Patients, Practitioners, Researchers and Public Submit Comments Ahead of FDA Advisory Committee on MDMA

Live Coverage Announcement: We will be covering next Tuesday’s Advisory Committee meeting live on Psychedelic Alpha. Join our newsletter to receive the link on the day.

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In less than a week, an FDA advisory committee will meet to discuss Lykos Therapeutics’ MDMA-assisted therapy for PTSD (see What to Expect: FDA Advisory Committee Set to Review MDMA-Assisted Therapy for PTSD). Last month, the agency established a docket and issued a request for comments from the public.

While the docket is open to comments until 11:59 PM EST on Monday the 3rd of June (the night before the advisory committee meets), the agency only committed to providing comments received on or before the 23rd to the committee. Comments received after that date will be “taken into consideration by FDA”, the notice reads.

There will be further opportunities to hear from the public on the day itself, with the schedule allowing for around an hour and forty-five minutes for oral comments, which are limited to three minutes per speaker. Originally, FDA had scheduled one hour for such comments, but nearly doubled the time due to high demand for slots.

At the time of writing, the docket has 46 public submissions. Here, we review most (but not all) of these comments submitted in advance of the advisory committee, organised by stakeholder type.

Professional Bodies

The only professional body to respond to the request for comments thus far is the American Psychiatric Association (APA). It penned a three-page letter that began by cautioning the agency “that decisions should not be made based on headlines, but rather with unbiased evidence that meets the scientific integrity and regulatory standards that patients and medical providers expect.” The APA goes on to say that studies of ‘recreational use’ should be discounted, and that there is a need for “more data on long-term follow-up among participants receiving MDMA, as well as use among diverse groups of patients.”

APA then provides a one-page review of the current state of research, as it sees it. Predictably, the Association notes that “MDMA is difficult to blind”, thus urging the advisory committee to “consider whether the current regulatory framework for clinical trials for psychedelics is ensuring the highest quality results or if it is creating bias in expectancy effects.”...