ora Pharm has confirmed that New Zealand patients, prescribers and pharmacies continue to have uninterrupted access to Helius Therapeutics products following the successful acquisition of the business and its key assets, directly challenging the misinformation being circulated to patients and prescribers by cannabis importer MW Pharma Limited (trading as NUBU).

Industry monitoring was highlighted on Monday, July 20th, when Helius Therapeutics announced that NZ Grow Co. As he inaugurated Growers Day. The event demonstrated the full operational strength, advanced capabilities and integrated supply chain now fully operational under Ora Pharm’s leadership to support the growth of the NZ sector.

At the event, CEO Zoë Reece addressed concerns stemming from a July 9 industry bulletin distributed by NUBU, which stated that “Helius Therapeutics has ceased production and all products are now discontinued.”

© Ora Pharm

Ora Pharm said the statement was incorrect and had the potential to create unnecessary uncertainty in a highly regulated healthcare sector.

“Inaccurate information about the availability of medicines can cause unnecessary worry for patients, prescribers and pharmacies, interfere with treatment decisions and undermine confidence in the New Zealand cannabis industry.”

Ora Pharm completed the business and acquisition of key assets of Helius Therapeutics on June 18, 2026, resuming manufacturing, packaging and nationwide distribution the following day. All Helius brand formulated products and locally grown products remain approved and available for patient supply.

CEO Zoë Reece said the company’s focus is on ensuring continuity of care while strengthening New Zealand’s medicinal cannabis industry.

“The Helius facility gives New Zealand growers direct access to world-class pharmaceutical drying, extraction and manufacturing capabilities. Combined with NZ Grow Co., we are creating a secure and integrated pathway from cultivation to finished products and international markets. Our focus is on clinical continuity, quality assurance and confidence in patients and prescribing physicians every day.”

© Ora Pharm

The integration of the GMP-certified Auckland manufacturing facility with NZ Grow Co.’s cultivation network creates New Zealand’s largest medicinal cannabis supply chain. This unified network insulates domestic patients from volatile international import dependencies while providing independent local growers with a transparent, high-standard route to export markets.

Ora Pharm remains committed to working collaboratively across the sector to support patient access, strengthen confidence in the New Zealand cannabis industry and continue to invest in New Zealand’s pharmaceutical manufacturing capacity.

For more information:
Ora Pharm
(email protected)
www.orapharm.co.nz

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