US DEA Facing Fresh Lawsuits After Denying Psilocybin Waiver, Rescheduling Request

For more than a year, a palliative care specialist has been fighting to be granted permission by the U.S. Drug Enforcement Administration (DEA) to administer psilocybin to his patients. Dr. Sunil Aggarwal had requested a federal waiver under the Right to Try statute, which would have allowed him to administer the psychedelic to his patients with terminal illnesses.

Aggarwal explained that Right to Try laws clearly stipulate that severely ill individuals qualified for investigational drugs, including psychedelics. However, the DEA rejected the request as well as a petition the doctor filed to reschedule psilocybin. In its argument, the federal agency states that this particular statute only discusses exemptions under the Federal Food, Drug and Cosmetic Act, which means that it does not have implications for the Controlled Substances Act.

The latest denial was announced in a letter, with the DEA stating that the FDA had not permitted the use of psilocybin as a medicine, which meant that it was still classified as a Schedule I substance under the Controlled Substances Act. This rejection letter doesn’t address the main point of Aggarwal’s petition, however, which is that the FDA has awarded breakthrough therapy designation to psilocybin for its use in treating severe depression. Last week, the physician’s attorneys challenged this rejection by the federal agency in the U.S. Court of Appeals for the Ninth Circuit. Opening briefs are due from the petitioners and the respondents on Jan. 9, 2023, and Feb. 7, 2023, respectively.

Aggarwal and his counsel have also submitted requests for various documents under the Freedom of Information Act in a bid to better understand the administrative process of the Drug Enforcement Administration. They have, in the past, accused the federal agency of purposely delaying the processing of these requests.

In addition to the ongoing litigation, the DEA is facing increased pressure from bipartisan legislators who filed measures in the Senate and House earlier this year to reaffirm that the scope of the Right to Try statute should include drugs classified under Schedule I.

The bill would make an amendment to the text of the current statute, with the primary objective being to clarify that the statute allows terminally ill patients to use investigational drugs even if they are controlled substances, as long as they have undergone clinical trials.

These companion measures were filed roughly six months after bipartisan legislators penned a letter to the DEA requesting that patients with terminal illnesses be permitted to use psilocybin as an investigational therapy without any legal repercussions.

Psychedelics companies such as Atai Life Sciences N.V. (NASDAQ: ATAI) are likely to watch closely as pioneering doctors such as Aggarwal battle to help terminally ill patients despite the DEA dragging its feet on the matter.

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