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Seth Mailhot

 

With an education in chemical engineering and a prior career at the U.S. Food and Drug Administration, Seth brings clients rare regulatory insight on food, medical device and drug matters. As Leader of the firm’s FDA group, Seth handles a broad array of matters involving FDA-regulated products and services including food, medical devices, pharmaceuticals, biotechnology, tobacco, radiation-emitting electronic products and cosmetics.

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On June 23, 2023 the U.S. Food and Drug Administration (FDA) published a draft guidance document with foundational considerations for researchers that are developing psychedelic drugs for the treatment of medical conditions. The guidance document applies to clinical trials that will be conducted under investigational new drug applications, including clinical trials that are not intended to support marketing applications. Notably, the use of the term “psychedelic” in the guidance document is intended to encompass “classic psychedelics” that are understood to be 5-HT2 agonists (e.g., psilocybin and lysergic acid diethylamide (LSD)) as well as entactogens or empathogens (e.g., methylenedioxymethamphetamine (MDMA)). This is the first FDA draft guidance that discusses designing clinical trials for psychedelic drugs.