FDA Fast-Tracks Psychedelic Drugs for Depression: Potential Approval by Summer 2021

The Trump administration is accelerating the approval process for psychedelic drugs to address America’s mental health crisis. On Friday, April 24, the FDA granted an expedited review to three experimental psychedelic treatments, issuing priority vouchers to three unnamed companies.

Two of the companies are expected to research psilocybin—a compound found in “magic mushrooms”—as a treatment for depression. The third company will study methylone, a stimulant similar to MDMA, for potential use in treating PTSD.

These priority vouchers significantly shorten the FDA’s review process from the standard 10 to 12 months to just one to two months. This expedited timeline could bring FDA-approved psychedelic treatments to market as soon as this summer.

Psychedelics and the Mental Health Crisis

FDA Commissioner Marty Makary emphasized the potential of psychedelics in a press release, stating:

“Psychedelics have the potential to address the nation’s mental health crisis, including conditions like treatment-resistant depression, alcoholism, and other serious mental health and substance abuse conditions.”

Historically, research into psychedelics has been limited due to their illegal status in the U.S. However, the Trump administration’s shift toward pro-drug research policies is changing the landscape.

Trump’s Executive Order and Marijuana Reclassification

The FDA’s fast-tracked approval for psychedelic research follows a broader push from the Trump administration. On Monday, April 18, President Donald Trump signed an executive order directing the FDA commissioner to grant priority vouchers to psychedelic drugs that receive Breakthrough Therapy designations. The goal was to “ensure that red tape does not delay the FDA’s gold standard review of any potential therapy.”

Beyond psychedelics, the administration is also advancing policies to make marijuana more accessible for medical research. On Thursday, April 23, the Justice Department announced a hearing scheduled for June 29 to reclassify marijuana from a Schedule I drug to a Schedule II drug.

Schedule I drugs, which include heroin, ecstasy, and LSD, are considered highly dangerous with no accepted medical use. Schedule II drugs, by contrast, have a recognized medical use but still carry a risk of abuse. This reclassification would ease restrictions on marijuana research and bring the U.S. closer to federal legalization.

The FDA’s New Priority Voucher Program

The expedited review process is part of the Commissioner’s National Priority Voucher (CNPV) program, launched in June 2025. Makary explained the program’s purpose at the time:

“Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the drug application before a clinical trial is complete so that we can reduce inefficiencies. The ultimate goal is to bring more cures and meaningful treatments to the American public.”

The CNPV program has faced criticism, however. It was implemented without Congress’s approval, raising concerns that pharmaceutical companies could exploit the system by contributing financially to secure vouchers. Experts stress that even with expedited approvals, rigorous research must remain a priority in drug trials.

Dr. Peg Nopoulos, chair of the University of Iowa’s psychiatry department, told NBC News that she is “happy