West Virginia And Mississippi Lawmakers Approve Psychedelics Bills To Fund Ibogaine Trials Toward FDA Approval

The West Virginia House of Delegates and Mississippi House of
Representatives have both approved bills to support research in hopes of
gaining federal Food and Drug Administration (FDA) approval for the
psychedelic ibogaine as a novel treatment option.

In West Virginia, the legislation from Del. Ryan Browning (R) unanimously
passed the House in a 96-0 vote on Thursday, sending it to the Senate for
consideration. The similar Mississippi legislation passed that
legislature’s House in an 111-1 vote earlier this month.

The research programs envisioned under both measures would focus on
supporting trials that look at ibogaine as a treatment option for opioid
use disorder, co-occurring substance use disorder and “any other
neurological or mental health conditions” for which the psychedelic
“demonstrates efficacy.”

Under the West Virginia bill, the secretary of the state Department of
Health would be tasked with issuing a notice of funding opportunities under
the program, allowing eligible applicants to submit their bids to
participate in the research initiative.

An eligible applicant must be a “for-profit, nonprofit, or public benefit
corporate entity that has the requisite organizational and financial
capacity” to conduct FDA drug development trials and seek approval from FDA
to develop ibogaine therapies.

They must also provide a “plan to establish a corporate presence in this
state and to promote and maintain ibogaine-related biomedical research,
development, treatment, manufacturing, and distribution in this state,”
according to the bill text.

The health department would need to create an advisory committee to review
and approve applications under the program, and that panel would need to be
comprised of “subject matter experts,” “philanthropic partners” and
“legislative designees.”

If an applicant is granted approval, they would need to submit an
investigational new drug (IND) to FDA and seek breakthrough therapy status
for ibogaine to expedite the drug development process.

“As soon as practicable after drug development trial sites are established…
the applicant shall begin a drug development trial to administer treatment
with ibogaine,” it says. “The secretary, in consultation with the selection
committee under §16-67-3 of this code, shall select an institutional review
board with a presence in this state to oversee and verify the drug
development trial research activity for scientific validation and
authentication under the requirements of” FDA.

With respect to funding, the state health secretary “may use money
appropriated to the secretary and money received as a gift, grant, or
donation to pay for a grant under this chapter.”

“The secretary may solicit and accept gifts, grants, and donations of any
kind and from any source for purposes of this section,” it says. “An
applicant selected to perform a drug development trial under this chapter
shall contribute toward the cost of developing the ibogaine treatment an
amount of money that is at least equal to the amount of money that the
applicant received in the form of a grant from the secretary.”

In Mississippi, the legislation calls for the establishment of a consortium
involving a drug developer, institution of higher education and hospital to
investigate the therapeutic efficacy of ibogaine.

“The lead institution of higher learning of a consortium shall submit to
the department a proposal for purposes of conducting an ibogaine drug
development clinical trial in accordance with this act,” it says.

The consortium would need to provide a “detailed plan to seek a
breakthrough therapy designation for ibogaine from the FDA” and a “proposal
to recognize this state’s commercial interest in all intellectual property
that may be generated over the course of the drug development clinical
trial.”


*— Marijuana Moment is tracking hundreds of cannabis, psychedelics and drug
policy bills in state legislatures and Congress this year. Patreon
supporters pledging at least $25/month get access to our interactive maps,
charts and hearing calendar so they don’t miss any developments.*


*Learn more about our marijuana bill tracker and become a supporter on
Patreon to get access. —*

Meanwhile, a top West Virginia GOP lawmaker recently said President Donald
Trump’s order to complete the process of federally rescheduling marijuana could
move the needle to enact cannabis reform in the state.

With proposals to legalize or decriminalize marijuana again on the table in
both chambers this session, House Speaker Roger Hanshaw (R) signaled that
there may be some bipartisan support for the legislation. He noted that
“we’ve had members of the Republican party” file adult-use legalization
bills similar to one that’s being sponsored by Del. Evan Hansen (D).

To what extent federal rescheduling could result in different outcome this
session is yet to be seen. Moving marijuana to Schedule III wouldn’t
federally legalize it, but lawmakers in several states have indicated that the
symbolic message behind the policy change could lend to actionable reform.

Pressure has been building in West Virginia to deliver on reform,
especially as the state’s medical cannabis patient population has faced
high prices that have driven some to buy from adult-use markets in
surrounding states.

West Virginia officials have also faced criticism for leaving millions in
medical marijuana tax and fee revenue unspent in the years since its
program launched, with the state’s treasurer expressing reservations given
the ongoing federal prohibition on cannabis that’s complicated banking
dynamics.

Prior to leaving office, then-Senate Majority Leader Craig Blair (R) said
in 2024 that legalizing marijuana in the state could help ease the state’s
crush of fatal fentanyl overdoses, predicting that the policy change will
come “sooner than later.”

Despite past surveys finding majority support among voters for the policy
change, marijuana legalization efforts have progressed slowly in West
Virginia.

In 2022, activists attempted to put decriminalization measures on two
municipal ballots in the state, but neither effort was ultimately
successful. Similar efforts were undertaken in four cities a year earlier,
but those efforts also fell short. In 2019, Salem voters rejected a similar
reform proposal at the ballot box.

Former Gov. Jim Justice (R), for his part, said in 2021 that although he
was not personally a fan of legalization, he would have supported the
reform if the legislature sent a bill to his desk.

*Photo courtesy of Flickr/Scamperdale.*

The post West Virginia And Mississippi Lawmakers Approve Psychedelics Bills
To Fund Ibogaine Trials Toward FDA Approval appeared first on Marijuana
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