President Donald Trump directed the FDA to provide Commissioner’s National Priority Vouchers to “appropriate psychedelic drugs” that have received the agency’s Breakthrough Therapy designation through an April 18 executive order, potentially cutting the review period for these drugs to 1–2 months and accelerating approval for serious mental health conditions. RBC Capital Markets stated in an April 19 note: “We see the signing of this EO as a substantial step towards diminishing regulatory risk in this emerging class of therapies, enabling investor comfort.”
The psychedelics industry has faced recent setbacks. In August 2024, the FDA rejected Lykos Therapeutics’ MDMA-assisted post-traumatic stress disorder drug due to selection bias. Earlier in 2026, Compass Pathways’ COMP360, a psilocybin drug for PTSD and treatment-resistant depression, was excluded from the initial list of Commissioner’s National Priority Voucher awardees despite being shortlisted.
Trump’s directive comes as the FDA continues to implement broader regulatory changes designed to accelerate drug development. The agency opened up use of “prior knowledge” for developers of cell and gene therapies, allowing companies to leverage publicly available information about manufacturing, non-clinical data, and clinical evidence in their submissions. The FDA also relaxed animal testing requirements for cancer biologics, recommending toxicology studies in a single rodent species where possible and offering alternatives including pharmacology studies and Weight of Evidence risk assessments.
Additional FDA policy shifts in 2026 include lifting suicide warnings from GLP-1 drug labels, implementing manufacturing carve-outs for cell and gene therapies, and positioning minimal residual disease as an endpoint for multiple myeloma trials. The agency also made the Regenerative Medicine Advanced Therapy designation available to investigational products even if they are on hold, a departure from previous guidance.
However, concerns about FDA politicization have surfaced. Critics point to controversial vaccine policy changes enacted by Health Secretary Robert F. Kennedy Jr. and question possible connections between the Commissioner’s National Priority Voucher program and other Trump administration priorities. In late January, Moderna halted all late-stage mRNA vaccine development for infectious diseases, citing policy headwinds in the U.S.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.biospace.com/fda/fda-policy-tracker-2026-priority-vouchers-questioned-prvs-return