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The U.S. Drug Enforcement Administration (DEA) is claiming that a federal law that affords severely ill individuals the right to try investigational medications doesn’t apply to drugs classified under the Controlled Substances Act. This is in response to a lawsuit filed by a doctor in Washington state who sought permission to legally administer psilocybin as treatment for patients in end-of-life care with cancer.
The agency argues that because drugs classified under Schedule I are said to have no accepted medical use, the law prevents them from being dispensed, even by professionals.
The doctor in question, Dr. Sunil Aggarwal, has been pursuing a range of regulatory and legal pathways to permit his clinic to administer psilocybin in palliative care. The clinic, in collaboration with the Advanced Integrative Medical Science Institute, asserts that the Controlled Substances Act has to accommodate a path to allow the legal access to psychedelics such as psilocybin under federal and state right to try laws.
Right to try laws afford patients with terminal illnesses the chance to try investigational drugs that aren’t yet approved for use by the general public. The state of Washington adopted this law in 2017, with then President Donald Trump signing the federal act governing this law in 2018.
In the years that followed, the Advanced Integrative Medical Science Institute has presented the DEA with different proposals to legally grow or acquire psilocybin to treat patients under right to try laws. Despite being legal, the agency has shot down every proposal presented.
In its opening brief, the institute explained that the DEA had denied every request filed while failing to address the arguments Aggarwal had tabled supporting them. The brief further noted that the agency needed to provide reasons explaining why it was against granting the good doctor access to psilocybin under the Controlled Substances Act and right to try laws.
Thus far, Washington D.C. and eight other states have filed friend-of-the-court briefs supporting the institute’s efforts to use psilocybin under the aforementioned laws.
In its statement, the DEA argued that if Aggarwal wants to administer psilocybin to his patients, he will need to register as a scientist carrying out an approved project. The statement explained that this shall be handled by different federal agencies, noting that the secretary of health and human services via the U.S Food and Drug Administration (FDA) is tasked with determining if the research protocol for a certain project is worthy and whether applicants are competent and qualified to conduct them.
Psychedelics startups such as Seelos Therapeutics Inc. (NASDAQ: SEEL) will be following this case to see if court decisions can influence the future decisions of regulators, including the DEA, on matters of psychedelic policy implementation.
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