A Long Strange Trip: Companion Bills Would Facilitate Psychedelics Research

April 11, 2023By Larry K. Houck

Drugs and substances classified within schedule I of the federal Controlled Substances Act (“CSA”) by definition have a high potential for abuse, no currently accepted medical use in treatment in the United States, and lack accepted safety for use under medical supervision.  21 U.S.C. § 812(b)(1).  Last month bipartisan legislation, S. 689 and H. 1393 introduced in the Senate and the House, would facilitate removing barriers to research and compassionate use for schedule I controlled substances including the psychedelics psilocybin and 3,4-methylenedioxymethamphetamine (“MDMA”).

Senator Cory Booker (D-NJ), a co-sponsor of the Breakthrough Therapies Act in the Senate with Senator Rand Paul (R-KY), stated that MDMA and psilocybin “have shown exceptional promise in treating an array of mental health conditions, including treatment-resistant suicidal depression, anxiety, PTSD, and substance use disorders.”  Booker, Paul, Mace, Dean Introduce Bipartisan Legislation to Promote Research and Access to Potential Life Saving Drugs, Mar. 8, 2023.  Booker opined that the Act would expedite rescheduling schedule I substances that receive breakthrough therapy designation to schedule II that “with DEA oversight-will enable patient access and reduce the burden on further clinical investigation.”  Id.

On the House side, Representative Nancy Mace (R-SC), a cosponsor of the companion House bill with Madeleine Dean (D-PA), noted that MDMA and psilocybin research “has been so promising” that the Food and Drug Administration (“FDA”) designated them as “Breakthrough Therapies,” meaning that “they demonstrate substantial improvement over any currently available treatments with a clear demonstration of efficacy.”  Rep. Mace & Dean with Sen. Booker & Paul introduce the Breakthrough Therapies Act for Veterans and Patients, Mar. 7, 2023.

Mace cited recent research in the U.S. and United Kingdom demonstrating “significant medical benefits” of MDMA and psilocybin, noting that The New England Journal of Medicine published Phase 2b clinical trial results showing that a small dose of psilocybin caused remission of treatment-resistant depression in about 30% of patients.  Id.  Likewise, a 2020 National Center for PTSD study of MDMA use by military veterans led to significant reductions in suicidal thoughts, PTSD, depression, and anxiety.  Id.

The Breakthrough Therapies Act would facilitate access research with schedule I substances like MDMA and psilocybin by amending the CSA’s “currently accepted medical use with severe restrictions” criteria.  Id.  The Act would revise criteria to include the active ingredients of therapies that receive FDA Breakthrough Therapy Designation or Expanded Access approval “to treat patients with serious or life-threatening diseases for which no comparable or satisfactory therapies are available.”  S. 689, § 1 (to be codified at 21 U.S.C. § 802(a) (7)(A)).  With this definition, DEA would begin making findings necessary to transfer breakthrough therapies involving schedule I substances to schedule II for limited research and compassionate medical use.  Schedule II regulatory requirements for research are less restrictive than schedule I requirements, which require schedule I researchers to submit and receive approval of a research protocol with detailed information depending upon whether their research involves human or animal subjects.

The legislation, while loosening requirements for necessary MDMA, psilocybin, and other research, presents no increased risk of diversion of those substances from legitimate channels.  The Act would create an expedited process for DEA to transfer an Expanded Access drug from schedule II back to schedule I if the drug is placed on clinical hold.  Id.

If enacted, the Act would facilitate research, access to, and potential roll-out of promising psychedelic and other potentially lifesaving therapies via compassionate use pilot programs.

The bills were introduced in their respective chambers on March 7th, then referred to the Senate and House Committee on the Judiciary, and to the House Committee on Energy and Commerce.

The text of the bill can be found here.