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Biden Administration Readies for Potential FDA Approval of Psychedelics for Therapeutic Use

In recent weeks, lawmakers across the country have proposed legislation to legalize the therapeutic use of psychedelics, even bringing legislation to both houses of congress, in what has become a steady trickle of rocks tumbling down the hill toward legalization. 

Now, it appears a landslide may be on the horizon.

Recently revealed correspondence between federal officials shows that the Biden administration is actively exploring the possibility of a task force to “address the myriad of complex issues” that comes with legalizing new treatments for mental health. The letter specifically mentions the “anticipated” approval of MDMA and psilocybin by the Food and Drug Administration, and sets the scene for a dramatic shift in how these substances are treated by the United States government. 

The letter, which was first reported by The Intercept, is from Assistant Secretary for Mental Health and Substance Use Miriam Delphin-Rittmon, and addresses a request by Rep. Madeline Dean (D-PA). Delphin-Rittmon indicated in the letter that the issue of emerging treatments has been referred to the Substance Abuse and Mental Health Services Administration (SAMHSA), and that she agrees the future of these treatments is best suited by a “public-private partnership” to navigate the legalization hurdles ahead. 

“Collaboration across federal agencies with outside stakeholders will be the most effective way to ensure we are thoughtfully coordinating work on emerging substances such as MDMA and psilocybin,” the letter read. 

Specifically, the letter references a 24-month timetable for the expected approval of MDMA as a treatment for PTSD and psilocybin as a treatment for depression. 

“SAMHSA agrees that too many Americans are suffering from mental health and substance use issues, which have been exacerbated by the ongoing COVID-19 pandemic, and that we must explore the potential of psychedelic-assisted therapies to address this crisis.”

To help ease this crisis, Delphin-Rittmon said it will require “a broad-spectrum interdisciplinary stakeholder approach to effectively tackle the complexity of issues that stakeholders anticipate will arise with their introduction.” The letter goes on to list harm reduction, risk mitigation and safety monitoring as potential areas the task force could address, and said it will take collaboration across agencies to handle potential legal uses of “emerging substances.” 

With the revelation of the Biden administration’s plans, the waiting game now begins to see which shoe will drop first: Whether this task force will be created in time before the FDA approves either of the substances for medical use. 

Last year, the Multidisciplinary Association of Psychedelic Studies (MAPS) announced it was releasing data for its Phase 3 trials for MDMA use among PTSD patients. Last month, MAPS moved forward with a “first-of-its-kind” group therapy after a clinical halt by the FDA held up the effort. 

The data gives an insight into why government agencies are readying for the potential of FDA approval. In the Phase 3 trials, 67 percent of patients no longer qualified for PTSD diagnosis two months after treatment began, and 88 percent in the test group saw a reduction in symptoms. 

Those results, as well as other preliminary research, has also led to a surge in support for these substances in Congress.

Earlier this month, Senators Cory Booker (D-NJ) and Rand Paul (R-KY) co-sponsored legislation to clarify that terminally ill patients have access to psychedelic treatments. That built on momentum created by a pair of amendments that were included in the House’s annual renewal of the National Defense Authorization Act. The amendments, which were proposed by members on each side of the political aisle, hoped to research the potential for psychedelics as a treatment option for veterans. 

Those efforts have been matched by a proposed ballot measure in Colorado, and a New Jersey state legislator introducing a bill to legalize psychedelic treatments as states race to catch Oregon, the first state to legalize psilocybin for medical uses. 

Across the map, at every level of government, the United States is now looking into how psychedelics can be used to help address the mental health “crisis” currently affecting America. And while many are still hesitant to accept these emerging substances, voices on both sides of the aisle have made their case for reconsidering how psychedelics are treated in this country.

“Many hear the word psychedelics and they think ‘acid trips from the 60s’,” said Rep. Dan Crenshaw (R-Tex), who sponsored one of the pro-psychedelic House amendments. “And they believe this amendment would legalize or deschedule psychedelics, but that is not what we are talking about here.”

“What we’re talking about is the proven use of psychedelics to treat PTSD.”  

Author

  • Patrick Radigan is a recovering sports journalist who had his eyes opened to the world of drug policy reform while covering a court case of a cannabis consultant found not guilty on trumped up possession charges. Since that case, he's covered legalization issues in multiple states, monitored tribal movements in the legal cannabis space and is now turning his attention to the wide spectrum of legalization and policy matters surrounding natural medicine alternatives. Patrick has written stories for newsprint, shot video for television news and got his start covering biofuels and soil science for a climate magazine. Originally from South Dakota, Pat earned a pair of journalism degrees from the University of Nebraska-Lincoln, and now resides in Colorado.