US FDA plans ultra-fast review of 3 psychedelic drugs after Trump directive
Priority review vouchers could cut approval timelines from months to weeks for psilocybin and MDMA-related drugs.
The US Food and Drug Administration (FDA) announced on Friday it will offer ultra-fast review to three psychedelic drugs being developed to treat mental health conditions, including depression and post-traumatic stress disorder (PTSD). This marks the latest indication of the Trump administration's commitment to experimental treatment approaches. 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 that remain illegal under federal law.
The FDA 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 methylene, a drug related to MDMA, for PTSD. The FDA did not name the companies in a press release announcing the vouchers. The vouchers do not guarantee approval but instead mean regulators will aim to shorten their review timeline from a period of months to weeks. The recent moves reflect growing popular support for psychedelics among Trump's supporters, including combat veterans and followers of the Make America Healthy Again movement spearheaded by Health Secretary Robert F. Kennedy Jr.
- FDA awarded priority review vouchers to two companies studying psilocybin for hard-to-treat depression and one studying methylene (MDMA-related) for PTSD.
- Vouchers shorten FDA review timeline from months to weeks but do not guarantee drug approval.
- Trump's executive order directs federal agencies to speed access and loosen restrictions on psychedelics, which remain federally illegal.
Why It Matters
This could dramatically accelerate access to novel treatments for millions with treatment-resistant depression and PTSD.