Void · Condition unmet
Rules 1.1.0 · as of 14 Sep 2026
Rick Doblin · Said 26 Aug 2020 · doblin-0254
Quote
“Right, so that's called the REMS, the risk evaluation and mitigation strategies. So the thalidomide, which was the sort of quintessential bad drug. It was for morning sickness because of birth defects. The FDA was able to develop special requirements for special risks for the drug and they first did that with thalidomide. Now they do that for every drug and there needs to be these REMS. So we're already preliminary negotiating this with FDA and DEA.”
Asked what MDMA approval will look like on the ground, Doblin says the answer is the REMS, states that FDA now requires a REMS for every drug, and says MAPS is already negotiating the MDMA REMS with FDA and DEA. He then describes the proposed terms: only sponsor-trained people may work with patients, and the drug is given only under direct supervision.
Intake
- EventA proposition written from a template on the asset, with a resolution criterion and a named public source, before the outcome is looked up. The same event resolves every person's items on it. Method ›
- FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD carries a REMS
- AreaOne of five topic classes: regulatory decisions, clinical trial outcomes, company and market outcomes, payer and policy, practice adoption. Every event has one area. Method ›
- Regulatory decisions
- DeadlineThe date by which the event must happen for the item to be true. It comes only from the person's words through the anchor table. Method ›
- None stated · undated panelItems with no deadline in the person's words, scored on a uniform 24-month window from the statement date. Part of the headline panel since rules 1.1.0; also shown on its own. Method ›, 24-month window to 26 Aug 2022
- Probability
- 0.90 LexiconThe fixed five-bin table that turns a phrase into a probability. The strongest phrase in the claim sentence decides; coders never read tone. Method › · binOne of five lexicon steps: A 'will' 0.90, B 'probably' 0.70, C 'may' 0.50, D 'unlikely' 0.30, E 'never' 0.10. A stated number goes to the nearest bin for calibration only. Method › A · “there needs to be these REMS ... we're already preliminary negotiating this with FDA and DEA”
- Base rateThe probability a published external study gives an event of that class and stage, fixed at intake. Halved when the item window is shorter than the class median time to decision. Never learned from the ledger's own items. Method ›
- None in the table
- Tags
- affiliated, conditional, retrospective
- Coder BCohen's kappa: agreement between two coders beyond chance, from -1 to 1. Reported for admit, event, deadline, bin and asserts from the second-coder match test. Method ›
- admittedA statement that passed intake: sincere, the person's own claim, forward-looking, inside the five areas, and not excluded by a reason code. Only admitted statements become items. Method › · event E-0076 · deadline none · bin A
Registry entry
The FDA approves midomafetamine (MDMA-assisted therapy) for post-traumatic stress disorder with a Risk Evaluation and Mitigation Strategy (REMS) that controls how the treatment is provided by prescription.
TRUE on the date of an FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD, under any sponsor name, whose approval letter or REMS@FDA entry shows a REMS in force at approval: any REMS with elements to assure safe use, or other elements that restrict who may prescribe, dispense or administer the drug, or where it is given. FALSE on the date of an approval with no REMS. A REMS added after approval does not count. The event is unresolved while no approval exists. Resolution source: Drugs@FDA (approval letter) read with REMS@FDA.
Resolution source: Drugs@FDA (approval letter) with REMS@FDA
Readings: The parenthetical example ('e.g. only by therapists who have been trained by MAPS in our therapeutic method') is illustrative and is not part of this criterion; the sponsor-trained-therapist restriction is the separate event mdma-rems-sponsor-trained-therapists.; Distinct from E-0023 (every psychedelic medicine the FDA approves carries a REMS, a class reading): this entry is on the single asset midomafetamine for PTSD.; A REMS added after approval does not count; the words say the REMS 'will control how ... will be provided by prescription', that is at the start of prescription use.
How to read
Coder A
Resolution
- State
- VoidAn item that cannot be scored: the coders disagreed (AMBIGUOUS), the condition was unmet, or the source never published (UNRESOLVABLE). Counted, never scored. Method ›
- Effective deadlineAn item enters the score only when its deadline has passed and the outcome is true or false. A claim already known true still waits for its deadline. Method ›
- 26 Aug 2022
- Outcome1 if the registry event happened on or before the item's deadline, 0 if it did not. Written by a resolver who never sees p. Method ›
- unresolvable · checked through 14 Sep 2026
- Resolver note
- The criterion cannot be applied yet: it holds the event unresolved while no approval exists, and sets FALSE only on an approval with no REMS. The FDA has not approved midomafetamine for PTSD under any sponsor name. Drugs@FDA holds no midomafetamine application record; the only FDA action on NDA 215455 is the complete response letter, which asks for a new Phase 3 trial. Lykos accepted that path in October 2024 and had announced no resubmission as of 2026-09-14. There is therefore no approval letter and no REMS@FDA entry to read. Re-check after any future approval.
- Evidence
- Drugs@FDA query, substance name MIDOMAFETAMINE: no matching application (HTTP 404, no matches) · 14 Sep 2026
- Complete Response Letter, NDA 215455 (midomafetamine capsules), Lykos Therapeutics · 8 Aug 2024
- Lykos Therapeutics Announces Complete Response Letter for Midomafetamine Capsules for PTSD · 9 Aug 2024
How to read
Registry
Receding horizon
Doblin promised FDA approval of midomafetamine (MDMA-assisted therapy) for PTSD carries a REMS 2 times; it has not happened.
Cluster E-0076
Timeline
1 claim against 60 events in the field.
Regulatory decisions