Pα+ Psychedelic Bulletin #218: FDA’s Farchione Says Psychedelic INDs Are “a Third” of Her Workload; Ipsos/Psychedelic Alpha Poll; Reunion Eyes Single Phase 3 in PPD; America's 10 Million Microdosers

FDA’s Farchione Says Psychedelic INDs Now “a Third” of Her Workload; NIDA’s Volkow Questions Schedule I Placement

Speaking at an American Brain Coalition webinar on the topic of psychedelics last month, FDA Division of Psychiatry Director Tiffany Farchione said, with a smirk, that psychedelics programs are “keeping us very busy.”

“It’s not just an interest from the public,” she added, “it’s an interest from academia, from commercial drug sponsors as well.” “It is fully a third of my workload at this point, just reviewing psychedelic INDs,” she told the audience.

The end goal of drug development activity is to secure an approval, she noted, “so that something can be available and marketed, and folks won’t have to go on a retreat in another country to receive these medications once they get to that state.”

“But we’re not there yet”, she continued, noting that just one NDA has been received, “and I think folks know what happened with the MDMA application.”

“But there are so many that are in development,” she added, “[and] there are some that are very close to coming in with their marketing applications, so it’s a really exciting time in terms of psychedelic drug development.”

But psychedelics programs, she stressed, must be held to the same standard as others...