Trump associates, including RFK Jr., advocate for approving psychedelic treatments
In a landscape of ongoing progress, the Food and Drug Administration (FDA) is carefully considering the therapeutic use of MDMA, commonly known as ecstasy, for depression, trauma, and similar conditions. However, final approval is yet to be granted.
A significant setback occurred in 2024 when the FDA rejected an application to approve MDMA for PTSD treatment. However, the situation has since evolved positively following key leadership changes and policy shifts. Robert F. Kennedy Jr., now Secretary of Health and Human Services (HHS), and HHS Commissioner Marty Makary, have expressed openness to psychedelic-assisted therapies, including MDMA, as part of Kennedy's "Make America Healthy Again" initiative.
The FDA's Center for Drug Evaluation and Research (CDER) recently hired Dr. Mike Davis, an expert in psychiatry and psychopharmacology, as deputy director. This appointment signals an agency-wide increased focus on reviewing psychedelic therapies efficiently and rigorously. Moreover, the Department of Health and Human Services has added legal expertise focused on psychedelic regulatory issues, reinforcing this momentum.
Meanwhile, outside the US, clinical trials and regulatory progress have been reported. For instance, in Australia, EMD Group has achieved Authorized Prescriber status from the Therapeutic Goods Administration (TGA) for MDMA-assisted therapy, delivering substantial improvements in PTSD symptoms and quality of life. They are scaling commercial delivery of these therapies following successful trial data, indicating international positive movement for MDMA therapeutics.
In the US, the FDA has yet to set a definitive approval date for MDMA for these indications but is expected to continue scheduling advisory committee meetings and Prescription Drug User Fee Act (PDUFA) dates for decision-making. The outlook suggests that 2025 could see important regulatory actions, although final approval is still pending.
On a different front, Ibogaine, another psychedelic, remains on the U.S. government's ultra-restrictive list of illegal, Schedule 1 drugs. However, the FDA and the U.S. Department of Health and Human Services have hired several new staffers with ties to the psychedelic movement, such as NIDA director Nora Volkow, who is funding an American drugmaker working to develop a safer, synthetic version of the drug.
The research grant for studying ibogaine's use, totalling $50 million, was passed with support from Texas' former GOP governor, Rick Perry, and combat veterans. Advocates in Texas are hoping to build a national movement to ease restrictions on researching ibogaine's use. Rick Perry, former Trump cabinet secretary and ex-governor, has thrown his support behind the effort to approve psychedelic therapy.
However, concerns have been raised about bypassing rigorous clinical trials and the potential for these drugs to be discredited if they appear to be rushed onto the market or are too closely linked with Kennedy, who is known for controversial views on vaccines, antidepressants, and fluoride. Some experts worry that such moves could set back the field and jeopardize patients.
As the debate continues, it is clear that the landscape for psychedelic therapies in America is evolving, with both progress and controversy shaping the future of these potentially transformative treatments.
- The Department of Health and Human Services, under the leadership of Robert F. Kennedy Jr. and HHS Commissioner Marty Makary, has shown openness to the use of MDMA for mental health treatments, such as PTSD, as part of Kennedy's "Make America Healthy Again" initiative.
- Despite concerns about bypassing rigorous clinical trials and potential discrediting of psychedelic therapies, strategic appointments within the FDA and the Department of Health and Human Services, like Dr. Mike Davis as deputy director and NIDA director Nora Volkow, are indicative of a growing focus on reviewing and developing therapies and treatments involving psychedelics like MDMA and Ibogaine.
