Episode #376
Navigating The FDA Playbook For Psychedelic Therapies
Recorded on 07/17/26 TD Cowen senior analyst Ritu Baral hosts Michael McCaughan, founder of Prevision Policy, a leading provider of regulatory and reimbursement policy analysis for the biopharma industry. Discussion focused on the evolving regulatory landscape for psychedelic treatments. McCaughan views FDA as already receptive to psychedelics from the bottom up, with the recent executive order on accelerating psychedelic development and approval adding clear new top-down support. He does not believe the updated 2026 FDA industry guidance meaningfully changes the approvability bar for psychedelic sponsors, especially those with NDAs in progress. He views the recommendation for 12-month blinded follow-up as unlikely to be an approvability issue for these near term, and even Ph3 programs, although it could influence label language, durability claims, and claims on repeat dosing. On safety, he expects FDA to focus on if benefit outweighs key risks, including suicidality, abuse potential, and class-specific concerns such as cardiovascular or valvulopathy signals. He also expects a REMS framework anchored by in-office administration and misuse prevention, likely informed by Spravato but tailored to the psychedelic treatment model. Importantly, he believes FDA and DEA are likely to work together to minimize the gap between approval and rescheduling, though process and bureaucracy remain key timing variables. https://go.td.com/PodcastDisclosure Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
