I will work 80-100 hour weeks as a paralegal to work for you and Shane if the need ever arises, this idea is brilliant, I have also concluded we need change to the entire system it’s not fixable and can do the research and communicate ideas well just throwing that out there
Re: Precondition 2, could one argue that by virtue of having received a Breakthrough Therapy Designation, FDA has deemed that several psychedelics, including MDMA, "may be effective"? (Given that such designations are awarded to drugs where "preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)".) It might also help with Precondition 3, no?
I’m a regulatory director in biotech (mostly oncology), and someone whose life has been transformed by psilocybin-assisted therapy for complex PTSD. My support for legal MDMA- and psychedelic-assisted therapy runs deep, and I provide pro bono help to companies and organizations that are trying to bring both into reality in the US and elsewhere.
That said, I hold that the pathway must remain grounded in science as opposed to the jiggling of legal words, because only rigorous evidence will bring lasting change - as well as safety AND efficacy. Respectfully I would like to address from a scientific perspective errors in your readings of guidance and the CFR so, from my perspective, those of us fighting for the same end don’t get distracted by false hope.
Dissecting the Argument for EUA as a Shortcut for MDMA
1. Statutory Reality of EUA:
The Emergency Use Authorization (EUA) pathway is not a catchall for bypassing clinical trials for any promising drug. Under Section 564 of the Food, Drug, and Cosmetic Act, EUA is strictly reserved for situations involving emergencies linked to biological, chemical, radiological, or nuclear (BCRN) threats.
The COVID-19 pandemic met these criteria because it was, by definition, a qualifying biological emergency. Countermeasures like vaccines received EUA based on direct statutory compliance.
Suggesting that the EUA could be used for psychedelics like MDMA in the context of a mental health crisis ignores the precise language and intent of the law. There is no legal precedent—domestically or globally—for deploying EUA for therapies addressing non-BCRN emergencies such as PTSD.
2. Step-by-Step Breakdown of EUA Criteria:
Emergency Declaration: Must relate to a BCRN threat. Attempting to shoehorn PTSD, or the broader mental health crisis, into a BCRN category stretches the statute far beyond reasonable interpretation.
“May be Effective” Standard: The EUA does use a lower evidence threshold ("reasonable to believe" the product "may be effective"), but there is still a requirement for some clinical data tied to the emergency. The FDA’s recent Lykos decision rejected MDMA-AT on grounds of insufficient efficacy evidence; lowering the bar via EUA would still not undo the statutory emergency linkage requirement.
No Adequate, Approved Alternatives: For EUA to apply, there must be no reasonable, available therapies. While SSRIs and psychotherapies have limits—and I personally know their shortcomings—they are widely available and recognized, further blocking EUA’s use for MDMA in this context.
3. Regulatory and Logical Refutations:
Agency Discretion is Framed: Agencies do have some interpretive leeway, but not to the extent posited by the editorial. Their actions must be based on substantial evidence, and courts retain the authority to review whether statutory criteria are met.
Global Regulatory Norms: No international regulator has used emergency authority for psychedelics outside BCRN contexts. Adopting such an approach would be unprecedented—and likely challenged.
Off-Label Use After EUA: The notion that EUA opens the floodgates for off-label MDMA prescribing mischaracterizes FDA practice. EUA products are strictly controlled; Schedule I status imposes additional criminal and regulatory restrictions above and beyond standard drug approvals.
4. Evidence and Safety—Why Science Must Win
As both a practitioner and patient, I see the immense promise of MDMA- and psychedelic-assisted therapies. The way forward is not through shortcuts, which risk backlash and erode regulatory trust, but through scientifically robust clinical trials, expanded access programs, and policy reforms clearly supported by therapeutic evidence.
Alternate legitimate pathways exist: Breakthrough Therapy designation, Right to Try laws, investigator-initiated studies, and ongoing efforts to reschedule and reclassify psychedelics, all grounded in science.
5. Unintended Consequences Matter
Overusing or distorting EUA could jeopardize public faith in drug regulation and create undue risks for vulnerable populations. Once regulatory trust is lost, progress stalls—not just for psychedelics, but for emerging therapies of all categories.
As someone with years of biotech expertise and lived experience benefiting from psychedelic therapy, my advocacy is unyielding: MDMA and similar treatments must eventually become accessible—but only through evidence-led, scientifically validated reform. Legal maneuvers and statutory workarounds may seem expedient, but science and reason are the only path to enduring progress, mainstream acceptance, and real healing for those who need it most.
I will work 80-100 hour weeks as a paralegal to work for you and Shane if the need ever arises, this idea is brilliant, I have also concluded we need change to the entire system it’s not fixable and can do the research and communicate ideas well just throwing that out there
Very interesting ideas, as usual.
Re: Precondition 2, could one argue that by virtue of having received a Breakthrough Therapy Designation, FDA has deemed that several psychedelics, including MDMA, "may be effective"? (Given that such designations are awarded to drugs where "preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)".) It might also help with Precondition 3, no?
Certainly.
Brother:
I’m a regulatory director in biotech (mostly oncology), and someone whose life has been transformed by psilocybin-assisted therapy for complex PTSD. My support for legal MDMA- and psychedelic-assisted therapy runs deep, and I provide pro bono help to companies and organizations that are trying to bring both into reality in the US and elsewhere.
That said, I hold that the pathway must remain grounded in science as opposed to the jiggling of legal words, because only rigorous evidence will bring lasting change - as well as safety AND efficacy. Respectfully I would like to address from a scientific perspective errors in your readings of guidance and the CFR so, from my perspective, those of us fighting for the same end don’t get distracted by false hope.
Dissecting the Argument for EUA as a Shortcut for MDMA
1. Statutory Reality of EUA:
The Emergency Use Authorization (EUA) pathway is not a catchall for bypassing clinical trials for any promising drug. Under Section 564 of the Food, Drug, and Cosmetic Act, EUA is strictly reserved for situations involving emergencies linked to biological, chemical, radiological, or nuclear (BCRN) threats.
The COVID-19 pandemic met these criteria because it was, by definition, a qualifying biological emergency. Countermeasures like vaccines received EUA based on direct statutory compliance.
Suggesting that the EUA could be used for psychedelics like MDMA in the context of a mental health crisis ignores the precise language and intent of the law. There is no legal precedent—domestically or globally—for deploying EUA for therapies addressing non-BCRN emergencies such as PTSD.
2. Step-by-Step Breakdown of EUA Criteria:
Emergency Declaration: Must relate to a BCRN threat. Attempting to shoehorn PTSD, or the broader mental health crisis, into a BCRN category stretches the statute far beyond reasonable interpretation.
“May be Effective” Standard: The EUA does use a lower evidence threshold ("reasonable to believe" the product "may be effective"), but there is still a requirement for some clinical data tied to the emergency. The FDA’s recent Lykos decision rejected MDMA-AT on grounds of insufficient efficacy evidence; lowering the bar via EUA would still not undo the statutory emergency linkage requirement.
No Adequate, Approved Alternatives: For EUA to apply, there must be no reasonable, available therapies. While SSRIs and psychotherapies have limits—and I personally know their shortcomings—they are widely available and recognized, further blocking EUA’s use for MDMA in this context.
3. Regulatory and Logical Refutations:
Agency Discretion is Framed: Agencies do have some interpretive leeway, but not to the extent posited by the editorial. Their actions must be based on substantial evidence, and courts retain the authority to review whether statutory criteria are met.
Global Regulatory Norms: No international regulator has used emergency authority for psychedelics outside BCRN contexts. Adopting such an approach would be unprecedented—and likely challenged.
Off-Label Use After EUA: The notion that EUA opens the floodgates for off-label MDMA prescribing mischaracterizes FDA practice. EUA products are strictly controlled; Schedule I status imposes additional criminal and regulatory restrictions above and beyond standard drug approvals.
4. Evidence and Safety—Why Science Must Win
As both a practitioner and patient, I see the immense promise of MDMA- and psychedelic-assisted therapies. The way forward is not through shortcuts, which risk backlash and erode regulatory trust, but through scientifically robust clinical trials, expanded access programs, and policy reforms clearly supported by therapeutic evidence.
Alternate legitimate pathways exist: Breakthrough Therapy designation, Right to Try laws, investigator-initiated studies, and ongoing efforts to reschedule and reclassify psychedelics, all grounded in science.
5. Unintended Consequences Matter
Overusing or distorting EUA could jeopardize public faith in drug regulation and create undue risks for vulnerable populations. Once regulatory trust is lost, progress stalls—not just for psychedelics, but for emerging therapies of all categories.
As someone with years of biotech expertise and lived experience benefiting from psychedelic therapy, my advocacy is unyielding: MDMA and similar treatments must eventually become accessible—but only through evidence-led, scientifically validated reform. Legal maneuvers and statutory workarounds may seem expedient, but science and reason are the only path to enduring progress, mainstream acceptance, and real healing for those who need it most.
Peace.