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Bipartisan Lawmakers Push FDA To Speed Up Approval Of Psychedelic Therapies

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2 months ago

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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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Village Farms International leads B.C. cannabis producers in global export push

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20 hours ago

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June 27, 2026

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Village Farms International, one of the world’s largest cannabis production facilities located in Delta, BC, increased its export volumes by more than 500 percent by the end of 2025, with international sales reaching US$37.9 million, or just over 20 percent of total cannabis revenue of US$188 million. The main export markets are Germany, Australia, the United Kingdom, New Zealand and Israel.

The company is also expanding, developing an additional 550,000 square feet of greenhouse space across the street from its main facility, designed to support both domestic and international cultivation. Orville Bovenschen, VFI’s global president of operations, points to the excise burden as a permanent strain on the domestic economy: “If you look at how much we paid in excise last year, it’s astronomical,” he says, although VFI declined to provide specific figures.

Walker Patton, one of the founders of the BC Cannabis Alliance, which represents about 50 licensed growers in the province, frames the domestic regulatory environment in stark terms: “With the rules that this industry was set up for, it’s like doing business right out of the gate.” Canada’s excise tax structure charges by weight instead of market price, meaning that since wholesale prices have fallen to roughly half of initial projections, effective tax rates for producers have risen.

© This is Holland

Sweetgrass Cannabis, a micro-farm located in the Kootenay region, now derives 60 to 70 percent of its sales from international markets after retreating from provinces such as Ontario and Alberta. Company CEO Gemma Hayes says: “Margins, as well as export opportunities, drove our decision.” Ontario’s wholesale markup of up to 25 per cent, layered with excise taxes, spurred what Hayes described as a “race to the bottom.”

Rubicon Organics, a Vancouver-based publicly traded company, entered international markets last year and recently opened a 47,500-square-foot facility in Hope in part to meet overseas demand. Speaking from the International Cannabis Conference in Berlin, Mathieu Aubin, director of marketing and new business, said: “Canada is very well positioned to access international markets for reliable and safe cannabis,” noting that reliability and product integrity are key to gaining access to the medical market.

Not all producers have equal access to these markets. Alex Rumi, founder of grower Good Buds out of Salt Spring Island, said established export markets are structured around an indoor pharmaceutical-style model that hurts sun-grown cannabis, and that Canada’s export system “works for big growers and doesn’t work for craft.” Julia Cameron, president of Cannabis Cultivators of BC and chair of communications and corporate affairs for the VFI, added that growers must secure permits for each shipment while navigating different rules across countries, creating a prohibitive barrier for small operators.

BC has more than 200 licensed growers and accounts for roughly a quarter of Canada’s legal cannabis production, but represents only 14 percent of national exports. Lana Popham, B.C.’s Minister of Agriculture and Food, points to the FIFA World Cup games in Vancouver as a near-term possibility: “It will be interesting to see how many people engage with what is a great product here in B.C.”

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Congressman And Other Media Outlets Join Marijuana Moment’s Push For DEA To Livestream Rescheduling Hearing

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20 hours ago

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June 27, 2026

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The momentum of the Marijuana Moment request for direct public and media access to historic federal cannabis rescheduling hearings they are being joined by a member of Congress and other reporters starting next week.

Representative Steve Cohen (D-TN) sent a letter to the head of the Drug Enforcement Administration (DEA) on Friday, calling the ongoing marijuana rescheduling process “historic.”

“I am writing to request that the hearings be made available to the public in real time,” Cohen wrote to DEA Administrator Terrance Cole. “Live streaming technologies have become ubiquitous and a common way for Americans to interact with the government. In late 2024, in a similar effort, your agency authorized live streaming of proceedings ‘due to the public interest in this matter’ and continued your agency’s ‘commitment to procedural transparency.’

“I see no reason why that reason wouldn’t hold today, especially when it comes to such an important and impactful issue,” the congressman wrote. “I have long been an advocate for transparency in court proceedings and I believe this is a rare opportunity to inform the public about rulemaking and administrative litigation.”

Cohen’s letter follows a couple Marijuana Moment’s attorney presented the petitions to Cole and DEA Chief Administrative Law Judge Derek Julius. to request access to a live stream of the hearing on the proposal to move cannabis from Schedule I to Title III of the Controlled Substances Act (CSA) — which includes only opponents of the reform as participants.

Also on Friday, an attorney from Portfolio Media, Inc., which publishes Law360, sent Cole a letter saying it “agrees with Marijuana Moment’s request” for streaming access.

“This approach is consistent with DEA’s prior approach to this hearing and the compelling public interest in rescheduling marijuana under the CSA, a policy change with profound social, legal, and regulatory implications,” the letter states.

Requiring observers to attend in person “limits real-time information about a consequential policy development to the press and a small audience in attendance, and removes the ability of the press to report on that development,” he says. “Live streaming is a safe, continuous and fair way to ensure meaningful public access and advance the DEA’s stated commitment to transparency.”

Separately, an attorney representing the cannabis publication Cultivated Media and also on behalf of New York Times reporter Ashley Southall sent a letter to the DEA administrator saying they “want the ability to monitor the proceedings in real time, to provide readers with reports on the progress and perspective of testimony and evidence during the hearing.”

“Cultivated Media, Ashley Southall and Marijuana Moment and all the other media because of this access to the live stream can simultaneously report on issues of important public concern related to a historic hearing,” he said.

The DEA announced Thursday that it would make the transcript available at the end of the multi-day hearing, but Marijuana Moment attorney Joseph A. Bondy wrote in his letter Thursday that it would not help the public follow the proceedings in real time on a daily basis.

“The final transcript is useful, but not a substitute for access to a live broadcast. A live broadcast allows the public and the press to observe the hearing as it unfolds without contesting admissions, filling the courtroom, or disrupting the proceedings,” the letter to Cole says. “After reviewing, correcting and releasing the transcript weeks after the testimony, the opportunity for real-time observation, timely reporting and public information response has passed.”

“For a large public audience seeking serious coverage of federal cannabis policy, Marihuana Moment is an important channel through which the public can understand these proceedings.”

“To the extent that the DEA now believes that live streaming is inappropriate, despite the DEA’s prior directive in this rulemaking, Marijuana Moment respectfully requests a written explanation identifying the specific basis for that conclusion, including why the public interest and transparency that previously warranted live streaming are being overridden here,” Bondy wrote.

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Separately, cannabis advocates sent a letter Thursday to Julius, the DEA judge, saying he would not consider submissions from outside parties, also requesting access to the live stream.

“Many of the patients most interested in this procedure cannot travel to Arlington, Virginia. Many are disabled, immunocompromised, elderly, financially limited, or managing serious medical conditions,” states the letter from Americans for Safe Access, Veterans Initiative-22, US Pain Foundation, Realm of Caring, Montel Williams and others.

“Patients and advocates who can travel will also be unable to physically wait in line for an uncertain chance of admission, only to be turned away when limited seats are filled,” they wrote. “So the audience may technically be open to the public, but virtually inaccessible to most.”

Meanwhile, the DEA said in a new filing that its witness list for the hearing includes a doctor. Testify on “How Medical Marijuana Provides Medical Benefit to Pain Patients.”

Separately, the opponents who are participating in the trial have presented their declarations this week anticipate the anti-marijuana arguments they intend to make during the procedure.

The hearing it will start on June 29 and end before July 15.

Acting Attorney General Todd Blanche in April He issued an order that immediately reclassified the state’s licensed medical cannabisas well as marijuana products approved by the Food and Drug Administration (FDA) under Schedule I through Schedule III of the Controlled Substances Act (CSA).

According to a separate order signed by the acting attorney general, the upcoming hearing will include Class III marijuana.

Preliminary hearing process on the marijuana redistricting process initiated by the Biden administration It was halted last year amid allegations of improper communications and witness selection.

the current The marijuana redistricting process is being challenged in several ways which have been upheld by a federal Court of Appeals. those pieces of State attorneys general have filed lawsuits against cannabis reform, Opponents of marijuana legalization and a a cannabis-based biopharmaceutical corporation.

Meanwhile, the reorganization of state-licensed medical cannabis is already having a major impact.

The Congressional Research Service published a report on the current rescheduling of cannabis Certified patients with medical marijuana from state licensed dispensaries are now eligible for Class III. “The order appears to allow end users to use marijuana medically without a CSA prescription,” he says.

The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) has published a Draft update to a gun purchase form to recognize the legal status of medical marijuana in the reprogramming. The revised section of the question states that only the “recreational use or possession of marijuana” is federally prohibited, omitting the prior form’s mention of medical cannabis.

The US Treasury and Internal Revenue Service (IRS) said they plan to issued new tax guidelines for the marijuana industry after reprogramming. The reform will benefit state-licensed marijuana businesses by allowing them to take federal tax deductions that are currently prohibited under IRS Code Section III, known as Section 280E.

Even the DEA, which has long opposed cannabis legalization and accused the Biden administration of stalling the initiative in the reorganization process, has done so. It launched a registration process for legal marijuana businesses in the state to take advantage of the federal benefits that come with the reform.

The Department of Transport, on the other hand, issued guidelines stating this use Legal medical cannabis in the state is still no excuse for truck drivers to test positive for drugspilots and other safety-sensitive personnel.

A congressional committee recently Federal officials voted to block further steps to reschedule cannabis.

read it the letters About DEA admin access to live streaming:

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New access solution for cannabis facilities designed to address limitations of traditional gates

Published

2 days ago

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June 26, 2026

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SpaceGuard Products, a North American manufacturer of wire mesh security solutions and security protection systems, has released the BeastWire® Tunnel Door. This access solution is designed to overcome the limitations of traditional balanced doors and is aimed at cannabis cultivation, processing, packaging and distribution environments. The BeastWire Tunnel Door is designed for installations that require vertical clearance, reliable movement and floor space efficiency.

The BeastWire Tunnel Door provides top clearance with no tracks in the operating path of the door. It is suitable for spaces where overhead paths are not feasible, such as facilities that use high-mast forklifts, oversized pallet loads or specialized material handling equipment. Tall equipment can pass through the opening unhindered, allowing for continuous workflow and flexibility in equipment movement.

© SpaceGuard Products

The door uses a track system designed to create consistent movement. This addresses issues such as stuttering, binding, and misalignment that can occur with conventional sliding or counterbalanced designs. The track controls the path of the door so that the locking mechanism aligns with each cycle, allowing operators to close the door with relatively low force.

Unlike lower track systems that require a soil trench, the BeastWire Tunnel Door mounts above ground. This avoids cutting the installation slab, simplifies installation and reduces maintenance requirements. The system can be installed as a retrofit or in new construction, without changing the floor.

© SpaceGuard Products

The door frame and retractable design reduces the need for side supports and additional space on the side of the door. This results in a smaller footprint and more usable surface area. The gate has the same construction approach as other BeastWire systems.

The BeastWire Tunnel Door is a high-access door designed for strength and ease of use in cannabis industry facilities.

For more information:
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Email: (email protected)
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