On April 18th President Trump signed an Executive Order to advance clinical research for psychedelics, syndicated in more detail by Psychedelic States of America here. The order includes language to direct federal agencies to reduce regulatory barriers for FDA approval, prompting a wave of discussion within psychedelic networks, especially in regard to commercialization.
Posing for a photo with Joe Rogan, Trump’s Executive Order makes it easier for people with business sense to draw a line in the sand - not because of politics, or ideology, but because the business math isn’t mathing.
Regulatory barriers for FDA approval have been proven optional since the NIH Revitalization Act of 1993. Prescription drugs go to market all the time without going through the full FDA regulatory process. The Special Protocol Assessment allows for these agreements to be established prior to the research being conducted:
“The SPA is a process in which sponsors may ask to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal studies (i.e., a Request for SPA (hereafter Request); see section III., Eligible Protocols and General Information) to determine if they adequately address scientific and regulatory requirements for a study that could support marketing approval.”
In the case of the new drug application for MDMA involving Lykos Therapeutics and Johns Hopskins, the clinical data failed to meet the criteria lined out by the FDA as it relates to diversity in research, and a sexual assault was perpetrated against a research participant during a trial.
Still, despite the gravity of SA occurring in a regulated clinical session, and the failure to meet basic data requirements, anyone assuming that the MDMA new drug application was denied because of regulatory barriers is missing the point.
MAPS was founded in 1986 and has been raising funds for this cause for four decades. After forty years, one would assume an organization would come to the FDA table ready to get something done. Instead, the trials missed some of the most basic standards required for approval.
Hey investors and donors……… where’s your money at?
Furthermore, anyone assuming that regulatory approval provides sufficient legal cover also misses the point. Regulatory agencies set scientific standards and policy, and while they are supposed to also enforce those standards, enforcement is truly optional based on a myriad of factors. Approval, then, does not imply the drug application met the FDA’s standards, it means it can be sold on the prescription drug marketplace and prescribed by a provider. When injuries occur from drugs approved by the FDA, the drug manufacturer can still be held liable.
Ever heard of OxyContin?
In the current psychedelic research literature, we already know there are major gaps in clinical research data, we’ve already alerted Rick and friends, and we’ve already reported it to the FDA. Receiving FDA approval without meeting even the most basic FDA standards doesn’t insure companies from liability, it regulates who can sell it on the prescription drug marketplace and then leaves them open to liability for not meeting the standards set by the marketplace.
The Great Setup……..
Pro-Tips for Investors
Prescription drugs have been approved without meeting FDA standards for decades, evidenced by the gaps in women’s health research. Regulatory barriers aren’t the issue here.
Prohibition, alongside heavy marketing, is a great condition for profiteering.
Deeper due diligence on the organizations and individuals that have raised funds for psychedelic causes and have not shown adequate results and / or returns is prudent. There are organizations that need to be cut out of business deals. The narrative that people are getting left behind in the movement applies to their leadership teams.
Also, individuals who conduct business with known pedophiles and sex trafficking networks display little concern for risking their own reputation. Due diligence prior to investing or donating prevents them from risking yours.
Get Your Early Bird Tickets Now……..
Join us in Detroit at the Women in Entheogens Conference:
Heal a Woman, Heal a Nation Presents: Women & Entheogens — Rise of the Dark Feminine (Early Bird Ticket)
$195.00 USD
Join Mama Ayana for the 2026 Women & Entheogens gathering, a sacred convening rooted in healing, wisdom, and the rising power of the Dark Feminine.
The event is currently planned for Sunday, July 26th at Marygrove College in Detroit, though final confirmation of date and location is pending initial funding and venue deposit.
Your early bird ticket purchase directly supports securing the venue and bringing this gathering to life. In the event that the venue or date must shift, all ticket holders will be notified promptly with updated details.
Thank you for supporting women-centered entheogenic work and helping us build this space together.
