Letter Shows Feds are Gearing Up for Psychedelic Drug Approvals

A recently published letter (“Letter”) indicates that the Biden administration is preparing for the approval of psychedelic drugs and MDMA to treat mental illness and PTSD. This type of federal agency correspondence would have been unimaginable five or six years ago. Things are changing fast!

There are well-known potential health benefits of MDMA and psychedelics like psilocybin and LSD. These benefits lie at the heart of the Letter, sent by Miriam Delphin-Rittmon, Assistant Secretary for Mental health and Substance Use at the Substance Abuse and Mental Health Services Administration (SAMHSA), to Representative Madeleine Dean (D-PA). The letter was sent in May and notes that the Biden administration anticipates that MDMA and psilocybin will be approved by regulators within the next two years for PTSD and depression. We’ve been predicting a similar timeline for MDMA and psilocybin drugs going back to 2018 (see here and here).

Delphin-Rittmon, responding on behalf of Health and Human Services Secretary Xavier Becerra, also writes that therapies involving psychedelics “must be explored.” The letter further explains that the Biden administration is exploring the possibility of establishing a federal task force to monitor developments in psychedelic treatments and therapies.

In the letter, Delphin-Rittmon explains that 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.”

The Letter acknowledges Dean’s proposal for an interagency task force to, over the next two years, head a public-private partnership and address the complexities and potential issues of FDA approval of MDMA to treat PTSD and psilocybin to treat depression.

The move comes on the heels of a few significant breakthroughs this week and last regarding psychedelics law. On July 26, Senators Cory Booker (D-NJ) and Rand Paul (R-KY) introduced a bipartisan bill which would prevent the Drug Enforcement Agency (DEA) from barring terminally ill patients from using controlled substances that have passed early trials. Should the bill become law, terminally ill patients could be treated with psilocybin, which is currently a Schedule I controlled substance.

We also covered the DEA retreat on July 22 from its effort to add five psychedelic compounds to Schedule I of the Controlled Substances Act (CSA). DEA faced serious public opposition and threatened legal action from three companies, Mindstate, Tactogen, and Panacea Plant Sciences. This illustrates the growing momentum to view psychedelics as possible treatment strategies rather than demonized substances worthy of an absolute ban.

Overall, the Letter is significant for several reasons. First, it demonstrates that the current administration is eyeing a clear path for FDA to approve psychedelic drugs to treat mental health disorders, which shows just how much perspectives on psychedelics as a means of treating mental health disorders have come in the past few years. While jurisdictions have undertaken decriminalization of psychedelics or even kicked off local regulatory regimes (Oregon), a federal approvals of MDMA and psychedelics to treat PTSD and depression would be a whole other ballgame.

Second, this news offers hope to many suffering from mental health disorders. Whether it is a drug overdose death brought on by depression or a former service member that takes their own life due to PTSD, Delphin-Rittmon and Dawn believe that psychedelics can play a role in preventing fatalities in the United States—just as they have in other countries.

“It is impossible that we take no action,” said Dean. As psychedelic drugs and MDMA appear set to be approved to treat mental illness and PTSD, this is indeed  an exciting time to follow legal developments in the psychedelics space.