The Hawaii Senate has approved a bill to create an advisory council to look into possible regulations to provide access to federal “breakthrough therapies” like psilocybin and MDMA.
The legislation from Rep. Adrian Tam (D), which previously moved through the House and has since been amended by Senate committees, passed the full chamber without discussion as part of a package of measures on the consent calendar on Tuesday. It now goes back to the House for concurrence.
Psychedelics reform has been a hot topic in the Aloha State this session, with numerous proposals being taken up in committee as lawmakers and state agencies work to advance research into the policy and science of entheogenic substances.
The bill that passed the Senate on Tuesday was recently amended to require, rather than allow, the state Department of Health (DOH) to establish the Breakthrough Therapy Designation Advisory Council. The department supported an earlier version that gave it the option to create such a panel; it’s unclear if the mandate language will affect its position on the legislation.
DOH separately provided neutral testimony on other psychedelics policy research proposals last month, and a representative said that the department felt it would be a “more meaningful” step for lawmakers to simply legalize substances like psilocybin and MDMA to prepare for their potential federal approval as medicines.
Descheduling would allow medical professionals to “more openly discuss their experiences” in their practices, and “the market will respond,” the DOH official said.
The department reiterated that position in written testimony in support of the legislation that was submitted last week prior to a Senate committee adopting the amendment to mandate an advisory council.
“For treatments with potentially broader application, a community conversation to prepare for the four- to six-year timeline post-Breakthrough Designation approval process is a prudent investment,” it said.
The governor’s Office of the Wellness and Resilience also testified in strong support for the measure.
“Research being conducted on the use of alternative therapies to treat mental health disorders have shown promising outcomes,” it said. “Creating the space to have this discussion in our state, sooner rather than later, will assist in making data-informed decisions about how we should address and resource attention on complex social issues, like mental health.”
“The proposed Breakthrough Therapy Designation Advisory Council will provide a dedicated venue to have these conversations, so when new therapies become known, a thorough review of the relevant research and literature can occur in a timely manner,” the office added.
The bill says that legislature finds that state officials “should be empowered to review relevant laws, regulations, and studies each time a breakthrough therapy designation is issued to review any new treatment intended for mental health or substance abuse to prepare the State for the treatment’s eventual approval by the federal Food and Drug Administration,”
Here’s what HB 1340 would accomplish as amended:
An advisory council would be created, tasked with exploring state and federal regulations on certain psychedelics, in addition to reviewing scientific literature related to using them for mental health treatment.
The council would need to assess FDA breakthrough therapies within three months of FDA giving the substance that designation.
Members of the council would need to include the OWR director, state attorney general, law enforcement director, legislative leadership and a physician. Others could be appointed by top lawmakers and the OWR director.
The body would need to examine the “requirements, specifications, and guidelines for a health care professional to prescribe and provide various treatments for patients who may benefit.”
No later than one year after convening, the council would need to submit a report, including any proposed legislation, to lawmakers with its findings.
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A Senate companion version from Sen. Chris Lee (D) passed the chamber last month and has been referred to a House committee.
Meanwhile, a Hawaii Senate-passed bill to legalize marijuana has stalled out in the House for the year—but advocates are shifting focus to 2024, hoping to enact the reform in the second half of the two-year legislative session.
The legislation from Sen. Joy San Buenaventura (D) cleared the Senate last month, and hopes were high that it’d make it through the House as well. But a hearing wasn’t scheduled before a deadline for bills that have been referred to three or more committees, meaning it will need to wait until next year to potentially advance further.
Legislators have worked to enact legalization in the Aloha State over several sessions, but while the reform was approved in the Senate in 2021, it stalled after failing to proceed past a House committee by a key deadline.
Advocates struggled under former Democratic governor, Dave Ige, who has resisted legalization, in part because he said he was reluctant to pass something that conflicts with federal law. That’s despite the fact that Hawaii has a medical marijuana system that allows people to grow and sell cannabis in contravention of broad federal prohibition.
But now that Gov. Josh Green (D) has been sworn in, activists are feeling emboldened. He said in November that he’d sign a bill to legalize cannabis for adults and already has ideas about how tax revenue from marijuana sales could be utilized.
Photo courtesy of Dick Culbert.