U.S. FDA plans ultra-fast review of three psychedelic drugs following Trump directive

A grower cuts psilocybin mushrooms to prepare for distribution in Springfield, Ore., Monday, Aug. 14, 2023. (AP Photo/Craig Mitchelldyer, File)

WASHINGTON — The U.S. Food and Drug Administration said Friday it will offer ultra-fast review to three psychedelic drugs being developed to treat mental health conditions, including depression, the latest indication of the Trump administration’s commitment to the experimental treatment approach.

U.S. President Donald Trump signed an executive order last weekend directing the FDA and other federal agencies to speed access and loosen restrictions on psychedelics, a class of hallucinogenic drugs which remain illegal under federal law.

The FDA said it awarded priority review vouchers to two companies studying psilocybin — the active ingredient in magic mushrooms — for hard-to-treat forms of depression. A third company received a voucher for methylone, a drug related to MDMA, for post-traumatic stress disorder. The FDA did not name the companies in a press release announcing the vouchers.

The vouchers don’t guarantee approval, but instead mean that regulators will aim to shorten their review timeline from a period of months to weeks.

The recent moves on psychedelics reflect growing popular support for the mind-altering substances among Trump’s supporters, including combat veterans and followers of the Make America Healthy Again movement spearheaded by U.S. Health Secretary Robert F. Kennedy Jr.

Last July, Kennedy told members of Congress his department aimed to make psychedelics available for hard-to-treat psychiatric conditions within one year. Some of Kennedy’s top allies and staffers are proponents of the drugs.

Calley Means, a former Kennedy campaign staffer now serving as a senior health adviser, has previously written about the “mind-blowing” power of psychedelics and his plans to invest in companies developing the drugs.

‘Do you want FDA approval? Let’s do it.’

FDA’s special treatment for psychedelics is likely to renew scrutiny of its program for speeding up drug reviews, known as the Commissioner’s National Priority Voucher program.

Democratic members of Congress have noted that vouchers have gone to companies that are politically favoured by the White House, including those that have agreed to cut prices on their medications.

In a separate move, the FDA authorized initial testing of a drug related to ibogaine, a powerful psychedelic made from an African shrub, for people with alcohol use disorder. Ibogaine is known to sometimes cause dangerous heart rhythms but has been embraced by combat veterans as a way to treat trauma and addiction.

The drugmaker, DemeRx, is led by a Florida-based researcher who first began studying ibogaine in the 1990s, before federal health officials pulled public funding for the work. DemeRx’s drug is a metabolite of ibogaine, and the company says it doesn’t carry the same risks as the original drug.

Saturday’s White House event on psychedelics suggested Trump’s political allies had a role in pushing the drugs to the top of his agenda.

Joe Rogan, the podcaster who appeared at the Oval Office event, said he texted Trump about the psychedelic ibogaine, which he’s repeatedly discussed on his show. According to Rogan, the president quickly responded: “Sounds great. Do you want FDA approval? Let’s do it.”

Rogan’s endorsement of Trump days before the November 2024 election was seen by White House aides as a key factor in his election victory.

On his show earlier this week, Rogan said he learned about ibogaine from his friend Ed Clay, a mixed martial arts trainer and entrepreneur who runs retreats making use of it in Mexico.

Virtually all psychedelics, including LSD, psilocybin and MDMA are classified as Schedule I substances, a category for high-risk drugs that have no medically accepted use.

For decades, drugmakers steered clear of the substances due to the difficulties of studying drugs that are illegal under federal law.

But dozens of small drugmakers, many fuelled by Silicon Valley investors, have recently jumped into the race to win FDA approval for various psychedelics. For example, tech billionaire Peter Thiel — who has made political donations to both Trump and U.S. Vice-President JD Vance — has invested in AtaiBeckley, a company studying MDMA and other psychedelic compounds.

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Matthew Perrone, The Associated Press

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