Dr. Sunil Aggarwal of Seattle, Washington filed a petition with the DEA to reschedule psilocybin from Schedule I to Schedule II. This decrease in scheduling would increase the amount of studies conducted as well as increased access for physicians like Dr. Aggarwal. He runs Advanced Integrated Medical Science (AIMS), which works with end of life patients. Dr. Aggarwal, along with two terminally ill patients and Washington State, sued the DEA over the right-to-try (RTT) laws patients have both federally and in Washington.
RTT laws allow patients with terminally ill conditions to try investigational meds not currently available to the general public. This should include psilocybin, which has been researched by the FDA and other institutions. These studies say psilocybin has merit for improving mental health of patients.
However, Dr. Aggarwal’s lawsuit became dismissed on February 1 by the U.S. Court of Appeals for the Ninth Circuit on a technicality and lack of jurisdiction. In a published opinion, the court said, “AIMS’s issue is not with the DEA’s letter, but with the CSA’s criminalization of psilocybin use, subject to narrow exemptions. An advice letter recognizing that Congress has not yet made an exception to the CSA to allow for the legal use of psilocybin for therapeutic purposes is not an agency decision.”
Petition Submission
Following the lawsuit dismissal on February 2, Dr. Aggarwal, along with his lawyers, filed a petition to the DEA. There, they asked the DEA to reschedule psilocybin. Currently, psilocybin, along with other substances such as cannabis, are Schedule I drugs. Schedule I drugs do not have accepted medical use and have a high potential for abuse. However, Dr. Aggarwal’s petition argues that psilocybin doesn’t have a high potential for abuse. It became a Schedule I drug before research showed it had medical benefits.
“Although psilocybin should be rescheduled as a matter of law, it is also good policy,” the petition argues. “Rescheduling psilocybin will not make the substance widely available as a prescription medicine or as a drug of abuse. While rescheduling alone would not make psilocybin available as prescription medicine in interstate commerce, it would give the federal regulators maximum flexibility to work with state governments, as opposed to silently against them.
“For example,” the petition continued, “the federal government could create limited pilot programs to be administered in a state or allow state programs to organically grow with federal oversight or guidance. It is imperative that scientists be able to examine the risks and dangers of real-world psilocybin being used in these jurisdictions in real-time. By rescheduling psilocybin, DEA can relieve some of these burdens and participate in the process as a regulator.”
Rescheduling Importance
Rescheduling psilocybin would not only open up research opportunities, but also give patients in 41 states access to the psychedelic drug under the RTT laws. Psilocybin has shown great potential helping patients with anxiety and depression in studies conducted by the FDA. But researching Schedule I substances is hard. Nora Volkow is the director of the National Institute on Drug Abuse (NIDA), the top research official in the country. She stated recently even she is nervous researching Schedule I substances, like cannabis and psilocybin, because of the legal tape surrounding Schedule I substances.
Additionally, the Biden Administration made comments about making it easier to research Schedule I drugs. However there has been no follow up to these comments. Research remains restricted, which leaves patients wondering if they can consume psilocybin under RTT laws. Under these laws, patients should have access to use these investigative drugs. However, according to the DEA, RTT laws didn’t open up pathways for patients to try Schedule I substances.
Future
Even though Dr. Aggarwal’s petition may or may not receive approval. Activists pushing for reform has proven helpful in other states. Several cities in Washington, California, Massachusetts, and Michigan have decriminalized the possession of psychedelics, including psilocybin. Treating psychedelics as not harmful or dangerous to the public has led to fewer arrests among individuals. With less arrests, officers can focus their attention on more important cases, even helping communities severely affected by the war on drugs which psychedelics were a part of.
More and more people are speaking out in favor of psilocybin and other psychedelics. And it shows at the polls, where voters continue to vote for decriminalization and even legalization. Whether the DEA will reschedule psilocybin because of this petition is unknown. But the pressure is starting to mount. It will be interesting to see where this petition leads psilocybin and psychedelic use across the country.
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