A letter from the Health and Human Services Department discloses the anticipated FDA approval of MDMA and psilocybin treatments.
AS TWIN MENTAL HEALTH and drug misuse crises kill thousands of people per week, the potential of psychedelic-assisted therapies “must be explored,” urges a federal letter on behalf of the U.S. health secretary and shared with The Intercept.
President Joe Biden’s administration “anticipates” that regulators will approve MDMA and psilocybin within the next two years for designated breakthrough therapies for PTSD and depression, respectively. The administration is “exploring the prospect of establishing a federal task force to monitor” the emerging psychedelic treatment ecosystem, according to the letter sent by Assistant Secretary for Mental Health and Substance Use Miriam Delphin-Rittmon to Rep. Madeleine Dean, D-Pa.
The May correspondence, not shared publicly until now, is the clearest indication yet that top officials are preparing for the approval of psychedelic drugs — demonized for decades after former President Richard Nixon sought means to attack the anti-Vietnam War counterculture in the late 1960s — which was arguably unthinkable even five years ago.
But as evidence grows of the healing potential of certain controlled substances, including many hallucinogens, the war on drugs in the U.S. is steadily being wound down. Late Friday, the Drug Enforcement Agency dropped plans to schedule several DMT analogues after facing serious opposition, including a legal threat from companies Mindstate, Tactogen, and Panacea Plant Sciences.
The move followed Thursday’s introduction of a bipartisan bill, co-sponsored by Sens. Cory Booker, D-N.J., and Rand Paul, R-Ky., to force the DEA to stop barring terminally ill patients from trying controlled drugs which have passed early trials. The right to try experimental therapies has been enshrined in federal law since 2018, but the DEA currently blocks its use among people with late-stage cancer who wish to be treated with psilocybin, a Schedule I controlled substance.
“Studies have shown that psilocybin produces substantial and sustained decreases in depression and anxiety among patients with life-threatening cancer,” Booker wrote in a statement tweeted Thursday. “While typically terminally ill patients are allowed to access drugs that are in FDA clinical trials, they are barred from accessing Schedule I drugs, despite their therapeutic potential.”
In the letter obtained by The Intercept, Delphin-Rittmon said that the Substance Abuse and Mental Health Services Administration, or SAMHSA, responding to Dean on behalf of Health and Human Services Secretary Xavier Becerra, “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.”
Dean had proposed an interagency task force, the letter notes, to lead a public-private partnership and address “the myriad of complex issues associated with the anticipated approval by the [FDA] of [MDMA] for the treatment of post-traumatic stress disorder and psilocybin for the treatment of depression within approximately 24 months.”
According to Delphin-Rittmon, SAMHSA and the assistant secretary for health are considering the establishment of such a task force including the private sector. “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,” she wrote.
Such a body would issue guidelines that assist states in addressing the complex clinical, regulatory, and public policy issues necessary for the deployment of MDMA- and psilocybin-assisted therapies. “This will increase our preparedness to implement this new form of treatment as safely, affordably, and equitably as possible into the health care system upon approval,” said Brett Waters, a New York-based attorney and founder of the psychedelic advocacy initiative Reason for Hope, which has concentrated its efforts on expediting the rollout of psychedelic therapies.
“Our case was simple: These treatments are coming through the FDA, and likely to be approved soon, so we should be taking proactive measures,” Waters said. “We hope to work with the Biden administration on a reasonable solution to this immoral policy failure.”
Even while millions of dollars in federal funding is directed toward psychedelic research and efforts within certain states — led by Oregon — seek to unravel anti-drug laws and provide treatments, many people have no time to waste.
“About 300 people a day from drug overdoses in this country,” Dean told The Intercept. “I call it a jetliner of souls every single day. We know the toll the loss of our loved ones takes on their immediate family and upon entire communities. My son Harry is now nine years, seven months into recovery for opioid addiction. This is a heart-wrenching crisis, and it’s time for bold, innovative solutions to save the lives of our children.”
More than 17 former U.S. service members are estimated to kill themselves per day as traumas from futile and damaging wars abroad over the past 20 years find scant respite through traditional avenues. But hundreds of veterans have traveled to Mexico, Costa Rica, and elsewhere in recent years for successful treatments with psychedelics to address war traumas.
“When you hear compelling testimonies from a retired army brigadier general and a retired three-star Marine Corps lieutenant general about the lives that have been saved by providing access to psychedelic-assisted therapy, it is impossible that we take no action,” Dean added.
Further legislation to widen access to psychedelics is soon to be deliberated, including one bill focused on research and pilot programs within the U.S. Department of Veterans Affairs. The bill would seek to help veterans receive psychedelic therapies within the United States, as many cannot afford to go abroad.
“We find it morally unacceptable that our nation’s Veterans should be forced to take such extreme, and often detrimentally expensive routes to potentially lifesaving interventions,” wrote retired U.S. Marine Corps Lt. Gen. Martin Steele, chief executive officer of Reason for Hope, in a letter supporting the Right to Try Clarification Act last week.
He said that for most veterans who have been able to access it, “psychedelic-assisted therapy has proved not only life-saving, but life-restoring,” and called Booker and Paul’s legislation “a small step in the right direction toward saving lives.”