Let’s Do It! FDA to Fast-Track Review of 3 Psychedelic Drugs Following Trump Order
· Telemundo McAllen (KTLM)
The U.S. Food and Drug Administration (FDA) announced Friday that it will fast-track the review of three psychedelic drugs being developed to treat mental health conditions, including depression. This move follows President Donald Trump’s executive order directing the FDA and other federal agencies to accelerate research and ease restrictions on psychedelics, a class of hallucinogenic substances that remain illegal under federal law. The FDA has issued priority review vouchers to two companies studying psilocybin—the active ingredient in magic mushrooms—for treatment-resistant 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 the companies in its press release. “We owe it to our nation’s veterans and all Americans suffering from these conditions to urgently evaluate these potential therapies,” FDA Commissioner Marty Makary said in a statement. The recent measures on psychedelics reflect growing popular support for these mind-altering substances among Trump supporters, including combat veterans and followers of the Make America Healthy Again movement led by Health Secretary Robert F. Kennedy Jr. In July, Kennedy told Congress that his department aimed to make psychedelics available for hard-to-treat psychiatric conditions within a year. Key allies of Kennedy, including Calley Means, a former campaign team member and current senior health advisor, have publicly advocated for the therapeutic potential of psychedelics. The FDA’s special treatment of psychedelics is likely to reignite scrutiny of its Priority National Voucher program, which accelerates drug reviews. Some Democratic lawmakers have criticized the program, alleging that vouchers have been awarded to companies politically favored by the White House. Separately, the FDA has authorized initial trials of a drug related to ibogaine, a powerful psychedelic derived from an African shrub, for alcohol use disorder. Ibogaine is known to cause dangerous heart rhythms but has been adopted by combat veterans as a treatment for trauma and addiction. Florida-based pharmaceutical company DemeRx is leading the research on a metabolite of ibogaine, which reportedly lacks the hallucinogenic effects and risks of the original compound. During a White House event on psychedelics last Saturday, political allies of Trump were credited with elevating these drugs to the top of his agenda. Podcaster Joe Rogan, who attended the event, shared that he texted Trump about ibogaine, and the president responded: “Sounds great. Want FDA approval? Let’s do it.” Rogan’s endorsement of Trump days before the November 2024 election was seen as pivotal to his victory. Earlier this week, Rogan revealed on his show that he learned about ibogaine from his friend Ed Clay, a mixed martial arts trainer and entrepreneur who organizes retreats using the substance in Mexico. Most psychedelics, including LSD, psilocybin, and MDMA, are classified as Schedule I substances, meaning they are considered high-risk drugs with no accepted medical use. For decades, pharmaceutical companies avoided these substances due to the challenges of studying drugs that are federally illegal. However, dozens of small pharmaceutical firms, many backed by Silicon Valley investors, have recently joined the race to secure FDA approval for various psychedelics. Tech billionaire Peter Thiel, a political donor to Trump and Vice President JD Vance, has invested in AtaiBeckley, a company researching MDMA and other psychedelic compounds.