On Monday, the U.S. Food and Drug Administration “announced a request for information describing approaches the agency is considering for the design of early-phase clinical trials of ibogaine drug products.” It’s now seeking public input on those approaches.
The announcement is in the wake of President Donald Trump’s April 2026 executive order accelerating medical treatments for serious mental illness.
In New York, advocates are pushing state lawmakers to approve a proposal that would “modernize” the state’s approval process for these types of treatments.
“It’s no secret that we’ve been navigating a mental health crisis,” said Win Thurlow, executive director of LifeSciencesNY. “Too many New Yorkers are suffering and existing solutions just don’t work for everyone.”
Thurlow says “it’s been several decades since we’ve seen a new medication approved” for mental health conditions including “general anxiety disorder and depression.”
And with encouraging developments with psychedelic compounds as treatment options, he says it’s time for New York state to act.
“We’re urging legislators in New York to ensure that once the FDA reschedules these drugs that they’ll be available in New York as well,” said Thurlow.
LifeSciencesNY is part of a coalition of different agencies that sent a letter to the New York state Legislature in June urging lawmakers to pass the Access to Innovative Mental Health Treatments Act.
The measure was introduced in both the state Senate and Assembly.
Democratic Assemblymember Patrick Burke is sponsoring it in his chamber.
“The research is pretty clear,” said Burke. “For PTSD, anxiety, depression, and several other issues, psilocybin and other psychedelic medicines help tremendously.”
Burke says he’s been working on this measure for six years in trying to get it across the finish line.
“The opportunity to do something is now,” he said. “I actually genuinely believe if the budget wasn’t jammed up last year that we had a real, real good opportunity to pass this in last year’s session.”
In a statement to Spectrum News 1, state Senate sponsor Jessica Scarcella-Spanton said in part:
“As our nation’s healthcare and mental health treatment solutions evolve, New York’s Public Health Law must follow suit. Once a treatment option is approved by the FDA and rescheduled by the U.S. Drug Enforcement Administration, New Yorkers who could benefit from it should have access to it. My legislation addresses the gap in state law that currently prevents people across our state from receiving the most innovative treatment options. As Chair of the NYS Senate Committee on Veterans, Homeland Security, and Military Affairs, I’ve seen how critical access to diverse treatment options is for our veterans — especially those dealing with mental health issues — and this will be a step towards helping them receive the most modern therapies available.”