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Bipartisan Lawmakers Push FDA To Speed Up Approval Of Psychedelic Therapies

Published

6 hours ago

May 8, 2026

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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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Cannabis News

GreenBe Pharma brings proven international genetics to European licensed grows

Published

5 hours ago

May 8, 2026

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Elicier Hernandez, CEO of GreenBe Pharma, says the varieties being tested in Canada and the US are not reaching licensed producers in Europe, and the reason is operational, not commercial.

“Genetics that are new to the market, not common in Europe, but already proven in Canada and the US, that’s what European operators are looking for,” he says. “The problem is that getting them in legally is complex. The regulatory pathways are not straightforward, and that’s why there’s a gap. New materials that work well elsewhere just don’t get here, and licensed growers end up growing the same varieties that everyone else is growing.”

Leveraging traditional farming expertise to serve cannabis
Phytosanitary requirements vary across European markets and change with some regularity. Plant material does not move freely across borders, and there is a heavy documentation burden at each stage of importation. The practical effect is that most licensed growers in Europe continue to work from a narrow genetic pool, rather than competing in execution, in varietal differentiation, while markets such as Canada and the US have advanced in terpene profiles, flower structure and cannabinoid content.

“We come from a large traditional farming background. We are part of a very large group that has been dealing with plant material for decades,” says Elicer. “We know how to do that within the regulations. And it’s not just about the legal paperwork. Phytosanitary requirements are a big part of it. When you’re doing nursery operations in millions of units a year, you develop the infrastructure and knowledge to move plant material properly.” In other words, GreenBe has all the proven and established legal means to bring non-European genetics into the EU market.

GreenBe is part of an agricultural group that distributes millions of certified plants to markets and species every year. This infrastructure applied to cannabis means the company has existing import protocols, established regulatory relationships and operational experience to meet phytosanitary compliance on a scale that most cannabis-specific operators have not built. Its nursery is subject to HLVd-free certification with full traceability from the mother plant to distribution.

The Mother Renewal Program is built on this infrastructure. It is aimed at two audiences: growers outside of Europe and varieties that have proven commercial performance in more mature markets, and licensed growers who wish to enter these varieties in Europe without having to undertake import compliance.

For more information:
GreenBe Pharma
www.greenbepharma.com

Cannabis News

UFCW Local 27 files federal unfair labor practice charges against The Apothecarium, TerrAscend

Published

1 day ago

May 7, 2026

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UFCW Local 27 filed unfair labor practice charges with the National Labor Relations Board on May 1 against Apothecarium Dispensary in Salisbury and TerrAscend Corp. against the parent company.

The charges stem from an incident in which an assistant general manager removed union cookies from an employee bulletin board, materials that are protected under federal law. Employees have a legally guaranteed right to organize, communicate and distribute union information in designated workplace areas. Impeding these rights is a direct violation of the National Labor Relations Act.

Such actions may result in federal consequences, including remedies established by the National Labor Relations Board.

Local 27 has replaced workers at The Apothecarium in Salisbury since fall 2024. Since organizing, workers have been working for a first-ever union contract that guarantees fair wages, workplace protections, and the dignity and respect every worker deserves.

Instead of negotiating in good faith, TerrAscend has wasted thousands of dollars on a professional anti-union law firm in an effort to delay and deny these workers a fair contract. These are resources that could have been used to improve workers’ wages, benefits and working conditions.

The company’s financial track record highlights the wrong priorities. TerrAscend’s stock, which once traded for more than $15 per share, is now around $0.69 per share and is down about $0.30 this year. Despite this decline, the company continues to invest in antagonizing its workers rather than working toward a fair cooperative agreement.

Local 27 remains positive about the prospects of concluding negotiations with the company in the coming weeks and securing a first fair contract for workers at the Salisbury location.

“Federal law is federal law,” said Local 27 President Jason Chorpenning. “Workers have the right to organize without interference, intimidation or retaliation. These workers have stood together, exercised their rights, and are demanding a fair contract and basic respect. We will not tolerate violations of those rights.”

Local 27 emphasized that it will continue to aggressively defend the rights of its members and ensure that employers are held accountable under federal labor law.

For more information:
UFCW
www.ufcw.org

Cannabis News

Florida Republican Governor Candidates Are United In Opposing Marijuana Legalization

Published

1 day ago

May 7, 2026

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“I don’t support recreational marijuana. I think the current regulatory system around medicinal use is fine.”

Author: Mitch Perry, Phoenix, Florida

the subject of Should Florida legalize recreational cannabis? Smart & Safe Florida, the organization behind the initiative to return to voters this November, disappeared as a major campaign issue earlier this year after falling short of the nearly 880,000 verified petition signatures needed to qualify for the statewide ballot.

That defeat came a year and a half after nearly 56 Floridians voted to legalize recreational marijuana on the November 2024 ballot, a clear majority but far short of the 60 percent needed for passage.

While it’s not something voters will decide this year, Floridians may want to know where the candidates for statewide office stand.

Speaking at a “Business Women for Byron” campaign event Tuesday at the Getaway, a waterfront restaurant and Tiki bar in St. Petersburg, the first question an audience member asked GOP gubernatorial candidate Byron Donalds was his stance on the issue.

“I don’t condone recreational marijuana,” Donalds responded. “I think the current regulatory system around drug use is fine.”

Donalds has previously admitted to being arrested for possession of “a dime bag of marijuana” as a teenager, and recently admitted to CBS Miami he actually sold small amounts of cannabis in his youth.

Now he says he doesn’t support expanding legal weed use beyond the 924,820 Floridians listed as medical marijuana patients, according to the Office of Medical Marijuana Use.

Acceptance in medicine, but never for entertainment

Other Republicans running for governor share Donalds’ sentiments.

“I am against recreational marijuana in Florida,” investment firm CEO James Fishback told the Phoenix in a text message. “I’ve seen what it’s done in cities that have already tried it, from New York to Chicago to Washington DC. The stench of pot in public parks and outside our schools can never reach Florida.”

However, Fishback says he will always protect “the right of those who have a legitimate medical purpose, including our U.S. military veterans.”

“No one should be denied herbal medicine and pushed toward an addictive prescription from big pharma for painkillers,” she said. “As governor, I will support medical marijuana. But I won’t allow champs to smoke pot in a public park, just like we already don’t allow them to drink in one.”

“I’ve been clear from day one. I am totally opposed to legalizing marijuana,” Gov. Jay Collins said in a video posted on social media on April 26. “We’ve seen the impact in other states, and it’s not where Florida is headed. I’m with Governor DeSantis on this one. No compromise, and no money from the marijuana industry. That’s all my opponents can say.”

“I’m against recreational marijuana,” former House Speaker Paul Renner said Wednesday at a panel discussion on high energy prices in Hillsborough County.

“We have medical. It was put in the Constitution (in 2016). If people want to get it, they can get it. And we opened that up as much as needed, but I’m against recreation. Period. If it goes back to the ballot, like Gov. DeSantis did.”

DeSantis announced in June 2024 that he would use a political action committee to fight the constitutional amendment on recreational marijuana, saying he could not believe the Florida Supreme Court had agreed to allow the measure’s language to go on the November ballot.

He later used tens of millions of taxpayer dollars to campaign against that proposal and another measure that would have guaranteed abortion rights in Florida, according to a Tampa Bay Times report.

Where are the Democrats?

Phoenix caught up with the two top Democrats running for governor this year: former GOP U.S. Rep. David Jolly and Orange County Mayor Jerry Demings.

“I think the role of the governor is to represent the majority of the state, and the majority of the state asked for it, and I think we should,” Jolly told the Phoenix in a phone call Tuesday.

The Pinellas County Democrat says he voted against Amendment 3 in 2024, which would have called for the legalization of recreational marijuana use for adults.

But since announcing his candidacy last year, Jolly has emphasized that he will work to implement all of the recent constitutional amendments that have been approved by a majority in Florida, but have failed to reach the high margin of 60 percent needed to take advantage.

“Recreational marijuana received more than 50 percent of the vote in the constitutional amendment process and I would support enactment and introduce any amendment that received more than 50 percent of the vote in the legislature. That includes open primaries, recreational marijuana, and the 4th Amendment on reproductive freedom,” he said.

The only major gubernatorial candidate Phoenix couldn’t clear was Demings. While serving as Orlando’s police chief in the 2010s, Demings opposed constitutional amendments that would have legalized medical marijuana. 2014 and 2016

The Phoenix reached out to the Demings campaign by phone and email for two days this week, but did not receive a response. Calls to the phone number listed in the latest press release from the Demings campaign were answered by a recording that the person with the number did not have a voice mail system set up.

President Trump passed the 3rd Amendment

One prominent Florida Republican who supported the 3rd Amendment in 2024 was President Donald Trump.

“As I’ve said before, I believe it’s time to end the unnecessary arrests and incarcerations of adults for small amounts of marijuana for personal use. We also need to put smart rules in place, giving adults access to a safe and tested product,” Trump posted on Truth Social in September 2024. “Like Florida, I will vote YES on Amendment 3 in November.”

In that position, the president promised to work to make marijuana a Schedule I drug under the Controlled Substances Act if elected to the White House, which he did in an executive order in December.

The US Department of Justice announced last month that it would immediately move FDA-approved marijuana products, along with items regulated by a state medical marijuana license, under Title III. Medical cannabis falls under the category of controlled drugs that have a recognized medical use, such as Tylenol, and not Schedule I drugs, such as heroin and LSD, which have no medical use and a high potential for abuse.

This story was first published by the Florida Phoenix.

user photo Philip Steffan.

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