The Food and Drug Administration says it will offer ultra-fast review to three psychedelic drugs being studied for hard-to-treat mental health conditions, including major depression. The agency announced the move Friday, following an executive order by President Donald Trump calling for the agency to speed up access to the mind-altering drugs. The move reflects growing popular support for the psychedelics among Trump's supporters, including combat veterans and followers of the Make America Healthy Again movement. The FDA also greenlighted initial testing of a drug related to ibogaine, a potent psychedelic linked to dangerous heart rhythms.
The Food and Drug Administration is proposing a system for approving customized drugs and medical treatments for patients with rare or hard-to-treat diseases. The pathway laid out Monday is aimed to approving one-of-a-kind therapies, including those using emerging gene-editing technology. It's a shift long sought by patients, advocates and researchers focused on rare diseases, which often do not fit within the pharmaceutical industry's business model. For many rare diseases, drug companies have had little financial incentive to develop new treatments. The FDA proposal, if finalized, would codify a path for drugmakers and researchers to study and commercialize treatments without conducting large, expensive clinical trials.