Post #2422910

2026-03-17 22:23 UTC

@akesi_Anima@mastodon.art @twistylittlepassages@weirder.earth I read that the PDF and that part. I guess what I'm confused about is there's already mandatory documentation of informed consent in states that allow for it. The documentation is help onsite in compliance with PHI laws. So my guess is that people are thinking this implies submitting that PHI to a registry of some kind?

Replies (2)

@RadiantEmber@weirder.earth 2026-03-17 23:10

@marz@caw.corbode.com @akesi_Anima@mastodon.art @twistylittlepassages@weirder.earth yes I think people have misinterpreted several parts of the document to say it will implement a registry of trans people. That seems really unlikely to me, and there is plenty of bad stuff in the document that no one appears to be talking about. It's certainly possible that if every suggestion here was taken that may open the door to possibly create something like that in the future, but it's very unlikely to happen as a result of this. And I seriously doubt the FDA will actually do all of the things being suggested here.

Open ##2422913
@jhwgh1968@chaos.social 2026-03-17 23:10

@marz@caw.corbode.com @akesi_Anima@mastodon.art @twistylittlepassages@weirder.earth The registry: > Mandate Enhanced Adverse Event Reporting: In addition to a robust REMS, establish a formal system for rigorous post-market surveillance of this off-label use [...] and require manufacturers to establish a patient registry as part of a REMS to capture real-world safety data ... safety data they can at min cherry pick, at max much worse Desp the FDA just removing a similar label, per the other link

Open ##2422914