Trump Orders FDA to Fast-Track Psychedelic Therapies Including Ibogaine for Mental Health Treatment

Joe Rogan, the influential podcaster known for his politically diverse audience, endorsed Donald Trump during the 2024 election. Rogan recently shared that he sent the president details about ibogaine, a psychedelic substance promoted as a highly effective treatment for addiction, post-traumatic stress disorder (PTSD), and other mental health conditions.

On the day Trump signed an executive order aimed at "accelerating medical treatments for serious mental illness," Rogan revealed the president’s response to his message. According to Rogan, Trump replied, "Sounds great. Do you want FDA approval? Let's do it."

Trump’s order does not guarantee ibogaine’s approval as a therapeutic tool but directs the Food and Drug Administration (FDA) to streamline the review process for "appropriate psychedelic drugs," including ibogaine. The order also allocates $50 million from existing funds to state programs investigating these treatments and mandates collaboration with the Department of Veterans Affairs on clinical trials.

Additionally, Trump’s directive instructs the FDA to facilitate access to psychedelics under the Right to Try Act. This law permits patients with life-threatening conditions to use investigational drugs after unsuccessful conventional treatments and if they cannot participate in clinical trials. However, ibogaine does not yet meet the requirement of having completed a Phase I clinical trial.

A $50 million research initiative approved by Texas legislators last year aims to bridge this gap by offering matching grants for privately funded studies. On the same day as Trump’s order, FDA Commissioner Marty Makary announced the agency had granted "the first iboga investigational new drug clearance," which will enable the first human trials of ibogaine in the United States.

Key Highlights of Trump’s Executive Order

• Directs the FDA to expedite the review process for psychedelic drugs like ibogaine.
• Allocates at least $50 million from existing funds to state programs researching psychedelic therapies.
• Mandates collaboration with the Department of Veterans Affairs on clinical trials.
• Instructs the FDA to facilitate access under the Right to Try Act, though ibogaine does not yet qualify.
• Establishes a voucher program for breakthrough therapies, including psychedelics, with a target review timeline of one to two months.

The order emphasizes the rising U.S. suicide rate over the past two decades and highlights the disproportionate impact on veterans. It positions ibogaine and other psychedelics as potential solutions for Americans battling severe mental illnesses.

The FDA has previously designated certain psychedelics, such as MDMA and psilocybin, as "breakthrough" therapies. This designation is intended to accelerate their review process, though it does not guarantee swift approval. Trump’s order goes further by instructing the FDA to issue national priority vouchers for psychedelics with breakthrough status. The voucher program, announced in June, aims for an ultra-fast regulatory review timeline of one to two months when aligned with national health priorities.

Makary confirmed that the FDA will issue vouchers for three psychedelics this week.

"I'm pleased to announce historic reforms to dramatically accelerate access to new medical research and treatments based on psychedelic drugs. In many cases, these experimental treatments offer hope where traditional therapies have failed."

Trump signed the executive order as part of a broader effort to address the mental health crisis in the U.S., particularly among veterans and individuals with treatment-resistant conditions.