TheFDAhas announced an "ultra-fast" review of three psychedelicdrugsaimed at treating mental health conditions including depression, signaling a significant commitment from the Trump administration to this experimental therapeutic approach.
PresidentDonald Trumpsigned an executive order last weekenddirecting the FDA and other federal agencies to accelerate access and ease restrictions onpsychedelics, a class of hallucinogenic drugs that remain illegal under federal law.
The FDA confirmed it has awarded priority review vouchers to two companies researchingpsilocybin– the active ingredient in magic mushrooms – for difficult-to-treat forms of depression.
A third company received a voucher for methylone, a drug related to MDMA, for post-traumatic stress disorder. The FDA did not disclose the names of these companies in its press release.
While these vouchers do not guarantee approval, they indicate that regulators will aim to shorten their review timeline from months to weeks.
These developments reflect growing public support for mind-altering substances among Trump’s supporters, including combat veterans and followers of the "Make America Healthy Again" movement, spearheaded by Health Secretary Robert F. Kennedy Jr.
Last July, Kennedy informed members of Congress that his department intended to make psychedelics available for hard-to-treat psychiatric conditions within a year.
Several of Kennedy’s key allies and staff are proponents of these drugs. Calley Means, a former Kennedy campaign staffer now serving as a senior health adviser, has previously written about the "mind-blowing" power of psychedelics and his plans to invest in companies developing them.
The FDA's special treatment for psychedelics is likely to intensify scrutiny of its Commissioner’s National Priority Voucher program, which expedites drug reviews. Democratic members of Congress have previously noted that vouchers have been granted to companies politically favored by the White House, including those that have agreed to reduce medication prices.
In a separate move, the FDA authorized initial testing of a drug related to ibogaine, a potent psychedelic derived from an African shrub, for individuals with alcohol use disorder.
Source: Drudge Report
