FDA plans ultra-fast review of three psychedelic drugs following Trump
directive
[April 25, 2026]
By MATTHEW PERRONE
WASHINGTON (AP) — The 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 step by
the Trump administration toward possible approval of the experimental
treatments.
President Donald Trump signed an executive order last weekend directing
the FDA and other federal agencies to speed research 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 news.
“We owe it to our nation’s veterans and all Americans who are suffering
from these conditions to evaluate these potential therapies with
urgency,” FDA Commissioner Marty Makary said in a statement.
The vouchers don’t guarantee approval, but instead mean that regulators
will try to shorten their reviews 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 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.
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 favored 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 as a treatment for cocaine addiction in the
1990s, before federal health officials pulled funding for the work.
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A grower cuts psilocybin mushrooms to prepare for distribution in
Springfield, Ore., Monday, Aug. 14, 2023. (AP Photo/Craig
Mitchelldyer, File)
“Every grant proposal that I submitted to (the National Institute on
Drug Abuse) was rejected,” Deborah Mash, a neurologist and founder of
DemeRx, told The Associated Press. “I couldn't get that funding and
that's why ibogaine didn't advance in the 1990s.”
Ibogaine is known to cause intense hallucinations, nausea, vomiting,
tremors and sometimes dangerous irregular heart rhythms. Mash says
DemeRx’s drug is a metabolite of ibogaine, and doesn't carry the same
hallucinogenic effects or 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 fueled 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 Vice President JD Vance — has
invested in AtaiBeckley, a company studying MDMA and other psychedelic
compounds.
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