Texas Governor Signs Psychedelics Bill Aimed At Developing Ibogaine Into An FDA-Approved Drug

Texas Gov. Greg Abbott (R) has signed into law a bill to create a
state-backed research consortium to conduct clinical trials on ibogaine as
a possible treatment for substance use disorders and other mental health
conditions. The ultimate goal of the project is to develop the psychedelic
into a prescription drug with U.S. Food and Drug Administration (FDA)
approval, with the state retaining a portion of the profit.

“Texas is now leading the way in the United States for the evaluation of
ibogaine as a potential medication that can help improve the lives of so
many Americans,” the governor said at a signing event on Wednesday. He
called the psychedelic “a therapy that has shown great promise in treating”
conditions such as depression, PTSD and opioid use disorder.

“I’m about to sign a law that will lead to an FDA-approved drug development
clinical trial that will seek approval of ibogaine as a medication for the
treatment of opioid use disorder and other behavioral health conditions,
especially those suffered by our veterans,” he added. “Texas will invest
$50 million to support this research, and these funds can be matched by
grants and private investments.”

Under the new law, approved by the state legislature earlier this month,
Texas will retain a commercial interest in “all intellectual property that
may be generated over the course of the drug development clinical trials,”
the legislation says, with an aim of making Texas a hub for
“ibogaine-related biomedical research, development, treatment,
manufacturing, and distribution.”

A quarter of revenue taken in by the state from any resulting intellectual
property would fund veterans programs.

House Speaker Dustin Burroughs (R) said at the event that while he knew
little about ibogaine before the session began, lawmakers “heard story
after story” from people who said the therapy had improved their lives.

“It made an impact,” he said, “and slowly, as session went on, the members
of the Texas House, members of the Senate, began to agree that this was
worth the next step. It was worth investing in and…seeing if we could do
something to bring this to more people.”

Bill sponsor Sen. Tan Parker (R) said the new law “is about the opportunity
to restore the lives of so many veterans that have put their lives on the
line for all of us.”

“We’re incredibly excited to take this step. There’s nothing more important
than protecting our veterans and our public at large,” Parker said. “This
will have benefits for everyone if the clinical trial is successful, as we
believe it will be.”

As for what happens next, he said that “within 60 days,” the state is
expected to start receiving proposals from institutions and organizations
to be part of the consortium.

“The money that Texas is investing will only be put in based on a match,
based on private funds being contributed by people that have great
expertise,” he continued. “So we’re looking forward to that
consortium…coming forward, and again, we’ll be receiving those proposals 60
days from now.”

Along with the legislation’s goal of winning FDA approval as a clinical
treatment, the bill says it also seeks “a breakthrough therapy designation
for ibogaine”—a designation FDA gives to emerging treatment options that
haven’t yet secured agency approval to treat a particular condition.

After the House and Senate passed separate versions of the measure, it was
amended by a bicameral conference committee. The compromise legislation
passed the Senate on a 26–5 vote and the House 134–4.

Rather than create a state grant program to support research on the
psychedelic, as previous forms of the bill would have done, the compromise
version of the bill establishes a “consortium”—including an institution of
higher education, a hospital and a drug developer—to develop and test
ibogaine drugs in an effort to secure FDA approval.

The educational institution would serve as the consortium’s leader,
representing the group to the state Health and Human Services Commission
(HHSC) and handling administrative functions. It would further be
responsible for submitting “a proposal and request for funding on behalf of
the consortium for purposes of conducting ibogaine drug development
clinical trials in accordance with this subchapter.”


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The program is set to be funded through a $50 million appropriation from
the state general fund, which would go to HHSC for disbursement to cover
the drug development trials, according to a conference committee report for SB
1, a massive state budget bill. Private gifts, grants and donations would
also be accepted.

“Initially, no state funding was appropriated for the initiative,” sponsor
Parker explained to colleagues earlier this month. “However, that has now
changed.”

A fiscal note on the final conference committee bill says HHSC will need to
appropriate money “to fund the consortium’s clinical trials, but the cost
of such funding is unknown at this time.”

As for revenue stemming from intellectual property resulting from the
research and new drug development, the analysis says the amount “is
indeterminate and would be dependent on the drug development trials.”

Revenue from the project would flow into Texas’s general fund, and from
there 25 percent would be earmarked “only to programs that assist veterans
in this state.”

Rep. Greg Bonnen (R) said on the House floor before the vote on the
proposal that said “the state will have negotiated for royalties at a
minimum of 20 percent.”

Reformers have cheered the legislation. Bryan Hubbard, executive director
of the American Ibogaine Initiative and an architect of the bill, said of
the final version that “I have to give the legislature an A across the
board.”

“I think that it can stand up as a national model for other states that
wish to replicate it in some form or fashion,” he said in an interview with
Marijuana Moment after the bill’s passage in the legislature, thanking in
particular sponsors Parker and Rep. Cody Harris (R) as well as House
Speaker Burroughs and Lt. Gov. Dan Patrick (R), who presides over the
Senate.

“Without the courage and vision of those four individuals, none of this
would have happened,” Hubbard said, “and I am forever grateful to Texas
leadership for making this, in my estimation, one of the greatest single
achievements in the history of the of the American psychedelic movement.”

Hubbard said at the time that he believes the state having a vested
interest in intellectual property produced by the research will ensure
Texans see “a perpetual return on their investment.”

“Most Americans, I believe, have had enough of public dollars going into
the pockets of private corporations with no return on investment for the
taxpayer,” he said. “With the way in which Texas has set this project up,
Texas taxpayers are going to be fully vested partners in this endeavor, and
the people of Texas will see—if we are successful—perpetual return on their
investment that will hopefully be used to assure universal treatment access
through a top-notch, ibogaine-based treatment and recovery system as time
and circumstances evolve.”

An earlier analysis of the legislation said that opioid use disorder
(OUD) “continues to be one of the most insidious threats to public health
of our time, devastating individuals, families, and communities across
Texas and our nation,” and “current treatment options are often
unsuccessful in treating OUD and lives are lost as a result.”

Hubbard noted that the new Texas plan is similar to an ibogaine research
proposal a few years ago in Kentucky that he also helped design. That bill
would have distributed at least $42 million in funding for research into
ibogaine’s potential to treat opioid addiction.

The effort fell through in late 2023 after the state’s new attorney general
replaced Hubbard, who was then serving as chair of the Kentucky Opioid
Commission, with a former Drug Enforcement Administration (DEA) official.

Last year advocates tried to enact a similar plan in Ohio.

“The legislation that you see is the Kentucky plan as implemented by the
state of Texas,” Hubbard said. In terms of the consortium, the way that
they have set this up is to create a cooperation framework on the front end
that I had always envisioned occurring on the back end.”

“When this program was designed for Kentucky, I had in mind that we would
essentially send out an RFP [request for proposals] for a drug developer,
send out an RFP for a trial site, and to pick the best. And to pair the
drug developer with trial science on the back end,” he explained.

“In the Texas framework, this is a cooperative partnership that will have
to be built on the front end by those who want to be able to pursue this
opportunity,” Hubbard continued. “There is a role for both universities and
private hospitals, which is important because they each have significant
things to contribute.”

HHSC will retain control over the consortium, he said, “and the reason that
that legal authority needs to be there is because you want the absolute
best drug developer and you want the absolute best aggregation of trial
sites within Texas, who can make sure that these trials are done safely,
efficiently and effectively.”

Meanwhile in Texas, a new statewide poll finds that Republican primary
voters oppose a separate proposal to ban hemp products containing THC that
lawmakers recent sent to the governor’s desk.

While Abbott has declined to say how he’ll act on SB 3—which advocates and
stakeholders say would decimate the state’s hemp industry—the policy change
evidently isn’t being embraced by voters, including a plurality of
Republicans (47 percent) who voiced opposition, said the survey, from
Ragnar Research Partners and commissioned the Texas Hemp Business Council
(THBC).

Military veterans advocates, including Texas Veterans of Foreign Wars, have
called on the governor to veto the hemp ban, saying it “would cause
irreversible harm to communities across the state.”

Farmers have also said the prohibition would devastate a key sector of the
state’s agriculture industry.

Last month, the Texas House also passed a pair of bills designed to ensure
speedy access to psychedelic-assisted therapy in the event of FDA approval,
but they did not clear the Senate by the end of the session.

More recently, lawmakers passed a bill to significantly expand the state’s
medical marijuana program, sending it to the governor.

The measure would expand the state’s list of medical cannabis qualifying
conditions to include chronic pain, traumatic brain injury (TBI), Crohn’s
disease and other inflammatory bowel diseases, while also allowing
end-of-life patients in palliative or hospice care to use marijuana.

Separately, a House committee approved a Senate-passed bill last month that
would prohibit cities from putting any citizen initiative on local ballots
that would decriminalize marijuana or other controlled substances—as
several localities have already done despite lawsuits from the state
attorney general.

Under the proposal, state law would be amended to say that local entities
“may not place an item on a ballot, including a municipal charter or
charter amendment, that would provide that the local entity will not fully
enforce” state drug laws.

While several courts have previously upheld local cannabis
decriminalization laws, an appellate court comprised of three conservative
justices appointed by the governor has recently pushed back against two of
those rulings, siding with the state in its legal challenge to the
marijuana policy in Austin and San Marcos.

Despite the ongoing litigation and advancement of the House and Senate
bills, Texas activists have their targets set on yet another city, Kyle,
where they hope put an initiative before voters to enact local marijuana
reform at the ballot this coming November.

A recent poll found that four in five Texas voters want to see marijuana
legalized in some form, and most also want to see regulations around
cannabis relaxed.

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*Photo courtesy of Flickr/Scamperdale.*

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