Against the backdrop of evolving state regulatory landscapes for controlled substances, including psychedelics for therapeutic uses, the US Food and Drug Administration (FDA) recently released a draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations – Guidance for Industry. FDA is soliciting comments to this draft guidance through August 25, 2023.
This draft guidance represents a tremendous step toward possible FDA approval of psychedelics as drug products. Although states have begun to regulate psychedelics (see our alert State psychedelic regulation: Oregon and California taking the lead), federal agencies have been much slower to act. In fact, most, if not all, psychedelics are US Drug Enforcement Administration (DEA) Schedule I controlled substances, which are illegal under federal law. While this is a step forward by FDA, it is not without regulatory hurdles and significant clinical and nonclinical requirements.
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