Overview
- The FDA, which on Friday issued national priority vouchers, set up ultra-fast reviews for two psilocybin depression programs and one methylone program for PTSD following Saturday’s executive order.
- The agency also cleared the first U.S. early-phase study of noribogaine, an ibogaine derivative, to test it for alcohol use disorder.
- Officials stressed the steps only speed process and do not show the drugs are safe or effective, and they said the FDA will prioritize projects with Breakthrough Therapy status.
- The companies were not named, and the 2025 voucher program can cut reviews from about 10 to 12 months to as little as weeks, according to agency statements and news reports.
- Researchers welcomed the faster path but warned of therapist shortages and high costs for supervised care, while critics said the voucher system lacked congressional input and could invite political or financial pressure.